U.S. patent application number 16/718022 was filed with the patent office on 2020-06-25 for intermittent monitoring.
The applicant listed for this patent is DexCom, Inc.. Invention is credited to Margaret A. Crawford, John Michael Gray, Hari Hampapuram, Matthew Lawrence Johnson, Apurv Ullas Kamath, Sumitaka Mikami, Subrai Girish Pai, Shawn Clay Sanders.
Application Number | 20200203012 16/718022 |
Document ID | / |
Family ID | 71097314 |
Filed Date | 2020-06-25 |
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United States Patent
Application |
20200203012 |
Kind Code |
A1 |
Kamath; Apurv Ullas ; et
al. |
June 25, 2020 |
INTERMITTENT MONITORING
Abstract
Various examples are directed to patient-management systems and
methods. A first application executing a patient-management system
may receive, from an analyte sensor, sensor data indicating the
analyte concentration of the user. The first application may
transmit a sensor message to a second application executing at the
patient-management system, the sensor message comprising an
indication of the analyte concentration. The second application may
deliver a device message to a wearable activity monitor device, the
device message based at least in part on the analyte
concentration.
Inventors: |
Kamath; Apurv Ullas; (San
Diego, CA) ; Crawford; Margaret A.; (Encinitas,
CA) ; Gray; John Michael; (San Diego, CA) ;
Hampapuram; Hari; (San Diego, CA) ; Johnson; Matthew
Lawrence; (Solana Beach, CA) ; Pai; Subrai
Girish; (San Diego, CA) ; Sanders; Shawn Clay;
(San Diego, CA) ; Mikami; Sumitaka; (San Diego,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DexCom, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
71097314 |
Appl. No.: |
16/718022 |
Filed: |
December 17, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16717834 |
Dec 17, 2019 |
|
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16718022 |
|
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62782291 |
Dec 19, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/7475 20130101;
G16H 10/60 20180101; A61B 5/14532 20130101; A61M 5/1723 20130101;
A61B 5/7267 20130101; A61B 2560/0214 20130101; A61B 5/002 20130101;
A61B 5/02438 20130101; A61B 5/1118 20130101; G06F 11/1004 20130101;
A61B 5/0205 20130101; A61B 5/1455 20130101; A61B 5/742 20130101;
G16H 20/17 20180101; A61B 5/14546 20130101; G16H 40/67 20180101;
A61B 5/0022 20130101; A61B 2560/0209 20130101 |
International
Class: |
G16H 40/67 20060101
G16H040/67; A61B 5/11 20060101 A61B005/11; A61B 5/145 20060101
A61B005/145; A61B 5/00 20060101 A61B005/00; A61B 5/0205 20060101
A61B005/0205; A61M 5/172 20060101 A61M005/172; G06F 11/10 20060101
G06F011/10 |
Claims
1. A patient-management system, comprising: an analyte sensor; and
a processor executing instructions to perform operations
comprising: receiving, by a first application executing at the
processor and from the analyte sensor, sensor data indicating an
analyte concentration of a user; transmitting, by the first
application and to a second application executing at the processor,
a sensor message comprising an indication of the analyte
concentration; and delivering, by the second application and to a
wearable activity monitor device, a device message, the device
message based at least in part on the analyte concentration.
2. The patient-management system of claim 1, further comprising the
wearable activity monitor device, wherein the wearable activity
monitor device comprises a motion sensor, and wherein the wearable
activity monitor device is programmed to generate a user interface
including data based at least in part on the device message and
data based at least in part on an output of the motion sensor.
3. The patient-management system of claim 1, wherein the operations
further comprise generating physiologic state data describing an
estimate of a physiologic state of the user, the generating based
at least in part on the analyte concentration of the user.
4. The patient-management system of claim 3, wherein the
physiologic state data is generated by the first application, and
wherein the sensor message comprises the physiologic state
data.
5. The patient-management system of claim 3, wherein the
physiologic state data is generated by the second application, and
wherein the device message comprises the physiologic state
data.
6. The patient-management system of claim 3, wherein the
physiologic state data comprises a time-in-range, a glucose
concentration level, or a glucose concentration range.
7. The patient-management system of claim 3, wherein the generating
of the physiologic state data is based upon a correlation between
previously-collected glucose concentration information and
previously-collected activity information.
8. The patient-management system of claim 1, wherein the device
message comprises display data for display at a user interface of
the wearable activity monitor device.
9. The patient-management system of claim 1, wherein generating the
sensor message comprises encrypting the indication of the analyte
concentration.
10. The patient-management system of claim 1, wherein generating
the sensor message comprises generating an error detection code
based at least in part on the analyte concentration.
11. A patient-management method, comprising: receiving, by a first
application executing at a patient-management system and from an
analyte sensor, sensor data indicating an analyte concentration of
a user; transmitting, by the first application and to a second
application executing at the patient-management system, a sensor
message comprising an indication of the analyte concentration; and
delivering, by the second application and to a wearable activity
monitor device, a device message, the device message based at least
in part on the analyte concentration.
12. The patient-management method of claim 11, wherein the wearable
activity monitor device comprises a motion sensor, further
comprising generating, by the wearable activity monitor device, a
user interface including data based at least in part on the device
message and data based at least in part on an output of the motion
sensor.
13. The patient-management method of claim 11, further comprising
generating physiologic state data describing an estimate of a
physiologic state of the user, the generating based at least in
part on the analyte concentration of the user.
14. The patient-management method of claim 13, wherein the
physiologic state data is generated by the first application, and
wherein the sensor message comprises the physiologic state
data.
15. The patient-management method of claim 13, wherein the
physiologic state data is generated by the second application, and
wherein the device message comprises the physiologic state
data.
16. The patient-management method of claim 13, wherein the
physiologic state data comprises a time-in-range, a glucose
concentration level, or a glucose concentration range.
17. The patient-management method of claim 13, wherein the
generating of the physiologic state data is based upon a
correlation between previously-collected glucose concentration
information and previously-collected activity information.
18. The patient-management method of claim 11, wherein the device
message comprises display data for display at a user interface of
the wearable activity monitor device.
19. The patient-management method of claim 11, wherein generating
the sensor message comprises generating an error detection code
based at least in part on the analyte concentration.
20. A machine-readable medium comprising instructions thereon that,
when executed by at least one processor, cause the at least one
processor to perform operations comprising: receiving, by a first
application executing at a patient-management system and from an
analyte sensor, sensor data indicating an analyte concentration of
a user; transmitting, by the first application and to a second
application executing at the patient-management system, a sensor
message comprising an indication of the analyte concentration; and
delivering, by the second application and to a wearable activity
monitor device, a device message, the device message based at least
in part on the analyte concentration.
Description
INCORPORATION BY REFERENCE TO RELATED APPLICATIONS
[0001] Any and all priority claims identified in the Application
Data Sheet, or any correction thereto, are hereby incorporated by
reference under 37 CFR 1.57. This application is a continuation of
U.S. application Ser. No. 16/717,834, filed on Dec. 17, 2019, which
claims the benefit of U.S. Provisional Patent Application Ser. No.
62/782,291, filed on Dec. 19, 2018. The aforementioned application
is incorporated by reference herein in its entirety, and is hereby
expressly made a part of this specification.
TECHNICAL FIELD
[0002] The present development relates generally to medical devices
such as analyte sensors, and more particularly, but not by way of
limitation, to systems, devices, and methods for intermittent use
of continuous glucose monitoring systems or other monitoring
systems.
BACKGROUND
[0003] Diabetes is a metabolic condition relating to the production
or use of insulin by the body. Insulin is a hormone that allows the
body to use glucose for energy, or store glucose as fat.
[0004] When a person eats a meal that contains carbohydrates, the
food is processed by the digestive system, which produces glucose
in the person's blood. Blood glucose can be used for energy or
stored as fat. The body normally maintains blood glucose levels in
a range that provides sufficient energy to support bodily functions
and avoids problems that can arise when glucose levels are too
high, or too low. Regulation of blood glucose levels depends on the
production and use of insulin, which regulates the movement of
blood glucose into cells.
[0005] When the body does not produce enough insulin, or when the
body is unable to effectively use insulin that is present, blood
sugar levels can elevate beyond normal ranges. The state of having
a higher than normal blood sugar level is called "hyperglycemia."
Chronic hyperglycemia can lead to several health problems, such as
cardiovascular disease, cataract and other eye problems, nerve
damage (neuropathy), and kidney damage. Hyperglycemia can also lead
to acute problems, such as diabetic ketoacidosis--a state in which
the body becomes excessively acidic due to the presence of blood
glucose and ketones, which are produced when the body cannot use
glucose. The state of having lower than normal blood glucose levels
is called "hypoglycemia." Severe hypoglycemia can lead to acute
crises that can result in seizures or death.
[0006] Diabetes conditions are sometimes referred to as "Type 1"
and "Type 2." A Type 1 diabetes patient is typically able to use
insulin when it is present, but the body is unable to produce
sufficient amounts of insulin, because of a problem with the
insulin-producing beta cells of the pancreas. A Type 2 diabetes
patient may produce some insulin, but the patient has become
"insulin resistant" due to a reduced sensitivity to insulin. The
result is that even though insulin is present in the body, the
insulin is not sufficiently used by the patient's body to
effectively regulate blood sugar levels.
[0007] Blood sugar concentration levels may be monitored with an
analyte sensor, such as a continuous glucose monitor. A continuous
glucose monitor may provide the wearer (patient) with information
such as an estimated blood glucose level or a trend of estimated
blood glucose levels.
[0008] This Background is provided to introduce a brief context for
the Summary and Detailed Description that follow. This Background
is not intended to be an aid in determining the scope of the
claimed subject matter nor be viewed as limiting the claimed
subject matter to implementations that solve any or all of the
disadvantages or problems presented above.
SUMMARY
[0009] This document discusses, among other things, systems,
devices, and methods for battery management in an analyte sensor,
such as a glucose sensor.
[0010] An example (e.g., "Example 1") of subject matter (e.g., a
method, device or system) may include
[0011] Example 1 is a method of monitoring a diabetic patient. The
method may include receiving first data of a first type of a
patient over a first time period. The method may also include
receiving second data of a second type of the patient over at least
a second time period. The first and second time periods may at
least partially overlap for an overlapping time period. The method
may include determining a correlation between the first and second
data over the overlapping time period and, at a subsequent time,
receiving data of the second type and determining diabetic
information about the patient based at least in part on the data of
the second type at the subsequent time and the determined
correlation.
[0012] In Example 2, the subject matter of Example 1 optionally
includes examples in which the first data includes high-fidelity
continuous glucose monitoring data.
[0013] In Example 3, the subject matter of any one or more of
Examples 1-2 optionally includes examples in which the second data
includes single-point glucose monitoring, blinded CGM, data from a
wearable monitor, flash glucose monitoring, or an optical
monitoring technique.
[0014] In Example 4, the subject matter of Example 3 optionally
includes examples in which the second data includes single-point
glucose monitoring. The method may further comprise calculating a
time window to take a single-point glucose measurement based on the
first data.
[0015] In Example 5, the subject matter of any one or more of
Examples 1-4 optionally includes examples in which the diabetic
information is selected from the group consisting of: an estimated
value for data of the first type at the subsequent time, a state of
the patient, or a patient insight.
[0016] In Example 6, the subject matter of Example 5 optionally
includes examples in which the state of the patient or the patient
insight is related to a lifestyle modification relating to diet,
exercise, glucose level monitoring, or medication.
[0017] In Example 7, the subject matter of Example 6 optionally
includes examples in which the state of the patient or the patient
insight is related to mealtime management, exercise management, or
sleep management.
[0018] In Example 8, the subject matter of any one or more of
Examples 1-7 optionally includes examples in which the first data
is high-fidelity data and the second data is low-fidelity data.
[0019] In Example 9, the subject matter of any one or more of
Examples 1-8 optionally include receiving a sensor signal from a
sensor and processing the sensor signal to generate at least a
portion of the second data.
[0020] In Example 10, the subject matter of Example 9 optionally
includes examples in which the sensing includes activity monitoring
by a wearable fitness tracker.
[0021] In Example 11, the subject matter of Example 10 optionally
includes examples in which the wearable fitness tracker includes a
wearable heart rate monitor, a wearable activity monitor, a smart
phone, smart glasses, or a smart watch.
[0022] In Example 12, the subject matter of any one or more of
Examples 1-11 optionally include examples in which determining a
correlation includes determining a relation between the obtained
first and the second data at corresponding times of day and/or days
of a week within the overlapping time period.
[0023] In Example 13, the subject matter of any one or more of
Examples 1-12 optionally include examples in which the second data
includes user input data.
[0024] In Example 14, the subject matter of Example 13 optionally
includes examples in which the user input data includes medicament
data, meal data, exercise data, sleep data, or any combination
thereof.
[0025] In Example 15, the subject matter of any one or more of
Examples 1-14 optionally includes intermittently monitoring the
first type of data and determining diabetic information using the
second data and the correlation during a period when the first type
of data is not available.
[0026] In Example 16, the subject matter of Example 15 optionally
includes examples in which the intermittently monitoring the first
type of data includes intermittent continuous glucose monitoring,
and the monitoring data of the second type includes monitoring
activity data with a wearable accelerometer, and optionally
includes examples in which the wearable accelerometer is configured
to at least monitor data when the continuous glucose monitoring is
not occurring.
[0027] In Example 17, the subject matter of any one or more of
Examples 1-16 optionally includes examples in which the first data
of a first type includes an estimated glucose concentration level
and the data of the second type includes heart rate, oxygen
concentration, skin tone, moisture content on skin, activity,
activity patterns, blood ketones, urine ketones, respiration, or
acoustic information.
[0028] In Example 18, the subject matter of any one or more of
Examples 1-17 optionally includes monitoring the first data and the
second data over a third time period, and updating the correlation
based on the first data and second data from the third time
period.
[0029] In Example 19, the subject matter of any one or more of
Examples 1-18 optionally includes administering a treatment based
at least in part on the determined diabetic information.
[0030] In Example 20, the subject matter of Example 19 optionally
includes examples in which the treatment includes a pharmaceutical
intervention.
[0031] In Example 21, the subject matter of any one or more of
Examples 19-20 optionally includes displaying diabetic information
about the patient on a user interface of a patient device.
[0032] In Example 22, the subject matter of Example 21 optionally
includes displaying a recommended dietary modification or lifestyle
modification on the user interface.
[0033] Example 23 is a method that may include receiving an
estimated glucose concentration level of a patient from a
continuous glucose monitoring (CGM) system for a first time period
and receiving non-CGM information relating to the patient for the
first time period. The method may also include determining a
relationship between the estimated glucose concentration level and
the non-CGM information. The method may also include receiving
non-CGM information relating to the patient for a second time
period for which estimated glucose concentration levels are not
available from the CGM and determining diabetic information about
the patient for the second time period based upon the determined
relationship and the non-CGM information. The method may further
include electronically delivering a notification about the diabetic
information.
[0034] In Example 24, the subject matter of Example 23 optionally
includes examples in which the non-CGM information includes
activity information.
[0035] In Example 25, the subject matter of any one or more of
Examples 23-24 optionally includes examples in which the non-CGM
information includes physiologic information about the patient.
[0036] In Example 26, the subject matter of Example 25 optionally
includes examples in which the physiologic information includes one
or more of heart rate, respiration, oxygen concentration, skin
tone, moisture content on the skin, activity, activity patterns,
blood ketones, urine ketones, respiration, or acoustic
information.
[0037] In Example 27, the subject matter of any one or more of
Examples 23-26 optionally includes examples in which the non-CGM
information includes location information.
[0038] In Example 28, the subject matter of any one or more of
Examples 23-27 optionally includes examples in which receiving
non-CGM information includes receiving user input data.
[0039] In Example 29, the subject matter of any one or more of
Examples 23-28 optionally includes examples in which determining
diabetic information about the patient includes determining a
patient state.
[0040] In Example 30, the subject matter of any one or more of
Examples 23-29 optionally includes examples in which determining a
patient state includes applying the non-CGM information to a
model.
[0041] In Example 31, the subject matter of any one or more of
Examples 23-30 optionally includes examples in which determining
diabetic information includes determining an estimated glucose
concentration level.
[0042] In Example 32, the subject matter of any one or more of
Examples 23-31 optionally includes examples in which determining
diabetic information includes determining a qualitative rating.
[0043] In Example 33, the subject matter of any one or more of
Examples 23-32 optionally includes examples in which determining
diabetic information includes determining a quantitative
metric.
[0044] In Example 34, the subject matter of Example 33 optionally
includes examples in which the quantitative metric is an estimate
of an amount or percentage of time that a glucose concentration
level was in range during a specified time period.
[0045] Example 35 is a system comprising an intermittent primary
subsystem configured to intermittently collect primary physiologic
information from a host and a secondary subsystem configured to
collect secondary data of a second type from a host. The system may
also include a user interface configured to display guidance that
is based upon the secondary data and the primary physiologic
information.
[0046] In Example 36, the subject matter of Example 35 optionally
includes a guidance system configured to receive the secondary data
and the primary physiologic information and determine the guidance
based at least in part on the secondary data and the primary
physiologic information.
[0047] In Example 37, the subject matter of Example 36 optionally
includes examples in which the guidance system determines a
relationship between the secondary data and the primary physiologic
information, and during time periods when the intermittent primary
physiologic information is not available the guidance system
determines the guidance based at least in part on the secondary
data and the relationship between the secondary data and the
primary physiologic information.
[0048] In Example 38, the subject matter of Example 37 optionally
includes examples in which the primary subsystem includes a
continuous glucose monitor (CGM) and the guidance system determines
diabetes management information based at least in part on the
secondary data and the relationship between the secondary data and
the primary physiologic information.
[0049] In Example 39, the subject matter of Example 38 optionally
includes examples in which the diabetes management information
includes an estimated glucose concentration level.
[0050] In Example 40, the subject matter of any one or more of
Examples 38-39 optionally includes examples in which the diabetes
management information includes a qualitative rating.
[0051] In Example 41, the subject matter of any one or more of
Examples 38-40 optionally include examples in which the diabetes
management information includes a metric.
[0052] In Example 42, the subject matter of Example 41 optionally
includes examples in which the diabetes management information
includes a time-in-range metric that indicates an estimate of an
amount or percentage of time that a glucose concentration level was
in range during a specified time period.
[0053] In Example 43, the subject matter of any one or more of
Examples 41-42 optionally includes examples in which the diabetes
management information includes statistical feedback.
[0054] In Example 44, the subject matter of any one or more of
Examples 35-43 optionally includes examples in which the secondary
subsystem includes a sensor and a memory circuit, and the secondary
subsystem determines the secondary data from data received from the
sensor and stores the received sensor data or the secondary data in
the memory circuit.
[0055] In Example 45, the subject matter of any one or more of
Examples 35-44 optionally includes examples in which the primary
subsystem includes a continuous glucose monitor (CGM), a memory
circuit, and the primary subsystem receives a CGM sensor signal
indicative of a glucose concentration in a host, determines an
estimated glucose concentration level based at least in part on the
CGM sensor signal, and stores a plurality of estimated glucose
concentration levels in the memory circuit, and in which the
primary physiologic information includes or is based on the
plurality of estimated glucose concentration levels.
[0056] Example 46 is a patient-management device, comprising a
sensor; a user interface; a communication circuit; and a processor.
The processor may execute instructions to perform operations. The
operations may comprise transmitting information based on input
from the sensor to a second device using the communication circuit
and receiving, using the communication circuit, an estimate of a
physiologic state based at least in part on the input from the
sensor. The operations may also include delivering information
relating the estimate of the physiologic state using the user
interface.
[0057] In Example 47, the subject matter of Example 46 optionally
includes examples in which the sensor is an activity sensor.
[0058] In Example 48, the subject matter of any one or more of
Examples 46-47 optionally includes examples in which the estimate
of a physiologic state is a glucose concentration level.
[0059] In Example 49, the subject matter of any one or more of
Examples 46-48 optionally includes examples in which the
information about the estimate of the physiologic state is a
time-in-range, a glucose concentration level, or a glucose
concentration range.
[0060] In Example 50, the subject matter of any one or more of
Examples 46-49 optionally includes examples in which the estimate
of the physiologic state is based upon a correlation between
previously-collected glucose concentration information and
previously-collected activity information.
[0061] In Example 51, the subject matter of any one or more of
Examples 46-50 optionally includes examples in which the device is
wearable.
[0062] In Example 52, the subject matter of Example 51 optionally
includes examples in which the device is a watch.
[0063] In Example 53, the subject matter of any one or more of
Examples 46-52 optionally include examples in which the operations
further comprise: generating, by a first application executed by
the processor, a sensor message comprising the estimate of the
physiologic state and sending, by the first application, the sensor
message to a second application executed by the processor; and
sending, by the second application, a device message to the second
device for display using the user interface.
[0064] In Example 54, the subject matter of Example 53 optionally
includes examples in which generating the sensor message comprises
encrypting the estimate of the physiologic state.
[0065] In Example 55, the subject matter of any one or more of
Examples 53-54 optionally includes examples in which generating the
sensor message comprises generating an error detection code based
at least in part on the physiologic state.
[0066] Example 56 is a method of monitoring a patient. The method
may comprise monitoring patient data of a first type with a
low-fidelity monitoring technique over a first time period and
evaluating patient engagement or behavior based on the monitored
first type of patient data The method may also include monitoring
over a second time period patient data of a second type with a
high-fidelity monitoring technique using a monitoring device. In
some examples, at least one hardware or software functionality of
the monitoring device is based on the evaluated patient engagement
or behavior during the monitoring.
[0067] In Example 57, the subject matter of Example 56 optionally
includes examples in which the at least one hardware or software
functionality corresponds to operation of a user interface.
[0068] In Example 58, the subject matter of any one or more of
Examples 56-57 optionally includes examples in which the
high-fidelity monitoring technique is continuous glucose
monitoring.
[0069] In Example 59, the subject matter of any one or more of
Examples 56-58 optionally includes examples in which the
low-fidelity technique includes: single-point glucose monitoring or
blinded CGM or an optical monitoring technique.
[0070] In Example 60, the subject matter of any one or more of
Examples 56-59 optionally includes examples in which the
low-fidelity monitoring technique includes activity monitoring by a
wearable fitness tracker.
[0071] In Example 61, the subject matter of Example 60 optionally
includes examples in which the wearable fitness tracker is a
wearable heart rate monitor, activity monitor, smart phone, smart
glasses, or smart watch.
[0072] In Example 62, the subject matter of any one or more of
Examples 56-61 optionally includes examples in which the
low-fidelity monitoring technique includes receiving user input
data.
[0073] In Example 63, the subject matter of Example 62 optionally
includes examples in which the received user input data includes
medicament data, meal data, exercise data, sleep data, or any
combination thereof.
[0074] In Example 64, the subject matter of any one or more of
Examples 56-63 optionally includes determining for the patient a
goal, and wherein the at least one hardware or software
functionality of the monitoring device is related to the goal.
[0075] In Example 65, the subject matter of Example 64 optionally
includes examples in which the goal includes a dietary goal, an
exercise goal, a glucose level monitoring goal, or a medication
goal.
[0076] In Example 66, the subject matter of Example 65 optionally
includes examples in which the at least one hardware or software
functionality of the monitoring device relates to mealtime glucose
management.
[0077] In Example 67, the subject matter of any one or more of
Examples 65-66 optionally includes examples in which the at least
one hardware or software functionality of the monitoring device
relates to sleep management.
[0078] In Example 68, the subject matter of any one or more of
Examples 64-67 optionally includes examples in which the
determining for the patient a goal is determined prior to the
monitoring over a first time.
[0079] In Example 69, the subject matter of any one or more of
Examples 64-68 optionally includes examples in which the
determining for the patient a goal is determined by the data of a
first type monitored over the first time period with the
low-fidelity monitoring technique.
[0080] In Example 70, the subject matter of any one or more of
Examples 56-69 optionally includes monitoring over the first time
period patient data of a physiological type, and wherein the basing
of the at least one hardware or software functionality of the
monitoring device is further based on the patient data of the
physiological type.
[0081] In Example 71, the subject matter of any one or more of
Examples 56-70 optionally includes examples in which the at least
one hardware or software functionality relates to frequency or
content of an automated coaching routine.
[0082] In Example 72, the subject matter of any one or more of
Examples 56-71 optionally includes detecting a change in a patient
parameter, the change measured as between the first time period and
the second time period and using the detected change to further
influence at least one hardware or software functionality of the
monitoring device.
[0083] In Example 73, the subject matter of any one or more of
Examples 56-72 optionally includes over the first time period,
providing a coaching functionality to the patient, the coaching
functionality comprising automated messages transmitted from a
server to the monitoring device based on patient profile data or
the patient data of the first type or a combination thereof.
[0084] In Example 74, the subject matter of any one or more of
Examples 56-73 optionally includes after the second time period,
determining an amount or frequency of subsequent data, the amount
or frequency of subsequent data being determined with the
low-fidelity monitoring technique or the high-fidelity monitoring
technique, the amount or frequency calculated to increase or
maximize a patient parameter.
[0085] In Example 75, the subject matter of Example 74 optionally
includes examples in which the patient parameter is
time-in-range.
[0086] In Example 76, the subject matter of Example 75 optionally
includes examples in which the amount or frequency of subsequent
data is determined with the low-fidelity monitoring technique.
[0087] In Example 77, the subject matter of Example 76 optionally
includes examples in which the amount or frequency of subsequent
data is represented by a number of sensors.
[0088] In Example 78, the subject matter of any one or more of
Examples 74-77 optionally examples in which the patient parameter
is A1c.
[0089] In Example 79, the subject matter of Example 78 optionally
includes examples in which the amount or frequency of subsequent
data is determined with the low-fidelity monitoring technique.
[0090] In Example 80, the subject matter of any one or more of
Examples 74-79 optionally include displaying on the monitoring
device an indication of the increased or maximized patient
parameter.
[0091] In Example 81, the subject matter of any one or more of
Examples 74-80 optionally include after the second time period,
determining a patient end goal, the patient end goal at least in
part dependent on the patient data of the first type or the patient
data of the second type, and displaying a therapy recommendation
calculated to cause a transition of a patient state towards the
patient end goal.
[0092] Example 82 is a system comprising a first system configured
to collect a first set of sensor data of a first type relating to a
patient and a second system configured to collect a second set of
sensor data of a second type of data relating to the patient. The
system may further comprise a decision system configured to
determine a user parameter for the second system based upon the
first set of sensor data.
[0093] In Example 83, the subject matter of Example 82 optionally
includes examples in which first system includes an activity
sensor.
[0094] In Example 84, the subject matter of any one or more of
Examples 82-83 optionally includes examples in which first system
includes a blood glucose meter.
[0095] In Example 85, the subject matter of any one or more of
Examples 82-84 optionally includes examples in which the second
system includes a continuous glucose monitor.
[0096] In Example 86, the subject matter of any one or more of
Examples 82-85 optionally includes examples in which the user
parameter includes a schedule for use of the second system.
[0097] In Example 87, the subject matter of any one or more of
Examples 82-86 optionally includes examples in which the user
parameter is a time to initiate us of the second system.
[0098] In Example 88, the subject matter of any one or more of
Examples 82-87 optionally includes examples in which the decision
system applies the first set of sensor data to a model.
[0099] In Example 89, the subject matter of any one or more of
Examples 82-88 optionally includes a third system configured to
collect a third set of sensor data relating to the patient, wherein
the decision system determines the user parameter based at least in
part on the first set of sensor data and the third set of data.
[0100] Example 90 is a patient-management device. The
patient-management device may comprise a sensor, a user interface,
a communication circuit, and a processor. The processor may execute
instructions to receive, using the communication circuit,
information about a subject and deliver, using the user interface,
information relating the management of a physiologic condition
based upon the received information about the subject and data from
the sensor.
[0101] In Example 91, the subject matter of Example 90 optionally
includes examples in which the sensor is an activity sensor.
[0102] In Example 92, the subject matter of any one or more of
Examples 90-91 optionally include examples in which the device is
wearable device.
[0103] In Example 93, the subject matter of Example 92 optionally
includes examples in which the device is a watch.
[0104] In Example 94, the subject matter of any one or more of
Examples 90-93 optionally includes examples in which the processor
is further executing instructions to determine a configuration for
the user interface using the information about the subject.
[0105] In Example 95, the subject matter of Example 94 optionally
includes examples in which the device displays a specified set of
metrics based upon previously-collected low-fidelity data.
[0106] In Example 96, the subject matter of any one or more of
Examples 94-95 optionally includes examples in which the device
delivers information at a specified time based upon
previously-collected low-fidelity data.
[0107] In Example 97, the subject matter of any one or more of
Examples 94-96 optionally includes examples in which the device
informs a patient management facilitator regarding an availability
of an estimate of a physiologic state and presents guidance from
the patient management facilitator using the user interface.
[0108] In Example 98, the subject matter of any one or more of
Examples 90-97 optionally includes examples in which the estimate
of a physiologic state is a glucose concentration level.
[0109] Example 99 is a method for selecting patients who are likely
to benefit from intermittent high-fidelity monitoring. The method
may comprise performing a first screening algorithm on a pool of
participants to determine a group of patients with diabetes or with
diabetic risk factors. The method may also include providing a
first kit to a participant in the determined group, the kit
structured and configured to enable the participant to perform
low-fidelity monitoring of their health for a first duration with a
first monitoring technique and obtaining first results. The method
may include performing a second screening algorithm on the
determined group to determine a cohort for participation in
intermittent high-fidelity monitoring, the second screening
algorithm using at least in part the obtained first results and
subsequently providing a second kit to participants in the
determined cohort, the second kit structured and configured to
enable a participant of the determined cohort to perform
high-fidelity monitoring of their health for a second duration with
a second monitoring technique and obtaining second results. The
method may also include providing a third kit to one or more
participants in the determined cohort, the one or more participants
determined according to, at least in part, the obtained second
results.
[0110] In Example 100, the subject matter of Example 99 optionally
includes examples in which the high-fidelity monitoring is
continuous glucose monitoring.
[0111] In Example 101, the subject matter of any one or more of
Examples 99-100 optionally includes examples in which performing
the second screening includes determining an estimated likelihood
that the patient will benefit from the high-fidelity
monitoring.
[0112] In Example 102, the subject matter of any one or more of
Examples 99-101 optionally includes examples in which the second
kit is structured and configured based on the obtained first
results.
[0113] In Example 103, the subject matter of any one or more of
Examples 99-102 optionally includes examples in which the third kit
is structured and configured based on the obtained second
results.
[0114] In Example 104, the subject matter of any one or more of
Examples 99-103 optionally include performing communications
between a server and a device in the first kit during at least the
first duration, the communications providing a guidance message to
the patient.
[0115] In Example 105, the subject matter of any one or more of
Examples 99-104 optionally includes examples in which the
low-fidelity monitoring includes: single-point glucose monitoring,
heart rate monitoring, activity monitoring, blinded continuous
glucose monitoring, or any combination thereof.
[0116] In Example 106, the subject matter of any one or more of
Examples 99-105 optionally include displaying an output to the
patient, the displayed output relating to diet, exercise, glucose
level monitoring, or medication.
[0117] In Example 107, the subject matter of any one or more of
Examples 99-106 optionally include displaying an output to the
patient, the displayed output indicating an optimized duration of
time for which the patient should employ high-fidelity
monitoring.
[0118] In Example 108, the subject matter of any one or more of
Examples 99-107 optionally include examples in which the algorithm
employs one or more factors selected from the group consisting of
electronic health records, type II diabetes diagnosis codes, family
history, weight, BMI, history of metabolic diseases, blood test
results, A1c, fasting glucose levels, oral glucose tolerance,
prescribed diabetes medications, or any combination thereof.
[0119] In Example 109, the subject matter of any one or more of
Examples 99-108 optionally includes examples in which the second
screening algorithm is based at least in part on a factor of
adherence to use of the low-fidelity monitoring during the first
duration.
[0120] Example 110 is a method of managing a parameter related to
patient health, the method including a phase of intermittent
high-fidelity monitoring. The method may comprise, first,
monitoring a patient for a first duration with a first monitoring
technique and obtaining first results. The method may also comprise
monitoring the patient for a second duration with a second
monitoring technique and obtaining second results. The method may
also comprise determining an action that the patient may perform,
the action based on the obtained first and second results, the
action calculated to increase a likelihood of satisfaction of a
management condition. In some examples, either the first monitoring
technique or the second monitoring technique includes high-fidelity
monitoring.
[0121] In Example 111, the subject matter of Example 110 optionally
includes examples in which the high-fidelity monitoring includes
continuous glucose monitoring.
[0122] In Example 112, the subject matter of any one or more of
Examples 110-111 optionally includes displaying an output to the
patient, the displayed output indicating patient performance in
relation to a dietary goal, an exercise goal, a glucose level
monitoring goal, or a medication goal.
[0123] In Example 113, the subject matter of any one or more of
Examples 110-112 optionally includes examples in which the
parameter related to patient health is selected from the group
consisting of: time-in-range and glycemic variability.
[0124] In Example 114, the subject matter of any one or more of
Examples 110-113 optionally includes examples in which the
satisfaction of the management condition comprises decreasing the
parameter related to patient health by greater than a predetermined
amount with a confidence greater than a predetermined confidence
level.
[0125] In Example 115, the subject matter of any one or more of
Examples 110-114 optionally includes selecting a patient. In some
examples, selecting the patient is performed by determining a
patient from a pool of patients likely to benefit from intermittent
high-fidelity monitoring, the likelihood greater than a calculated
value.
[0126] In Example 116, the subject matter of any one or more of
Examples 110-115 optionally includes examples in which the first
duration is a subset of the second duration.
[0127] In Example 117, the subject matter of any one or more of
Examples 110-116 optionally includes examples in which the first
duration overlaps the second duration.
[0128] In Example 118, the subject matter of any one or more of
Examples 110-117 optionally includes performing communications
between a server and a device associated with the patient during
the first duration or the second duration or both, the
communications providing a coaching functionality to the
patient.
[0129] In Example 119, the subject matter of any one or more of
Examples 110-118 optionally includes displaying an output to the
patient, the displayed output indicating an optimized duration of
time for which the patient should employ high-fidelity
monitoring.
[0130] In Example 120, the subject matter of any one or more of
Examples 110-119 optionally includes examples in which the first
monitoring technique is a low-fidelity monitoring technique and the
second monitoring technique is the high-fidelity monitoring.
[0131] In Example 121, the subject matter of Example 120 optionally
includes examples in which the low-fidelity monitoring technique
includes: single-point glucose monitoring or blinded CGM.
[0132] In Example 122, the subject matter of any one or more of
Examples 120-121 optionally includes examples in which the
low-fidelity monitoring technique includes activity monitoring by a
wearable fitness tracker.
[0133] In Example 123, the subject matter of Example 122 optionally
includes examples in which the wearable fitness tracker is a
wearable heart rate monitor, activity monitor, smart phone, smart
glasses, or smart watch.
[0134] In Example 124, the subject matter of any one or more of
Examples 120-123 optionally includes correlating the obtained first
and second results, the correlating including determining a
relation between the obtained first and second results at
corresponding times of day and/or days of a week, and determining
an estimated value for a high-fidelity monitoring technique at a
given time based at least in part on a correlated value for the
given time and a result obtained by the low-fidelity monitoring
technique.
[0135] In Example 125, the subject matter of Example 124 optionally
includes determining the estimated value based at least in part on
population data.
[0136] In Example 126, the subject matter of any one or more of
Examples 120-125 optionally includes examples in which the
low-fidelity monitoring technique includes receiving user input
data.
[0137] In Example 127, the subject matter of Example 126 optionally
includes examples in which the received user input data includes
medicament data, meal data, exercise data, sleep data, or any
combination thereof.
[0138] In Example 128, the subject matter of any one or more of
Examples 120-127 optionally includes correlating the obtained first
and second results, the correlating including determining a
relation between the obtained first and second results at
corresponding times of day or days of a week, and determining an
estimated value for a high-fidelity monitoring technique at a given
time based at least in part on the estimation of a correlated value
for the given time and a result obtained by the low-fidelity
monitoring technique.
[0139] In Example 129, the subject matter of Example 128 optionally
includes determining the estimated value based at least in part on
population data.
[0140] Example 130 is a method for measuring a parameter related to
patient health. The method may comprise detecting, by an analyte
sensor system, that the analyte sensor system has been applied to a
host. The method may also comprise storing, by the analyte sensor
system, analyte data describing the host;
[0141] determining, by the analyte sensor system, that sensor use
at the analyte sensor system has terminated and uploading, by the
analyte sensor system, stored analyte data to an upload computing
device.
[0142] In Example 131, the subject matter of Example 130 optionally
includes, responsive to determining that the sensor use at the
analyte sensor system has terminated, broadcasting, by the analyte
sensor system, system identification data; receiving, by the
analyte sensor system and from the upload computing device, a
communication request comprising the system identification data,
and establishing, by the analyte sensor system, a communication
session with the upload computing device responsive to the
communication request, wherein the uploading transmitting the
stored analyte data to the upload computing device.
[0143] In Example 132, the subject matter of any one or more of
Examples 130-131 optionally includes after determining that the
sensor use at the analyte sensor system has terminated, receiving,
by the analyte sensor system, an upload request from the upload
computing device and broadcasting, by the analyte sensor system,
system identification data; receiving, from the upload computing
device, authentication data. The method may also include
establishing, by the analyte sensor system, a communication session
with the upload computing device, wherein the uploading
transmitting the stored analyte data to the upload computing
device.
[0144] Example 133 is a method comprising: receiving an estimated
glucose concentration level of a patient from a continuous glucose
monitoring (CGM) system for a first time period; receiving
non-glucose information relating to the patient for the first time
period; determining a relationship between the estimated glucose
concentration level and the non-glucose information; receiving
non-glucose information relating to the patient for a second time
period; determining diabetic information about the patient for the
second time period based upon the determined relationship and the
non-glucose information; and electronically delivering a
notification about the diabetic information.
[0145] In Example 134, the subject matter of Example 133 optionally
includes receiving a plurality of estimated glucose concentration
levels from the first time period from the CGM system, and wherein
receiving the non-glucose information for the first time period
comprises receiving at least one single-point glucose measurement
taken during the first time period.
[0146] In Example 135, the subject matter of any one or more of
Examples 133-134 optionally includes wherein estimated glucose
concentration levels are not available from the CGM during the
second time period.
[0147] In Example 136, the subject matter of any one or more of
Examples 133-135 optionally includes receiving second non-glucose
information related to the patient for the first time period,
wherein the second non-glucose information is different than the
non-glucose information, and wherein the relationship is between
the estimated glucose concentration level, the non-glucose
information, and the second non-glucose information.
[0148] In Example 137, the subject matter of any one or more of
Examples 133-136 optionally includes wherein the non-glucose
information includes physiologic information about the patient.
[0149] In Example 138, the subject matter of Example 137 optionally
includes wherein the physiologic information includes at least one
of heart rate, respiration, oxygen concentration, skin tone,
moisture content on the skin, activity, activity patterns, blood
ketones, urine ketones, respiration, or acoustic information.
[0150] In Example 139, the subject matter of any one or more of
Examples 133-138 optionally includes wherein the non-glucose
information includes location information.
[0151] In Example 140, the subject matter of any one or more of
Examples 133-139 optionally includes wherein determining diabetic
information includes determining an estimated glucose concentration
level.
[0152] In Example 141, the subject matter of any one or more of
Examples 133-140 optionally includes wherein determining diabetic
information includes determining an estimate of an amount or
percentage of time that a glucose concentration level was in range
during a specified time period.
[0153] Example 142 is a system comprising: a primary subsystem
configured to intermittently collect primary physiologic
information from a host; a secondary subsystem configured to
collect secondary data of a second type from a host; a guidance
system configured to determine guidance based at least in part on
the primary physiologic information and the secondary data; and a
user interface configured to display the guidance.
[0154] In Example 143, the subject matter of Example 142 optionally
includes wherein the guidance system is also configured to:
determine a relationship between the secondary data and the primary
physiologic information; and determine the guidance during a time
period in when primary physiologic information is not collected,
wherein determining the guidance is based at least in part on the
secondary data and the relationship between the secondary data and
the primary physiologic information.
[0155] In Example 144, the subject matter of any one or more of
Examples 142-143 optionally includes wherein the primary subsystem
includes a continuous glucose monitor (CGM) and wherein the
guidance system is further configured to determine a patient state
based at least in part on the secondary data and a relationship
between the secondary data and the primary physiologic
information.
[0156] In Example 145, the subject matter of Example 144 optionally
includes wherein the patient state comprises an estimated glucose
concentration level.
[0157] In Example 146, the subject matter of any one or more of
Examples 144-145 optionally includes wherein the patient state
comprises a time in range metric that indicates an estimate of an
amount or percentage of time that a glucose concentration level was
in range during a specified time period.
[0158] In Example 147, the subject matter of any one or more of
Examples 142-146 optionally includes wherein the secondary
subsystem includes a sensor and a memory circuit, and wherein the
secondary subsystem is further configured to: determine the
secondary data from sensor data received from the sensor; and store
the sensor data or the secondary data in the memory circuit.
[0159] In Example 148, the subject matter of any one or more of
Examples 142-147 optionally includes wherein the primary subsystem
includes a continuous glucose monitor (CGM), and a memory circuit,
and wherein the primary subsystem is configured to: receive a CGM
sensor signal indicative of a glucose concentration in a host;
determine an estimated glucose concentration level based at least
in part on the CGM sensor signal; and store a plurality of
estimated glucose concentration levels in the memory circuit,
wherein the primary physiologic information includes or is based on
the plurality of estimated glucose concentration levels.
[0160] Example 149 is a computer-readable medium comprising
instructions thereon that, when executed by at least one processor,
causes the at least one processor to perform operations comprising:
receiving an estimated glucose concentration level of a patient
from a continuous glucose monitoring (CGM) system for a first time
period; receiving non-glucose information relating to the patient
for the first time period; determining a relationship between the
estimated glucose concentration level and the non-glucose
information; receiving non-glucose information relating to the
patient for a second time period; determining diabetic information
about the patient for the second time period based upon the
determined relationship and the non-glucose information; and
electronically delivering a notification about the diabetic
information.
[0161] In Example 150, the subject matter of Example 149 optionally
includes wherein the operations further comprise receiving a
plurality of estimated glucose concentration levels from the first
time period from the CGM system, and wherein receiving the
non-glucose information for the first time period comprises
receiving at least one single-point glucose measurement taken
during the first time period.
[0162] In Example 151, the subject matter of any one or more of
Examples 149-150 optionally includes the operations further
comprising: determining guidance based at least in part on the
diabetic information; and displaying the guidance at a user
interface.
[0163] In Example 152, the subject matter of any one or more of
Examples 149-151 optionally includes receiving second non-glucose
information related to the patient for the first time period,
wherein the second non-glucose information is different than the
non-glucose information, and wherein the relationship is between
the estimated glucose concentration level, the non-glucose
information, and the second non-glucose information.
[0164] Example 153 is a patient-management system, comprising: an
analyte sensor; and a processor executing instructions to perform
operations comprising: receiving, by a first application executing
at the processor and from the analyte sensor, sensor data
indicating an analyte concentration of a user; transmitting, by the
first application and to a second application executing at the
processor, a sensor message comprising an indication of the analyte
concentration; and delivering, by the second application and to a
wearable activity monitor device, a device message, the device
message based at least in part on the analyte concentration.
[0165] In Example 154, the subject matter of Example 153 optionally
includes the wearable activity monitor device, wherein the wearable
activity monitor device comprises a motion sensor, and wherein the
wearable activity monitor device is programmed to generate a user
interface including data based at least in part on the device
message and data based at least in part on an output of the motion
sensor.
[0166] In Example 155, the subject matter of any one or more of
Examples 153-154 optionally includes wherein the operations further
comprise generating physiologic state data describing an estimate
of a physiologic state of the user, the generating based at least
in part on the analyte concentration of the user.
[0167] In Example 156, the subject matter of Example 155 optionally
includes wherein the physiologic state data is generated by the
first application, and wherein the sensor message comprises the
physiologic state data.
[0168] In Example 157, the subject matter of any one or more of
Examples 155-156 optionally includes wherein the physiologic state
data is generated by the second application, and wherein the device
message comprises the physiologic state data.
[0169] In Example 158, the subject matter of any one or more of
Examples 155-157 optionally includes wherein the physiologic state
data comprises a time-in-range, a glucose concentration level, or a
glucose concentration range.
[0170] In Example 159, the subject matter of any one or more of
Examples 155-158 optionally includes wherein the generating of the
physiologic state data is based upon a correlation between
previously-collected glucose concentration information and
previously-collected activity information.
[0171] In Example 160, the subject matter of any one or more of
Examples 153-159 optionally includes wherein the device message
comprises display data for display at a user interface of the
wearable activity monitor device.
[0172] In Example 161, the subject matter of any one or more of
Examples 153-160 optionally includes wherein generating the sensor
message comprises encrypting the indication of the analyte
concentration.
[0173] In Example 162, the subject matter of any one or more of
Examples 153-161 optionally includes wherein generating the sensor
message comprises generating an error detection code based at least
in part on the analyte concentration.
[0174] Example 163 is a patient-management method, comprising:
receiving, by a first application executing at a patient-management
system and from an analyte sensor, sensor data indicating an
analyte concentration of a user; transmitting, by the first
application and to a second application executing at the
patient-management system, a sensor message comprising an
indication of the analyte concentration; and delivering, by the
second application and to a wearable activity monitor device, a
device message, the device message based at least in part on the
analyte concentration.
[0175] In Example 164, the subject matter of Example 163 optionally
includes wherein the wearable activity monitor device comprises a
motion sensor, further comprising generating, by the wearable
activity monitor device, a user interface including data based at
least in part on the device message and data based at least in part
on an output of the motion sensor.
[0176] In Example 165, the subject matter of any one or more of
Examples 163-164 optionally includes generating physiologic state
data describing an estimate of a physiologic state of the user, the
generating based at least in part on the analyte concentration of
the user.
[0177] In Example 166, the subject matter of Example 165 optionally
includes wherein the physiologic state data is generated by the
first application, and wherein the sensor message comprises the
physiologic state data.
[0178] In Example 167, the subject matter of any one or more of
Examples 165-166 optionally includes wherein the physiologic state
data is generated by the second application, and wherein the device
message comprises the physiologic state data.
[0179] In Example 168, the subject matter of any one or more of
Examples 165-167 optionally includes wherein the physiologic state
data comprises a time-in-range, a glucose concentration level, or a
glucose concentration range.
[0180] In Example 169, the subject matter of any one or more of
Examples 165-168 optionally includes wherein the generating of the
physiologic state data is based upon a correlation between
previously-collected glucose concentration information and
previously-collected activity information.
[0181] In Example 170, the subject matter of any one or more of
Examples 163-169 optionally includes wherein the device message
comprises display data for display at a user interface of the
wearable activity monitor device.
[0182] In Example 171, the subject matter of any one or more of
Examples 163-170 optionally includes wherein generating the sensor
message comprises generating an error detection code based at least
in part on the analyte concentration.
[0183] Example 172 is a machine-readable medium comprising
instructions thereon that, when executed by at least one processor,
cause the at least one processor to perform operations comprising:
receiving, by a first application executing at a patient-management
system and from an analyte sensor, sensor data indicating an
analyte concentration of a user; transmitting, by the first
application and to a second application executing at the
patient-management system, a sensor message comprising an
indication of the analyte concentration; and delivering, by the
second application and to a wearable activity monitor device, a
device message, the device message based at least in part on the
analyte concentration.
[0184] Example 173 is a method of monitoring a patient, comprising:
monitoring patient data of a first type with a low-fidelity
monitoring technique over a first time period; evaluating patient
behavior based on the monitored first type of patient data; and
monitoring over a second time period patient data of a second type
with a continuous glucose monitor device, wherein a parameter of
the continuous glucose monitor device is based on the evaluated
patient behavior during the monitoring.
[0185] In Example 174, the subject matter of Example 173 optionally
includes wherein the parameter of the continuous glucose monitor
device corresponds to operation of a user interface.
[0186] In Example 175, the subject matter of any one or more of
Examples 173-174 optionally includes wherein the low-fidelity
monitoring technique comprises at least one of single point glucose
monitoring, blinded continuous glucose monitoring, or an optical
monitoring technique.
[0187] In Example 176, the subject matter of any one or more of
Examples 173-175 optionally includes wherein the low-fidelity
monitoring technique comprises activity monitoring by a wearable
fitness tracker.
[0188] In Example 177, the subject matter of Example 176 optionally
includes wherein the wearable fitness tracker comprises at least
one of a wearable heart rate monitor, activity monitor, smart
phone, smart glasses, or smart watch.
[0189] In Example 178, the subject matter of any one or more of
Examples 173-177 optionally includes wherein the low-fidelity
monitoring technique comprises receiving user input data comprising
at least one of medicament data, meal data, exercise data, or sleep
data.
[0190] In Example 179, the subject matter of any one or more of
Examples 173-178 optionally includes determining a goal for the
patient, and wherein the parameter of the continuous glucose
monitor device is related to the goal.
[0191] In Example 180, the subject matter of Example 179 optionally
includes wherein the goal includes a dietary goal, an exercise
goal, a glucose level monitoring goal, or a medication goal.
[0192] In Example 181, the subject matter of any one or more of
Examples 179-180 optionally includes wherein the determining the
goal for the patient is based at least in part on the data of the
first type monitored over the first time period with the
low-fidelity monitoring technique.
[0193] In Example 182, the subject matter of any one or more of
Examples 173-181 optionally includes determining the parameter of
the continuous glucose monitor device at least in part by
determining at least one parameter for an automated coaching
routine.
[0194] In Example 183, the subject matter of any one or more of
Examples 173-182 optionally includes detecting a change in a
patient parameter between the first time period and the second time
period; and determining the parameter of the continuous glucose
monitor device using the detected change in the patient
parameter.
[0195] In Example 184, the subject matter of any one or more of
Examples 173-183 optionally includes providing a coaching
functionality to the patient over the first time period, the
coaching functionality comprising automated messages transmitted
from a server to the continuous glucose monitor device, wherein the
coaching functionality is based on patient profile data or the
patient data of the first type or a combination thereof.
[0196] Example 185 is a system comprising: a low-fidelity system
configured to collect a first set of sensor data of a first type
relating to a patient over a first time period; a continuous
glucose monitor device configured to collect a second set of sensor
data of a second type of data relating to the patient; and a
decision system configured to determine a parameter for the
continuous glucose monitor device based upon the first set of
sensor data.
[0197] In Example 186, the subject matter of Example 185 optionally
includes wherein low-fidelity system includes an activity
sensor.
[0198] In Example 187, the subject matter of any one or more of
Examples 185-186 optionally includes wherein low-fidelity system
includes a blood glucose meter.
[0199] In Example 188, the subject matter of any one or more of
Examples 185-187 optionally includes wherein the continuous glucose
monitor device includes a continuous glucose monitor.
[0200] In Example 189, the subject matter of any one or more of
Examples 185-188 optionally includes wherein the parameter includes
a schedule for use of the continuous glucose monitor device.
[0201] In Example 190, the subject matter of any one or more of
Examples 185-189 optionally includes wherein the parameter is a
time to initiate us of the continuous glucose monitor device.
[0202] In Example 191, the subject matter of any one or more of
Examples 185-190 optionally includes a third system configured to
collect a third set of sensor data relating to the patient, wherein
the decision system determines the parameter based at least in part
on the first set of sensor data and the third set of sensor
data.
[0203] Example 192 is a machine-readable medium comprising
instructions thereon that, when executed by at least one processor,
cause the at least one processor to perform operations comprising:
monitoring patient data of a first type with a low-fidelity
monitoring technique over a first time period; evaluating patient
behavior based on the monitored first type of patient data; and
monitoring over a second time period patient data of a second type
with a continuous glucose monitor device, wherein a parameter of
the continuous glucose monitor device is based on the evaluated
patient behavior during the monitoring.
[0204] Example 193 is a method for measuring a parameter related to
patient health, the method comprising: detecting, by an analyte
sensor system, that the analyte sensor system has been applied to a
host; storing, by the analyte sensor system, analyte data
describing the host; determining, by the analyte sensor system,
that sensor use at the analyte sensor system has terminated; and
uploading, by the analyte sensor system, stored analyte data to an
upload computing device.
[0205] In Example 194, the subject matter of Example 193 optionally
includes after determining that the sensor use at the analyte
sensor system has terminated, broadcasting, by the analyte sensor
system, system identification data; receiving, by the analyte
sensor system and from the upload computing device, a communication
request comprising the system identification data; and
establishing, by the analyte sensor system, a communication session
with the upload computing device responsive to the communication
request, wherein the uploading is performed using the communication
session.
[0206] In Example 195, the subject matter of any one or more of
Examples 193-194 optionally includes after determining that the
sensor use at the analyte sensor system has terminated, receiving,
by the analyte sensor system, an upload request from the upload
computing device; and receiving, from the upload computing device,
authentication data.
[0207] In Example 196, the subject matter of any one or more of
Examples 193-195 optionally includes after determining that the
sensor use at the analyte sensor system has terminated, receiving,
by the analyte sensor system, an upload request from the upload
computing device; broadcasting, by the analyte sensor system,
system identification data; receiving, from the upload computing
device, authentication data; and establishing, by the analyte
sensor system, a communication session with the upload computing
device, wherein the uploading transmitting the stored analyte data
to the upload computing device.
[0208] In Example 197, the subject matter of any one or more of
Examples 193-196 optionally includes wherein detecting that the
analyte sensor system has been applied to a host comprises
determining that the analyte sensor system has provided sensor
readings above a threshold value.
[0209] In Example 198, the subject matter of any one or more of
Examples 193-197 optionally includes wherein detecting that the
analyte sensor system has been applied to a host comprises
determining that the analyte sensor system has provided sensor
readings above a threshold value for more than a threshold
time.
[0210] In Example 199, the subject matter of any one or more of
Examples 193-198 optionally includes wherein determining that
sensor use at the analyte sensor system has terminated comprises
determining that more than a threshold time has elapsed since the
analyte sensor system was applied to the host.
[0211] In Example 200, the subject matter of any one or more of
Examples 193-199 optionally includes uploading the stored analyte
sensor data to a server system by the upload computing device.
[0212] Example 201 is a system for measuring a parameter related to
patient health, the system comprising: an analyte sensor system
configured to perform operations comprising: detecting that the
analyte sensor system has been applied to a host; storing, by the
analyte sensor system, analyte data describing the host;
determining, by the analyte sensor system, that sensor use at the
analyte sensor system has terminated; and uploading, by the analyte
sensor system, stored analyte data to an upload computing
device.
[0213] In Example 202, the subject matter of Example 201 optionally
includes the operations further comprising: after determining that
the sensor use at the analyte sensor system has terminated,
broadcasting, by the analyte sensor system, system identification
data; receiving, by the analyte sensor system and from the upload
computing device, a communication request comprising the system
identification data; and establishing, by the analyte sensor
system, a communication session with the upload computing device
responsive to the communication request, wherein the uploading is
performed using the communication session.
[0214] In Example 203, the subject matter of any one or more of
Examples 201-202 optionally includes the operations further
comprising: after determining that the sensor use at the analyte
sensor system has terminated, receiving, by the analyte sensor
system, an upload request from the upload computing device; and
receiving, from the upload computing device, authentication
data.
[0215] In Example 204, the subject matter of any one or more of
Examples 201-203 optionally includes the operations further
comprising: after determining that the sensor use at the analyte
sensor system has terminated, receiving, by the analyte sensor
system, an upload request from the upload computing device;
broadcasting, by the analyte sensor system, system identification
data; receiving, from the upload computing device, authentication
data; and establishing, by the analyte sensor system, a
communication session with the upload computing device, wherein the
uploading transmitting the stored analyte data to the upload
computing device.
[0216] In Example 205, the subject matter of any one or more of
Examples 201-204 optionally includes wherein detecting that the
analyte sensor system has been applied to a host comprises
determining that the analyte sensor system has provided sensor
readings above a threshold value.
[0217] In Example 206, the subject matter of any one or more of
Examples 201-205 optionally includes wherein detecting that the
analyte sensor system has been applied to a host comprises
determining that the analyte sensor system has provided sensor
readings above a threshold value for more than a threshold
time.
[0218] In Example 207, the subject matter of any one or more of
Examples 201-206 optionally includes wherein determining that
sensor use at the analyte sensor system has terminated comprises
determining that more than a threshold time has elapsed since the
analyte sensor system was applied to the host.
[0219] In Example 208, the subject matter of any one or more of
Examples 201-207 optionally includes the upload computing device,
wherein the upload computing device is configured to perform
operations comprising uploading the stored analyte sensor data to a
server system.
[0220] Example 209 is a machine-readable medium comprising
instructions thereon that, when executed by at least one processor,
cause the at least one processor to perform operations comprising:
detecting that an analyte sensor system has been applied to a host;
storing analyte data describing the host; determining that sensor
use at the analyte sensor system has terminated; and uploading
stored analyte data to an upload computing device.
[0221] In Example 210, the subject matter of Example 209 optionally
includes the operations further comprising: after determining that
the sensor use at the analyte sensor system has terminated,
broadcasting system identification data; receiving from the upload
computing device a communication request comprising the system
identification data; and establishing a communication session with
the upload computing device responsive to the communication
request, wherein the uploading is performed using the communication
session.
[0222] In Example 211, the subject matter of any one or more of
Examples 209-210 optionally includes the operations further
comprising: after determining that the sensor use at the analyte
sensor system has terminated, receiving an upload request from the
upload computing device; and receiving, from the upload computing
device, authentication data.
[0223] In Example 212, the subject matter of any one or more of
Examples 209-211 optionally includes the operations further
comprising: after determining that the sensor use at the analyte
sensor system has terminated, receiving an upload request from the
upload computing device; broadcasting system identification data;
receiving authentication data; and establishing a communication
session with the upload computing device, wherein the uploading
transmitting the stored analyte data to the upload computing
device.
[0224] This summary is intended to provide an overview of subject
matter of the present patent application. It is not intended to
provide an exclusive or exhaustive explanation of the disclosure.
The detailed description is included to provide further information
about the present patent application. Other aspects of the
disclosure will be apparent to persons skilled in the art upon
reading and understanding the following detailed description and
viewing the drawings that form a part thereof, each of which are
not to be taken in a limiting sense.
BRIEF DESCRIPTION OF THE DRAWINGS
[0225] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0226] FIG. 1 is an illustration of an example medical device
system.
[0227] FIG. 2 is a schematic illustration of various example
electronic components that may be part of the medical device system
shown in FIG. 1.
[0228] FIG. 3 is table that shows example patient states,
physiologic conditions, and example treatments.
[0229] FIG. 4 is a flowchart illustration of an example method of
progressing from a low-fidelity data collection technique to a
high-fidelity data collection technique.
[0230] FIG. 5 is a flowchart illustration of a method of collecting
high-fidelity data and collecting low-fidelity data.
[0231] FIG. 6 is a flowchart illustration of a method of collecting
low-fidelity data and intermittently collected high-fidelity
data.
[0232] FIG. 7 is a flowchart illustration of a method of managing a
patient condition.
[0233] FIG. 8A-8C are flowchart illustration of example processes
of management of a patient.
[0234] FIG. 9 is a flowchart illustration of a process for
monitoring a patient using a primary monitoring technique and a
secondary monitoring technique.
[0235] FIG. 10 is a flowchart illustration of an example method
1001 of determining and notifying a patient about diabetic
information.
[0236] FIG. 11 is a flowchart illustration of an example method of
determining a monitoring scheme based on collected sensor
information.
[0237] FIG. 12A is an illustration of an example user
interface.
[0238] FIG. 12B is an enlarged view of a portion of the user
interface shown in FIG. 12A.
[0239] FIG. 12C is an illustration of an example user interface
including a target A1C indicator.
[0240] FIG. 13 is a flowchart illustration of a method of
identifying or selecting a patient who may benefit from an enhanced
disease management program.
[0241] FIG. 14 is a flowchart illustration of an example method of
managing a parameter related to patient health.
[0242] FIG. 15 is a flow chart illustration of an example login
process.
[0243] FIG. 16 is an illustration of an example user interface.
[0244] FIGS. 17-20 are illustrations of example chat
interfaces.
[0245] FIG. 21 is an illustration of an example trend graph.
[0246] FIG. 22A is an illustration of an example system in which
the methods, devices, and subsystems may be implemented.
[0247] FIG. 22B is an illustration of an example system that is an
arrangement of the system of FIG. 22A.
[0248] FIG. 22C is a flowchart showing one example of a process
that can be executed in the system of FIG. 22B to display CGM data
at the activity sensor.
[0249] FIG. 23 is a more detailed illustration of the example
system shown in FIG. 22A.
[0250] FIG. 24 illustrates an example system that may be used in
connection with implementing embodiments of the disclosure.
[0251] FIG. 25 illustrate an example of an automated or
semi-automated coaching system, which can be used with the
embodiment of FIG. 4.
[0252] FIGS. 26A and 26B are flow illustrations of example
processes to initiate a patient with automated or semi-automated
coaching system of FIG. 5.
[0253] FIG. 27 is a flow chart illustration of an example process
to initiate an exercise module.
[0254] FIG. 28 is a flow chart illustration of an example process
to implement a follow up module.
[0255] FIG. 29 is a flow chart illustration of an example process
to implement a confidence assessor/booster module.
[0256] FIG. 30 is a flow chart illustration of an example process
to implement a diet module.
[0257] FIG. 31 is a flow chart illustration of an example process
to implement a meal tracking module.
[0258] FIG. 32 is a flow chart illustration of an example process
to implement a module designed to encourage the use of the
embodiment of FIG. 11.
[0259] FIG. 33 is a flow chart illustration of an example process
to implement a sleep module.
[0260] FIG. 34 is an illustration of an example system that can
include an analyte sensor system configured to upload captured
analyte data after collection.
[0261] FIG. 35 is a flowchart showing one example of a process that
can be executed by the analyte sensor system of FIG. 34 to collect
and upload analyte data.
[0262] FIG. 36 is a flowchart showing one example of a process that
can be executed by the sensor electronics to upload collected
analyte data.
[0263] FIG. 37 is a flowchart showing another example of a process
that can be executed by the sensor electronics to upload collected
analyte data.
DETAILED DESCRIPTION
[0264] The present inventors have recognized, among other things,
that a patient may advantageously be monitored or managed with a
combination of techniques that have differing patterns of
information collection. Typically, to enhance patient management,
higher-fidelity and greater quantities of data is desired to inform
patient management decisions. A counter-intuitive approach uses
less data or lower-fidelity data, in combination with information
learned from high-fidelity data (e.g., a correlation between the
types of data) to guide patient management. For example, a
relationship between the different types of collected data may be
used to inform management of the patient during time periods when
one or more of the types of data is not available. In some
examples, analyte information that is automatically collected by a
sensor from a host on a schedule ("continuous analyte monitoring"),
such as glucose information that is automatically collected by a
glucose sensor ("continuous glucose monitoring" or "CGM") may be
correlated to other types of information (e.g., activity captured
by a wearable activity sensor), which may allow for estimation of
an estimated glucose concentration level (or level of another
analyte) based on the correlation. In some examples, two or more
types of data (e.g., CGM data and activity data) may be collected
from a patient, and data obtained during a period when both CGM and
activity data are collected may be used to develop or tune a system
or algorithm to infer a first type of data (e.g., glucose
concentration level) from a second type of data (e.g., activity or
heart rate) or from the second type of data and an auxiliary input
(e.g., administration of a medication or consumption of a meal.) In
other words, a non-CGM sensor system may be "calibrated" to
estimated glucose values using contemporaneously-obtained CGM data
and non-CGM data. In some examples, continuous glucose monitoring
may be performed intermittently: during collection periods, glucose
concentration levels may be collected on a schedule (e.g., every 5
minutes), but the CGM data collection may only occur during certain
time periods, such as when a patient is wearing an activated CGM
sensor, which may occur, for example, for a one-week or ten day
period each month or every 3 months.
[0265] In some examples, a need or desire to implement a second
type of data collection (e.g., intermittent CGM data collection) or
a collection parameter (e.g., periodicity for intermittent
collection), may be determined based upon a first type of data
(e.g., blood glucose meter data or activity data). In some
examples, a relationship or aspects of intermittent collection may
be used to determine a collection parameter for a different
monitoring technique. For example, CGM data may be used to
determine a time or schedule for one or more blood glucose meter
tests. In another example, blood glucose meter test results or
activity data may be used to determine a CGM monitoring scheme
(e.g., a schedule for intermittent CGM data collection or a number
of sensors to be used in CGM monitoring.) In some examples, an oral
medication therapy or injected insulin therapy (e.g., basal
insulin) may be determined (or evaluated or redetermined) based in
part on CGM information, such as intermittent CGM monitoring. While
CGM information is referenced as an example throughout this
description, the described examples are also applicable to other
types of analytes (e.g., references to continuous glucose
monitoring are applicable generally to continuous analyte
monitoring.)
Overview
[0266] Patient management may be more effective when informed by
timely information about the patient. For example, physiologic
information, environmental information, or behavioral information
may be used to determine guidance (e.g., dietary or exercise
guidance) or therapy (e.g., oral medication regime) for the patient
or to determine changes or improvements to a patient management
scheme. Patients who have a blood glucose control condition such as
type 2 diabetes may especially benefit from a patient management
scheme that uses timely information. Some monitoring systems or
devices, such as a continuous glucose monitor, may provide a strong
signal about the glucose control condition (e.g., high glucose
concentration level, normal level, or low level) of a patient, but
continuous use of such systems may not be desired due to expense
(e.g., the expense of CGM sensors and monitoring) or a burden on
the patient (e.g., the need to wear and manage a CGM on the body.)
Other systems and devices (e.g., wearable activity monitor, smart
watch, smart phone) may be less burdensome or less expensive but
tend to provide information that may have less direct relation to
blood glucose levels. For example, activity tends to be helpful in
controlling blood glucose levels, but an actual blood glucose
concentration level cannot be easily inferred from activity
information alone, and the effect of activity on blood glucose may
vary widely among patients, or types of patients (e.g., amongst
subgroups in a population.)
[0267] To balance cost and the need for accurate information about
glucose management, different types of patient data may be
collected for one or more overlapping time periods, which may allow
for determination of patient management information based on
relationships between different types of data. Such a relationship
may be used to guide patient management when one of the types of
data is not available. For example, a continuous glucose monitor
and an activity monitor may be used during an overlapping time
period, and a relationship between glucose concentration level
information and activity information may be learned from the CGM
and activity data. In some examples, a user may be instructed to
wear an activity sensor (e.g., watch) continuously (e.g., at least
a portion of each day), and the user may be instructed to wear a
continuous glucose sensor for a defined time period (e.g., two-week
trial period) or continuously (e.g., for a two-week session every
three months). The data may be collected by a system (e.g., using a
mobile device and server) and analyzed to determine a relationship
between glucose levels and activity. In various examples, activity
may be correlated with a glucose concentration level or range, or
may be correlated with an impact on glucose concentration (e.g., a
particular amount of activity causes a determined impact on
glucose, which may vary based on glucose level due to lower insulin
sensitivity (i.e., insulin resistance) at higher glucose levels) or
may be correlated with a glucose level trend (e.g., rate of change
of the glucose level associated with an amount, intensity, or type
of activity), any of which may be used to infer an estimated
glucose concentration level (e.g., 120 mg/dL), range (e.g., 120-160
mg/dL), status (e.g., out of target range, or in range), or other
estimate of glucose level management. One or more of these glucose
estimates, or information based on an estimate (e.g., time-in-range
for a day) may be delivered to the patient, which, in various
examples, may occur in real time, or on demand, or recurrently
(e.g., hourly, daily, weekly, three times a day, or before or after
meals.)
[0268] To facilitate determination of relationships amongst types
of data, different types of data (e.g., CGM data and activity data)
may be correlated with one or more of time (e.g., to allow matching
of CGM data with corresponding activity data), location, day,
patient-input data (e.g., meals or activity), or other information.
The correlations with time, location, day, patient-input data, or
other information may also be used to determine a relationship
between types of data.
[0269] In some examples, the collected sensor data may be used in
combination with population-based data, such as gender, age,
location, ethnicity, job type, A1C, BMI, weight, or other
demographic information to determine a glucose control estimate
(e.g., estimated glucose level, range, or status.) In some
examples, a system may build up population cohorts segmented by
glucose profile behavior, and a user matched up to a specific
cohort may receive statistical feedback. Based on this type of
population information, a glucose estimate may be used to determine
population-based guidance, which may be delivered (e.g., presented
on a smart device) to the patient. For example, a patient may
receive guidance: "70% of people like you are estimated to be out
of range around this time. Have you considered going for a
walk?"
[0270] In some examples, a model may be developed (e.g., learned
from collected data), and relationships may be reflected in the
model. For example, a state, such as glucose state, may be
determined by applying one or more inputs (e.g., activity), to the
model.
[0271] While specific types of patient management information
(e.g., CGM and activity data) may be the subject of specific
examples for purpose of explanation, it is understood that the
techniques and methods, and system herein may be applied to other
differing types of information, such as different types of
monitored analytes (other than glucose), or different types of
physiologic information (e.g., heart rate, respiration, galvanic
skin response or other skin qualities, blood ketones, urine
ketones, oxygen concentration) or types of ambient information
(e.g., location, environment, temperature) and relationships among
two or more types of information may be used to determine health
(e.g., diabetic) information about the patient when one or more
types of information are not available.
Example System
[0272] FIG. 1 is an illustration of an example system 100 that may
include a variety of sensor systems of devices. The system 100 may
include an analyte sensor system 102 that may be coupled to a host
101. The host 101 may be a human patient. The patient may, for
example, be subject to a temporary or permanent diabetes condition
or other health condition for which data-driven patient management
or analyte monitoring may be useful.
[0273] The analyte sensor system 102 may include an analyte sensor
104, which may for example be a glucose sensor. The glucose sensor
may be any device capable of measuring the concentration of
glucose. For example, the analyte sensor 104 may be fully
implantable, or the analyte sensor may be wearable on the body
(e.g., on the body but not under the skin), or the analyte sensor
may be a transcutaneous device (e.g., with a sensor residing under
or in the skin of a host). It should be understood that the devices
and methods described herein can be applied to any device capable
of detecting a concentration of glucose and providing an output
signal that represents the concentration of glucose (e.g., as a
form of analyte data).
[0274] The analyte sensor system 102 may also include sensor
electronics 106. In some examples, the analyte sensor 104 and
sensor electronics 106 may be provided as an integrated package. In
other examples, the analyte sensor 104 and sensor electronics 106
may be provided as separate components or modules. For example, the
analyte sensor system 102 may include a disposable (e.g.,
single-use) base that may include the analyte sensor 104, a
component for attaching the sensor to a host (e.g., an adhesive
pad), or a mounting structure configured to receive another
component. The system may also include a sensor electronics
package, which may include some or all of the sensor electronics
106 shown in FIG. 2. The sensor electronics package may be
reusable.
[0275] An analyte sensor may use any known method, including
invasive, minimally-invasive, or non-invasive sensing techniques
(e.g., optically excited fluorescence, microneedle, transdermal
monitoring of glucose), to provide a data stream indicative of the
concentration of the analyte in a host. The data stream may be a
raw data signal, which may be converted into a calibrated and/or
filtered data stream that is used to provide a useful value of the
analyte (e.g., estimated blood glucose concentration level) to a
user, such as a patient or a caretaker (e.g., a parent, a relative,
a guardian, a teacher, a doctor, a nurse, or any other individual
that has an interest in the wellbeing of the host).
[0276] Analyte sensor 104 may, for example, be a continuous glucose
sensor, which may, for example, include a subcutaneous, transdermal
(e.g., transcutaneous), or intravascular device. In some
embodiments, such a sensor or device may recurrently (e.g.,
periodically or intermittently) analyze sensor data. The glucose
sensor may use any method of glucose-measurement, including
enzymatic, chemical, physical, electrochemical, spectrophotometric,
polarimetric, calorimetric, iontophoretic, radiometric,
immunochemical, and the like. In various examples, the analyte
sensor system 102 may be or include a continuous glucose monitor
sensor available from DexCom.TM. (e.g., the DexCom G5.TM. sensor or
Dexcom G6.TM. sensor or any variation thereof), from Abbott.TM.
(e.g., the Libre.TM. sensor), or from Medtronic.TM. (e.g. the
Enlite.TM. sensor).
[0277] In some examples, analyte sensor 104 may be an implantable
glucose sensor, such as described in U.S. Pat. No. 6,001,067 and
U.S. Patent Publication No. US-2005-0027463-A1. In some examples,
analyte sensor 10 may be a transcutaneous glucose sensor, such as
described in to U.S. Patent Publication No. US-2006-0020187-A1. In
some examples, analyte sensor 10 may be configured to be implanted
in a host vessel or extracorporeally, such as is described in U.S.
Patent Publication No. US-2007-0027385-A1, co-pending U.S. Patent
Publication No. US-2008-0119703-A1 filed Oct. 4, 2006, U.S. Patent
Publication No. US-2008-0108942-A1 filed on Mar. 26, 2007, and U.S.
Patent Application No. US-2007-0197890-A1 filed on Feb. 14, 2007.
In some examples, the continuous glucose sensor may include a
transcutaneous sensor such as described in U.S. Pat. No. 6,565,509
to Say et al., for example. In some examples, analyte sensor 10 may
be a continuous glucose sensor that includes a subcutaneous sensor
such as described in U.S. Pat. No. 6,579,690 to Bonnecaze et al. or
U.S. Pat. No. 6,484,046 to Say et al., for example. In some
examples, the continuous glucose sensor may include a refillable
subcutaneous sensor such as described in U.S. Pat. No. 6,512,939 to
Colvin et al., for example. The continuous glucose sensor may
include an intravascular sensor such as described in U.S. Pat. No.
6,477,395 to Schulman et al., for example. The continuous glucose
sensor may include an intravascular sensor such as described in
U.S. Pat. No. 6,424,847 to Mastrototaro et al., for example.
[0278] The system 100 may also include a second medical device 108,
which may, for example, be or include a wearable monitor or a drug
delivery device. For example, the second medical device 108 may be
or include a drug delivery device such as an insulin pump, insulin
pen, or similar device. In some examples, the medical device 108
may be or include a sensor, a heart rate sensor, a respiration
sensor, a motion sensor (e.g. accelerometer), posture sensor (e.g.
3-axis accelerometer), acoustic sensor (e.g. to capture ambient
sound or sounds inside the body, such as respiration), or another
analyte sensor. In some examples, medical device 108 may be
wearable, e.g. on a watch, glasses, contact lens, patch, wristband,
ankle band, or other wearable item, or may be incorporated into a
handheld device (e.g., a smartphone). In some examples, the medical
device 108 may include a multi-sensor patch that may, for example,
detect one or more of an analyte level (e.g. glucose, lactate,
insulin or other substance), heart rate, respiration (e.g., using
impedance), activity (e.g. using an accelerometer), posture (e.g.
using an accelerometer), galvanic skin response, tissue fluid
levels (e.g. using impedance or pressure).
[0279] The analyte sensor system 102 may communicate with the
second medical device 108 via a wired connection, or via a wireless
communication signal 110. For example, the analyte sensor system
may be configured to communicate using via radio frequency (e.g.
Bluetooth, Bluetooth Low Energy (LE), Medical Implant Communication
System (MICS), Wi-Fi, NFC, RFID, Zigbee, Z-Wave or other
communication protocols), optically (e.g. infrared), sonically
(e.g. ultrasonic), or a cellular protocol (e.g., CDMA (Code
Division Multiple Access) or GSM (Global System for Mobiles), or
wired connection (e.g. serial, parallel, etc.).
[0280] The system 100 may also include a wearable sensor 130, which
may include a sensor circuit (e.g., a sensor circuit configured to
detect a glucose concentration or other analyte concentration) and
a communication circuit, which may, for example, be a near field
communication (NFC) circuit. In some examples, information from the
wearable sensor 130 may be retrieved from the wearable sensor 130
using a user device 132 such as a smart phone that is configured to
communicate with the wearable sensor 130 via NFC when the user
device 132 is placed near the wearable sensor 130 (e.g., swiping
the user device 132 over the sensor retrieves sensor data from the
wearable sensor using NFC.) The use of NFC communication may reduce
power consumption by the wearable sensor, which may reduce the size
of a power source (e.g., battery or capacitor) in the wearable
sensor or extend the usable life of the power source. In some
examples, the wearable sensor 130 may be wearable on an upper arm
as shown. In some examples, a wearable sensor 134 may additionally
or alternatively be on the upper torso of the patient (e.g. over
the heart or over a lung), which may, for example, facilitate
detecting heart rate, respiration, or posture. A wearable sensor
136 may also be on the lower body (e.g., on a leg).
[0281] In some examples, an array or network of sensors may be
associated with the patient. For example, one or more of the
analyte sensor system 102, medical device 108, wearable device 120
and an additional sensor 130 may communicate with one another via
wired or wireless (e.g., Bluetooth, Bluetooth LE, MICS, NFC, or any
of the other options discussed above,) communication. The
additional sensor 130 may be any of the examples discussed above
with respect to medical device 108. The analyte sensor system 102,
medical device 108, and additional sensor 130 on the host 101 are
provided for the purpose of illustration and discussion and are not
necessarily drawn to scale.
[0282] The system 100 may also include one or more peripheral
devices, such as a hand-held smart device (e.g., smartphone) 112, a
tablet 114, a smart pen 116 (e.g., insulin delivery pen with
processing and communication capability), a computer 118, a
wearable device such as a wearable device 120, or a peripheral
medical device 122 (which may be a proprietary device such as a
proprietary user device available from DexCom), any of which may
communicate with the analyte sensor system 102 via a wireless
communication signal, and may also communicate over a network 124
with a server system (e.g., remote data center) 125 or with a
remote terminal 128 to facilitate communication with a remote user
(not shown) such as a technical support staff member or a
clinician.
[0283] The wearable device 120 may include an activity sensor, a
heart rate monitor (e.g., light based sensor or electrode based
sensor), a respiration sensor (e.g., acoustic or electrode based),
a location sensor (e.g., GPS), or other sensors.
[0284] The system 100 may also include a wireless access point
(WAP) 138 that may be used to communicatively couple one or more of
analyte sensor system 102, network 124, one or more server systems
126, 125, 127, medical device 108 or any of the peripheral devices
described above. For example, WAP 138 may provide Wi-Fi and/or
cellular connectivity within system 100. Other communication
protocols (e.g., Near Field Communication (NFC) or Bluetooth) may
also be used among devices of the system 100.
[0285] In some examples, a first server system 125 may be used to
collect analyte data from analyte sensor system 102 and/or the
plurality of other devices, and to perform analytics on collected
data, generate or apply universal or individualized models for
glucose levels, and communicate such analytics, models, or
information based thereon back to one or more of the devices in the
system 100. The system may include one or more additional servers
126, 127. For example, the first server system 125 may handle
(e.g., receive or store or send) CGM data, and a second server
system 126 may house general patient information or medical data
(e.g., insurance information). The first server system 125 or
second server system 126 may include a decision-support system,
which may, for example, determine guidance for a patient, determine
an estimated blood glucose level (e.g., based on a surrogate data)
or may determine other information (e.g., a correlation with other
types of information) using any of the various techniques described
herein. The guidance, glucose concentration level, or other
information may be transmitted via a network 124 and delivered to a
patient or caretaker device, such as hand-held device 112 or tablet
114. In some examples, CGM information may be delivered to both a
patient device (such as hand-held device 112) and shared with a
device of a caretaker or family member. Information about remote
monitoring of analyte measurements is provided in U.S. patent
application Ser. No. 15/632,181, which is published as U.S.
publication number 20170293732A1, and which is incorporated by
reference.
[0286] The system 100 may also include a third server system 127,
which may receive or store a second type of patient information or
information from another source, such as sensor data from a
wearable sensor. In various examples, two or more of the servers
125, 126, 127 may be combined, or all three servers may be
combined, or the operations may be distributed differently amongst
the servers or sub-tasks may be delegated to additional servers or
other resources. In some examples, a smart device such as wearable
device 120 or hand-held device 112 may run a single application
that collects, processes, or transmits (e.g., to a server or
another smart device) two types of data (e.g., high-fidelity data
and low-fidelity data, or CGM data and activity data). In another
example, a smart device may run two separate applications that each
collect, processes, or transmits a type of data. In some examples,
a smart device may run separate applications for collection of
data, and one application may receive data from the other
applications (e.g., a CGM application may receive activity
information collected by an activity app.) Information about
inter-application communications is described in U.S. patent
application Ser. No. 15/474,886, U.S. publication number
20170286194A1, which is incorporated by reference.
[0287] In some examples, one smart device may collect information
from another smart device, e.g., the hand-held device 112 may
collect activity information from wearable device 120. In some
examples, a correlation between types of data (further described
below) may be determined by a smart device, or by a server (e.g.,
server 125), or both or a combination thereof.
[0288] FIG. 2 is a schematic illustration of various example
electronic components that may be part of a medical device system
200. In an example, the system may include a sensor electronics 106
and a base 290. While a specific example of division of components
between the base and sensor electronics is shown, it is understood
that some examples may include additional components in the base
290 or in the sensor electronics 106, and some of the components
that are shown in the sensor electronics 106 may be alternative or
additionally (e.g., redundantly) provided in the base. In an
example, the base 290 may include the analyte sensor 104 and a
battery 292. In some examples, the base may be replaceable, and the
sensor electronics 106 may include a debouncing circuit (e.g., gate
with hysteresis or delay) to avoid, for example, recurrent
execution of a power-up or power down process when a battery is
repeatedly connected and disconnected or avoid processing of noise
signal associated with removal or replacement of a battery.
[0289] The sensor electronics 106 may include electronics
components that are configured to process sensor information, such
as sensor data, and generate transformed sensor data and
displayable sensor information. The sensor electronics 106 may, for
example, include electronic circuitry associated with measuring,
processing, storing, or communicating continuous analyte sensor
data, including prospective algorithms associated with processing
and calibration of the sensor data. The sensor electronics 106 may
include hardware, firmware, and/or software that enables
measurement of levels of the analyte via a glucose sensor.
Electronic components may be affixed to a printed circuit board
(PCB), or the like, and can take a variety of forms. For example,
the electronic components may take the form of an integrated
circuit (IC), such as an Application-Specific Integrated Circuit
(ASIC), a microcontroller, and/or a processor.
[0290] As shown in FIG. 2, the sensor electronics 106 may include a
potentiostat 202, which may be coupled to the analyte sensor 104
and configured to recurrently obtain analyte sensor readings using
the analyte sensor, for example by continuously or recurrently
placing a voltage bias across sensor electrodes and measuring a
current flow indicative of analyte concentration. The sensor
electronics may also include a processor 204, which may retrieve
instructions 206 from memory 208 and execute the instructions to
determine control application of bias potentials to the analyte
sensor 104 via the potentiostat, interpret signals from the sensor,
or compensate for environmental factors. The processor may also
save information in data storage memory 210 or retrieve information
from data storage 210. In various examples, data storage memory 210
may be integrated with memory 208, or may be a separate memory
circuit, such as a non-volatile memory circuit (e.g., flash RAM).
Examples of systems and methods for processing sensor analyte data
are described in more detail herein and in U.S. Pat. Nos. 7,310,544
and 6,931,327.
[0291] The sensor electronics 106 may also include a sensor 212,
which may be coupled to the processor. The sensor 212 may, for
example, be a temperature sensor or an accelerometer. The sensor
electronics 106 may also include a power source such as a capacitor
or battery 214, which may be integrated into the sensor
electronics, or may be removable, or part of a separate electronics
package. The battery 214 (or other power storage component, e.g.,
capacitor) may optionally be rechargeable via a wired or wireless
(e.g., inductive or ultrasound) recharging system 216. The
recharging system may harvest energy or may receive energy from an
external source or on-board source. In various examples, the
recharge circuit may include a triboelectric charging circuit, a
piezoelectric charging circuit, an RF charging circuit, a light
charging circuit, an ultrasonic charging circuit, a heat charging
circuit, a heat harvesting circuit, or a circuit that harvests
energy from the communication circuit. In some examples, the
recharging circuit may recharge the rechargeable battery using
power supplied from a replaceable battery (e.g., a battery supplied
with a base component.)
[0292] The sensor electronics 106 may also include a wireless
communication circuit 218, which may for example include a wireless
transceiver operatively coupled to an antenna. The wireless
communication circuit 218 may be operatively coupled to the
processor and may be configured to wirelessly communicate with one
or more peripheral devices or other medical devices, such as an
insulin pump or smart insulin pen.
[0293] The peripheral device 250 may, for example, be a wearable
device (e.g., activity monitor), such as a wearable device 120. In
other examples, the peripheral device 250 may be a hand-held device
112 (e.g., smartphone or other device such as a proprietary
handheld device available from Dexcom), a tablet 114, a smart pen
116, or special-purpose computer 118 shown in FIG. 1.
[0294] The peripheral device 250 may include a user interface 252,
a memory circuit 254, a processor 256, a wireless communication
circuit 258, a sensor 260, a power source 262 (e.g., battery or
capacitor) or any combination thereof. The peripheral device may
not necessarily include all of the components shown in FIG. 2. The
user interface 252 of the peripheral device 250 may, for example,
include a touch-screen interface, a microphone (e.g., to receive
voice commands), or a speaker, a vibration circuit, or any
combination thereof, which may receive information from a user
(e.g., glucose values) or deliver information to the user such as
glucose values, glucose trends (e.g., an arrow, graph, or chart),
or glucose alerts. The processor 256 may be configured to present
information to a user, or receive input from a user, via the user
interface 252. The processor 256 may also be configured to store
and retrieve information, such as communication information (e.g.,
pairing information or data center access information), user
information, sensor data or trends, or other information in the
memory circuit 254. The wireless circuit communication circuit 258
may include a transceiver and antenna configured communicate via a
wireless protocol, such as Bluetooth, MICS, or any of the other
options discussed above. The sensor 260 may, for example, include
an accelerometer (e.g., in an activity monitor such as a watch), a
temperature sensor, a location sensor, biometric sensor, or blood
glucose sensor, blood pressure sensor, heart rate sensor,
respiration sensor, or another physiologic sensor. The device may
include a plurality of sensors of differing types.
[0295] The peripheral device 250 may be configured to receive and
display sensor information that may be transmitted by sensor
electronics 106 (e.g., in a customized data package that is
transmitted to the display devices based on their respective
preferences). Sensor information (e.g., blood glucose concentration
level) or an alert or notification (e.g., "high glucose level",
"low glucose level" or "fall rate alert" may be communicated via
the user interface 252 (e.g., via visual display, sound, or
vibration). In some examples, the peripheral device 250 may be
configured to display or otherwise communicate the sensor
information as it is communicated from the sensor electronics
module (e.g., in a data package that is transmitted to respective
display devices). For example, the peripheral device 250 may
transmit data that has been processed (e.g., an estimated analyte
concentration level that may be determined by processing raw sensor
data), so that a device that receives the data may not be required
to further process the data to determine usable information (such
as the estimated analyte concentration level.) In other examples,
the peripheral device 250 may process or interpret the received
information (e.g., to declare an alert based on glucose values or a
glucose trend. In various examples, the peripheral device 250 may
receive information directly from sensor electronics 106, or over a
network (e.g., via a cellular or Wi-Fi network that receives
information from the sensor electronics or from a device that is
communicatively coupled to the sensor electronics 106.)
[0296] Referring again to FIG. 2, the medical device 270 may
include a user interface 272, a memory circuit 274, a processor
276, a wireless communication circuit 278, a sensor 280, a therapy
circuit 282, or any combination thereof. In some examples, the
medical device 270 may not include all of the components
illustrated in FIG. 2. For example, the medical device may not
include a user interface 272, or may not include a therapy circuit
282, or may not include a sensor 280.
[0297] The user interface 272 may, for example, include a
touch-screen interface, a microphone, or a speaker, a vibration
circuit, or any combination thereof, which may receive information
from a user (e.g., glucose values, alert preferences, calibration
coding) or deliver information to the user, such as e.g., glucose
values, glucose trends (e.g., an arrow, graph, or chart), or
glucose alerts. The processor 276 may be configured to present
information to a user, or receive input from a user, via the user
interface 272. The processor 276 may also be configured to store
and retrieve information, such as communication information (e.g.,
pairing information or data center access information), user
information, sensor data or trends, or other information in the
memory circuit 274. The wireless circuit communication circuit 278
may include a transceiver and antenna configured to communicate via
a wireless protocol, such as Bluetooth, Medical Implant
Communication System (MICS), Wi-Fi, Zigbee, or a cellular protocol
(e.g., CDMA (Code Division Multiple Access) or GSM (Global System
for Mobiles). The sensor 280 may, for example, include an
accelerometer, a temperature sensor, a location sensor, biometric
sensor, or blood glucose sensor, blood pressure sensor, heart rate
sensor, respiration sensor, or another physiologic sensor. The
medical device 270 may include two or more sensors (or memories or
other components), even though only one is shown in the example in
FIG. 2. In various examples, the medical device 270 may be a smart
handheld glucose sensor (e.g., blood glucose meter), a drug pump
(e.g., insulin pump), or any other physiologic sensor device (e.g.,
wearable device 120), therapy device, or combination thereof. In
various examples, the medical device 270 may be the medical device
108, peripheral device 122, wearable device 120, wearable sensor
130, wearable sensor 134, or wearable sensor 136 shown in FIG. 1.
In examples where the medical device 270 is an insulin pump, the
pump and analyte sensor system may be in two-way communication
(e.g., so the pump can request a change to an analyte transmission
protocol, e.g., request a data point or request data on a more
frequency schedule), or the pump and analyte sensor system may
communicate using one-way communication (e.g., the pump may receive
analyte concentration level information from the analyte sensor
system. In one-way communication, a glucose value may be
incorporated in an advertisement message, which may be encrypted
with a previously-shared key. In a two-way communication, a pump
may request a value, which the analyte system may share, or obtain
and share, in response to the request from the pump, and any or all
of these communications may be encrypted using one or more
previously-shared keys. An insulin pump may receive and track
analyte (e.g., glucose) values transmitted from analyte sensor
system 102 using one-way communication to the pump for one or more
of a variety of reasons. For example, an insulin pump may suspend
or activate insulin administration based on a glucose value being
below or above a threshold value.
[0298] In some examples, the system 100 shown in FIG. 1 may include
two or more peripheral devices that each receive information
directly or indirectly from the analyte sensor system 102. Because
different display devices may provide different user interfaces,
the content of the data packages (e.g., amount, format, and/or type
of data to be displayed, alarms, and the like) may be customized
(e.g., programmed differently by the manufacture and/or by an end
user) for each particular device. For example, in the embodiment of
FIG. 1, a plurality of different peripheral devices may be in
direct wireless communication with a sensor electronics module
(e.g., such as an on-skin sensor electronics 106 that is physically
connected to the continuous analyte sensor 104) during a sensor
session to enable a plurality of different types and/or levels of
display and/or functionality associated with the displayable sensor
information, or, to save battery power in the sensor system 102,
one or more specified devices may communicate with the analyte
sensor system and relay (i.e., share) information to other devices
directly or through a server system (e.g., network-connected data
center) 125.
[0299] FIG. 3 shows a table 301 that shows example patient states
305, physiologic conditions 310, and example treatments 315. The
table is arranged to reflect a typical progression of a patient
from a normal state into pre-diabetes and eventually into a
diabetic state (e.g., Type 2 diabetes), which may occur over days,
weeks, months, or years, depending on the circumstances. The
alignment of states, conditions, and treatments in the table is
provided for purpose of explanation and may not be the same for
each patient. In some patients, insulin resistance or insufficient
insulin production by pancreatic .beta.-cells may contribute to the
progression of a patient into pre-diabetes and eventually into Type
2 diabetes. Type 2 diabetes and high blood glucose levels are
associated with risks of myocardial infarction, stroke, vascular
problems and mortality.
[0300] A patient in a normal state may have no problematic
physiologic conditions to be managed, and consequently may need no
treatment. A patient may become insulin resistant due to one or
more of a variety of factors, such as age, diet, lifestyle,
pregnancy, genetic factors, or other factors.
[0301] As a patient becomes insulin resistant, the patient may
begin to experience higher than normal circulating levels of
insulin, known as "hyperinsulinemia." To manage hyperinsulinemia
and insulin resistance, a patient may begin a patient management
regimen, which may include diet and exercise modifications, such as
consumption of fewer calories or fewer carbohydrates (especially
simple sugars and other carbohydrates that may be quickly processed
by the body into glucose) and an increase in activity or amount of
exercise.
[0302] As a patient's condition worsens, the patient may develop
higher than normal blood glucose concentration levels, which is
known as "hyperglycemia." For example, a patient may initially
exhibit post-meal hyperglycemia, in which glucose levels spike to
higher-than-normal levels after consumption of a meal, and then
trend back down as time passes after the meal. Glucose levels that
are higher than normal, but not high enough to trigger a Type 2
diabetes diagnosis may be referred to as "impaired glucose
tolerance." The patient continues with diet and exercise
modifications to address post-meal glycemia or impaired glucose
tolerance, and the patient may also be prescribed an oral
medication. An oral medication may, for example, stimulate the
production of insulin by pancreatic beta cells (e.g., sulfonylureas
or meglitinides), decrease glucose production by the liver (e.g.,
biguanides), improve the operation of circulating insulin (e.g.,
thiazolindinediones), reabsorb glucose in the kidneys (e.g., SGLT2
inhibitors) block the breakdown of starches in the intestine (e.g.,
alpha-glucosidase inhibitors), or prevent the breakdown of
glucose-lowering compounds (e.g., DPP-4 inhibitors). Other oral
medications and combinations of complimentary or compatible
medications are also possible treatments.
[0303] Impaired glucose intolerance can progress into impaired
fasting glucose, in which a patient may have abnormally high
glucose concentration levels not just soon after a meal, but also
when fasting ("fasting hyperglycemia.") For example, a fasting
blood glucose level over 100 mg/dL may be considered prediabetes. A
patient may continue with diet and exercise treatments and oral
medication. The patient may also be prescribed insulin to attempt
to lower glucose levels.
[0304] Information about the patient may also be used to assist
with management of a patient's condition. For example, sensor data,
such as activity data or physiological data (e.g., heart rate or
respiration) may be used to develop guidance for the patient about
management of their health. Information about a patient may be of a
particular physiological type (e.g., glucose information, heart
rate information, respiration information, pulse information,
etc.).
[0305] Despite efforts to control glucose or insulin levels, the
condition of some patients may continue to decline, and they may
eventually progress into Type 2 diabetes. For example, when fasting
(overnight) glucose levels are 126 mg/dL or higher, a patient may
be considered to have type 2 diabetes. Some patients may progress
deeper into diabetes, with glucose levels that continue to
increase, which tends to raise the risk of complications such as
cardiovascular disease, vascular problems, or stroke.
[0306] To help manage glucose levels, prediabetes, or Type 2
diabetes, a patient may benefit from monitoring using a
physiological sensor, such as a continuous glucose monitor. In some
examples, information from other sources, such as data or data
patterns from an activity sensor or blood glucose meter, may be
used to determine whether to begin use of a physiological sensor,
such as a continuous glucose monitor.
[0307] In some examples, a continuous glucose monitor (or other
physiologic sensor) may be used for a trial period (e.g., 3 days, 7
days, 10 days, 14 days, 30 days, or 3 months). In some examples,
information about management of glucose levels may be learned from
a trial period. The learned information from the trial period may
be subsequently applied, optionally in combination with other
information such as activity, location, heart rate, user input
information, or other glucose information (e.g., single-point
glucose data such as blood glucose meter data, glucose data from an
NFC enabled sensor, optical glucose data, or glucose information
collected with another technique) to better manage a patient's
condition. For example, the relationship of patient's activity or
behavior (as deduced from activity, location, heart rate, or user
input information or other information) on a patient's glucose
concentration level may be learned during the trial period, and
this relationship may be later used to determine guidance for the
patient.
[0308] In some situations, a continuous glucose monitor may be used
intermittently. For example, glucose concentration levels may be
collected from a patient using a continuous glucose monitor on a
specified schedule, e.g., a specified number of days, weeks, or
series of days (e.g., 10 days) per quarter month, or year.
Intermittently collected CGM information may be used to actively
manage glucose levels (e.g., in real time), or may be used to
update or refine learned relationship between estimated glucose
levels from a CGM and other information, such as activity.
[0309] FIG. 4 is a flowchart illustration of a method 401 of
progressing from a low-fidelity data collection technique to a
high-fidelity data collection technique. At 405, low-fidelity data
is collected. The low-fidelity data may provide information that is
related to management of a health condition, such as diabetic
health (e.g., control of glucose concentration levels.) In some
examples, the low-fidelity data may provide information that
indirectly relates to diabetic health. The low-fidelity data may,
for example, be activity data (e.g., from a smartwatch or other
wearable sensor), which may indicate the amount of exercise or
movement by a patient. The activity data may be accurate with
respect to activity level, but may be considered low-fidelity in
the sense that it does not provide a high degree of precision about
the condition of a patient from a glucose management or diabetic
condition management perspective, for example because the
low-fidelity data is indirectly related to glucose control or has a
relatively weak correlation with glucose levels, compared to
high-fidelity data. Low-fidelity data may additionally or
alternatively include location, user-input, or other physiological
data (e.g., heart rate or respiration.) In some examples,
low-fidelity data may glucose concentration data, such as
single-point glucose data (e.g., blood glucose meter data), glucose
data from an NFC enabled sensor, optical glucose data, or glucose
information collected with another technique. Low-fidelity data may
also include test results, such as fasting glucose level, or
hemoglobin A1C. The low-fidelity data may be used to conduct a
diabetic health assessment or to provide guidance to a patient to
improve or control their diabetic health condition.
[0310] Additional information may also be collected during
low-fidelity data collection. For example, a system may collect
information regarding use of an activity tracker, food tracker, or
self-monitoring of blood glucose. Patient engagement may also be
collected, such as level of engagement or success in coaching or
goal-setting programs. Preference information may also be
collected, such as a preferred method for viewing and reviewing
health data (e.g. type and timing of app views, chats, and coaching
calls, or a style of learning (e.g. reviewing patterns versus
real-time tracking and interaction), or a preferred graphical style
(e.g., analyzing user interface screen views for examples of
specific types of details examined, or a preference for qualitative
versus quantitative viewing), or a communication style (short
messaging versus videos or reading), or a preferred health metric
(e.g. number of steps, exercise streaks, daily carbs, current app
configuration). One or more goals may also be determined (e.g.
meals choices, exercise, basal or drug titration, or hypo
avoidance). A risk metric for the patient may also be determined,
for example based upon demographics, medical records, average or
fasting glucose levels or post-meal glucose excursion
characteristics. In some examples, a patient may be assigned to a
goal or risk metric based at least in part on a cohort of previous
subjects that had similar starting situations, goals, or
characteristics.
[0311] At 410, high-fidelity data may be collected. During
high-fidelity data collection, low-fidelity data collection may be
suspended, or both low-fidelity and high-fidelity data may be
collected. The high-fidelity data may provide information that is
highly related to management of a patient health condition. For
example, the high-fidelity data may be data from a continuous
glucose monitor. High-fidelity data may be more expensive,
burdensome, or invasive to collect than low-fidelity data, so it
may be necessary to determine a justification for the collection of
high-fidelity data.
[0312] In an example, a determination that the high-fidelity data
collection is needed, or otherwise justified, based at least in
part upon low-fidelity data. For example, low-fidelity information
may be used to determine or identify subjects that are likely to
gain health benefits by transitioning to intermittent or continuous
high-fidelity data collection. Such a determination may be based,
for example, on a risk metric as described above, or another
assessment of a diabetes or cardiovascular risk, or an
identification of glucose concentration patterns that may benefit
from high-resolution information (e.g. high-resolution data for
post-meal rise in glucose concentration, as well as peaks, and
duration or glucose excursions, may be used to understand a meal's
glycemic load and glycemic load), or an identification of a subject
with significant meal-to-meal or day-to-day variation (e.g.,
high-fidelity (e.g., CGM and activity) could correlate glucose
patterns with activity or sleep patterns). A determination to
engage in high-fidelity monitoring may also be based on
identification of a subjects with an upcoming medication change, or
a subject making progress in a coaching plan, or a recommendation
from a coach or other health care providers.
[0313] In some examples, a machine learning technique is used to
determine whether high-fidelity data collection is needed or
justified based at least in part on the low-fidelity data. Any
suitable machine learning technique can be used such as, for
example, a supervised learning model, an unsupervised learning
model, and/or a reinforcement learning model.
[0314] According to a supervised learning technique, a model is
trained using a set of labeled training data. In this example,
labeled training data can include sets of low-fidelity data and
labels indicating whether each set of low-fidelity data justifies
high-fidelity data collection. A trained supervised learning model
can receive low-fidelity data and generate an output indicating
whether the received low-fidelity data indicates high-fidelity data
collection is needed or justified. Example supervised learning
models that can be used include classification algorithms such as
logistic regression algorithms, naive Bayes classifiers, support
vector machines, decision tree algorithms, boosted tree algorithms,
random forest algorithms, some neural networks, nearest neighbor
algorithms, and so on.
[0315] According to an unsupervised learning technique, a model is
generated using low-fidelity training data that may not be labeled.
The model identifies instances of low-fidelity data that are
similar to one another. The model can then be used to identify
low-fidelity data that is similar to previous instances of
low-fidelity data that needed or justified high-fidelity data
collection. Examples of unsupervised learning algorithms that can
be used include clustering algorithms, anomaly detection
algorithms, latent variable models, and some neural networks.
[0316] According to a reinforcement learning technique, a
reinforcement learning model can be provided with low-fidelity data
and can make a determination of whether the low-fidelity data
justifies high-fidelity data collection. The reinforcement learning
model can bet provided with feedback indicating whether the
determination is correct and can use the feedback to improve its
performance. Example reinforcement learning models that can be used
include Q-learning algorithms, Sarsa algorithms, Markov decision
process algorithms, and so on.
[0317] A determination to initiate collection of high-fidelity data
may be based at least in part on collection of information from an
activity sensor worn on the patient. For example, the determination
to initiate collection of high-fidelity data may be based upon
satisfaction of an activity condition. For example, the activity
condition may include evidence that a patient exhibits activity in
excess of a threshold, or that the patient periodically
participates in some kind of exercise (e.g., walking, running, or
activity in excess of a specified baseline) on a sufficiently
frequent basis). In other examples, a determination to initiate
high-fidelity data collection may be based on blood glucose meter
data (e.g., satisfaction of a blood glucose condition, such as
determinization that an average blood glucose level exceeds a
threshold, or a specified number of glucose readings over a
threshold) or location (e.g., frequent visits to an exercise
facility or an unhealthy restaurant). A determination may also be
based on a combination of two or more types of low-fidelity data.
For example, activity and blood glucose meter data may be used in
combination, or activity and location may be used in combination,
or blood glucose meter data and location may be used in
combination. In an example, a determination that blood glucose
levels (as determined for example by a blood glucose meter) respond
to a secondary factor such as activity (e.g., activity reduces
blood glucose levels) or a location (e.g., blood glucose levels
fall or are more controlled after a visit to a park or gym, or
blood glucose levels rise or are less controlled after a visit to
fast food restaurant.)
[0318] A characteristic of the high-fidelity data collection 410
may be based at least in part on the low-fidelity data collection.
For example, a system may estimate a duration or schedule (e.g.,
intermittent period) for high-fidelity monitoring and may initiate
shipment of required supplies (e.g., a CGM sensor) according to the
schedule, or determine a quantity for shipment (e.g., how many CGM
sensors to ship). In some examples, a high-fidelity system (e.g.,
CGM system) may be preconfigured, based at least in part on
low-fidelity data, to match a subject's needs. For example, one or
more preferred metrics for a current health goal or goals may be
selected or ranked, or a system may automatically reconfigure a
coaching system (e.g., a chat bot or other coaching application
running on a smart device, such as a watch) with preferred or
specified information, such as enhanced glucose metrics. In some
examples, a system may integrate enhanced glucose metrics (e.g.
meal metrics) to one or more specified (e.g., most viewed)
application screens or devices (e.g. display on a watch). A system
may inform a patient management facilitator, such as a human coach
or a chat bot, about patient-management related information, such
as when high-fidelity data is available, or specified metrics to
highlight for a subject. A system may also determine guidance or
other patient management factors based on behavioral learnings
about a subject, such as timing and types of messaging, such as
delivery of information about a post-meal recap (e.g., extent or
nature of glucose level control or loss of control), an exercise
benefit, an improvement with medicine changes, or adherence, or to
conduct an information-gathering period. A system may also
determine a goal (e.g., target for time-in-range) based upon
low-fidelity data. Any of the guidance examples described above or
below may be employed in the method 401.
[0319] FIG. 5 is a flowchart illustration of a method 501 of
collecting high-fidelity data and collecting low-fidelity data. At
505, high-fidelity may be collected. The high-fidelity data may be
used for a diabetic health assessment or for improvement of
diabetic health (e.g., to obtain better control of glucose
concentration levels or patterns), or both. The high-fidelity data
may be CGM data, or any of the other examples of high-fidelity data
described above or below.
[0320] At 510, low-fidelity data may be collected for diabetic
health assessment or improvement of diabetic health (or both). The
low-fidelity data may be activity data, or any of the other
examples of low-fidelity data described above or below. In some
examples, the low-fidelity data collection may be based at least in
part on the high-fidelity data collection. In some examples, an
insight from high-fidelity data collection may be used to inform
app functionality, graphic and phone apps. For example, a time to
obtain low-fidelity data (e.g., check glucose level using a meter)
may be determined, for example to capture high or low glucose
concentration values.
[0321] In some examples, at 515 guidance may be delivered to the
patient to improve diabetic health. For example, a subject (e.g.,
patient) may be educated or reminded about the importance of
exercise or dietary choices, or a patient may be congratulated or
otherwise recognized for an achievement such as an exercise goal or
glucose control condition (e.g., maintain a glucose level in a
specified range.) Patient guidance may be based in part on the
high-fidelity data. For example, a patient may be informed that
glucose levels tend to rise or fall, or tend to rise or fall a
certain amount, at a particular time of day (e.g., a glucose level
may tend rise in the morning) or around the time of a particular
event (e.g., a glucose level may peak a certain amount of time
after a meal.)
[0322] In some examples, high-fidelity data collection stage may
personalize metrics, guidance or other information relating to
management of a physiologic condition of a patient, such as
glycemic health. For example, an insight based on high-fidelity
monitoring may be used to inform app functionality, graphic or a
smart device application. In some examples, health concepts (e.g.,
potential guidance or action to be taken by a subject may be ranked
or quantified for potential health impact, a list of patient
management options may be formed into a personalized list for a
subject, e.g., by determination of one or more estimates of a
quantifiable benefit on a physiological outcome (e.g., achievement
of a glucose concentration range, goal, time-in-range, or A1C.) For
example, one or more patterns (e.g., dietary choice, exercise or
activity, or sleep) that result in a benefit (e.g., better glucose
control) may be determined based at least in part on high-fidelity
data. In some examples, a correlation may be determined between a
glucose concentration level and one or more lifestyle factors
(e.g., activity (e.g., steps), meal timing, or food choice.)
[0323] Guidance may be based on a correlation determined at least
in part from high-fidelity data, such as a correlation between
glycemic health and another measurable feature or pattern. For
example, guidance may be based on a correlation with exercise and
activity amount and intensity with glucose improvements (e.g. how
many minutes or steps were shown to reduce glucose by 20 mg/dL), or
a correlation with food and dietary choices and glucose
improvements (e.g. which foods caused large glucose spikes).
[0324] In some examples, a glucose metric, glucose excursion (e.g.,
deviation from a desired range) or glucose profile (e.g., glucose
concentration pattern) may be determined from low-fidelity data and
previously-collected high-fidelity data (e.g., using a correlation
between the low-fidelity data and high-fidelity data).
[0325] The use of high-fidelity data as described can increase the
performance of devices that measure and/or utilize low-fidelity
data. For example, low-fidelity data alone may be used to provide
generalized guidance to a user, for example, by comparing activity
levels or other low-fidelity data to generalized guidelines or
standards. Using high-fidelity data in conjunction with
low-fidelity data, as described herein, can allow the devices to
provide user guidance that is tailored to the individual user and,
therefore, more likely to provide meaningful results, such as
achievement of a glucose concentration range, goal, time-in-range,
or A1C.
[0326] FIG. 6 is a flowchart illustration of a method 601 of
collecting low-fidelity data and intermittently collected
high-fidelity data. At 605, low-fidelity data is collected. The
low-fidelity data may be activity, blood glucose meter data, or any
of the low-fidelity examples identified above or below.
[0327] At 610, high-fidelity data is collected. During a period in
which high-fidelity data is collected, collection of low-fidelity
data may continue, or collection of low-fidelity data may be
suspended. Preferably, collection of low-fidelity continues during
for at least a portion of the high-fidelity data collection period,
so that both high and low-fidelity data are collected during an
overlapping period. A relationship (e.g., correlation) between
low-fidelity data and high-fidelity data may be determined from
data collected during the overlapping period. For example, the
relationship between low-fidelity data and high-fidelity data can
be found using a machine learning technique, such as, for example,
the techniques described herein.
[0328] The method may return to low-fidelity data collection 605
during a subsequent low-fidelity data collection period, during
which time guidance for a patient may be determined based upon the
low-fidelity data and a determined relationship between the
high-fidelity data and the low-fidelity data. In some examples, the
low-fidelity data may be used as a surrogate for the high-fidelity
data in determining patient guidance. The process may cycle between
a low-fidelity collection period at 605 and a high-fidelity
collection period at 610, so that high-fidelity data is
intermittently collected. The intermittent high-fidelity data may
be used to refine or update (e.g., recalibrate) a determined
relationship between the high-fidelity data and low-fidelity data.
In some examples, the process may return to high-fidelity
collection at 610 responsive to a detected or reported change in
health (e.g., a change in glucose concentration levels, weight,
activity, or a new diagnosis.) In some examples, high-fidelity data
is collected periodically (e.g., once a quarter, once a year,
etc.). Upon the collection of a new set of high-fidelity data, the
relationship or correlation between low-fidelity data and
high-fidelity data can be updated and patient guidance revised.
[0329] FIG. 7 is a flowchart illustration of a method 701 of
managing a patient condition. At 705 a patient is identified for
screening from a patient pool. The patient pool may, for example,
include a group of patients at a clinical practice, or in a
specified insurance pool or program, or in a geographic location,
or at a workplace, or any combination thereof. For example, a pool
of 100, 10,000, or 100,000 patients may be identified.
[0330] At 710, the patient's condition or health history is
evaluated for diabetes or diabetes risk factors. For example, the
patient's weight, body mass index, family history, genetic markers,
prescription history (e.g., prescribed medications), medical
history (e.g., diagnosis of type 2 diabetes or another metabolic
disease, which may be determined for example from electronic health
record codes or other data) test results (e.g., A1C, fasting
glucose level, oral glucose tolerance), other metabolic diseases,
or other factors may be evaluated to identify a potential for
diabetes, prediabetes, or risk factors that may indicate a
vulnerability to development of diabetes. Exclusion criteria may
also be applied, such as a type 1 diabetes diagnosis, or type 2
diagnosis with intensive insulin therapy. In some examples, the
screening may generate a simple yes/no output. In some examples, a
subset of 10% of patients in the pool (e.g., 10,000 out of 100,000)
may be identified as candidates for enrollment in an enhanced
diabetes management program. In other examples, more granular
output may be provides, such as a classification as type 1
diabetes, type 2 diabetes, gestational diabetes, or a
classification of type 2 diabetes in terms of disease progression
or glycemic control (e.g., prediabetes, early type 2, or full type
2), or quantification of disease progression (e.g., on a scale of 0
(normal glucose tolerance) to 9 (persistent uncontrolled
hypoglycemia or hyperglycemia.)
[0331] At 715, an enrollment selection is performed to determine
whether the patient will be enrolled in a diabetes management
program. An enrollment selection may occur, for example, in
response to satisfaction of an enrollment condition, which may be
based upon additional screening input, an additional review of
current or previous medications, diabetes progression,
effectiveness of previous treatments, predicted disease
progression, adherence or participation in previous health
promotion programs (e.g., exercise or medication compliance), or
any of the factors described above (weight, BMI, family history,
etc.). In some examples, a score or other prediction may be
determined based on a future diabetes risk or a cost if the patient
were to continue on a current diabetes management program.
Additionally, or alternatively, a score or other prediction may be
determined based upon a calculated potential benefit or prediction
of success of an enhanced diabetes program. In some examples, a
weighted score may be determined based upon a combination of a
potential health risk or cost (or both) and a potent benefit (e.g.,
cost savings or impact on patient heath). Based on the scores or
other information described above, the enrollment selection may
determine a patient assignment for enrollment at 725 in an enhanced
diabetes patient management program or for continuation of a
current diabetes management program at 720. The identification at
705, evaluation at 710, and enrollment selection at 715 may be
performed by one or more decision systems, such as execution of an
algorithm on a computer system or mobile device, such as one or
more of the devices shown in FIGS. 1 and 2. If the patient is not
selected for enhanced diabetes management program at 720, the
method returns to patient selection from the patient pool.
[0332] At 725, a patient may be enrolled in an enhanced diabetes
management program. In an example, a diabetes management system may
enroll the patient in the enhanced diabetes management program,
e.g., in response to satisfaction of an enrollment condition. At
730, a data-driven patient management process may be performed. For
example, data such as activity (e.g., using a wearable device),
blood glucose meter data, user-input data (e.g., food or drink
selection), location, or physiological data (e.g., heart rate or
respiration) may be used to determine guidance for a patient
regarding management of their physiologic condition. Activity data
measured by a wearable device can include, for example, data
captured using an accelerometer of other motion sensor associated
with the wearable device. The guidance may, for example, educate or
remind a patient about exercise or dietary selection, or may
congratulate or otherwise recognize a patient for an achievement
(e.g., completion of exercise, or exercising on a specified number
of consecutive days, or a specified number of days in a time period
(e.g. three times per week or 10 times per month), or congratulate
or otherwise acknowledge a positive dietary choice (e.g., selection
of a healthy meal or a restriction of caloric intake.) In some
examples, the enhanced diabetes management may include collection
and correlation of low-fidelity and high-fidelity data, such as
described above in reference to FIG. 4, 5, or 6 and described below
in reference to FIGS. 8B and 8C.
[0333] At 735, a determination is made as to the data-driven
patient management. For example, the determination may be based on
satisfaction of a diabetes management condition. The diabetes
management condition may, for example, be based on one or more of
an amount (e.g., percentage) of time that a blood glucose (e.g., as
determined by a blood glucose meter) is in a target range (e.g.,
70-160 mg/dL), a level of glycated hemoglobin or hemoglobin A1c in
the blood (e.g., A1C test result), other diagnostic tests, a change
in BMI, weight, or body composition (e.g., body fat percentage),
cardiovascular health, or other factors or diagnostic tests. The
determination may be made, for example, by a computer system that
is configured to determine from collected data whether the diabetes
management condition is satisfied. In some examples, the computer
system may apply data inputs to a model, which may be based upon a
particular patient, or a population. The model output may include a
satisfaction state (e.g., satisfied or not satisfied) or a
prediction about a future health state (e.g., patient health likely
to improve, or patient health likely to be steady, or patient
health likely to deteriorate.)
[0334] If the diabetes management condition is satisfied, the
method may return to data-driven patient management at 730, and a
system may continue with a previous patient management scheme, or
may implement an improvement (e.g., more frequent data collection
or more aggressive guidance), which may be based upon the
determination at 735 or information used in making the
determination.
[0335] If the diabetes management condition is not satisfied at
735, the process may progress to a stronger patient management
scheme at 740. For example, the process may begin collecting or
receiving continuous glucose monitoring information. For example,
information from a continuous glucose monitor on a patient may be
used to determine patient guidance. The CGM data may be combined
with other sources of data to determine guidance. In some examples,
the CGM-driven patient management scheme may use intermittent CGM
data. For example, CGM data may be collected during a first period,
and data collected during the first period may be used (optionally
in combination with other non-CGM data) to determine guidance for a
patient for a second time period in which CGM data is not
available. In some examples, the CGM-driven patient management may
include an ongoing cycle of intermittent CGM usage, such as
implementing CGM data collection for a specified number of times
per a specified time period (e.g., one week or ten days or two
weeks per month, per quarter, or per year.) Intermittent CGM usage
may reduce the cost of managing the patient. For example,
intermittent CGM usage may be less expensive than non-intermittent
(e.g., continuous) use of a CGM, because intermittent CGM data
collection requires fewer sensors and only intermittent monitoring
service via a CGM server. Intermittent CGM usage may also reduce
the cost of managing the patient, compared to no CGM usage, by
providing additional insights on management of glucose
concentration levels for the patient and slowing or stopping the
progression into Type 2 diabetes, which may both reduce overall
health care expenses and improve the outcome (e.g., improve health)
for the patient.
[0336] In some examples, after a period of CGM-driven patient
management, the process may return to data-driven patient
management at 730, at which point the collection of CGM data may be
stopped, and the patient may be managed based upon non-CGM
information. Information collected during the CGM-driven patient
management 740 may be used to manage the patient (e.g., to
determine guidance for the patient) during the data-driven patient
management 730 in which CGM data is not available. For example, a
relationship (e.g., correlation) between CGM information and
non-CGM information may be used to infer an estimated glucose
concentration level or range from non-CGM data.
[0337] In various examples, all of the steps in the process may be
performed by a patient management system, which may collect, store,
and analyze data about a patient. In some examples, data-driven
patient management 730 may include collection of low-fidelity data,
and the second stage of patient management 740 may include
collection of high-fidelity data. While CGM data is provided as an
example, it is understood that other sources of high-fidelity data
may also be used, and that the example method may also be adapted
to management of other diseases in addition to or instead of
managing a diabetes or pre-diabetes condition.
[0338] FIG. 8A is a flowchart illustration of a process 801 of
management of a first patient. At 805, Patient 1 is selected. At
810, an enrollment determination is made, for example by
application of an enrollment algorithm by a computer system, which
may use health data as described above (e.g., height, weight, body
mass index, blood glucose levels). At 815, a determination is made
to maintain a current patient management program, which may for
example include periodic testing and delivery of guidance at
regular checkups, without ongoing data collection between checkups.
The regular checkup may be a doctor's office visit or may be an
electronic checkup based upon known or periodically (e.g.,
semi-annually or annually) collected information about the patient.
In some examples, each of the steps in the management of Patient 1
may be conducted by a patient management system, which may receive
or collect information about the patient and make one or more
determinations based on patient data (e.g., apply an algorithm or
apply data to a model).
[0339] FIG. 8B is a flowchart illustration of an example process
803 of management of a second patient. At 830, Patient 2 is
selected for evaluation. At 835, an enrollment determination is
made, for example by application of an enrollment algorithm by a
computer system, which may use health data as described above
(e.g., height, weight, body mass index, blood glucose levels). At
840, Patient 2 is enrolled in a stage 1 coaching scheme in which,
for example, guidance may be provided to the patient, e.g., via a
handheld device or watch, based on low-fidelity data. For example,
a chat bot functionality, as described herein, can be used to
provide guidance to the patient. At 845, low-fidelity data is
collected, and coaching or other guidance is determined based at
least in part on the low-fidelity data. At 850, a therapy selection
is made. The therapy selection 850 may be based at least in part on
the low-fidelity data. The therapy may, for example, include
initiation of a therapy, such as insulin delivery (e.g., via a
smart insulin pen) or initiation of an oral medication. In some
examples, the therapy selection may include guidance to deliver a
specific bolus of medication (e.g., consider an insulin injection
now) or to partake in an activity (e.g., take a walk or run to
lower your glucose level.) At 855, low-fidelity monitoring and
coaching is continued for Patient 2.
[0340] FIG. 8C is a flowchart illustration of an example process
805 of management of a third patient. At 860, Patient 3 is selected
for evaluation. At 865, an enrollment determination is made, for
example by application of an enrollment algorithm by a computer
system, which may use health data as described above (e.g., height,
weight, body mass index, blood glucose levels). At 870, Patient 3
is enrolled in a stage 1 coaching scheme in which guidance may be
provided to the patient, e.g., via a handheld device or watch. At
875, low-fidelity data is collected for Patient 3, and coaching or
other guidance for Patient 3 is determined based at least in part
on the low-fidelity data. The coaching and/or other guidance can be
provided to Patient 3 via the hand-held device 112, for example,
utilizing a chat bot, video, animation, or other user interface
mode. At 880, a therapy selection is made. The therapy selection
880 may be based at least in part on the low-fidelity data. The
therapy selection may be an initiation of a therapy such as an
insulin injection program or oral medication. The therapy selection
may in some cases be a determination to engage the patient in a
stage 2 coaching scheme that may be based at least in part on
collected high-fidelity data (e.g., CGM data) regarding the
patient. For example, the factors or process steps described above
in reference to FIG. 4 may be applied in the low-fidelity
monitoring 875 or therapy selection 880.
[0341] At 885, the patient may be enrolled in the stage 2 coaching
program. At 890, high-fidelity monitoring may be performed. For
example, CGM data may be received or collected. In some examples,
high-fidelity data may be analyzed to determine whether the data
satisfies a condition (e.g., statistical metric) for correlation or
identification of a pattern or one or more correlations. In some
examples, a machine learning technique may be used, as described
herein. At 895, low-fidelity monitoring may be performed, and
coaching or other guidance may be delivered to a patient (e.g., via
an interface on a user device such as smart phone or watch.) In
some examples, the guidance at 895 may be based at least in part on
high-fidelity data (e.g., CGM data) collected during a
high-fidelity data collection period or based on a relationship
between high-fidelity data and low-fidelity data.
[0342] FIG. 9 is a flowchart illustration of a process for
monitoring a patient using a primary monitoring technique and a
secondary monitoring technique. The primary technique may include
receipt or collection of a first type of data ("primary data" or
"first data"), and the secondary technique may include receipt or
collection of a second type of data ("secondary data" or "second
data"). For example, the primary monitoring may include collection
or receipt of high-fidelity information about a patient and the
secondary monitoring may include collection or receipt of
low-fidelity information about the patient. In an example where the
patient is a diabetic patient, the primary technique may, for
example, include continuous glucose monitoring. The secondary
technique may, for example, include receipt or collection of
activity information, location information, user input information,
or glucose concentration information (e.g., single-point glucose
data such as blood glucose meter data, glucose data from an NFC
enabled sensor, optical glucose data, or glucose information
collected with another technique).
[0343] At 902, primary monitoring is performed to collect first
data of a first type during a primary monitoring period. In some
examples, the monitoring may include receiving the first data from
a sensor system, such as a continuous glucose monitoring system. In
some examples, the monitoring may include receiving a sensor signal
from a sensor circuit and processing the sensor signal to generate
at least a portion of the first data.
[0344] At 904, secondary monitoring is performed to collect second
data of a second type during a secondary monitoring period. The
secondary monitoring period may overlap, in an overlapping time
period, with all or a portion of the primary monitoring period. In
some examples, the monitoring may include receiving the second data
from a second sensor system. In some examples, the secondary
monitoring may include receiving a sensor signal from a sensor and
processing the sensor signal to generate at least a portion of the
second data.
[0345] In some examples, the secondary monitoring may include
monitoring activity using a wearable fitness tracker. The wearable
fitness tracker may include, for example, a wearable heart rate
monitor, a wearable activity monitor, a smart phone, smart glasses,
or a smart watch.
[0346] In some examples, the second data may include user input
data. For example, the user input data may include medicament data,
meal data, exercise data, sleep data, or any combination
thereof.
[0347] In some examples, the first data may include an estimated
glucose concentration level, and the data of the second type may
include one or more detected physiologic signals, such as heart
rate, oxygen concentration, skin tone, moisture content on skin,
activity, activity pattern, blood ketone concentration level, urine
ketone concentration level, respiration.
[0348] At 906, a correlation between the first data and the second
data is determined. The correlation may be a positive correlation,
or a negative correlation. The correlation may be determined, for
example, by determining a pattern or relationship between a
plurality of data points in the first data and a plurality of data
points in the second data that corresponds to the first data (e.g.,
corresponding to the same point in time, or time-shifted such to
recognize a change in the first data after a change or event in the
second data, or time-shifted such to recognize a change in the
second data after a change or event in the first data.) In various
examples, the correlation may be calculated, e.g., using a
processor and data retrieved from storage in a memory circuit. In
some examples, the correlation may be determined using a processor
by retrieving stored data from memory and using a machine learning
technique based upon at least some of the stored data. In some
examples, determining a correlation may include determining a
relationship between the obtained first and the second data at
corresponding times of day and/or days of the week within the
overlapping time period. For example, a processor may determine
from stored data that a glucose concentration level tends to trend
high (e.g., over 150 mg/dL during morning hours (e.g., 7-10 AM or
for three hours after waking), but that the glucose concentration
does not trend high, or trends less high (e.g. glucose
concentration under 126 mg/DL), on days where a patient takes an
early morning walk.
[0349] In some examples, a correlation is based on multiple types
of secondary data. For example, a model may be learned to determine
a relationship between activity, heart rate, and estimated glucose
concentration level (e.g., as determined using a CGM system).
[0350] In some examples, the method may include, at 908,
determining a therapy or a monitoring scheme using the correlation
and the primary data. For example, the secondary data may include
single-point glucose monitoring (e.g., a blood glucose meter
reading), and the method may include calculating, based at least in
part on the primary data, a time window (e.g., optimal window or
recommended window) to take a single-point glucose measurement. In
some examples, obtaining one or more well-timed single-point
glucose measurements may allow for an accurate determination of one
or more estimated glucose concentration levels (e.g. a specific
level or a range) between measurements, e.g., based on or more of:
an interpolation technique, the determined correlation, additional
types of secondary data (e.g., heart rate or activity), or any
combination thereof. In some examples, the method may include
determining a time window for obtaining or using non-glucose
information, such as activity information, heart rate information,
or user input. The method may further include prompting a user
(e.g., patient) to obtain a measurement (e.g., check blood glucose
with a blood glucose meter) or attach a sensor (e.g. put on a
wearable activity monitor). The prompt may be delivered through a
smart device such as a watch or handheld device.
[0351] At 910, the process may include an additional period of
secondary monitoring. The secondary monitoring 910 may occur during
a time period when primary monitoring is not occurring. The
secondary monitoring may include obtaining a single-point glucose
measurement (or other sensor information or user input) at a time
determined in step 908.
[0352] At 912, the process may include determining diabetic
information using the determined correlation (from step 906) and
secondary data (from step 908.) In various examples, the diabetic
information may include an estimated value for data of the first
type at the subsequent time, a state of the patient, or a patient
insight. The state of the patient or the patient insight may, for
example, be related to a lifestyle modification relating to diet,
exercise, glucose level monitoring, or medication. In some
examples, the state of the patient or the patient insight may be
related to mealtime management, exercise management, or sleep
management.
[0353] In an example, when the primary data is an estimated glucose
concentration level (e.g., from a CGM), an estimated glucose
concentration level may be determined from the secondary data based
on the determined (e.g., learned) relationship between the
secondary data and the estimated glucose concentration level. In an
example, the secondary data is or includes physiologic information
(e.g., activity data, heart rate data), or both, and an estimated
glucose concentration level or range (real time or average for a
specified time period) is determined using the determined
relationship and the physiologic information.
[0354] In some examples, the method may include intermittently
monitoring the first type of data (e.g., CGM data) and determining
diabetic information using the second data (e.g., activity or
single-point blood glucose, or both) and the correlation during one
or more periods of time when the first type of data is not
available. For example, the monitoring 902 data of the first type
may include continuous glucose monitoring, and the monitoring data
904 of the second type may include monitoring activity data with a
wearable accelerometer. The wearable accelerometer may be
configured to monitor data when the continuous glucose monitoring
is not occurring.
[0355] At 914, the method may include delivering guidance or
therapy. For example, the method may include displaying diabetic
information about the patient on a user interface of a patient
device, such as a handheld device, a watch, or on a display on
wearable glasses. Displaying diabetic information may include, for
example, displaying a recommended dietary modification or lifestyle
modification on a user interface.
[0356] In some examples, the method may include at 914
administering a treatment based at least in part on the determined
diabetic information. The treatment may include, for example, a
pharmaceutical intervention, such as an oral medication or a
medication delivered through a pump.
[0357] In some examples, the method may include primary monitoring
during a third time period at 916.
[0358] At 918, the correlation may be updated based at least in
part on primary data gathered during the primary monitoring during
the third time period at 916. In some examples, the secondary
monitoring step 910 may extend at least part way through the
primary monitoring during the third period 916, and the correlation
may be updated based upon the secondary monitoring 910 and the
primary monitoring 916.
[0359] At 920, the method may include secondary monitoring 920
during a fourth time period. The method may return to step 912, and
diabetic information may be determined using the updated
correlation (from step 918) and the secondary monitoring data from
step 920. The process may deliver guidance or therapy at 914,
perform primary monitoring at 916, update the correlation at 918,
again perform secondary monitoring 920, and return again to step
912, resulting in intermittent primary monitoring as the process
cycles through the method steps.
[0360] In various examples, any of the steps in the method 901 may
be omitted or combined with other steps. For example, step 912 may
be omitted, or may be combined with step 910, or step 910 may occur
after step 912.
[0361] FIG. 10 is a flowchart illustration of an example method
1001 of determining and notifying a patient about diabetic
information. The method 1001 may be executed on a system, such as
the system 100 shown in FIG. 1. At 1002, an estimated glucose
concentration level may be received from a continuous glucose
monitoring (CGM) system for a first time period. The method may
optionally include detecting the estimated glucose concentration
level using a CGM sensor. The first time period may, for example,
be a number of days (e.g., 7 days, 10 days, or 14 days) or weeks
(e.g., four weeks or ten weeks). For example, a patient may be
enrolled in a CGM study to gather information about the patient's
response to various stimuli, such as oral medication, exercise, or
activity.
[0362] At 1004, non-CGM information relating to the patient may be
received for the first time period. The method may optionally
include detecting the non-CGM information using a sensor. In some
examples, the non-CGM information may include activity information,
location information, or user input data. In some examples, the
non-CGM information may include physiologic information about the
patient. The physiologic information may, for example, include one
or more of heart rate, respiration, oxygen concentration, skin
tone, moisture content on the skin, activity, activity patterns,
blood ketones, urine ketones, respiration, or acoustic
information.
[0363] At 1006, a relationship between the estimated glucose
concentration levels and the non-CGM information is determined. For
example, a correlation may be calculated between the non-CGM
information and the estimated glucose concentration levels. In some
examples, a model may be learned from collected CGM and non-CGM
data, such that an estimated glucose concentration level may be
determined from non-CGM data by applying the non-CGM data to the
model.
[0364] At 1008, non-CGM information relating to the patient for a
second time period may be received. The second period may be a
period in which estimated glucose concentration levels are not
available from a CGM. At 1010, diabetic information about the
patient for the second time period may be determined based upon the
determined relationship and the non-CGM information.
[0365] Determining diabetic information about the patient may
include determining a patient state. Determining a patient state
may include applying the non-CGM information to a model. In some
examples, determining diabetic information may include determining
an estimated glucose concentration level. For example, an algorithm
may infer an estimated glucose concentration level from activity
information that is calibrated to glucose concentration levels at
an individual level (e.g., based on information about the patient)
or at a population level, or both (e.g., using a predictive
learning model.)
[0366] In some examples, determining diabetic information may
include determining a qualitative rating, such as green, yellow,
red, or "good control," "moderate control," poor control."
[0367] In some examples, determining diabetic information may
include determining a quantitative metric. The quantitative metric
may, for example, be an estimate of an amount or percentage of time
that a glucose concentration level was in range during a specified
time period. In some examples, a quantitative metric may not be
available in real time. For example, a quantitative metric may
include time-in-range for a specified period of time (e.g., a day,
or a number of hours), which may be reported at the end of the day
or intermittently, such as, for example, hourly, daily, weekly,
etc.
[0368] At 1012, the system may electronically notify the patient
about the diabetic information. For example, the system may present
a notification (e.g., word(s) or symbol) on display of a hand-held
device, smart watch, glasses, or other wearable electronic item, or
the system may present a sound notification (e.g., verbal message
or sound) or tactile notification (e.g., vibration) on a speaker of
such a device. In examples in which a sound notification is used,
the sound notification can be provided by a chat bot implemented,
as described herein. In some examples, the notification is related
to the severity of the diabetic information. Consider an example in
which the non-CGM information is indicative of a hypoglycemic
condition. The system may present a notification that is more
severe to indicate urgency. For example, the system may present a
high frequency or high duration sound, a verbal message presented
at increased cadence or volume and/or a tactile notification of a
high duration and/or amplitude. Consider another example, in which
the non-CGM information is indicative of a normal or favorable
blood glucose level. The system may present a notification that is
less severe such as, for example, a lower frequency or lower
duration sound, a verbal message presented at a reduced cadence or
volume, and/or a tactile notification of a shorter duration and/or
amplitude.
[0369] The system may improve patient management by, for example,
managing the cost incurred by continuous glucose monitoring, or
enabling glucose estimation to motivate a user (e.g. patient) to
take steps to manage glucose levels. For example, utilizing low and
high-frequency data in the manner described, by example, with
respect to the example method 1001, can provide the benefits of
high-fidelity data collection at reduced cost. For example, because
the performance of the system during low-fidelity data collection
may be comparable to the performance during high-fidelity data
collection, it may not be necessary to perform higher-cost
high-fidelity data collection as often. Also, glycemic control for
the patient can be improved, for example, with the cost of
full-time high-fidelity data collection.
[0370] FIG. 11 is a flowchart illustration of an example method of
determining a monitoring scheme based on collected sensor
information, which may for example indicate qualities about the
engagement or behavior of a patient. For example, a decision to use
CGM sensing, a CGM sensing parameter (e.g., a schedule or quantity
of CGM sensing), a user interface parameter (e.g., type or content
of guidance), or a goal (e.g., glucose target range or A1C target)
may be determined based on activity data or other collected
information.
[0371] The method 1101 may include, at 1102, monitoring a first
sensor input to obtain first data of a first type. For example, the
method 1101 may include monitoring patient data of a first type
with a low-fidelity monitoring technique over a first time period.
In various examples, the low-fidelity technique may include
receiving user input data, such as medicament data, meal data,
exercise or activity data, sleep data, or any combination
thereof.
[0372] The monitoring of the first sensor input may include, for
example, activity monitoring, single point blood glucose monitoring
(e.g., monitoring using blood glucose meter information), optical
glucose monitoring (e.g., using a watch with an optical sensor), or
"blinded CGM" (e.g., continuous glucose monitoring where estimated
glucose levels are not presented to a patient, e.g., glucose levels
are transmitted to a server or stored in memory of a CGM or device
local to the patient, for later analysis.) In some examples,
monitoring the first sensor input may include activity monitoring
by a wearable fitness tracker, such as a wearable heart rate
monitor, activity monitor, smart phone, smart glasses, or smart
watch.
[0373] The method 1101 may further include at 1104 evaluating
patient engagement or behavior based on the monitored first type of
patient data. For example, a remote system (e.g., server executing
algorithms) or local system (e.g., handheld device) may evaluate a
user's aptitude or preferences with respect to the complexity or
number of features available on the user interface. A sophisticated
or highly-engaged user may prefer a more complex or full-feature
interface than a less-sophisticated or less-engaged user. Such a
determination may be made, for example, based on the frequency of
interactions with a device (e.g., handheld device or watch),
timeliness of interactions, relevancy of interactions (e.g.,
responsiveness to alerts), compliance with guidance (e.g.,
partaking in exercise in response to guidance to do so), or
interaction with another application (e.g., based on an interaction
with a fitness tracker application.)
[0374] The method may include at 1106 determining a monitoring
scheme based on an evaluation of patient engagement or behavior.
For example, the method may include determining a hardware or
software functionality of a device. The hardware or software
functionality may, for example, correspond to operation of a user
interface. In some examples, the determined functionality may
include a simple or light-featured interface, which may be applied
in response to identifying, as part of the evaluation, a
low-engagement patient or a patient who may benefit from a less
complex interaction. The determined functionality may also include
a relatively complex or full-featured interface, which may be
applied in response to identification of a highly-engaged user, or
a user (e.g., sophisticated user) who may prefer a more complex
interface (e.g., an interface that includes more features or
provides more configuration options, such as programmable alerts or
more frequent guidance.) In some examples, the user interface may
additionally or alternatively adapt based at least in part on the
age or date (e.g., year) of birth of a user. For example, the user
interface may use larger fonts or user interface elements (e.g.,
buttons) or a different presentation scheme (e.g., more contrast or
a specified color scheme) for older users. In some examples, a user
interface may provide a visual challenge to ascertain whether a
user has difficulty differentiating or selecting user interface
elements or may prompt a user for information about visual acuity,
and the user interface may adapt based on the response to the
challenge or prompt.
[0375] In some examples, the determined hardware or software
functionality may relate to a frequency (e.g., how often the device
communicates with a user) or content (e.g., the subject matter of a
communication to a user) of an automated coaching routine. For
example, if a user is contacted too often, the user can become
fatigued and may disengage. On the other hand, if a user is not
contacted often enough, the user may not receive sufficient
guidance to achieve desired results. The method 1101 can include
correlating patient behaviors to different contact frequencies.
[0376] In some examples, determining the monitoring scheme may
include determining a goal for a patient. The method may include
determining a hardware or software functionality of a monitoring
device (e.g., handheld device or body-worn device) related to or in
furtherance of the goal. In various examples, the goal may include,
a dietary goal, an exercise goal, a glucose level monitoring goal,
or a medication goal. In some examples, the at least one hardware
or software functionality of the monitoring device may relate to
mealtime glucose management (e.g., strategies to manage glucose
levels before, during, or after a meal, or any combination thereof,
for example by exercising before or after a meal or delivery of
insulin before a meal (a "pre-bolus" strategy). In some examples,
the at least one hardware or software functionality of the
monitoring device may relate to sleep management (e.g., strategies
to control glucose levels during sleep or to avoid or minimize
interruptions of sleep to address a glucose level problem).
[0377] In some examples, a goal for a patient may be determined at
least in part based upon the first sensor input (e.g., data
monitored with a low-fidelity monitoring technique.)
[0378] The method 1101 may further include, at 1108, determining an
amount or frequency of monitoring. In some examples, the amount or
frequency of subsequent data (e.g., second sensor input or
high-fidelity data) may be determined based at least in part on the
first sensor input, e.g., based on data collected by the
low-fidelity monitoring technique. The amount or frequency of data
may include a volume of data points, or a number of high-fidelity
sensors to be used (e.g., number of CGM sensors to be sequentially
or intermittently used to gather CGM data), or a periodicity (a
consistent or irregular periods) between data collection events.
The amount or frequency of subsequent data may also be based at
least in part on a specified goal or result. For example, the
amount or frequency of data may be calculated to increase or
maximize a patient parameter, such as an amount or percentage of
time in a specified range of glucose concentration levels, or a
patient A1c level.
[0379] The method 1101 may include at 1110 monitoring a second
sensor input according to the determined monitoring scheme. For
example, the method may include monitoring, over a second time
period, patient data of a second type with a high-fidelity
monitoring technique using a monitoring device. The high-fidelity
monitoring may, for example, include continuous glucose
monitoring.
[0380] The method 1101 may further include, at 1112 providing a
guidance to the patient, e.g., via the system 100 shown in FIG. 1.
For example, the system may provide automated messages transmitted
from a server to the monitoring device based on patient profile
data or the first sensor input. In some examples, the guidance may
be provided using a fitness tracker application, a meal tracking
application, or a dedicated CGM or guidance application. For
example, an application may deliver (e.g., display) CGM data,
information based on CGM data (e.g., time-in-range), guidance for a
subject (e.g., "consider an exercise session"), a predicted,
estimated, or measured exercise benefit on glucose control. In some
examples, an application may educate a user about food choices and
resulting post-meal glucose control (e.g., excursions), or may
educate a user or quantify a relationship between exercise and
glucose-lowering effect of exercise. For example, the application
may indicate that the user's selected activity is estimated to
bring the user's glucose level to a desired value or range (e.g.,
"Your recent activity should bring your glucose level into a
desired range."). In another example, the application may indicate
that a suggested activity is likely to bring the user's glucose
level to a desired value or range (e.g., "We estimate that one hour
of running will lower your glucose by 15 mg/dl."). In some
examples, guidance can be provided by chatbot functionality
provided as described herein.
[0381] The method 1101 may further include, at 1114, detecting a
change in a patient parameter (e.g., improvement in glucose
concentration control at a specified time or in a specified
condition, or an improvement in A1C.) The change may be measured
between the first time period during which the first sensor input
is collected, and the second time period during which the second
sensor input is collected. The detected change may be used to
further influence at least one hardware or software functionality
of the monitoring device. In some examples, machine learning
techniques can be used to relate characteristics of the monitoring
or guidance scheme to changes in patient parameters. For example, a
positive change may be correlated with a particular aspect of the
monitoring scheme or guidance, and the hardware or software
functionality of the monitoring device may be modified to emphasize
the aspects that are correlated with the positive change. Such
iterative changes may improve the performance of the monitoring
system in guiding the patient to positive clinical outcomes or
achievement of a management goal. (e.g., toward better controlled
glucose levels or a lower A1c test results). In some examples, an
indication of the increased or maximized patient parameter may be
displayed on the monitoring device.
[0382] The method may be repeated to provide ongoing guidance for
the patient. For example, after step 1114, the method may return to
step 1102, 1106, or 1110. In some examples, one or more steps of
the method may be omitted every time, or when the method is
repeated.
[0383] In some examples, the method may include determining a
patient end goal. The patient end goal may be based at least in
part on the patient data of the first type or the patient data of
the second type, or both. The method may further include displaying
a therapy recommendation (e.g., displayed as guidance) calculated
to cause a transition of a patient state towards the patient end
goal.
[0384] FIG. 12A is an illustration of an example user interface
1202, which may be presented on a user device, such as user device
132, or additionally or alternatively may be presented on hand-held
smart device (e.g., smartphone) 112, tablet 114, computer 118, a
wearable device 120, a peripheral medical device 122, or remote
terminal 128.
[0385] The user interface 1202 may include a chart 1204, which may
show glucose concentration levels 1236 (e.g., measured in mg/dL)
plotted against a time axis 1234. The user interface 1202 may also
show an upper bound 1230 and lower bound 1232 for a target range.
In various examples, the target range may be set by a user (e.g.
patient), or determined by a device or system (e.g., hand-held
device 112 or 120 shown in FIG. 1), or may be provided by a coach
(e.g., human coach or computerized "chat bot" coach.) In the
illustrated example, the upper bound is set at 180 mg/dL and the
lower bound is set at 80 mg/dL. In some examples, a range may be
set (e.g., by a system or by default) for 70-160 mg/dL, and the
range may be expanded (e.g., to 70-180 mg/dL) or contracted as is
appropriate for a particular patient, which may be determined for
example from a pattern of CGM or low-fidelity data or input from a
user. An enlarged view of the chart is shown in FIG. 12B. In
various examples, the glucose concentration level may be an
estimated blood glucose concentration level (e.g., GCM data, or a
level calculated based on other data), or the plotted glucose level
may include blood glucose levels from a meter. The example chart
1204 shows a 24-hour time period (from 12 AM to 12 AM the next
day), but, in various other examples, the chart may show shorter
time periods (e.g., 1 hour, 3 hours, 6, hours, or 12 hours) or
longer time periods (e.g., 2 days, 3 days, 1 week, 2 week, 1 month,
or 3 months). For longer time periods, a plotted value may
correspond to an average for a day or week, or the graph may show a
range or distribution of values or averages (e.g., a bar showing
high and low, and a point or line showing a median or mean.) While
glucose concentration levels are shown, other types of analyte
levels, or other types of sensor data may be shown instead of
glucose concentration levels, or in addition to glucose
concentration levels (e.g., on the same chart or on a different
chart.)
[0386] The user interface 1202 may include a plurality of event
indicators, which may show a physiological event, a meal event, an
activity event, a medication event. For example, the user interface
1202 shows a glucose event 1206 around 4:30 AM, at which point the
glucose concentration level reached a low point at 51 mg/dL with a
steep downward trend indicated by two downward arrows. In some
examples, especially where the user is known to be a heavy user of
insulin, the event 1206 may correspond with an alert on a smart
device (e.g., wearable device 120 or user device 132) to provoke a
user to consume carbohydrates to avoid a potential low-blood
glucose problem. The user interface shows a second glucose event
indicator 1214 around 1:30 PM, at which time the glucose
concentration level was moderate (129 mg/dL) and the trend was
steady (indicated by a sideways arrow). The glucose event 1214 may,
for example, correspond with a user-specified after-lunch report,
or may occur at a time calculated by a system (e.g., mid-day or
post-lunch report). The example user interface 1202 shows a third
glucose indicator 1222 around 7:30 PM, at which point the glucose
concentration level was high (203 mg/dL) and trending upward
quickly, as shown in this example by two upward arrows. In some
examples the glucose indicators may be shaded, colored, or
otherwise visibly identified to indicate whether the glucose
concentration level satisfies a glucose management condition, e.g.,
whether the glucose concentration levels are within a specified
range.
[0387] The user interface 1202 may include a plurality of meal
indicators, e.g., a breakfast indicator 1208, a lunch indicator
1212, and a dinner indicator 1220. The meal indicators 1208, 1212,
1220 may correspond to the user's meals. User meals can be
identified from user input, such as a smartphone input that
indicates a meal was consumed and may optionally include
information about the meal such as meal content (e.g.,
carbohydrates, protein and fat, or food type such as "one slice of
pizza and a glass of milk"). User meals, in some examples, are also
identified from other types of input including, for example,
geolocation data, motion data, etc. For example, geolocation data
may indicate that the user is present in the user's kitchen, at a
restaurant, or at another location where food is prepared and/or
served. Also, for example, motion data can indicate user motion
consistent with eating. Such motion can include, for example, the
user repeatedly moving the user's hand to the user's mouth.
[0388] The user interface 1202 may also include an activity event,
such as walk event 1216. In some examples, the walk event 1216 may
be determined by a system based at least in part on activity data
from an activity sensor (e.g., from a wearable device 120) or based
on a physiologic sensor (e.g., heart rate sensor), or a combination
thereof. In some examples, the walk event 1216 may be based at
least in part on user input (e.g., input via a user device 132
indicating that a walk occurred.)
[0389] The user interface may include a medication event 1224,
which may be based on user input (e.g., input received via a user
device 132) or may be based on sensed or controlled event from a
device (e.g., from an event sensor on an insulin injection device
or medication information received from a pump.)
[0390] The user interface may also include guidance comments. For
example, the user interface may include a guidance bubble 1210 that
states that "You had a spike the last three days at 1 pm" and a
second guidance bubble 1226 that states that "Medication is best
taken before bedtime." In some examples, the guidance bubbles are
provided in the morning, and the data event indicators appear as
time passes through the day. When the guidance bubbles 1210, 1226
are provided prospectively, the guidance may prompt the use to act,
e.g., to modify a breakfast meal content or to take a mid-day walk
to address the recurrent glucose spike at 1 PM. In some examples, a
guidance bubble 1210, 1226, etc., can be selected to launch chatbot
functionality for providing guidance to the user.
[0391] In some examples, the user interface may include game
features (e.g., awards or badges) to promote user engagement. For
example, the user interface 1202 may present a badge 1218, which
may show a still or animated walking person, and may also present a
comment that "Post-meal walking skill unlocked!" to acknowledge an
activity behavior by the patient. In some examples, a determination
to award the post-meal walking skill may be made by a system (e.g.,
remote system connected via a network 124 or a processor in user
device 132.) The user interface may also include a medication badge
(Rx) 1228 that may be presented with a message "Medication
optimization skill unlocked." In some examples, a system may
determine to award the medication badge 1228 based upon
satisfaction of a delivery condition, such as delivery of
medication within a specified period of time before sleep (which
may be detected by an activity sensor, posture sensor,
physiological sensor(s), or any combination thereof.) In some
examples, a machine learning technique can be used to relate game
features to patient outcomes, such as desired levels of glycemic
control. In this way, the system can arrange game features to
improve patient results, thereby increasing the effectiveness of
the system.
[0392] In some examples, a user interface can provide a plot of
glucose levels along with an indication of an average glucose level
for achieving a particular A1C value. FIG. 12C is an illustration
of an example user interface 1250 including a target A1C indicator
1254. The user interface 1250 includes a plot 1252 of blood glucose
over time. The target A1C indicator 1254 indicates an average blood
glucose corresponding to a desired A1C for the user. In the example
of FIG. 12C, the A1C indicator 1254 is situated at a blood glucose
level of 154 mg/dl, which corresponds to an A1C of 7.0. In some
examples, a target A1C indicator, such as the example 1254, can be
used in other user interfaces, such as the user interface 1202
described herein. Also, like the user interface 1202, the user
interface 1202 may be presented on a user device, such as user
device 132, or additionally or alternatively may be presented on
hand-held smart device (e.g., smartphone) 112, tablet 114, computer
118, a wearable device 120, a peripheral medical device 122, or
remote terminal 128.
[0393] FIG. 13 is a flowchart illustration of a method of
identifying or selecting a patient who may benefit from an enhanced
disease management program, such as intermittent CGM for management
of type 2 diabetes or other high-fidelity monitoring, or
low-fidelity monitoring (e.g., activity monitoring) with optional
correlation to high-fidelity (e.g., CGM) information. In some
examples, the method may include determining whether a patient
improvement condition is likely to be satisfied by enhanced
monitoring. For example, the method may include determining an
estimated likelihood that the patient will benefit from enhanced
monitoring scheme. The estimated likelihood may be a calculated
value or percentage, such as 75%, 90%, or 95%, which may optionally
be configurable by a user (e.g., patient or health system
administrator.) The method may include a measurable improvement as
an indicator that the patient will benefit (or has benefitted) from
enhanced monitoring, such as a reduction in A1c, an achievement of
an A1c goal (e.g., A1c under 7.0), or a reduction in glucose
variability, or any combination thereof.
[0394] At 1302, a system, such as system 125, 126, or 127, may
screen for a first characteristic. For example, the system may
perform a first screening algorithm (e.g., on a processor) on
stored data for a pool of participants (e.g., patients) to
determine a group of individuals with diabetes or with the diabetic
risk factors. The method may employ factors such as electronic
health records, type II diabetes diagnosis codes, family history,
weight, BMI, history of metabolic diseases, blood test results,
A1c, fasting glucose levels, oral glucose tolerance, prescribed
diabetes medications, or any combination thereof.
[0395] At 1304, a first monitoring scheme may be applied to obtain
additional data for the determined group of individuals. For
example, the method 1301 may include providing a first kit to
participants in the determined group. The kit may be structured and
configured to enable a participant of the determined group to
perform low-fidelity monitoring of their health for a first
duration with a first monitoring technique and obtaining first
results. Information may be received from a device in the kit by
system 127, or by another system or device.
[0396] In various examples, the low-fidelity monitoring may include
single-point glucose monitoring, heart rate monitoring, activity
monitoring, blinded continuous glucose monitoring, or any
combination thereof.
[0397] At 1306, a system (e.g., system 127, or user device 132) may
screen for a second characteristic. For example, the system may
perform a second screening algorithm on the determined group to
determine a cohort for participation in intermittent high-fidelity
monitoring. The second screening algorithm may be based at least in
part on the results obtained using the first monitoring scheme. In
some examples, the intermittent high-fidelity monitoring may
include continuous glucose monitoring. In some examples, the
screening may be based at least in part on a factor of adherence
(e.g., whether a user adhered to a monitoring plan) to use of the
first scheme (e.g., low-fidelity monitoring technique). For
example, a factor in determining to utilize high-fidelity
monitoring may be the degree to which the patient complied with
instructions or procedures for low-fidelity monitoring, such as
wearing an activity monitor or taking blood glucose meter
measurements according to a specified schedule.
[0398] At 1308, a second monitoring scheme may be applied. For
example, the method 1301 may include providing a second kit to
participants in the determined cohort. The second kit may be
structured and configured to enable a participant of the determined
cohort to perform high-fidelity monitoring of their health, for a
second duration with a second monitoring technique, and obtaining
second results. In some examples, the second kit may include a
continuous glucose monitor. The second kit may be structured and
configured based on the obtained first results. For example, in an
example where the second monitoring scheme is continuous glucose
monitoring, a quantity or type (or both) of glucose sensors that
are provided in the second kit may be determined based on the
obtained first results. In some examples, a determination may be
made to include a number of a first type of sensors that use a
first communication technology (e.g., NFC, which must be swiped by
a smart device to pull glucose data), or a number of sensors of a
second type that are designed for use with a longer-range
transmitter (e.g., Bluetooth) that may provide glucose information
to a wireless device (e.g., smart phone) without human interaction,
or a blend of the first type of sensors and second type of
sensors.
[0399] At 1310, the method may include providing guidance. For
example, the method may include presenting guidance on a display of
a user device, such as a handheld device (e.g., smartphone.) In
some example, the guidance may be provided using chatbot
functionality, as described herein. In some examples, the method
may include performing communications between a server and a device
in the first kit. The communications may, for example, be provided
during the first monitoring. The communications may provide the
guidance to the patient or caregiver (e.g., coaching information
about steps to take to lower glucose level, such as exercise, or
feedback on glucose control, such as an estimated average glucose
concentration or variability or both for a specified time period.)
The guidance may, for example, include diabetes management guidance
that involves a lifestyle modification relating to diet or
exercise, glucose level monitoring, or medication, or any
combination thereof. In some examples, the guidance may include an
indication of a duration or schedule of time for to employ
high-fidelity monitoring, such as one week, or ten days, or one
week per month.
[0400] The method may optionally further include providing a third
kit to one or more participants in the determined cohort, the one
or more participants determined according to, at least in part, the
obtained second results. The third kit may be structured and
configured based on the obtained second results. For example, the
third kit may include a quantity of continuous glucose monitoring
sensors, where the quantity or type (or both) of sensors is
determined based at least in part on the obtained second
results.
[0401] While a low-fidelity to high-fidelity progression is
described above, the method may alternatively include a
high-fidelity to low-fidelity progression. For example, the first
monitoring scheme may include high-fidelity monitoring (e.g., using
a CGM), the screening for a second characteristic at 1306 may be
based at least in part on information from the high-fidelity
monitoring, and the second monitoring may include low-fidelity
monitoring, such as activity monitoring.
[0402] The method 1300 may be implemented in a specialized system,
which may include hardware components, software components, or
both, such as the system 2200 shown in FIGS. 22A, 22B, 22C, and 23.
For example, patient data may be retrieved from electronic storage,
analyzed using a process, e.g., to determine patients who may
benefit from high-fidelity monitoring, and electronic instructions
may be sent to a provisioning system to initiate delivery of one or
more sensing kits to a specified patient or cohort of patients.
[0403] FIG. 14 is a flowchart illustration of an example method of
managing a parameter related to patient health using intermittent
high-fidelity monitoring. At 1402, a patient is selected. The
selecting a patient may, for example, include determining a patient
from a pool of patients likely to benefit from intermittent
high-fidelity monitoring, the likelihood greater than a calculated
value. The patient pool may, for example, represent a group of
patients at a clinical practice, or in a specified insurance pool
or program, or in a geographic location, or at a workplace, or any
combination thereof.
[0404] At 1404, a patient may be monitored for a first duration
(e.g. period of time) using a first monitoring technique, which may
produce a first result (or set of results.) The first technique
may, for example, include high-fidelity monitoring (e.g., using
CGM) or low-fidelity monitoring (e.g., using a blood glucose
meter.)
[0405] At 1406, the patient may be monitored for a second duration
using a second monitoring technique, which may produce a second
result (or set of results.) In various examples, the first duration
may be a subset of the second duration or may overlap the second
duration.
[0406] In some examples, the first technique may include
high-fidelity monitoring, and the second technique may include
low-fidelity monitoring, which may be determined at least in part
by the results of the high-fidelity monitoring. In some examples,
the first technique may be single-point glucose monitoring, or
blinded continuous glucose monitoring (e.g., continuous glucose
monitoring where the patient does not receive some or all of the
estimated glucose concentration levels.) In some examples, the
first technique may include activity monitoring using a wearable
fitness tracker, such as a heart rate monitor, activity monitor,
smart phone, smart glasses, or smart watch, or any combination
thereof. In some examples, the second monitoring, the low-fidelity
technique may include receiving user input data, such as medicament
data meal data, exercise data, sleep data, or any combination
thereof.
[0407] In other examples, the second technique may include
low-fidelity monitoring, and the first technique may include
high-fidelity monitoring, which may be determined at least in part
by the results of the high-fidelity monitoring.
[0408] At 1408, an action the patient may perform may be determined
based on the first result and second result. The action may be
calculated to increase a likelihood of satisfaction of a management
condition. For example, the action may be calculated to increase a
parameter related to patient health by greater than a predetermined
amount with a confidence greater than a predetermined confidence
level. For example, the action may be calculated to increase a
time-in-range, such as an amount (e.g., percentage or number of
minutes or hours) that an estimated glucose concentration level is
in a specified range. In another example, the action may be
calculated to change (e.g., increase, or decrease) a glycemic
variability by a specified amount.
[0409] At 1410, guidance may be delivered. For example, the
guidance may be presented on a display. In various examples, the
guidance may relate to a diet, exercise, glucose level monitoring,
or medication. In some examples, the guidance may indicate the
performance of a patient in satisfaction of a condition (e.g.,
goal) relating to diet, exercise, glucose level monitoring, or
medication, or another health-related matter. Delivering the
guidance may include performing communications between a server and
a device associated with the patient. In some examples, delivering
the guidance can include delivering a chat bot functionality to the
device associated with the patient. The communications may occur
during the first time period or during the second time period, or
both, or after the second time period. In some examples, the
communications may provide a coaching functionality to the
patient.
[0410] In some examples, delivering the guidance may include
displaying (or otherwise communicating via a device or system) an
optimized duration of time for which the patient should employ
high-fidelity monitoring.
[0411] In some examples, the method may include correlating the
obtained first and second results, for example by determining a
relation between the obtained first and second results at
corresponding times of day, days of the week, locations, or other
correlating factors. The method may further include calculating an
estimated value for a high-fidelity monitoring technique at a given
time based on the correlated value for the given time obtained by
the low-fidelity monitoring technique. In some examples, the
guidance delivered at 1410 may be based on the estimated value for
the high-fidelity monitoring technique. In various examples,
calculating an estimated value for a high-fidelity monitoring
technique, or determining a correlation, may be based at least in
part on population data corresponding to the patient, or
physiologic or other data about the patient collected using a
sensor, or user input regarding the patient, or any combination
thereof.
[0412] FIG. 15 shows one example of a method 1501 in which a
patient's user account may be set up on a server so that the
patient is able to automatically log-in using the app on their
mobile device while only entering a minimal amount of
information.
[0413] In step 1502, prior to providing the kit to the patient, the
patient account is set up on the patient's behalf in a database
that is maintained on a server. Among other things that are
provisioned in the patient account such as the patient name, data
of birth (DOB), and so on, the patient account is provisioned with
a unique identifier of the mobile device that is included with the
kit that is to be provided to the patient. For example, the
identifier may be the international Mobile Equipment Identity
(IMEI) of the mobile device. If the mobile device that is used is
provided by the user and is not part of the kit, a different mobile
device identifier may be assigned and used as the unique
identifier.
[0414] In step 1504, the patient is provided with the kit,
including the mobile device. In step 1506, the user launches the
app, which establishes communication with the server and
automatically sends the unique identifier of the mobile device. The
app will also send patient information that has also been
pre-provisioned in the patient record, which is used to associate
the patient with the mobile device. This information may include,
for example, one or more of the following: the patient's email
address, DOB, phone number, and so on.
[0415] In step 1508 the server attempts to match the unique
identifier of the mobile device and the patient information to a
patient record that is stored in its database. If the match is
successful, then in step 1510 the server sends the app the
credentials needed to log in or otherwise access the matching
patient record in the database. The app then logs in using the
credentials to access the patient record in step 1512.
[0416] The automatic log-in procedure described above has been
illustrated for a new patient for which a user record needs to be
created. The procedure may also be used for existing patients. For
instance, if in step 1504 instead of providing a kit to a new
patient, an existing patient is provided with a new transmitter,
then in step 1502 instead of creating a new patient account, the
identifier of the new transmitter will be entered into the
patient's existing record. Thus, in this way the process shown in
FIG. 15 allows both new and existing patients to automatically
log-in and access their patient account record with minimal
effort.
[0417] It should be noted that the functionality of the server
employed in the automatic log-in procedure discussed above in some
cases may be distributed among multiple servers which may or may
not be controlled by the same entity. For instance, in one
particular example one or more of the servers may be controlled and
operated by a device manufacturer and one or more additional
servers may be controlled and operated by a database provider.
[0418] FIG. 16 is an illustration of an example user interface
1600, which may for example be presented on a display of a smart
device such as hand-held device 112 or on a display of a wearable
device 120. The user interface 1600 may include a trend graph 1602
that may show high-fidelity data (e.g., CGM data) plotted against
time for a portion of a present day. The user interface screen
shown in FIG. 16 may be accessed by selecting a button (labeled
"Glucose") on the user interface. The user interface 1600 may
include a legend 1604 that provides explanatory information about
the plot. A time selector user interface element 1610 may allow a
user to control the time period for which data is displayed (e.g.,
today, yesterday, two days ago, or an entire week.) The user
interface 1600 may also provide a time-in-range chart 1606, which
may for example show a percentage (as shown) or amount of time
(e.g., minutes or hours) in range for a number of time periods
(e.g., days in a week, as shown, or portions of a day, such as
morning, afternoon, evening, night). The interface 1600 may include
an input element 1608 that allows a user to choose a
percentage-based display as shown in FIG. 16, or a time-based
display 1902 as shown FIG. 19. A time selector user interface
element 1612 may receive user input for the time-in-range chart,
and may allow a user to select, for example, a specific week for
which to show data, or a different size time periods (e.g.,
time-in-range for portions of a day, or for weeks, or for months.)
In some examples, both the trend graph may be shown at the same
time, or a scrollable portion 1614 (indicated by dashed lines) may
be visible on a display screen, and the user interface may receive
a user input (e.g., via a touch screen) to scroll or zoom to show
the time-in-range graph in addition to or as an alternative to the
trend graph.
[0419] In an intermittent monitoring example, the trend graph may
be presented for time periods (e.g., days) when high-fidelity
collected data (e.g., CGM data) is available, and the time-in-range
chart may be provided for time periods (e.g., weeks) when
low-fidelity collected data is available (with or without
high-fidelity data).
[0420] FIG. 17 is an illustration of an example chat user interface
1700, which may for example be presented on a display of a hand
held device 112 or on a display of a wearable device 120. The chat
user interface 1700 may be accessed by selecting a chat user
interface element 1702, which may initiate a chat session in a chat
window 1704 with a human coach or a chat bot coach. The chat user
interface 1700 may also include a context field 1706. The context
field 1706 may for include a guidance message, which may for
example be provided in response to high-fidelity or low-fidelity
collected data. The chat interface may present information 1708
from the coach and comments or questions 1710 from the user. Input
from a user may be received via a virtual keyboard (not shown) or
using a microphone and voice recognition software. For example, a
user may ask "Why should I eat vegetables" and a coach (e.g., chat
bot) may respond "Vegetables tend to help you keep your glucose in
range because they have fewer simple carbohydrates that foods like
bread or sweets." In some examples, the chat session may be
conducted using a microphone and speaker in addition to or as an
alternative to the on-screen chat shown in FIG. 17.
[0421] FIG. 18 shows a chat interface 1800 with a chart in a
context field 1802. The chart may, for example, be a time-in-range
chart (as shown), such as a percentage-based chart shown in the
context field in FIG. 18, or a time-based chart in the context
field as shown in the user interface 1900 shown in FIG. 19, or the
chart may be or a trend, as shown in FIGS. 16 and 21. In another
example, a user interface 2000 may include a text message in the
context field 2002. A user and coach may interact in the chat field
1804, 1904, 2004, for example to ask or answer questions with
respect to the chart. In a device with space constraints, input
from a user may advantageously be received via a microphone and
voice recognition software to avoid conflicts in demands for screen
space with the chat field 1804, keyboard (not shown) and context
field 1802. For example, an auditor chat functionality (e.g., using
microphone and speaker) may be initiated by selecting a chat button
1620 in the interface shown in FIG. 16. In some examples, a chat
session may be triggered by sensed data, information about a
patient, or other chat trigger condition. For example, a chat
session may be triggered responsive to a trend that satisfies a
trend condition or range condition, which may for example enable a
patient or user to take corrective action (e.g., participate in an
activity such as exercise or change a dietary choice or administer
a medication). For example, a chat session may be triggered by an
estimated glucose concentration level that is rising or falling
quickly, or likely to trend far out of range, or out of range at a
time or under circumstances where glucose would normally be in
range, or out of range for more than a specified period of time
(e.g., out of range for 12 hours), or out of range for more than a
specified percentage of time over a specified period (e.g., more
than 60% for a specified day or week.)
[0422] In some examples, the user interface 1600, 1700, 1800, 1900,
2000 shown in FIGS. 16-20 may adapt based on information about a
user. For example, the user interface may adapt based upon
preferences or characteristics about the sophistication or use of
the interface by a user. In some examples, the user interface may
provide fewer options, a larger display, or simpler information to
accommodate a user who exhibits a tendency or preference toward
less sophisticated interactions. In some examples, the user
interface may adapt based upon an age or time (e.g., year) of birth
of a user. For example, a user who satisfies a particular age
condition (e.g., over 60, 65, or 70 years) may be presented with a
user interface that has a specified appearance scheme (e.g., color
scheme or high-contrast) or larger buttons or larger fonts.
[0423] FIG. 21 is an illustration of an example user interface
2000. The user interface 2000 may be a landscape mode view (e.g.,
width larger than length, which may be useful when a handheld smart
device is turned on its side.) The user interface 2000 may be
laterally scrollable to show data for time periods to the left
(i.e. earlier) or to the right (i.e., later) of the data presently
shown. For example, the data may "slide" to the right when a user
touches the screen and swipes to the right, to show data for time
before 9 PM, and the data may slide to the left responsive to a
user swipe to the left, e.g., to show data for a time after 4 PM.
The user interface 2100 may also include a user interface element
2102 (e.g., "See Now" button), and, responsive to a user selection
of the user interface element 2102, that user interface may
refresh, or slide left or right as appropriate, to show data for
the current time. The slideable user interface may be useful in
coaching, e.g., a user may receive an instruction from a coach to
view data for a specific time or event (e.g. dinner), and
subsequently receive an instruction to select the user interface
element 2102 to return to current data.
[0424] FIG. 22A is an illustration of an example system in which
various examples described herein may be used or applied. The
system 2200 may include a continuous glucose monitoring sensor 2202
and activity sensor 2204 (e.g., a watch), which may be worn by a
participant (e.g., patient) 2201 to generate glucose concentration
information and activity information regarding the patient. The CGM
sensor 2202 may provide activity information to a user computing
device 2206 (e.g., smart phone or watch) and the activity sensor
2204 may provide activity information to the user computing device
2206, which may for example be a hand-held device (as shown) or a
wearable device, such as a watch. While the user computing device
2206 and activity sensor 2204 are illustrated as separate devices,
in some examples, the activity sensor 2204 may be part of the user
computing device 2206 (e.g., the smart device may be a wearable
device such as a watch that includes the activity sensor.)
[0425] One or more applications may run on the user computing
device 2206 to provide glucose concentration information, activity
information, or guidance to a patient. For example, a first
application 2208 running on a smart device may provide information
about glucose concentration levels, and optionally also provide
guidance relating to managing the glucose concentration levels, and
a second application 2210 running on the smart device may provide
information about activity, and optionally also provide guidance
relating to activity (e.g., "Consider a vigorous walk this
afternoon" or to glucose concentration level management (e.g., "You
may need to take steps to lower your glucose level today"), or to
both (e.g., "Consider a vigorous walk this afternoon to help lower
your glucose level today.") While two discrete applications are
illustrated, in some examples the smart device may run a single
application that combines the features described above (i.e., a
single application may provide information on both glucose
concentrations and activity and guidance relating thereto.)
[0426] The system may include one or more web services systems,
which may for example include one or more servers configured to
communicate over a network with or regarding the user computing
device 2206, CGM sensor 2202, activity sensor 2204, or other
devices. For example, a first web services system 2212 may collect
information relating to continuous glucose management, and a second
web services system 2214 may collect activity information and may
optionally collect CGM information from the first web services
system 2212. A third web services system 2216 may operate as a
coaching server to facilitate interaction with a human or
computerized coach via coaching guidance through the user computing
device 2206 or phone call follow-up communications. In some
examples, the coaching server 2216 may be or include the coaching
server 2412 or coaching server 2512 shown in FIGS. 24 and 25 and
described below. While the web services systems 2212, 2214 and
coaching server 2216 are shown as three separate systems, they may
alternatively be portions of a single system (e.g., sub-systems),
or a single system may perform tasks of two or more systems.
[0427] FIG. 22B is an illustration of an example system 2200A that
is an arrangement of the system 2200 of FIG. 22A. In this example,
the first data application 2208 is configured to establish a first
communication link with the continuous glucose monitoring sensor
2202. The first communication link, in some examples, administered
by the user computing device 2206, for example, by an operating
system of the user computing device 2206. The first communication
link can be a wireless communication link such as, for example, a
Bluetooth, Bluetooth LE, or other suitable wireless communication
link. The continuous glucose monitor sensor 2202 can transmit CGM
data to the first data application via the first communication link
including, for example, glucose data describing an estimated
glucose value for the participant 2201. In some examples, the CGM
data provided by the continuous glucose monitor sensor 2202 also
includes metadata describing the participant 2201 and/or diagnostic
data describing the performance of the continuous glucose monitor
sensor 2202.
[0428] The second data application 2210 can be configured to
establish a second communication link with the activity sensor
2204. The second communication link can be a wireless communication
link, for example, similar to the first communications link. The
activity sensor 2204 can provide the second data application with
activity data describing activities of the participant 2201 via the
second communication link. For example, an accelerometer or other
suitable sensor of the activity sensor 2204 can capture data
indicating motion or other activities of the participant 2201 and
provide corresponding data to the second data application 2210 via
the second communications link. The second data application 2210,
in some examples, provides UI data to the activity sensor 2204 via
the second communication link. For example, the activity sensor
2204 can include an output device such as, for example, a lamp, a
display screen, a speaker, etc., to convey the UI data to the
participant 2201. The UI data, for example, can describe the
activities of the participant 2201, for example, as captured by the
activity sensor 2204.
[0429] In some examples, the first data application 2208 is
configured to communicate CGM data to the second data application
2210. The second data application 2210 can then provide the CGM
data to the activity sensor 2204 as UI data to be provided to the
participant via the output device of the activity sensor 2204. In
this way, the activity sensor 2204 can provide the participant with
an indication of glucose data such as the participant's current
estimated glucose value and/or of metadata such as a direction in
which the participant's glucose value is trending, past glucose
values for the participant 2201, etc.
[0430] Communicating CGM data between the first data application
2208 and the second data application 2210, however, can raise data
security issues. For example, CGM data may be at risk of being
nefariously intercepted by another application (not shown)
executing at the user computing device 2206.
[0431] To prevent CGM data from being intercepted, the first data
application 2208 and second data application 2210 can be configured
to communicate via a secure communication protocol. Examples of the
secure communication protocol are described herein with respect to
FIG. 22C.
[0432] The example system 2200A also shows links between the data
applications 2208, 2210 and the respective web services systems
2212, 2214 and coaching server 2216. For example, the first data
application 2208 may provide CGM data to the web services system
2212. The web services system 2212 may provide CGM data to the
coaching server 2216. The second data application 2210 can provide
activity data describing activities of the participant 2201 to the
web services system 2214. The web services system 2214 can provide
the activity data to the coaching server 2216. The coaching server
2216 can provide guidance to the participant 2201. The guidance can
be in any of the forms described herein including, for example, as
described in FIGS. 12A, 12B, 12C, via a chat bot such as
illustrated at FIG. 17, etc. In various examples, the guidance is
provided via the first data application 2208. For example, the
first data application 2208 can provide a user interface for
providing guidance, such as, for example, the user interface of
FIGS. 12A, 12B, 12C, 17, etc.
[0433] FIG. 22C is a flowchart showing one example of a process
2270 that can be executed in the system 2200A of FIG. 22A to
display CGM data at the activity sensor 2204. The process 2270
includes three columns 2271, 2273, 2275. The column 2271 includes
operations executed by the first data application 2208. The column
2273 includes actions executed by the second data application 2210.
The column 2275 includes actions executed by the activity sensor
2204.
[0434] At step 2272, the first data application 2208 receives CGM
data from the continuous glucose monitor sensor 2202. The CGM data
can include, for example, glucose data such as an estimated glucose
value and/or metadata as described herein. At step 2274, the first
data application 2208 generates a CGM message 2277. Generating the
CGM message 2277 can include generating a data structure including
the CGM data. The first data application 2208 can encrypt the data
structure using a cryptographic key. Any suitable encryption
technique can be used.
[0435] In some examples, the first data application 2208 also adds
an error detection code to the CGM data. The error detection code
is data that can be used to verify the CGM data. The first data
application 2208 generates the error detection code based on the
CGM data to be included in the CGM message 2277. The error
detection code is a data value smaller than the CGM data that can
be used by the second data application 2210, as described herein,
to verify that CGM data has been accurately transmitted. Some error
detection code techniques allow the second data application 2210 to
correct transmission errors in the CGM data. Any suitable error
detection technique can be used. In some examples, a cyclic
redundancy check (CRC) technique is used. The error detection code
can be encrypted or not encrypted.
[0436] At step 2274, the first data application 2208 sends the CGM
message 2277 to the second data application 2210. For example, the
first data application 2208 can provide the CGM message 2277 to an
operating system of the user computing device 2206. The operating
system can deliver the CGM message 2277 to the second data
application 2210. In examples where the CGM data is encrypted, the
it may not be readable by the operating system and/or any other
applications that may intercept the CGM message 2277 between the
first data application 2208 and the second data application
2210.
[0437] The second data application 2210 receives and processes the
CGM message 2277 at step 2278. Processing the CGM message 2277 can
include decrypting the CGM data included with the CGM message 2277.
Decryption can be performed using a cryptographic key. For example,
the second data application 2210 may have access to the same
cryptographic key used by the first data application 2208 to
encrypt the CGM data. In other examples, the first data application
2208 encrypts the CGM data using a public (e.g., non-secret)
cryptographic key of the second data application 2210. The second
data application 2210 can decrypt the CGM data using its private
(e.g., secret) cryptographic key that is not shared. Processing the
CGM message 2277 can also include using the error detection code to
verify the accuracy of the CGM data in the CGM message 2277 and/or
correct detected errors.
[0438] At step 2280, the second data application 2210 generates a
device CGM message 2279. The device CGM message 2279 includes some
or all of the CGM data for display by the activity sensor 2204. In
some examples, generating the device CGM message 2279 also includes
encrypting CGM data and/or adding an error correction code. The
second data application 2210 sends the device CGM message 2279 to
the activity sensor 2204, for example, utilizing a wireless
transmitter of the user computing device 2206. For example, the
second data application 2210 can send direct the device CGM message
2279 to the operating system of the user computing device 2206. The
operating system can instruct a wireless transmitter of the user
computing device 2206 to transmit the device CGM message 2279 to
the activity sensor 2204.
[0439] The activity sensor 2204 receives the device CGM message
2279 at step 2282. The activity sensor 2204, in some examples,
decrypts and/or performs error detection or correction on the CGM
data included in the device CGM message 2279. At step 2284, the
activity sensor 2204 provides an indication of some or all of the
CGM data at an output device of the activity sensor 2204, as
described herein. For example, the activity sensor 2204 can
incorporate some or all of the CGM data into a user interface
provided to the participant 2201.
[0440] FIG. 23 is a more detailed illustration of the example
system shown in FIG. 22A. In some examples, the first application
2208 may provide synced data (e.g., CGM data) 2218 which may be
delivered (e.g., over a wireless or wired network) to a sensor data
subsystem 2220 and passed on to a data services portion 2222 of the
first web services system 2212. The first web services system 2221
may also include an enrollment subsystem 2224 and a provisioning
subsystem 2226 that may provide information to an eligibility
subsystem 2228, which may determine an eligibility of a subject
(e.g., participant 2201) to receive a CGM sensor system, and may
interact with a CGM fulfillment subsystem 2230 (which may be
operated by a third party, e.g., a medical supply service) to
deliver a CGM sensor to participant 2201. The data services portion
2222 of the first system 2212 may also receive another type of
sensor data (e.g., low-fidelity data or blinded CGM data) from a
second sensor data subsystem 2232, which may provide information
that may be used to determine enrollment, provisioning, or
configuration of the CGM sensor system.
[0441] The user computing device 2206 may provide activity data
2234 (e.g., via the second app 2210) to an external system such as
the second system 2214, or to a web application program interface
(API) 2258, which may facilitate communication with the second
subsystem 2214. The second system 2214 may receive participant
information, CGM information, or other information from the first
system 2212.
[0442] The second system 2214 may include an activity detection
system 2236, which may receive and process activity data 2234 to
identify a problem state (e.g., insufficient activity), and may
communicate with an intervention engine 2238, which may initiate a
conversation server 2240, which may provide information to a
coaching dashboard 2242. A coach 2241 may interact with the
coaching dashboard 2242, e.g., to develop guidance for delivery to
the participant 2201 via a guidance portion 2244 of the second app
2210 on the user computing device 2206 or via the guidance portion
2246 of the first app 2208. In some examples, the functionality of
the coach 2241 is implemented using a coaching server, such as the
coaching server 2216, and/or using chat bot functionality, as
described herein. For example, the processes illustrated in FIGS.
26A-33 (described below) may be implemented on the user computing
device 2206.
[0443] The coaching server 2216 may receive an identification of an
eligible coach from a coach pool 2248 (e.g., administered by an
insurance entity or other entity). The coaching sever may make a
coach assignment for a particular participant, maintain call
records, generate weekly coaching reports, facilitate communication
with the user computing device 2206, or facilitate follow-up via a
call center 2250. The coaching server 2216 may also generate a
report 2252 of adverse events, if any, for regulatory, process
improvement, or other purposes.
[0444] The second system 2214 (or the coaching server) may generate
a push notification 2254 for delivery to the participant via the
smart device (e.g., via second app 2210) or via the activity sensor
(e.g., watch) 2204. The push notification 2254 may, for example,
indicate that a new coach message is available. The second system
2214 may also generate a second push notification 2256, which may,
for example, communicate CGM information, such as a message or
guidance about glucose concentration level information, or
information about provision, delivery, application (e.g., on the
body of participant), replacement, scheduling (e.g., when or how
long to wear), or use of a CGM sensor.
[0445] The second system 2214 may also include an authorization
system 2262, which may for example provide authorization to the
first app 2208, second app 2210, or both, or may provide
information to an activity sensor authorization system 2260 for use
of the API 2258 (e.g., to "activate" an activity sensor on the
system.) The second system 2214 may also include a glucose level
application program interface (API) 2266, which may receive glucose
information (e.g., CGM information or sensor information or an
estimate thereof) from the first system 2212 and may communicate
the received information (e.g., 105 mg/dL) to the activity sensor
2204 for display to the participant.
[0446] The system may also include a group system 2264, which may
for example include group information, such as an identification of
participants, which may be used in the web API 2258 or for sensor
fulfillment to facilitate delivery of an activity sensor 2204 to
the participant 2201.
[0447] Any of the systems shown in FIGS. 22A and 23 may be
implemented as a hardware system, a software module or application,
or a combination thereof. The interaction of the various systems
and subsystems may improve the delivery of guidance or sensors or
both to the participant to improve patient management and promote
positive clinical outcomes.
[0448] FIG. 24 illustrates an example of a continuous glucose
monitoring (CGM) system 2400 in which coaching personnel operate
the coaching server 2412 to support and provide coaching services
to patients who use the CGM system 2400. Some references to the
coaching server 2412 may refer to the personnel operating the
coaching server 2412. The CGM system 2400 can include a continuous
glucose monitor (CGM) 2402 to transmit glucose monitoring data to a
transceiver 2404. The transceiver 2404 can be a dedicated display
device or a smart phone or other display device configured to
send/receive data and communications within the CGM system 2400.
The transceiver 2404 can transmit some or all patient's analyte
data to a cloud computing architecture 2410 for future reference,
further processing, record keeping or other purposes relevant to
managing or improving patient's health.
[0449] The cloud computing architecture 2410 can include one or
more health data servers configured to receive patient's analyte
data. The transceiver 2404 and/or cloud computing architecture 2410
are capable of receiving patient's analyte data and generating
self-referential data structures from which more meaningful patient
analyte data may be displayed or analyzed. For example, the CGM
2402 readings can be used to generate a self-referential data
structure for displaying patient's analyte data in a meaningful and
easy to understand graphical display to be used by the patient
and/or coaching personnel operating coaching server 2412. The
display self-referential data structure can contain tables encoded
with flagged analyte sensor data such that the self-referential
data structure can be used to independently generate various
analyte trend displays on demand without querying multiple
databases to gather data needed to generate a desired graphical
display.
[0450] In some aspects in accordance with the systems, devices and
methods of the present disclosure, health-related and non-health
related data are aggregated, structured, and/or transformed for
intelligently producing outputs including new analytical data
constructions, displays, and controls of the system's devices and
devices of other systems. Such health-related information can
include glucose and related data (for example, insulin, meal,
activity, etc.), and non-health related data can include location
data, user demographic data, etc. Implementations in accordance
with such aspects of the present technology are perceived to
improve the operation of the system, for example, by reducing
complexities in data processing and data transmissions between
devices, reducing the amount of data and processing algorithms to
be stored and operated, and thereby speeding up the performance of
the systems as described herein. Moreover, implementations in
accordance with such aspects of the present technology are
envisioned to improve the ability of users to manage their diabetes
or other disorders with continuous analyte monitoring.
[0451] Some advantages of the described method and system can
include the following. The self-referential data structure obviates
the need for the processor to search for and recall the necessary
information from various parts of the system to generate graphical
displays. Otherwise, for example, without the self-referential data
structures, the processor would have to search, query and/or call
various parts of the system every time the user requests a
different graphic or requests a modification of the displayed
graphic. As such, the self-referential data structure improves the
operation of the system by reducing complexities in data processing
and data transmission between various parts of the system. For
example, using the self-referential data structure, the system does
not have to store or process additional algorithms, e.g., such as
pattern recognition algorithms, to produce outputs such as displays
to convey pattern information to the user. Additionally,
self-referential data structures can reduce the amount and
frequency of data to be transmitted for the purpose of generating
graphical displays. Associated processing or graphing algorithms to
be stored and operated are also accordingly reduced and the
performance of the system is increased.
[0452] The transceiver 2404 can run an analyte sensor application
2405. The analyte sensor application 2405 can facilitate the
connection between the coaching personnel 2412 and the patient
using the CGM system 2400 as well as provide other services related
to the CGM system 2400, such as providing alarms, displays,
monitoring, storage and other functions. When appropriate legal and
privacy permissions are obtained, the coaching personnel 2412 can
have access to patients' data on transceiver 2404 or the cloud
computing architecture 2410 to better support patients in
management of their diabetes. The analyte sensor application 2405
can include a coaching module 2414, which can handle tasks
associated with providing automated or semi-automated coaching to
the patient.
[0453] FIG. 25 illustrates an example coaching system 2500, which
can be used to implement automated and semi-automated coaching
services for users of CGM system 2400. The coaching system 2500 can
include a coaching module 2502. The coaching module 2502 can
include subroutines, programs, algorithms providing coaching
assistance to patients in one or more areas affecting the patient's
health. For example, the coaching module 2502 can include an
initializer module 2504 designed to introduce a patient to
available sub-coaching modules and initiate the patient in one or
more of those modules; an exercise module 2506 designed to
encourage and coach the patient in engaging in movement and
physical activity; a diet module 2508 designed to help the patient
better understand the relationship between meal choices and blood
glucose levels; and a sleep module 2510 designed to encourage and
coach the patient in obtaining quality sleep while monitoring and
managing glucose levels to avoid diabetic complications. The
described sub-coaching modules are intended as examples and are not
meant to be limiting. Persons of ordinary skill in the art can
envision other sub-modules of the coaching module 2502, which can
provide support, education, monitoring and coaching of different
skills or activities beneficial to the management and improvement
of diabetes. The coaching module 2502 can be in communication with
a coaching server 2512 to provide coaching services to the patients
of the CGM system 2400. The coaching server 2512 may be in part or
in whole operated by human personnel trained in coaching diabetes
patients.
[0454] The coaching module 2502 and its sub-modules provide
coaching by proposing an activity, by creating a commitment to
perform the activity (e.g., by scheduling a time and/or a place to
perform the activity), by setting goals (e.g., by requesting the
patient commit to performing the activity for a desired number of
repetitions, or by refraining from an activity for a number of
days, etc.), by monitoring the results (e.g., by examining one or
more relevant glucose trend graphs), by eliciting alternative
approaches to an activity in the case of suboptimal results (e.g.,
going for walks closer to the meal time if PPW glucose levels are
not improving despite walks) and by repetition. The coaching module
2502 provides alarms, scheduling, reminder and follow up services
to continuously encourage and monitor the patient's progress,
interest and engagement. The coaching module 2502 can provide
congratulatory messages in case of good results, encouraging and/or
motivating messages when the results are mediocre, and it can alert
the coaching personnel when the results are alarming or subpar.
[0455] Initializer Module
[0456] When a patient is newly set up with a CGM system 2400, an
opportunity exists to also set up the patient with automated
coaching and provide preliminary general or specific education on
diabetes and techniques and approaches to living with diabetes.
FIG. 26A illustrates an example process 2600A executed by the
initializer module 2504. The process 2600A can start at the step
2602A via an action of the patient (for example, by inputting a
desire to run or enroll in the coaching program via a touch screen
or other input devices connected with the analyte sensor
application 2405). The process 2600A can start automatically when
the analyte sensor application 2405 detects a new patient. At the
step 2604A, the process determines whether a new patient has set up
a new CGM device. If the answer is no, the process 2600B of FIG.
26B will be executed. If the answer is yes, the process 2600A moves
to the step 2606A by displaying a message containing general
educational information about the blood glucose level, its meaning,
its behavior and the aims of the coaching program. The coaching
module 2502 and its sub-modules may use colloquial and/or simple
conversational language to remove the possibility of confusion,
elicit more interest in the coaching program and to create a
friendly and relaxed attitude and relationship between the patients
and the coaching program. For example, the displayed information at
the step 2606A can include the following: "your blood sugar level
doesn't remain constant, it changes. Sometimes it goes up, even way
up; and sometimes it goes down."
[0457] The process then moves to the step 2608A by generating a
graphical display of the patient's analyte data (e.g., a glucose
trend graph related to the patient's glucose levels over the past
few hours). Along with the graphical display of the patient's
analyte data, the process can display an educational graphics
demonstrating what may be considered a "spike" or excursion in
analyte data. The educational graphics can include animation, text,
or other visual indications to convey information to the patient,
display the patient's glucose trend graph, and if not available, a
sample general glucose trend graph to the patient. When available
the initializer module 2504 can query and recall a self-referential
dataset related to the patient's recent past and generate an
analyte trend graph from the self-referential dataset and display
that graph to the patient. The self-referential dataset may be
recalled from the storage on the transceiver 2404 or the cloud
computing architecture 2410.
[0458] In the step 2610A, the process can invite the patient to
examine her analyte trend graph and determine whether a spike or
excursion in the analyte data can be observed. If the answer is no,
the process moves to the step 2612A by displaying a message or
graphics congratulating the patient and encouraging the patient to
continue to monitor her blood glucose levels and take healthy
actions. The process then moves to the process 2600B of FIG. 26B.
If at the step 2610A, the patient indicates observing a spike or
undesirable excursion in the analyte data, the process 2600A moves
to the step 2614A by asking the patient whether she can recall the
events or circumstances before the spike or undesirable excursion
occurred. The patient is therefore encouraged to think and recall
the patient's choices, circumstances or environment and develop an
awareness of what influences her health. If the patient recalls
that the event E occurred prior to the spike, the process moves to
the step 2616A and a message is displayed emphasizing the
relationship between the event E and the patient's blood glucose
level and encouraging the patient to take note of this relationship
next time the event E occurs. The process then moves to the process
2600B of FIG. 26B. If the patient does not recall what occurred
prior to the observed spike in the analyte data, the process 2600A
moves to the step 2618A. A message is displayed encouraging the
patient to utilize the tools and sub-modules provided by the
coaching module 2502 to learn how various activities, circumstances
and life events affect blood glucose levels. The process then moves
to the process 2600B of FIG. 26B.
[0459] Consider an example in which a patient is experiencing early
morning highs glucose events. The coaching module may access data
(e.g., at the cloud computing architecture 2410, indicating that
the patient has been prescribed medication to be taken in the early
morning. The process 2600A can proceed as described above to step
2610A, where the early morning spikes are detected. At step 2614A,
the coaching module 2502 can query the patient about whether the
patient is still taking prescribed medication at the appointed time
in the morning. If the patient is taking the medication, the
coaching module 2502 can be configured to display a message of
encouragement (for example, at step 2618A) or to further query the
patient about other events that may have caused the spike. If the
patient is not taking the medication, the coaching module 2502 can
be configured to display a message, at step 2616A, encouraging the
patient to resume taking the medication.
[0460] FIG. 26B illustrates an example process 2600B executed by
the initializer module 504. The process starts at the step 2602B
and moves to the step 2604B by displaying educational information
on safe ranges of blood glucose level. The patient can be provided
with information on multiple safe blood glucose levels depending on
the circumstances the patient might encounter. For example, the
displayed educational information can say "safe blood sugar ranges
vary based on the individual's circumstances, but broadly blood
sugar should be between 70 and 180 after a meal and it should drop
below 130 in a couple of hours after a meal. Before bedtime it
should be between 100 and 140.'' The displayed educational
information on safe ranges can caution the patient to use custom
ranges if they are prescribed by the patients' physician. The
displayed educational information can further contain an
introduction to tools available with the coaching module 2502 to
support the patient in keeping her blood glucose levels in safe
ranges.
[0461] The patient is further encouraged to check her blood glucose
levels often, and more frequently after activities that affect
blood glucose levels. For example, the patient is coached to check
her glucose readings before and after taking a meal, physical
activity, when stressed or before going to bed. Another recommended
time to check one's glucose level is when calibrating the CGM 2402.
If the patient can be accustomed to checking her blood glucose
levels more frequently, the patient will have a better chance and
increased opportunity to observe and learn the effects of various
choices and activities on her blood glucose level. The process can
move to the step 2606B by asking the patient to guess what her
current blood glucose level might be. Fun and engaging questions
can be used by the coaching module 2502 and its sub-modules to
encourage further engagement from the patient. The patient can
input an estimate of her current blood glucose level via an
interesting and engaging graphical display, for example a sliding
bar, scroll bar, text and arrows or other visuals designed to work
with touch screens or voice recognition technology. The process
then moves to the step 2608B by presenting the patient with her
recent glucose trend graph, which can include an indication of
actual current glucose level. The patient is invited to examine the
trend graph and observe her current blood glucose level and its
recent levels.
[0462] Next the process moves to the step 2610B inviting the
patient to examine the glucose graph to see whether any spikes or
excursions in the glucose data can be observed. Next the process
moves to the step 2612B by asking the patient what activities
affect blood glucose level. The patient can be presented with
multiple choices, for example, "diet, exercise, sleep or all of the
above." In this example, all of the provided answers are true, so
the correct response is "all of the above." If the patient responds
with an answer other than "all of the above," the process moves to
the step 2614B displaying an encouraging message indicating that
all choices affect blood glucose level and that the coaching module
can coach the patient through each activity step by step. The
process then moves to the step 2618B. If the patient responds by
indicating that all the listed activities affect blood glucose, the
process moves to the step 2616B by displaying a congratulatory and
encouraging message to the patient for choosing the right answer.
The displayed message can state that the coaching module can coach
the patient through learning and understanding each listed factor
and its effect on the patient's blood glucose level. The process
then moves to the step 2618B asking the patient which activity or
skill the patient would like to learn about first. If the patient
makes no choice or indicates a lack of interest or motivation, the
process moves to the step 2620B and a coaching alert ticket is
generated and transmitted to the coaching personnel via coaching
server 2512. The process then ends at the step 2626B. If the
patient indicates an interest by choosing one of the activities or
skills presented, the process moves to the step 2622B by displaying
a message congratulating the patient on her enthusiasm. The process
then moves to the sub-module chosen by the patient. For example, if
exercise, diet or sleep are chosen, correspondingly, the exercise
module 2506, the diet module 2508 or the sleep module 2510,
respectively, are recalled and executed by the coaching module
2502. The process then moves to the step 2624B and the coaching
server 2512 is updated to reflect the patients chosen activity
module. In some embodiments, the coaching personnel operating the
coaching server 2512 can manually assign a sub-coaching module and
update the coaching server 2512 accordingly. The process then ends
at the step 2626B.
[0463] Generally, the coaching module 2502 can be configured to
generate a coaching alert ticket and notify the coaching personnel
when the patient's responses and interactions with the patient
indicate a lack of interest, motivation or commitment. Living with
diabetes can be challenging. Responses showing lack of interest and
commitment can be indicators of depression or a sign that the
patient may need psychological or mental help to deal with
challenges of living with diabetes. As part of generating a
coaching alert ticket, the coaching module 2502 or its sub-modules
can gather relevant contextual information to assist coaching
personnel to efficiently and promptly attend to the patient. For
example, depending on the activity for which the patient
demonstrates a lack of enthusiasm, the coaching module 2502 can
present questions to the patient and obtain answers relevant to
providing coaching and counseling on that activity.
[0464] The coaching module can further annotate, label and
categorize the patient's contextual information so the coaching
personnel can more efficiently and effectively provide counseling
and coaching services. For example, if the patient has initiated
and predicted a healthy activity but has failed to achieve her
predicted goals, the contextual information used for building the
coaching alert ticket can include a label stating, "committed but
unable to achieve." On the other hand, if the patient refuses to
schedule an activity and her response indicate a lack of confidence
in the proposed activity, the contextual information can include a
label stating, "the patient does not believe in the proposed
activity." The coaching personnel operating the coaching server
2512 can examine the contextual information labels for efficient
and timely review of the patient's history and her present issues.
In some embodiments, the coaching personnel operating the coaching
servers 2512 can specialize in particular areas of providing
coaching and assistance to the patients. For example, some coaching
personnel may specialize in and possess special training in
providing counseling and coaching to patients that lack discipline
in monitoring their diets. The contextual information labels can be
used to route coaching alert tickets to coaching personnel
specializing in handling the underlying issue.
[0465] An overall theme informing the interactions between the
coaching module 2502 and the patient is to encourage engaging with
the CGM system 2400 and the coaching module 2502, by for example
using the tools provided and observing the analysis and
recommendations of the tools in relation to the patient's blood
glucose levels. Such engagement can increase the patient's
understanding of the disease and improve the patient's intuitive
response to her condition. Exercise Module
[0466] The coaching module 2502 can include an exercise module 2506
to encourage and coach patients to engage in physical activity and
observe the benefits and correlation between physical activity and
improved glucose levels. FIG. 27 illustrates a process 2700 which
can initiate a patient with an automated or semi-automated coaching
system sub-module focused on exercise and physical activity.
Movement and physical activity beneficial to diabetes patients can
be as simple as going for walks after meals. As Post Prandial Walk
(PPW) can be an area of focus for coaching, process 2700 of FIG.
27, process 2800 of FIG. 28 and process 2900 of FIG. 29 will be
described in relation to PPW. Persons of ordinary skill in the art
can envision other types of physical activity or movement which can
be implemented using the processes 2700, 2800 and 2900 without
departing from the spirit of the described technology.
[0467] The process 2700 starts at the step 2702. The exercise
module 2506 can educate the patient on the beneficial effects of
physical movement on blood glucose level and recommend exercise as
a method of keeping blood glucose levels within a safe range. The
process moves to the step 2704, where the patient is asked about
her prior experience with a recommended physical activity such as
PPW. If the patient indicates she has not tried PPW, the process
moves to the step 2706 asking if the patient would like to choose a
meal in the future to practice PPW. If the patient indicates a lack
of interest, the process moves to the step 2708, where additional
contextual information is obtained from the patient, or from the
patient's records in the cloud computing architecture 2410 and/or
the transceiver 2404. At the step 2710 a coaching alert ticket is
generated and transmitted to the coaching server 2512 and the
coaching personnel are notified. The process ends at the step 2712.
The same process can be repeated, and a coaching alert ticket
generated and transmitted if at any time the patient's responses
indicate a lack of interest or motivation for managing or improving
her health.
[0468] If the patient indicates an interest in trying PPW, the
process moves to the step 2714, where the patient is asked to
choose a meal for practicing PPW and time by which the exercise
module 2506 can check back with the patient on the result. A follow
up reminder is scheduled based on the patient's response. When the
time for follow up comes, the process moves to the step 2716 and
the patient is asked whether the patient could practice PPW as
scheduled and what the results were. If the patient's response
indicates a failure to practice or unexpected results after having
practiced PPW, the process can perform the steps 2708 and 2710 to
collect information, build and transmit a coaching alert ticket.
The process ends at the step 2712. If the result of the PPW was a
success, the process moves to the step 2720 asking the patient if
she would like to repeat the success attained by scheduling more
PPW sessions.
[0469] The success or failure of the PPW sessions can be determined
from presenting questions to the patient and presenting multiple
choice option responses such as "what happened to your blood sugar
level?", "went up more slowly," "didn't go as high as expected,"
"didn't change," "went up a little," or "went up a lot." A group of
possible patient's responses can be categorized as success and if
those responses are detected, the process 2700 can be routed based
on a successful result. Similarly, some responses may be
categorized as failed results and if those responses are detected,
the process 2700 can be routed accordingly. In some embodiments,
the success or failure of PPW or other proposed activity may be
determined by querying the patient's records in the cloud computing
architecture 2410, the transceiver 2404 or both to automatically
determine whether the patient's glucose levels were in a safe
region after the scheduled PPW session. Alternatively, to encourage
the patient to learn to interpret her glucose trend graph or other
available glucose data, the patient might be asked to determine the
success or failure of the PPW sessions by examining her glucose
data manually. The stored analyte data in the CGM system 2400 can
be used as a secondary check and the patient can be prompted to
reevaluate her response or the stored data if discrepancies are
detected. Similarly, whether the patient could practice PPW may be
determined by presenting a textual or graphical question to the
patient or by querying the transceiver 2404, for example for global
positioning system GPS data if the transceiver 2404 is retrofitted
with that option.
[0470] If the patient does not indicate an interest in scheduling
more PPW sessions, the process can perform the steps 2708 and 2710
to collect information, generate and transmit a coaching alert
ticket. The process then ends at the step 2712. If the patient
indicates an interest in repeating the achieved success by
scheduling more PPW sessions, the process moves to the step 2722
and schedules a future PPW session based on the patient's desired
time and meal. The process then moves to the step 2724 where the
scheduled PPW session is used to execute a follow-up process 2800
as will be described in relation to FIG. 28. The process 2700 then
ends at the step 2726.
[0471] As described, in the step 2704 of the process 2700, the
patient is asked whether she has tried PPW before? If the patient's
response is yes, the process moves to the step 2718 asking the
patient what the result of the patient's prior experience with PPW
has been. If the patient indicates a failure or unexpected result,
the process can move to the step 2728 asking the patient whether
there is anything the patient can do differently to make PPW more
successful. The patient can respond by free text or by interacting
with a menu or other visual interface, such as choosing from a
drop-down menu or radio buttons from a menu of prepopulated
responses (e.g., "take a longer walk," "walk more quickly," "walk
closer in time to eating"). The process can move to the step 2730
asking the patient whether she would like to try one or more of the
alternative approaches the patient has just indicated. If the
patient responds with lack of interest, the process can perform the
steps 2708 and 2710 to collect information, generate and transmit a
coaching alert ticket. The process then ends at the step 2712. If
the patient responds positively, the process can move to the step
2732 and schedule a future PPW session based on the patient's
desired time and meal. The scheduled PPW session is used to execute
the follow-up process 2800 as will be described in relation to FIG.
28. The process 2700 then ends at the step 2734.
[0472] FIG. 28 illustrates a process 2800 for performing follow-ups
on the progress of the patient who has been introduced and
scheduled for PPW or other recommended activity beneficial to
diabetes management. The process 2800 starts at the step 2802.
After a prescheduled time for a PPW session has arrived or after a
predetermined time after a scheduled time, the process moves to the
step 2804 asking the patient whether she could practice PPW as
scheduled. If the patient responds negatively, the process can
perform the steps 2806 and 2808 to collect context information,
built and transmit a coaching alert ticket. The process then ends
at the step 2810.
[0473] If the patient indicates she could practice PPW as
scheduled, the process moves to the step 2812 asking the patient
whether her blood glucose level was within safe or desirable ranges
after a PPW session. If the answer is no, the process performs the
steps 2806 and 2808 to collect information, build and transmit a
coaching alert ticket. The process then ends at the step 2810. If
the answer is yes, the process moves to the step 2814 asking the
patient how many days she predicts she can practice PPW. If the
patient's response is less than a minimum threshold (e.g., 0 or 1
day), the process can perform the steps 2806 and 2808 to collect
information, build and transmit a coaching alert ticket. The
process then ends at the step 2810. If the answer is equal or more
than a minimum threshold (e.g., 2 days), the process can move to
the step 2816 where the number of predicted days for PPW activity
is saved and transmitted to a confidence assessor/booster process
2900 as will be described in relation to FIG. 29. The process then
ends at the step 2810.
[0474] Consider an example in which a patient has an acceptable A1C
level, as indicated previously and stored at the cloud computing
architecture 2410. In this example, the patient also has indicated
previously, at step 2806 of a previous execution of the process
2800, that an injury has preventing the patient from performing
desired exercise. This data may also be stored in the cloud
computing architecture and used in a subsequent execution of the
process 2800. For example, at step 2804, the patient can be queried
about whether his injury has healed in addition to whether the
patient has been able to take the PPW.
[0475] FIG. 29 illustrates an example process 2900 which can be
executed by the exercise module 2506 to further follow up, assess
or boost the patient's confidence in PPW practice or other proposed
activity beneficial to diabetes. The process starts at the step
2902. The exercise module 2506 can keep track of the number of days
in which the patient practices PPW. The process moves to the step
2904 to determine whether the days the patient practiced PPW are
equal or greater than the days the patient predicted she would
practice PPW. If the answer is yes, the process moves to the step
2906 asking the patient on a predetermined scale (e.g. on a scale
of 0-10) how confident the patient is that she can practice PPW
over the next 7 days. If the patient's confidence level is more
than a predetermined minimum confidence number (e.g., 7), the
process moves to the step 2908 displaying a message congratulating
the patient on her resolve and commitment. Then the process can
return to the step 2902 and repeat the process 2900 after one week
or another predetermined period. If the patient's confidence level
in her ability to practice PPW is less than the predetermined
confidence number (e.g. less than 7), the process can move to the
step 2910 and ask whether the patient can do anything to increase
her confidence level for being able to achieve the scheduled number
of PPW practices. If the answer is no, the process performs the
steps 2918 and 2920 to collect information, build and transmit a
coaching alert ticket. The process ends at the step 2922. If the
answer is yes, the process moves to the step 2912 asking the
patient to input the patient's plan for succeeding in practicing
the scheduled number of PPWs. The process can move to the step 2914
asking the patient whether she believes she can follow through with
the plan. If the answer is yes, the process moves to the step 2916
where the patient's PPWs are tracked daily or obtained after a
predetermined time (e.g., one week) and then the process moves to
the step 2902 and the process 2900 is repeated. If the answer is
no, the process can perform the steps 2918 and 2920 to collect
information, build and transmit a coaching alert ticket. The
process then ends at the step 2922.
[0476] If, at the step 2904 it is determined that the days the
patient practiced PPW is less than the scheduled number, the
process moves to the step 2924. If the number of days the patient
practiced PPW is less than or equal to a predetermined minimum
number (e.g., less than or equal to 2 days), the process performs
the steps 2918 and 2920 to collect information, build and transmit
a coaching alert ticket. The process then ends at the step 2922. If
the number of days the patient practiced PPW is more than the
predetermined minimum number (e.g., more than 2 days), the process
moves to the step 2926 asking the patient whether she believes she
can achieve the scheduled number of PPW practice days. If the
answer is yes, the process moves to the step 2916 where the
patient's PPWs are tracked daily or obtained after a predetermined
time (e.g., one week) and then the process moves to the step 2902
and the process 2900 is repeated. If the answer is no, the process
performs the steps 2918 and 2920 to collect information, build and
transmit a coaching alert ticket. The process then ends at the step
2922.
[0477] The coaching module 2502 can include a diet module 2508 to
encourage and coach patients to understand and learn the effects of
their diet choices on their blood glucose levels and diabetes. FIG.
30 illustrates a process 3000 which can initiate a patient with an
automatic or semi-automatic coaching system sub-module focused on
diet. The process 3000 starts at the step 3002. At the step 3004,
the patient is asked whether she would like to learn how different
foods and diet choices can affect her blood glucose levels. If the
answer is no, the process performs the steps 3006 and 3008 to
collect information, build and transmit a coaching alert ticket.
The process then ends at the step 3010. If the answer is yes, a
message to the patient is displayed encouraging the patient's
interest and engagement. The message can further remind the patient
on the connection and correlation between diet and blood glucose
levels. The message can encourage the patient to continue to review
her blood glucose readings to learn more about how different diet
choices affect her glucose readings.
[0478] The process moves to the step 3012 asking the patient to
choose a meal time M to start learning about the effects of diet on
blood glucose levels. The patient's chosen meal time M, can be
stored and a reminder scheduled to follow up with the patient. The
process moves to the step 3014 asking the patient whether she knows
what she will be eating for the chosen meal. If the answer is no,
the process moves to the step 3016 displaying an encouraging
message and informing the patient that she can track what she eats
and observe the effects on her blood glucose level using the tools
provided in the CGM 2400 system. Shortly or a predetermined time
after the scheduled meal time M, the process moves to the step 3018
where the patient is asked what the effect of consuming the meal
was on her blood glucose level. The patient can enter text or
choose an answer from an array of possible scenarios, such as "went
way up and stayed there," "went up but came down quickly," "did not
change much," or "went down." The patient's response can be stored
in a variable, S. The process moves to the step 3020 asking what
the patient ate at the scheduled meal M. The patient can enter free
text or choose from a menu of available options to describe the
meal she has had, and her answer can be stored in a variable F.
[0479] The process moves to the step 3022 displaying a message
linking the patient meal M and her blood glucose level S via a text
block or other graphical or visual displays. The message can be a
sentence populated with the values stored in the variables M, F and
S. For example, the message can be constructed from the sentence
"you ate <F> at the meal <M> and your blood glucose
level <S>." If F=chocolate cake, M=breakfast and S=went way
up and stayed there, the displayed message can read: "you ate
chocolate cake at the meal breakfast and your blood glucose level
went way up and stayed there." Various messaging formats and
scenarios can be employed to strengthen the patient's understanding
and learning the effects of food and diet on her blood glucose
level.
[0480] The process then moves to the step 3024 asking whether the
patient is surprised by the result. If the answer is no, the
process can move to the step 3026 where the patient is
congratulated for keeping track of her glucose level after a meal
and invited to continue checking her glucose levels after a meal.
The process then moves to the step 3028 where the patient is
invited to work with a meal tracking tool to track more meals and
their effects on her glucose levels. The meal tracking tool will be
described in relation to the process 3100 of FIG. 31. The process
then ends at the step 3030. If the patient is surprised by the
result of her glucose reading and her answer in the step 3024 is
yes, the patient may need additional or individualized coaching on
the types of foods and diets and their effect on diabetes. The
process can perform the steps 3006 and 3008 to collect information,
build and transmit a coaching alert ticket. The process then ends
at the step 3010.
[0481] If at step 3014, the patient knows what she will be having
for a scheduled meal time M, the process moves to the step 3032
storing the patient's planned meal in a variable F. Shortly, or a
predetermined time after a scheduled meal time M, the process moves
to the step 3034 and the patient is asked what the effect of
consuming food F at meal M was on the patient's blood glucose
level. The patient's response can be stored in a variable S. The
process moves to the step 3036 displaying a message constructed
from variables M, F and S. For example, the message can be
constructed from the sentence "you ate <F> at the meal
<M> and your blood sugar <S>" and variables F=grilled
fish, whole wheat toast and garden salad, M=Lunch and S=went down.
The displayed message can read: "you ate grilled fish, whole wheat
toast and garden salad at lunch and your blood sugar went down."
Next the process moves to the step 3024 to encourage the patient to
use the meal tracking tool of FIG. 31 to deepen her understanding
of the correlation between diet and blood glucose.
[0482] FIG. 31 illustrates an example process 3100 which can be
executed by the diet module 2508 to implement a meal tracking tool
to encourage and coach patients in understanding the relationship
between their diet and their blood glucose level. The process 3100
starts at the step 3102 via an input from the user indicating an
interest in starting the operations of the tool or by a
complementary process or tool such as the process 3000. The process
3100 moves to the step 3104 asking the patient to schedule a meal M
to track. The patient's choice is stored, and a reminder is
scheduled for a predetermined period T after the scheduled meal M.
T can be for example 1 to 2 hours. The process moves to the step
3106 waiting a predetermined time T after the meal M. The process
moves to the step 3108 asking the patient what she ate at the
scheduled meal M and storing the patient's response in a variable
F. Next, the process moves to the step 3110 where the patient's
glucose data is obtained for a period before meal M and a time
period after the meal M plus the predetermined time T. The glucose
data for the relevant time period can be obtained from the patient,
where the patient examines a glucose trend graph of the relevant
time or obtained from other parts of the CGM system 2400 such as
the transceiver 2404 or the cloud computing architecture 2410. The
glucose data is presented to the patient and the process moves to
the step 3112 asking whether the patient observes a spike or
undesirable excursion in the glucose data. In other embodiments,
the diet module can automatically examine and scan the glucose data
for excursions by comparing the stored glucose values to a high or
low threshold. If there is no spike or undesirable excursion in the
glucose data, the process moves to the step 3114 displaying a
message encouraging the patient to continue checking her blood
glucose level and learn how to eat safely. The message can for
example read: "OK, each time you check your glucose after eating,
you'll learn more about how to eat safely and enjoy food."
[0483] If the patient observes a spike or excursion in the blood
glucose level and her response in the step 3112 is yes, the process
moves to the step 3118 asking the patient whether she can eat
another food that might have a better effect on her blood glucose
level. If the patient shows a lack of interest or knowledge about
what can be done differently, the process can perform the steps
3120 and 3122 to collect information, build and transmit a coaching
alert ticket. The process then ends at the step 3124. If the
patient responds with indicating an ability to make a better meal
choice, the process moves to the step 3126 asking more questions of
the patient to help determine the patient's resolve and interest.
For example, at the step 3126, the patient can be asked to input in
the system what the patient can do differently next time (e.g.,
what the patient meal choice might be in the future). The process
moves to the step 3128, where it is determined whether the
patient's planned choice is similar or different than her prior
choice leading to an undesirable excursion in blood glucose level.
If the patient's planned choice is same or similar to her previous
choice, the process can perform the steps 3120 and 3122 to collect
information, build and transmit a coaching alert ticket. The
process then ends at the step 3124. If the patient's choice is
different than her prior choice indicating a plan aimed at
maintaining safe blood glucose level, the process can move to the
step 3104 to schedule follow up meal tracking sessions and the
process 3100 is repeated.
[0484] FIG. 32 illustrates an example process 3200 which can be
implemented in the diet module 2508 to encourage and coach patients
to increase their efforts in monitoring their blood glucose after
meals by using the meal tracking tool described in relation to FIG.
31. The process 3200 can be run automatically on a predetermined
time interval (e.g., weekly) or run manually by the patient
starting at the step 3202. The meal tracking tool implemented via
the process 3100 can be configured to keep track of and store the
number of times the tool was used and/or the number of meals the
patient tracked in a variable MT (Meals Tracked).
[0485] The system can by default designate a desirable number of
tracked meals in a variable D or query the patient, a patient's
guardian or health care professional and/or the coaching personnel
for the number of meals a patient is expected to track and store
that value in the variable D. At the step 3204, the patient's Meals
Tracked MT is compared against the desired or expected number of
meals to be tracked D. If the Meals Tracked MT is equal to or
exceeds the expected tracked meals D, the process moves to the step
3206 displaying a congratulatory message and the process ends at
the step 3208. At the step 3210, if the Meals Tracked MT is less
than the expected number D, but more than half of the expected
number D, the process moves to the step 3212, where the diet module
2508 can be configured to send reminders, offers and invitations to
the patient to track meals and check glucose data. The process then
ends at the step 3214. If the meals tracked MT are less than or
equal to half of the desired number D, the patient might need more
individualized coaching to increase her efforts in tracking meals
and checking glucose data. The process can perform the steps 3216
and 3218 to collect information, build and transmit a coaching
alert ticket. The process then ends at the step 3220. Sleep
Module
[0486] FIG. 33 illustrates an example process 3300 which can be
implemented by the sleep module 2510 to encourage and coach
patients to monitor their night time glucose behavior and better
understand the beneficial effects of proper sleep on their blood
glucose level. The process 3300 starts at the step 3302. At the
step 3304, the process displays general and/or patient-specific
data on the relationship of sleep and blood glucose. For example,
such a display may read: "the better you sleep, the safer/healthier
you will be. Keeping your glucose in range (e.g., 100 to 140 mg/dL)
during sleep will help you sleep better and improve how you are
handling diabetes." The process then moves to the step 3306. A
glucose trend graph is generated from the self-referential data
structures stored in the CGM system 2400 and presented to the
patient. The patient is asked to examine the glucose trend graph of
the past 7 nights and determine how many nights the patient's
glucose levels were in a safe range during the first few hours of
sleep. In some embodiments, the sleep module 2510 may automatically
determine whether the patient's glucose level has been safe during
a relevant period. In some examples, a machine learning technique,
as described herein, can be used to generate a model of the
relationship between patient sleep and blood glucose.
[0487] In the context of providing automated coaching, encouraging
the patient to examine her glucose trend graph and learn how to
read and correctly interpret glucose data and graphs may be more
desirable than purely determining unsafe glucose excursions. Other
safety and monitoring tools and modules within the CGM 2400 can
more appropriately undertake those tasks. As such, within the
context of providing automated coaching, the ability of the CGM
system to automatically analyze the patient's glucose data can be
used secondarily and to double check the patient's analysis and
determination. The patient's analysis and interpretation of her
glucose data can be matched against the automated analysis of the
CGM system 2400 and if discrepancies are detected, the patient, the
coaching personnel or other involved individuals can be
notified.
[0488] At the step 3308, if the number of nights the patient's
glucose level has been within a safe range, the process moves to
the step 3310, where a message is displayed congratulating the
patient on her approach and inviting her to continue checking night
time or sleep time glucose levels and trends. The process ends at
the step 3312.
[0489] At the step 3314, it is determined whether the patient's
nightly glucose levels have been safe for at least 5 or 6 nights.
If the answer is no, the process moves to the step 3316 to
determine if the patient's nightly glucose levels have been safe
for at least 3 or 4 nights. If the answer is no, the patient might
need more individualized or immediate coaching assistance to better
manage her blood glucose levels at sleep time. The process performs
the steps 3318 and 3320 to collect information, build and transmit
a coaching alert ticket. The process then ends at the step
3322.
[0490] If at the step 3314, it is determined that the patient's
nightly glucose levels have been in safe ranges for at least 5 or 6
nights, the process moves to the step 3324, asking the patient
whether there was something the patient had done differently in
nights that her glucose stayed in safe ranges. If the patient does
not recall or does not know, the process moves to the step 3326
displaying a message inviting the patient to track the nightly
glucose levels for the next 7 days (or other period as may be
desired based on the patient's age, history or other factors). The
process moves to the step 3328 asking the patient how many nights
she believes her glucose levels will stay within a safe range. The
patient's response is stored in a variable NP (Nights Predicted).
At the step 3330, if the Nights Predicted are more than or equal to
5 nights, the process moves to the step 3332. A message is
displayed congratulating the patient on her engagement and
commitment to health.
[0491] After a week delay, the process moves to the step 3334 and
the patient is asked to check her blood glucose levels for the past
7 nights. If the patient's nightly glucose levels stayed within a
safe range for more than or equal to the Nights Predicted NP, the
process moves to the step 3336, a congratulatory message is
displayed, the patient is encouraged to continue tracking night
time glucose levels and the process ends at the step 3338. If the
number of nights the patient's nightly glucose level remained in
safe ranges is less than the Nights Predicted NP, the process moves
to the step 3340 where an encouraging message is displayed
acknowledging the challenges the patient might have faced and
inviting the patient to discuss those challenges with her coach.
The process performs the steps 3318 and 3320 to collect
information, build and transmit a coaching alert ticket. The
process then ends at the step 3322.
[0492] If at the step 3330 the patient predicts that her glucose
levels would stay within safe ranges for less than 5 nights, the
process moves to the step 3342 displaying a message inviting the
patient to discuss with her coach possible challenges that might
affect her ability to maintain safe nightly glucose levels. The
process then performs the steps 3318 and 3320 to collect
information, build and transmit a coaching alert ticket. The
process ends at the step 3322.
[0493] If at the step 3316, the patient's nightly glucose levels
have been within safe ranges for at least 3 to 4 nights, the
process moves to the step 3344. The patient is monitored more
closely by the sleep module 2510. For example, at step 3344, the
patient can be prompted each morning or at some time before her
sleep time whether she predicts that her nightly glucose levels
will be in a safe range for that night. The process is repeated
over a week period or other desirable period and the Nights
Predicted NP are counted and stored. The process then moves to the
step 3334.
[0494] If at the step 3324, the patient knows what had changed for
her to be able to maintain safe nightly glucose, the process moves
to the step 3346, where the patient is asked about what made the
difference between the safe nights and other nights. The patient's
response is recorded. At the step 3348 a message is displayed
congratulating the patient on her proactive and engaged attitude.
The process moves to the step 3350 asking the patient whether she
is ready to achieve the same level of success again in having safe
nightly glucose levels for the next week. If the patient's response
is yes, the process moves to the step 3328. If the patient's
response is no, the patient might have less confidence in her
ability to maintain safe nightly glucose levels. She may need more
individualized coaching to increase her confidence level. The
process performs the steps 3318 and 3320 to collect information,
build and transmit a coaching alert ticket. The process ends at the
step 3322.
[0495] The information gathered to provide automated or
semi-automated coaching (e.g., information gathered in the
processes 2600A, 2600B, 2700, 2800, 2900, 3000, 3100, 3200 and
3300) can be obtained from the patient as described above or can be
obtained or inferred from other data available in the CGM system
2400. For example, the patient's actions during prescheduled
activities can be inferred from Global Positioning System (GPS)
data of the transceiver 2404 or the patient's glucose data stored
on the transceiver 2404 or the cloud computing architecture 2410.
The patient can be asked to confirm whether an automatic
determination of the events is correct. For example, the coaching
module 2502 can automatically detect an in-range blood glucose
level for a period after a PPW session. The coaching module 2502
can present a glucose trend graph of the relevant period to the
patient and request the patient to confirm glucose levels were
within range during that period. If appropriate permissions are
obtained, the coaching module 2502 can determine a patient went for
a walk during a period scheduled for PPW activity by consulting GPS
data stored on the transceiver 2404. The coaching module can
confirm this determination with the patient.
[0496] In some examples, an analyte sensor system can be configured
to execute a high-fidelity data collection where captured data is
retrieved after collection. This can be useful for patients who do
not have access to a wireless network and/or do not regularly carry
a smart device or other user computing device. After-collection
data retrieval can also minimize or eliminate the need for the user
to set up a smart device to communicate with the analyte sensor
system. This can allow clinicians to provide patients with access
to the analyte sensor with fewer training costs.
[0497] FIG. 34 is an illustration of an example system 3400 that
can include an analyte sensor system 3402 configured to upload
captured analyte data after collection. The analyte sensor system
3402 may be coupled to a host 3401, similar to the host 101 of FIG.
1. The analyte sensor system 3402 can be similar to the analyte
sensor 102 of FIG. 1. For example, the analyte sensor system 3402
can include an analyte sensor 3404, such as a glucose sensor.
Sensor electronics 3406 may be similar to the sensor electronics
106 of FIG. 1. Sensor electronics 3406 can include data storage
hardware for storing analyte data captured by the analyte sensor
3404. Sensor electronics 3406 can also be programmed to upload
captured analyte data after collection, for example, as described
herein with respect to FIGS. 35-37.
[0498] The example system 3400 includes an optional smart device
3412 that can be used, similar to the hand-held device 112, to
communicate with the analyte sensor system 3402, via one or more
wireless communication signals 3410. The smart device 3412 can
provide the host 3401 with an indication of analyte data detected
by the analyte sensor system 3402, for example, as that data is
collected. In some examples, the analyte sensor system 3402
operates in a blinded mode and the smart device 3412 may be
omitted.
[0499] The example system 3400 also includes an upload device 3450.
The upload device 3450 can be or include any suitable computing
device configured to communicate with the analyte sensor system
3402 (e.g., the sensor electronics 3406 thereof) via the wireless
communication signals 3410. The upload device 3450, in some
examples, is remote from the host 3401 while analyte data is
collected by the analyte sensor system 3402. In some examples, the
analyte sensor system 3402 (or just the sensor electronics 3406
thereof) are removed from the host 3401 after data collection and
physically transported to a location of the upload device 3450. For
example, the upload device 3450 can be located at a pharmacist, a
clinician's office, or other suitable location. The upload device
3450 can couple to the sensor electronics 3406 and retrieve
collected analyte data. The upload device 3450, in some examples,
provides the downloaded analyte data to one or more of server
systems 3425, 3426, 3427 via network 3424. Server systems 3425,
3426, 3427 can be similar to the server systems 125, 126, 127
described herein.
[0500] FIG. 35 is a flowchart showing one example of a process 3500
that can be executed by the analyte sensor system 3402 (e.g., the
sensor electronics 3406 thereof) to collect and upload analyte
data. At step 3502, the sensor electronics 3402 detect that the
analyte sensor system 3402 has been applied to the host 3401. The
detection may occur, for example, when the analyte sensor 3404
begins to provide analyte data. In some examples, the sensor
electronics 3402 detects that the analyte sensor system 3402 has
been applied to the host 3401 when the analyte sensor 3404 provides
sensor readings above a threshold value for two different time
periods. Consider an example in which the analyte sensor 3404 is a
glucose sensor that is configured to capture an estimated glucose
value for the patient every thirty (30) seconds. The sensor
electronics 3406 may detect application of the analyte sensor
system 3402 when the analyte sensor 3404 detects an estimated
glucose value above a threshold value (e.g., 60 mg/dL) for two
different thirty (30) second periods. In some examples, the sensor
electronics 3406 detects application of the analyte sensor system
3402 when the analyte sensor 3404 detects an estimated glucose
value above a threshold value (e.g., 60 mg/dL) for two consecutive
thirty (30) second periods.
[0501] In some examples, the sensor electronics 3406 receive a
serial number of other sensor identifier of the analyte sensor
3404, for example, to properly calibrate analyte data received from
the analyte sensor 3404. The sensor electronics 3406 can receive
the sensor identifier in any suitable manner. In some examples, the
sensor electronics 3406 establish a wireless communication link
with the analyte sensor 3404. The analyte sensor 3404 provides the
sensor identifier via the wireless link. Any suitable type of wired
or wireless communication link can be used such as, for example, a
Bluetooth LE connection, a near field communication (NFC)
connection. Also, in some examples, the analyte sensor 3404
includes a radio frequency identifier (RFID) circuit. The sensor
electronics 3404 can illuminate the RFID circuit with
electromagnetic radiation, which may cause the RFID circuit to
broadcast the sensor identifier. At optional step 3504, the sensor
electronics 3406 can establish a wireless communication session
with the smart device 3412, for example, as described herein. Step
3504 may be omitted in examples where blinded analyte measurement
is performed.
[0502] At step 3506, the sensor electronics 3406 periodically
receive analyte data from the analyte sensor 3404 and store the
received analyte data, for example, at data storage hardware in
communication with the sensor electronics 3406. Analyte data can
include analyte values and/or metadata describing the host 3401
and/or diagnostic data describing the performance of the analyte
sensor 3404. The sensor electronics can receive and store analyte
data at any suitable period such as, for example, every thirty (30)
seconds, every five (5) minutes, or any other suitable period. In
some examples, the sensor electronics 3406 are programmed to prompt
the analyte sensor 3404 to provide analyte data. For example, such
prompting can occur once per period. In examples where the sensor
electronics 3406 have a communication session with the smart device
3412, the sensor electronics 3406 may also transmit some or all of
the collected analyte data to the smart device 3412 for display
(e.g., to the host 3401).
[0503] At step 3508, the sensor electronics 3406 determine if the
use of the analyte sensor 3404 is over. The use may be over, for
example, if a sensor use period has expired. For example, the
analyte sensor 3404 can be configured for use during a defined use
period (e.g., one week, ten (10) days, etc.). The use of the sensor
can be over if the sensor has been in use for the full use period.
In other examples, use of the sensor can be over if the analyte
sensor 3404 has become disengaged from the host 3401 or otherwise
fails. For example, the sensor electronics 3406 can determine that
the analyte system 3404 has failed if it fails to receive analyte
data within a defined range for more than a threshold number of
measurements.
[0504] If the analyte sensor 3404 use is not over, the sensor
electronics 3406 may continue to periodically receive and store
analyte data at step 3506. If the use is over, the sensor
electronics 3406 can enter an upload routine at step 3510. Example
upload routines are described herein with respect to FIGS. 36 and
37.
[0505] FIG. 36 is a flowchart showing one example of a process 3600
that can be executed by the sensor electronics 3406 to upload
collected analyte data. The process 3600 is one example way that
the sensor electronics 3406 can upload collected analyte data at
step 3510 of the process 3500.
[0506] When the sensor use is over, in some examples, the analyte
sensor device 3402 (or in some examples, just the sensor
electronics 3406) are mailed or otherwise physically transported to
a site where the upload device 3450 is present. In the example of
FIG. 36, the sensor electronics 3406 begin broadcasting system
identification data at step 3602. The system identification data
can identify the sensor electronics 3406, the analyte sensor 3404
or both. The system identification data can be broadcast using any
suitable wired or wireless communication technology including, for
example, Bluetooth, Bluetooth LE, MICS, NFC, etc.
[0507] When the sensor electronics 3406 are within range of the
upload device 3450, the upload device 3450 can receive the
transmitted system identification data and use the system
identification data to establish a communication link (e.g., a
wireless communication link) with the sensor electronics. At
operation 3604, the sensor electronics determines if it has
received a request to establish a communications link, for example,
with the upload device 3450. If no such request is received, the
sensor electronics 3406 can continue to broadcast the system
identification data at step 3602.
[0508] If a communication request is received at operation 3604,
the sensor electronics 3406 establish a communication link, for
example, with the upload device 3450 at step 3608. In some
examples, establishing the communication link includes
authenticating the upload device 3450. For example, the
communication request from the upload device 3450 can include
authentication data for authenticating the upload device 3450. The
communication link can be according to any suitable wired or
wireless technology including, for example, Bluetooth, Bluetooth
LE, MICS, NFC, etc. Upon establishing the communication link, the
sensor electronics 3406 can begin uploading collected analyte data
to the upload device 3450 at operation 3610. The upload device 3450
may, in turn, upload the uploaded analyte data to one or more of
the servers 3425, 3426, 3427 for further consideration. For
example, the analyte data collected in this manner may constitute
high-fidelity data that can be used, for example, in conjunction
with low-fidelity data, as described herein.
[0509] FIG. 37 is a flowchart showing another example of a process
3700 that can be executed by the sensor electronics 3406 to upload
collected analyte data. The process 3700 is another example way
that the sensor electronics 3406 can upload collected analyte data
at step 3510 of the process 3500. As described herein, when sensor
use is over, the analyte sensor device 3402 (or in some examples,
just the sensor electronics 3406) are mailed or otherwise
physically transported to a site where the upload device is
present.
[0510] In the example of FIG. 37, when the sensor use is over, the
sensor electronics 3406 determines, at 3702, whether it has
received an upload request (e.g., from the upload device 3450). The
upload request can be sent using any suitable wired or wireless
communication protocol. In some examples, a wireless protocol such
as NFC is used, although other protocols such as Bluetooth,
Bluetooth LE, MICS, etc. can also be used. If no upload request is
received, the sensor electronics 3406 continue waiting for an
upload request at operation 3702.
[0511] If an upload request is received at operation 3702, the
sensor electronics 3406 broadcasts system identification data at
step 3704. At step 3704, the sensor electronics establishes a
communication session with the upload device 3450 using the system
identification data. For example, the upload device 3450 can
receive the system identification data and retrieve authentication
data for the sensor electronics 3406 using the system
identification data. The upload device 3450 can use the
authentication data to establish the communication session. When
the communication session is established, the sensor electronics
3406 upload stored analyte data to the upload device 3450 at step
3708. The upload device 3450 may, in turn, upload the uploaded
analyte data to one or more of the servers 3425, 3426, 3427 for
further consideration. For example, the analyte data collected in
this manner may constitute high-fidelity data that can be used, for
example, in conjunction with low-fidelity data, as described
herein.
[0512] While the methods and systems are often described herein in
terms of estimated blood glucose concentration levels, such as
levels determined by a CGM that estimates a blood glucose
concentration level from a measurement of subcutaneous fluid, the
methods and systems may also be applied to other types of
concentration levels, such as actual blood glucose concentration
level, or levels of other analytes in blood or other body fluids or
substances. The methods and systems may also be applied to other
physiologic states or conditions for which management is desirable
for health or other reasons.
[0513] Each of these non-limiting examples can stand on its own or
can be combined in various permutations or combinations with one or
more of the other examples.
[0514] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." Such
examples can include elements in addition to those shown or
described. However, the present inventors also contemplate examples
in which only those elements shown or described are provided.
Moreover, the present inventors also contemplate examples using any
combination or permutation of those elements shown or described (or
one or more aspects thereof), either with respect to a particular
example (or one or more aspects thereof), or with respect to other
examples (or one or more aspects thereof) shown or described
herein.
[0515] In the event of inconsistent usages between this document
and any documents so incorporated by reference, the usage in this
document controls.
[0516] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "at least one" or
"one or more." In this document, the term "or" is used to refer to
a nonexclusive or, such that "A or B" includes "A but not B," "B
but not A," and "A and B," unless otherwise indicated. In this
document, the terms "including" and "in which" are used as the
plain-English equivalents of the respective terms "comprising" and
"wherein." Also, in the following claims, the terms "including" and
"comprising" are open-ended, that is, a system, device, article,
composition, formulation, or process that includes elements in
addition to those listed after such a term in a claim are still
deemed to fall within the scope of that claim. Moreover, in the
following claims, the terms "first," "second," and "third," etc.
are used merely as labels, and are not intended to impose numerical
requirements on their objects.
[0517] Geometric terms, such as "parallel", "perpendicular",
"round", or "square", are not intended to require absolute
mathematical precision, unless the context indicates otherwise.
Instead, such geometric terms allow for variations due to
manufacturing or equivalent functions. For example, if an element
is described as "round" or "generally round", a component that is
not precisely circular (e.g., one that is slightly oblong or is a
many-sided polygon) is still encompassed by this description.
[0518] Method examples described herein can be machine or
computer-implemented at least in part. Some examples can include a
computer-readable medium or machine-readable medium encoded with
instructions operable to configure an electronic device to perform
methods as described in the above examples. An implementation of
such methods can include code, such as microcode, assembly language
code, a higher-level language code, or the like. Such code can
include computer readable instructions for performing various
methods. The code may form portions of computer program products.
Further, in an example, the code can be tangibly stored on one or
more volatile, non-transitory, or non-volatile tangible
computer-readable media, such as during execution or at other
times. Examples of these tangible computer-readable media can
include, but are not limited to, hard disks, removable magnetic
disks, removable optical disks (e.g., compact disks and digital
video disks), magnetic cassettes, memory cards or sticks, random
access memories (RAMs), read only memories (ROMs), and the
like.
[0519] The above description is intended to be illustrative, and
not restrictive. For example, the above-described examples (or one
or more aspects thereof) may be used in combination with each
other. Other embodiments can be used, such as by one of ordinary
skill in the art upon reviewing the above description. The Abstract
is provided to comply with 37 C.F.R. .sctn. 1.72(b), to allow the
reader to quickly ascertain the nature of the technical disclosure.
It is submitted with the understanding that it will not be used to
interpret or limit the scope or meaning of the claims. Also, in the
above Detailed Description, various features may be grouped
together to streamline the disclosure. This should not be
interpreted as intending that an unclaimed disclosed feature is
essential to any claim. Rather, inventive subject matter may lie in
less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description as examples or embodiments, with each claim standing on
its own as a separate embodiment, and it is contemplated that such
embodiments can be combined with each other in various combinations
or permutations. The scope of the invention should be determined
with reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.
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