U.S. patent application number 13/790281 was filed with the patent office on 2014-05-08 for systems and methods for managing glycemic variability.
This patent application is currently assigned to DexCom, Inc.. The applicant listed for this patent is DEXCOM, INC.. Invention is credited to Naresh C. Bhavaraju, Arturo Garcia, Thomas Hall, Hari Hampapuram, Apurv Ullas Kamath, Murrad Kazalbash, Aarthi Mahalingam, Phil Mayou, Michael Robert Mensinger, Thomas A. Peyser, David Price, Kevin Sayer, Jorge Valdes.
Application Number | 20140129151 13/790281 |
Document ID | / |
Family ID | 50623022 |
Filed Date | 2014-05-08 |
United States Patent
Application |
20140129151 |
Kind Code |
A1 |
Bhavaraju; Naresh C. ; et
al. |
May 8, 2014 |
SYSTEMS AND METHODS FOR MANAGING GLYCEMIC VARIABILITY
Abstract
Methods and apparatus, including computer program products, are
provided for processing analyte data. In some example
implementations, a method may include generating glucose sensor
data indicative of a host's glucose concentration using a glucose
sensor; calculating a glycemic variability index (GVI) value based
on the glucose sensor data; and providing output to a user
responsive to the calculated glycemic variability index value. The
GVI may be a ratio of a length of a line representative of the
sensor data and an ideal length of the line. Related systems,
methods, and articles of manufacture are also disclosed.
Inventors: |
Bhavaraju; Naresh C.; (San
Diego, CA) ; Garcia; Arturo; (Chula Vista, CA)
; Mayou; Phil; (San Diego, CA) ; Peyser; Thomas
A.; (Menlo Park, CA) ; Kamath; Apurv Ullas;
(San Diego, CA) ; Mahalingam; Aarthi; (San Diego,
CA) ; Sayer; Kevin; (Carlsbad, CA) ; Hall;
Thomas; (San Diego, CA) ; Mensinger; Michael
Robert; (San Diego, CA) ; Hampapuram; Hari;
(San Diego, CA) ; Price; David; (Carlsbad, CA)
; Valdes; Jorge; (San Diego, CA) ; Kazalbash;
Murrad; (Placentia, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DEXCOM, INC. |
San Diego |
CA |
US |
|
|
Assignee: |
DexCom, Inc.
San Diego
CA
|
Family ID: |
50623022 |
Appl. No.: |
13/790281 |
Filed: |
March 8, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61723642 |
Nov 7, 2012 |
|
|
|
Current U.S.
Class: |
702/19 |
Current CPC
Class: |
G16H 40/67 20180101;
A61M 5/142 20130101; G16H 50/00 20180101; G16H 50/30 20180101; G16H
15/00 20180101; G16H 40/63 20180101; G16H 20/17 20180101; G01N
33/49 20130101; A61M 5/1723 20130101 |
Class at
Publication: |
702/19 |
International
Class: |
G06F 19/00 20060101
G06F019/00; G01N 33/49 20060101 G01N033/49 |
Claims
1. A computer-implemented method comprising: generating glucose
sensor data indicative of a host's glucose concentration using a
glucose sensor; calculating a glycemic variability index value
based on the glucose sensor data; and providing output to a user
responsive to the calculated glycemic variability index value.
2. The method of claim 1, wherein the glycemic variability index
(GVI) is defined as equal to L/L.sub.o, wherein L is a length of a
line representative of the host's glucose concentration over a
period of time and L.sub.o is an ideal line length for the given
period of time.
3. The method of claim 1, further comprising calculating a patient
glycemic status, wherein patient glycemic status (PGS) is defined
as equal to GVI*MG*(1-PTIR)+Penalty, wherein MG is a mean glucose
value of the sensor data, PTIR is a percentage of time the sensor
data is within a predefined range of glucose concentration values,
and the Penalty is a non-linear hyperbolic function that asymptotes
with a predetermined number of determined episodes of severe
hypoglycemia within a predetermined amount of time.
4. The method of claim 3, wherein the predefined range of glucose
concentration values is from about 80 mg/dL to about 180 mg/dL.
5. The method of claim 2, wherein the providing output is
responsive to the GVI calculation and the PSG calculation.
6. The method of claim 1, wherein the providing output comprises
generating a report to a user, wherein the report includes a
calculated GVI numerical value.
7. The method of claim 1, wherein the providing output comprises
triggering an alert to a user when the GVI exceeds a predetermined
threshold, wherein the alert is one or more of an audible alert,
visual alert and tactile alert.
8. The method of claim 1, wherein the calculating is automatically
performed periodically on a defined window of time of sensor
data.
9. The method of claim 1, wherein the calculating comprising
calculating a plurality of GVI values based on the sensor data,
wherein each of the GVI values is based on a different period of
time of the sensor data.
10. The method of claim 1, wherein the method is performed by a
processor executing code embodied in a non-transitory
computer-readable medium.
11. A non-transitory computer-readable medium including code which
when executed by at least one processor provides operations
comprises: providing a scoring map that converts glucose values to
a clinical relevance score; converting glucose values generated
using a continuous glucose sensor from units of glucose
concentration to clinical relevance scores using the scoring map;
applying a statistical algorithm to the clinical relevance scores
to generate a processed clinical relevance score; and outputting
information based on the processed clinical relevance score to a
user interface of an electronic device.
12. The non-transitory computer-readable medium of claim 11,
wherein the scoring map is embodied as one or more mathematical
equations.
13. The non-transitory computer-readable medium of claim 11,
wherein the scoring map comprises an above target coordinate space
and a below target coordinate space.
14. The non-transitory computer-readable medium of claim 11,
wherein a scale of the clinical relevance score is linear and a
scale of the glucose concentration is non-linear.
15. The non-transitory computer-readable medium of claim 11,
wherein the statistical algorithm comprises one or more of a sum,
mean, average and standard deviation of the clinical relevance
scores.
16. The non-transitory computer-readable medium of claim 11,
wherein the outputted information comprises one or more of a
numerical clinical relevance score and a graph of the clinical
relevance scores over time.
17. A system comprising: at least one processor; at least one
memory including code which when executed by the at least one
processor provides operations comprising analyzing glucose data
generated by a continuous glucose sensor over a time period,
identifying an event based on the analyzing, and outputting
information to a user via a user interface of the system, the
information based on the identified event.
18. The system of claim 17, wherein the event is a missed meal
event, and wherein the information includes a prompt for a user to
enter meal information.
19. The system of claim 17, wherein the event is a missed insulin
administration event, and wherein the identifying includes
monitoring whether a rate of change of the host's measured glucose
levels exceeds a threshold for a predetermined period of time.
20. The system of claim 17, wherein the information comprises an
indication of glucose control associated with the wear of an
insulin infusion pump.
21. The system of claim 17, wherein the information comprises a
message indicating a percentage of measured glucose values falling
within a target range over a predetermined time period.
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 claims the benefit of
U.S. Provisional Application No. 61/723,642, filed on Nov. 7, 2012,
the disclosure of which is hereby expressly incorporated by
reference in its entirety and is hereby expressly made a portion of
this application.
FIELD OF THE INVENTION
[0002] The present disclosure generally relates to data processing
of glucose data of a host.
BACKGROUND OF THE INVENTION
[0003] Diabetes mellitus is a disorder in which the pancreas cannot
create sufficient insulin, such as in the case of Type I diabetes
and/or in which insulin is not effective, such as Type 2 diabetes.
In a diabetic state, a victim suffers from high blood sugar, which
causes an array of physiological derangements, such as kidney
failure, skin ulcers, or bleeding into the vitreous of the eye,
associated with the deterioration of small blood vessels. A
hypoglycemic reaction, such as low blood sugar, may be induced by
an inadvertent overdose of insulin, or after a normal dose of
insulin or glucose-lowering agent accompanied by extraordinary
exercise or insufficient food intake.
[0004] A diabetic person may carry a self-monitoring blood glucose
(SMBG) monitor, which typically requires uncomfortable finger
pricking methods. Due to the lack of comfort and convenience, a
diabetic typically measures his or her glucose level only two to
four times per day. Unfortunately, these time intervals are spread
so far apart that the diabetic will likely find out too late,
sometimes incurring dangerous side effects, of a hyperglycemic or
hypoglycemic condition. In fact, it is not only unlikely that a
diabetic will take a timely SMBG value, but additionally the
diabetic will not know if his blood glucose value is higher or
lower based on conventional methods.
[0005] Consequently, a variety of non-invasive, transdermal (e.g.,
transcutaneous) and/or implantable electrochemical sensors are
being developed for continuously detecting and/or quantifying blood
glucose values. These devices and other types of devices generally
transmit raw or minimally processed data for subsequent analysis at
a remote device, which can include a display, to allow presentation
of information to a user hosting the sensor.
SUMMARY OF THE INVENTION
[0006] The various embodiments and implementations of the present
systems and methods have several features, no single one of which
is solely responsible for their desirable attributes. Without
limiting the scope of the present embodiments and implementations
as expressed by the claims that follow, their more prominent
features now will be discussed briefly. After considering this
discussion, and particularly after reading the section entitled
"Detailed Description," one will understand how the features of the
present embodiments provide the advantages described herein.
[0007] Methods and apparatus, including computer program products,
are provided for processing analyte data. In a first aspect, a
computer-implemented method is provided. The method comprises
generating glucose sensor data indicative of a host's glucose
concentration using a glucose sensor; calculating a glycemic
variability index (GVI) value based on the glucose sensor data; and
providing output to a user responsive to the calculated glycemic
variability index value.
[0008] In an implementation of the first aspect, which is generally
applicable, particularly with any other implementation of the first
aspect, the GVI is defined as GVI=L/Lo, wherein L is a length of a
line representative of the host's glucose concentration over a
period of time and Lo is an ideal line length for the given period
of time.
[0009] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the first aspect further comprises calculating a
Patient Glycemic Status (PGS), wherein PGS is defined as PGS=GVI*MG
*(1-PTIR)+Penalty, wherein MG is a mean glucose value of the sensor
data, PTIR is a percentage of time the sensor data is within a
predefined range of glucose concentration values, and the Penalty
is a non-linear hyperbolic function that asymptotes with a
predetermined number of determined episodes of severe hypoglycemia
within a predetermined amount of time. The predefined range of
glucose concentration values can be between about 80 mg/dL and
about 180 mg/dL.
[0010] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the providing output is responsive to the GVI
calculation and the PSG calculation.
[0011] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the providing output comprises generating a
report to a user, wherein the report includes a calculated GVI
numerical value.
[0012] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the providing output comprises triggering an
alert to a user when the GVI exceeds a predetermined threshold,
wherein the alert is one or more of an audible alert, visual alert
and tactile alert.
[0013] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the calculating is automatically performed
periodically on a defined window of time of sensor data.
[0014] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the calculating comprising calculating a
plurality of GVI values based on the sensor data, wherein each of
the GVI values is based on a different period of time of the sensor
data.
[0015] In another implementation of the first aspect, which is
generally applicable, particularly with any other implementation of
the first aspect, the method is performed by a processor executing
code embodied in a non-transitory computer-readable medium.
[0016] In a second aspect, a non-transitory computer-readable
medium including code which when executed by at least one processor
provides operations is provided. The operations comprise: providing
a scoring map that coverts glucose values to a clinical relevance
score; converting glucose values generated using a continuous
glucose sensor from units of glucose concentration to clinical
relevance scores using the scoring map; applying a statistical
algorithm to the clinical relevance scores to generate a processed
clinical relevance score; and outputting information based on the
processed clinical relevance score to a user interface of an
electronic device.
[0017] In an implementation of the second aspect, which is
generally applicable, particularly with any other implementation of
the second aspect, the scoring map is embodied as one or more
mathematical equations.
[0018] In another implementation of the second aspect, which is
generally applicable, particularly with any other implementation of
the second aspect, the scoring map comprises an above target
coordinate space and a below target coordinate space.
[0019] In another implementation of the second aspect, which is
generally applicable, particularly with any other implementation of
the second aspect, the scale of the clinical relevance score is
linear and the scale of the glucose concentration is
non-linear.
[0020] In another implementation of the second aspect, which is
generally applicable, particularly with any other implementation of
the second aspect, the statistical algorithm comprises one or more
of a sum, mean, average and standard deviation of the clinical
relevance scores.
[0021] In another implementation of the second aspect, which is
generally applicable, particularly with any other implementation of
the second aspect, the outputted information comprises one or more
of a numerical clinical relevance score and a graph of the clinical
relevance scores over time.
[0022] In a third aspect, a system is provided. The system
comprises: at least one processor; at least one memory including
code which when executed by the at least one processor provides
operations comprising analyzing glucose data generated by a
continuous glucose sensor over a time period, identifying an event
based on the analyzing, and outputting information to a user via a
user interface of the system, the information based on the
identified event.
[0023] In another implementation of the third aspect, which is
generally applicable, particularly with any other implementation of
the third aspect, the event is a missed meal event, and wherein the
information includes a prompt for a user to enter meal
information.
[0024] In another implementation of the third aspect, which is
generally applicable, particularly with any other implementation of
the third aspect, the event is a missed insulin administration
event, and wherein the identifying includes monitoring whether a
rate of change of the host's measured glucose levels exceeds a
threshold for a predetermined period of time.
[0025] In another implementation of the third aspect, which is
generally applicable, particularly with any other implementation of
the third aspect, the information comprises an indication of
glucose control associated with the wear of an insulin infusion
pump.
[0026] In another implementation of the third aspect, which is
generally applicable, particularly with any other implementation of
the third aspect, the information comprises a message indicating a
percentage of measured glucose values falling within a target range
over a predetermined time period.
DESCRIPTION OF THE DRAWINGS
[0027] In the drawings,
[0028] FIG. 1 depicts a diagram illustrating a continuous analyte
sensor system including a sensor electronics module in accordance
with some exemplary implementations;
[0029] FIG. 2 depicts a block diagram illustrating the sensor
electronics module in accordance with some exemplary
implementations;
[0030] FIG. 3 is a graph of glucose concentration data plotted over
several days indicative of poor glucose control in accordance with
some exemplary implementations;
[0031] FIG. 4 is a graph of glucose concentration data plotted over
several days indicative of improving glucose control in accordance
with some exemplary implementations;
[0032] FIGS. 5A-5C are a graphs of glucose concentration data
plotted over several days indicative of different levels of glucose
control and associated Glucose Variability Index scores in
accordance with some exemplary implementations;
[0033] FIG. 6 is a graphs of glucose concentration data plotted
over several days indicative of different levels of glucose control
and associated Glucose Variability Index scores and Patient
Glycemic Status scores in accordance with some exemplary
implementations;
[0034] FIG. 7 is a flowchart of a glycemic variability management
process in accordance with some implementations;
[0035] FIG. 8 is a graph of a combined Clinical Relevance score
over time and a numerical combined Clinical Relevance score value
in accordance with some implementations;
[0036] FIG. 9 is a graph of a composite high/low Clinical Relevance
scores over time and numerical composite high/low Clinical
Relevance score values in accordance with some implementations;
[0037] Like labels are used to refer to same or similar items in
the drawings.
DETAILED DESCRIPTION
[0038] FIG. 1 depicts an example system 100, in accordance with
some exemplary implementations. The system 100 includes a
continuous analyte sensor system 8 including a sensor electronics
module 12 and a continuous analyte sensor 10. The system 100 may
include other devices and/or sensors, such as medicament delivery
pump 2 and glucose meter 4. The continuous analyte sensor 10 may be
physically connected to sensor electronics module 12 and may be
integral with (e.g., non-releasably attached to) or releasably
attachable to the continuous analyte sensor 10. The sensor
electronics module 12, medicament delivery pump 2, and/or glucose
meter 4 may couple with one or more devices, such as display
devices 14, 16, 18, and/or 20.
[0039] In some exemplary implementations, the system 100 may
include a cloud-based analyte processor 490 configured to analyze
analyte data (and/or other patient related data) provided via
network 406 (e.g., via wired, wireless, or a combination thereof)
from sensor system 8 and other devices, such as display devices
14-20 and the like, associated with the host (also referred to as a
patient) and generate reports providing high-level information,
such as statistics, regarding the measured analyte over a certain
time frame. Although the example implementation described with
respect to FIG. 1 refers to analyte data being received by analyte
processor 490, other types of data processed and raw data may be
received as well.
[0040] In some exemplary implementations, the sensor electronics
module 12 may include electronic circuitry associated with
measuring and processing data generated by the continuous analyte
sensor 10. This generated continuous analyte sensor data may also
include algorithms, which can be used to process and calibrate the
continuous analyte sensor data, although these algorithms may be
provided in other ways as well. The sensor electronics module 12
may include hardware, firmware, software, or a combination thereof
to provide measurement of levels of the analyte via a continuous
analyte sensor, such as a continuous glucose sensor. An example
implementation of the sensor electronics module 12 is described
further below with respect to FIG. 2.
[0041] The sensor electronics module 12 may, as noted, couple
(e.g., wirelessly and the like) with one or more devices, such as
display devices 14, 16, 18, and/or 20. The display devices 14, 16,
18, and/or 20 may be configured for presenting (and/or alarming)
information, such as sensor information transmitted by the sensor
electronics module 12 for display at the display devices 14, 16,
18, and/or 20.
[0042] The display devices may include a relatively small, key
fob-like display device 14, a relatively large, hand-held display
device 16, a smart phone or tablet computing device 18, a computer
workstation 20, and/or any other user equipment configured to at
least present information (e.g., a medicament delivery information,
discrete self-monitoring glucose readings, heart rate monitor,
caloric intake monitor, and the like).
[0043] In some exemplary implementations, the relatively small, key
fob-like display device 14 may comprise a wrist watch, a belt, a
necklace, a pendent, a piece of jewelry, an adhesive patch, a
pager, a key fob, a plastic card (e.g., credit card), an
identification (ID) card, and/or the like. This small display
device 14 may include a relatively small display (e.g., smaller
than the large display device) and may be configured to display
certain types of displayable sensor information, such as a
numerical value and an arrow.
[0044] In some exemplary implementations, the continuous analyte
sensor 10 comprises a sensor for detecting and/or measuring
analytes, and the continuous analyte sensor 10 may be configured to
continuously detect and/or measure analytes as a non-invasive
device, a subcutaneous device, a transdermal device, and/or an
intravascular device. In some exemplary implementations, the
continuous analyte sensor 10 may analyze a plurality of
intermittent blood samples, although other analytes may be used as
well.
[0045] In some exemplary implementations, the continuous analyte
sensor 10 may comprise a glucose sensor configured to measure
glucose in the blood using one or more measurement techniques, such
as enzymatic, chemical, physical, electrochemical,
spectrophotometric, polarimetric, calorimetric, iontophoretic,
radiometric, immunochemical, and the like. In implementations in
which the continuous analyte sensor 10 includes a glucose sensor,
the glucose sensor may be comprise any device capable of measuring
the concentration of glucose and may use a variety of techniques to
measure glucose including invasive, minimally invasive, and
non-invasive sensing techniques (e.g., fluorescent monitoring), to
provide a data, such as a data stream, indicative of the
concentration of glucose in a host. The data stream may be raw data
signal, which is converted into a calibrated and/or filtered data
stream used to provide a value of glucose to a host, such as a
user, 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). Moreover, the
continuous analyte sensor 10 may be implanted as at least one of
the following types of sensors: an implantable glucose sensor, a
transcutaneous glucose sensor, implanted in a host vessel or
extracorporeally, a subcutaneous sensor, a refillable subcutaneous
sensor, an intravascular sensor.
[0046] In some implementations, the system 100 includes a DexCom
G4.RTM. Platinum continuous analyte monitor commercially available
from DexCom, Inc., for continuously monitoring a host's glucose
levels.
[0047] Although the description herein refers to some
implementations that include a continuous analyte sensor 10
comprising a glucose sensor, the continuous analyte sensor 10 may
comprises other types of analyte sensors as well. Moreover,
although some implementations refer to the glucose sensor as an
implantable glucose sensor, other types of devices capable of
detecting a concentration of glucose and providing an output signal
representative of glucose concentration may be used as well.
Furthermore, although the description herein refers to glucose as
the analyte being measured, processed, and the like, other analytes
may be used as well including, for example, ketone bodies (e.g.,
acetone, acetoacetic acid and beta hydroxybutyric acid, lactate,
etc.), glucagon, Acetyl Co A, triglycerides, fatty acids,
intermediaries in the citric acid cycle, choline, insulin,
cortisol, testosterone, and the like.
[0048] FIG. 2 depicts an example of a sensor electronics module 12,
in accordance with some exemplary implementations. The sensor
electronics module 12 may include sensor electronics that are
configured to process sensor information, such as sensor data, and
generate transformed sensor data and displayable sensor
information. For example, the sensor electronics module may
transform sensor data into one or more of the following: filtered
sensor data (e.g., one or more filtered analyte concentration
values), raw sensor data, calibrated sensor data (e.g., one or more
calibrated analyte concentration values), rate of change
information, trend information, rate of acceleration information,
sensor diagnostic information, location information (which may be
provided by a location module 269 providing location information,
such as global positioning system information), alarm/alert
information, calibration information, smoothing and/or filtering
algorithms of sensor data, and/or the like.
[0049] In some exemplary implementations, the sensor electronics
module 12 may be configured to calibrate the sensor data, and the
data storage memory 220 may store the calibrated sensor data points
as transformed sensor data. Moreover, the sensor electronics module
12 may be configured, in some exemplary implementations, to
wirelessly receive calibration information from a display device,
such as devices 14, 16, 18, and/or 20, to enable calibration of the
sensor data from sensor 12 and data line 212. Furthermore, the
sensor electronics module 12 may be configured to perform
additional algorithmic processing on the sensor data (e.g.,
calibrated and/or filtered data and/or other sensor information),
and the data storage memory 220 may be configured to store the
transformed sensor data and/or sensor diagnostic information
associated with the algorithms.
[0050] In some exemplary implementations, the sensor electronics
module 12 may comprise an application-specific integrated circuit
(ASIC) 205 coupled to a user interface 122. The ASIC 205 may
further include a potentiostat 210, a telemetry module 232 for
transmitting data from the sensor electronics module 12 to one or
more devices, such devices 14, 16, 18, and/or 20, and/or other
components for signal processing and data storage (e.g., processor
module 214 and data store 220). Although FIG. 2 depicts ASIC 205,
other types of circuitry may be used as well, including field
programmable gate arrays (FPGA), one or more microprocessors
configured to provide some (if not all of) the processing performed
by the sensor electronics module 12, analog circuitry, digital
circuitry, or a combination thereof.
[0051] In the example depicted at FIG. 2, the potentiostat 210 is
coupled to a continuous analyte sensor 10, such as a glucose
sensor, via data line 212 to receive sensor data from the analyte.
The potentiostat 210 may also provide via data line 212 a voltage
to the continuous analyte sensor 10 to bias the sensor for
measurement of a value (e.g., a current and the like) indicative of
the analyte concentration in a host (also referred to as the analog
portion of the sensor). The potentiostat 210 may have one or more
channels (and corresponding one or more data lines 212), depending
on the number of working electrodes at the continuous analyte
sensor 10.
[0052] In some exemplary implementations, the potentiostat 210 may
include a resistor that translates a current value from the sensor
10 into a voltage value, while in some exemplary implementations, a
current-to-frequency converter may also be configured to integrate
continuously a measured current value from the sensor 10 using, for
example, a charge-counting device. In some exemplary
implementations, an analog-to-digital converter may digitize the
analog signal from the sensor 10 into so-called "counts" to allow
processing by the processor module 214. The resulting counts may be
directly related to the current measured by the potentiostat 210,
which may be directly related to an analyte level, such as a
glucose level, in the host.
[0053] The telemetry module 232 may be operably connected to
processor module 214 and may provide the hardware, firmware, and/or
software that enable wireless communication between the sensor
electronics module 12 and one or more other devices, such as
display devices, processors, network access devices, and the like.
A variety of wireless radio technologies that can be implemented in
the telemetry module 232 include Bluetooth, Bluetooth Low-Energy,
the ANT protocol, NFC (near field communications), ZigBee, IEEE
802.11, IEEE 802.16, cellular radio access technologies, radio
frequency (RF), infrared (IR), paging network communication,
magnetic induction, satellite data communication, spread spectrum
communication, frequency hopping communication, near field
communications, and/or the like. In some exemplary implementations,
the telemetry module 232 comprises a Bluetooth chip, although the
Bluetooth technology may also be implemented in a combination of
the telemetry module 232 and the processor module 214.
[0054] The processor module 214 may control the processing
performed by the sensor electronics module 12. For example, the
processor module 214 may be configured to process data (e.g.,
counts), from the sensor, filter the data, calibrate the data,
perform fail-safe checking, and/or the like.
[0055] In some exemplary implementations, the processor module 214
may comprise a digital filter, such as for example an infinite
impulse response (IIR) or a finite impulse response (FIR) filter.
This digital filter may smooth a raw data stream received from
sensor 10, data line 212 and potentiostat 210 (e.g., after the
analog-to-digital conversion of the sensor data). Generally,
digital filters are programmed to filter data sampled at a
predetermined time interval (also referred to as a sample rate). In
some exemplary implementations, such as when the potentiostat 210
is configured to measure the analyte (e.g., glucose and the like)
at discrete time intervals, these time intervals determine the
sampling rate of the digital filter. In some exemplary
implementations, the potentiostat 210 is configured to measure
continuously the analyte, for example, using a current-to-frequency
converter. In these current-to-frequency converter implementations,
the processor module 214 may be programmed to request, at
predetermined time intervals (acquisition time), digital values
from the integrator of the current-to-frequency converter. These
digital values obtained by the processor module 214 from the
integrator may be averaged over the acquisition time due to the
continuity of the current measurement. As such, the acquisition
time may be determined by the sampling rate of the digital
filter.
[0056] The processor module 214 may further include a data
generator configured to generate data packages for transmission to
devices, such as the display devices 14, 16, 18, and/or 20.
Furthermore, the processor module 215 may generate data packets for
transmission to these outside sources via telemetry module 232. In
some exemplary implementations, the data packages may, as noted, be
customizable for each display device, and/or may include any
available data, such as a time stamp, displayable sensor
information, transformed sensor data, an identifier code for the
sensor and/or sensor electronics module, raw data, filtered data,
calibrated data, rate of change information, trend information,
error detection or correction, and/or the like.
[0057] The processor module 214 may also include a program memory
216 and other memory 218. The processor module 214 may be coupled
to a communications interface, such as a communication port 238,
and a source of power, such as a battery 234. Moreover, the battery
234 may be further coupled to a battery charger and/or regulator
236 to provide power to sensor electronics module 12 and/or charge
the batteries 234.
[0058] The program memory 216 may be implemented as a semi-static
memory for storing data, such as an identifier for a coupled sensor
10 (e.g., a sensor identifier (ID)) and for storing code (also
referred to as program code) to configure the ASIC 205 to perform
one or more of the operations/functions described herein. For
example, the program code may configure processor module 214 to
process data streams or counts, filter, calibrate, perform
fail-safe checking, and the like.
[0059] The memory 218 may also be used to store information. For
example, the processor module 214 including memory 218 may be used
as the system's cache memory, where temporary storage is provided
for recent sensor data received from data line 212 and potentiostat
210. In some exemplary implementations, the memory may comprise
memory storage components, such as read-only memory (ROM),
random-access memory (RAM), dynamic-RAM, static-RAM, non-static
RAM, easily erasable programmable read only memory (EEPROM),
rewritable ROMs, flash memory, and the like.
[0060] The data storage memory 220 may be coupled to the processor
module 214 and may be configured to store a variety of sensor
information. In some exemplary implementations, the data storage
memory 220 stores one or more days of continuous analyte sensor
data. For example, the data storage memory may store 1, 3, 4, 5, 6,
7, 8, 9, 10, 11, 12, 13, 14, 15, 20, and/or 30 (or more days) of
continuous analyte sensor data received from sensor 10 via data
line 212. The stored sensor information may include one or more of
the following: a time stamp, raw sensor data (one or more raw
analyte concentration values), calibrated data, filtered data,
transformed sensor data, and/or any other displayable sensor
information.
[0061] The user interface 222 may include a variety of interfaces,
such as one or more buttons 224, a liquid crystal display (LCD)
226, a vibrator 228, an audio transducer (e.g., speaker) 230, a
backlight, and/or the like. The components that comprise the user
interface 222 may provide controls to interact with the user (e.g.,
the host). One or more buttons 224 may allow, for example, toggle,
menu selection, option selection, status selection, yes/no response
to on-screen questions, a "turn off" function (e.g., for an alarm),
a "snooze" function (e.g., for an alarm), a reset, and/or the like.
The LCD 226 may provide the user with, for example, visual data
output. The audio transducer 230 (e.g., speaker) may provide
audible signals in response to triggering of certain alerts, such
as present and/or predicted hyperglycemic and hypoglycemic
conditions. In some exemplary implementations, audible signals may
be differentiated by tone, volume, duty cycle, pattern, duration,
and/or the like. In some exemplary implementations, the audible
signal may be configured to be silenced (e.g., snoozed or turned
off) by pressing one or more buttons 224 on the sensor electronics
module and/or by signaling the sensor electronics module using a
button or selection on a display device (e.g., key fob, cell phone,
and/or the like).
[0062] Although audio and vibratory alarms are described with
respect to FIG. 2, other alarming mechanisms may be used as well.
For example, in some exemplary implementations, a tactile alarm is
provided including a poking mechanism configured to "poke" the
patient in response to one or more alarm conditions.
[0063] The battery 234 may be operatively connected to the
processor module 214 (and possibly other components of the sensor
electronics module 12) and provide the necessary power for the
sensor electronics module 12. In some exemplary implementations,
the battery is a Lithium Manganese Dioxide battery, however any
appropriately sized and powered battery can be used (e.g., AAA,
Nickel-cadmium, Zinc-carbon, Alkaline, Lithium, Nickel-metal
hydride, Lithium-ion, Zinc-air, Zinc-mercury oxide, Silver-zinc, or
hermetically-sealed). In some exemplary implementations, the
battery is rechargeable. In some exemplary implementations, a
plurality of batteries can be used to power the system. In yet
other implementations, the receiver can be transcutaneously powered
via an inductive coupling, for example.
[0064] A battery charger and/or regulator 236 may be configured to
receive energy from an internal and/or external charger. In some
exemplary implementations, a battery regulator (or balancer) 236
regulates the recharging process by bleeding off excess charge
current to allow all cells or batteries in the sensor electronics
module to be fully charged without overcharging other cells or
batteries. In some exemplary implementations, the battery 234 (or
batteries) is configured to be charged via an inductive and/or
wireless charging pad, although any other charging and/or power
mechanism may be used as well.
[0065] One or more communication ports 238, also referred to as
external connector(s), may be provided to allow communication with
other devices, for example a personal computer (PC) communication
(com) port can be provided to enable communication with systems
that are separate from, or integral with, the sensor electronics
module. The communication port, for example, may comprise a serial
(e.g., universal serial bus or "USB") communication port, to
communicate with another computer system (e.g., PC, personal
digital assistant or "PDA," server, or the like). The communication
port may also be coupled to a wireless transceiver to allow
wireless communications as well. In some exemplary implementations,
the sensor electronics module 12 is able to transmit historical
data to a PC or other computing device (e.g., an analyte processor
as disclosed herein) for retrospective analysis by a patient and/or
physician.
[0066] In some continuous analyte sensor systems, an on-skin
portion of the sensor electronics may be simplified to minimize
complexity and/or size of on-skin electronics, for example,
providing only raw, calibrated, and/or filtered data to a display
device configured to run calibration and other algorithms required
for displaying the sensor data. However, the sensor electronics
module 12 may be implemented to execute prospective algorithms used
to generate transformed sensor data and/or displayable sensor
information, including, for example, algorithms that: evaluate a
clinical acceptability of reference and/or sensor data, evaluate
calibration data for best calibration based on inclusion criteria,
evaluate a quality of the calibration, compare estimated analyte
values with time corresponding measured analyte values, analyze a
variation of estimated analyte values, evaluate a stability of the
sensor and/or sensor data, detect signal artifacts (noise), replace
signal artifacts, determine a rate of change and/or trend of the
sensor data, perform dynamic and intelligent analyte value
estimation, perform diagnostics on the sensor and/or sensor data,
set modes of operation, evaluate the data for aberrancies, and/or
the like.
[0067] Although separate data storage and program memories are
shown in FIG. 2, a variety of configurations may be used as well.
For example, one or more memories may be used to provide storage
space to support data processing and storage requirements at sensor
electronic module 12.
[0068] Some implementations evaluate a host's glycemic variability
over time and provide output responsive to the evaluation.
Variability of a host's glucose concentration is recognized as a
risk factor for long-term complications and a factor for severe
hypoglycemia. Further, glycemic variability has been associated
with physical and emotional distress. FIG. 3 is a graph
illustrating glucose readings of a user that is believed to be
exhibiting high glucose variability, as it can be seen from the
graph that the user's glucose levels are rapidly swinging between
high and low glucose levels.
[0069] It is believed that a user that can continuously monitor his
or her glucose levels can reduce glycemic variability. FIG. 4 is a
graph of a glucose concentration of a user as measured using the
DexCom STS.RTM. continuous glucose monitoring system over six days.
The DexCom STS.RTM. continuous glucose monitoring system is
commercially available from DexCom, Inc. FIG. 4 illustrates that
this user's glucose concentration varied significantly more over
the first three days than the following three days. It is believed
that the reduction in glucose variability is due to the user being
able to monitor his or her glucose concentration in real time using
the DexCom STS system, thereby being able to more effectively
manage his or her condition.
Glycemic Variability Index
[0070] In some implementations, a computing system, such as any of
the computing systems described herein, calculates a Glycemic
Variability Index (GVI) and processes data and/or provides output
responsive to the GVI. The GVI can be a useful representation of
the user's glucose variability over time and can consist of one or
more numerical values.
[0071] In some implementations, the GVI is determined based on the
length of a line or distance traveled of a host's glucose
concentration over a defined period of time. That is, the GVI can
be indicative of the length of the line representing the host's
glucose concentration as plotted on a chart over a defined period
of time. In some implementations, the length of the line may then
be normalized for the defined period of time to provide a numerical
value representative of the host's GVI. The following equation (1)
can be used to represent the GVI:
GVI=L/L.sub.o (1)
where L is the length of the line of the user's glucose
concentration over a defined duration of time and L.sub.o is an
ideal length of line for the given duration.
[0072] As a non-limiting example illustrating how a GVI can be
implemented using the above GVI methodology, a GVI of 1.0 can
indicate no variability (is a flat line), a GVI between the range
of about 1.0 and 1.2 can indicate a low variability (likely a
non-diabetic), a GVI between the range of about 1.2 and 1.5 can
indicate a modest variability, and a GVI greater than 1.5 can
indicate a high glycemic variability.
[0073] For non-limiting illustrative purposes, FIGS. 5A-5C are
graphs of different glucose concentrations of a host measured by a
continuous glucose monitoring system and the associated GVI score
calculated using equation (1). FIG. 5A illustrates what is believed
to be a very low glycemic variability, FIG. 5B illustrates what is
believed to be a low glycemic variability and FIG. 5C illustrates
what is believed to be a high glycemic variability.
[0074] In some implementations, the length of the line of the
user's glucose concentration can be calculated using known
mathematical geometrical or topographical methods. For example, in
some implementations the length of the line is calculated by
summing small sections of the line of the user's glucose
concentration falling within the defined duration of time. In some
implementations, this operation can be performed using a computer
spreadsheet application, such as Excel.RTM. commercially available
by Microsoft Corp.
Patient Glycemic Status
[0075] Additional indexes may be calculated based on GVI, as well.
For example, some implementations calculate a Patient Glycemic
Status (PGS) based on the product of the GVI, the patient's mean
glucose concentration, and one minus the percentage time the host
was in range during the defined period of time. Accordingly, the
following equation (2) can be used:
PGS=GVI.times.MG.times.(1-PTIR) (2)
where MG is the mean glucose and PTIR is the percentage of time "in
range." In range can be defined as a range of glucose values
between which is believed to be acceptable glucose levels for the
user. This range can be preset or it can be user-configured. In one
implementation, in range is defined as glucose levels falling
between 88 and 120 mg/dL. It is believed that the PGS can provide a
good indication of a host's overall glycemic status over the
defined period of time.
[0076] As a non-limiting example illustrating how a PGS can be
implemented using the equation (2), a PGS less than about 30 can
indicate excellent glycemic status (likely a non-diabetic), a PGS
between the range of about 30 and 80 can indicate a good glycemic
status, a PGS between the range of about 80 and 130 can indicate a
poor glycemic status, and a PGS greater than 130 can indicate a
very poor glycemic status.
[0077] While calculating PGS using equation (2) is believed to be
adequate in many situations, it is believed that additionally
adding a non-linear hypoglycemic penalty to equation (2) can help
identify situations in which a user suffers from frequent
hypoglycemic episodes. Accordingly, equation (3) can be used to
calculate PGS in some implementations:
PGS=GVI.times.MG.times.(1-PTIR)+Penalty (3)
where the Penalty of equation (3) is a non-linear hyperbolic
function that asymptotes with 5 to 7 episodes of severe
hypoglycemia a week. Sever hypoglycemia can be defined using a
glucose level threshold and/or a glucose level threshold and a time
the user's glucose concentration spends below a glucose level
threshold.
[0078] The Penalty of equation (3) can effectively double the
threshold PGS values described above with respect to equation (2).
Accordingly, using equation (3), a PGS less than about 60 can
indicate excellent glycemic status (likely a non-diabetic), a PGS
between the range of about 60 and 160 can indicate a good glycemic
status, a PGS between the range of about 160 and 260 can indicate a
poor glycemic status, and a PGS greater than 260 can indicate a
very poor glycemic status.
[0079] In some implementations, one or both of GVI and PGS can be
used to identify problems in glycemic control. A computer system
can be used to automatically identify problems by comparing the GVI
and/or PGS to one or more predetermined thresholds and triggering
an alert responsive thereto. Further, a computer system can
generate a report that indicates one or both of the GVI and PGS.
The report can be viewed by the host, caretaker and/or a healthcare
professional to identify problems and suggest modifications to the
host's management routine to improve managing his or her
condition.
[0080] To illustrate, FIG. 6 is a graph of a user's glucose
concentration over time with an indication of GVI and PGS (PGS
calculated using equation (2)) for each three sections of data. The
three sections illustrate different GVI and PGS scores and the
associated sensor data.
[0081] FIG. 7 is a flowchart of glycemic variability management
process 700 in accordance with some implementations. Process 700
may be implemented using system 100 of FIG. 1. Further,
instructions for implementing process 700 may be embodied as
computer code stored in computer memory and executed by one or more
processors of the system 100 of FIG. 1.
[0082] Further to FIG. 7, process 700 monitors a host's glucose
concentration at block 710. Any of the glucose monitoring devices
and systems described herein can be used to monitor the host's
glucose concentration, such as the DexCom G4.RTM. Platinum
continuous glucose monitoring system. Sensor electronics module 8
and/or display device 14, 16, 18, 20 can receive the sensor data
generated by the sensor and process and store the sensor data.
Further, the sensor data can be transmitted to cloud-based
processor 490 via network for processing using process 700.
[0083] At block 720, process 700 determines a GVI and/or PGS score
based on the sensor data. The GVI and PGS scores can be calculated
using any of the methodologies described herein. Further, because
the GVI and PGS scores can be calculated over a defined period of
time in some implementations, a user may select the defined period
of time using a user interface of one of devices 14, 16, 18, 20 of
FIG. 1 for which the GVI and PGS scores are calculated, for
example. The defined period of time can be three days, one week or
one month, for example.
[0084] At block 730, process 700 provides output responsive to the
GVI and/or PGS score determination. The output can be a report
displayed on a user interface or printed using a printer. The
report can include an indication of the GVI and/or PGS as a
numerical value or using a graphic, such as a bar graph, arrow, and
the like. The output can additionally or alternatively be in the
form of an alert that is triggered responsive to the GVI and/or PGS
exceeding one or more predetermined thresholds. The alert can be
automatically sent to the host, host's caretaker or health care
provider over network 406, for example.
[0085] Further, process 700 can be performed periodically or
continuously in real time. That is, as new sensor data is
generated, process 700 can periodically or continuously determine
GVI based on the new sensor data and the past data that falls
within a defined period of time. To illustrate, in one example, a
new sensor data point is generated every five minutes. Process 700
may be performed wherein the defined period of time spans from the
most recent data point to a defined period in the past, such as 5
hours. Process 700 can be repeated for each new data point that is
received, or repeated every predetermined amount of time, such as
one hour or one day.
[0086] Additionally, in some implementations, process 700 can
include calculating a GVI for a plurality of different time frames.
For example, a GVI may be calculated based on the past hour, the
past five hours, past 24 hours, past day and past month. A user can
then compare the GVI for each of the time frames to understand
changes in his or her glycemic control.
Clinical Relevance Scoring
[0087] A pattern algorithm can be applied to statistical data (e.g.
measured analyte values) and scored according to clinical
relevance, in accordance with some embodiments. The score can then
be outputted to a host or caretaker to provide a useful indication
of the user's control of a health characteristic over a period of
time. The following is a non-limiting example algorithm for scoring
clinical relevance, where the analyte is glucose.
[0088] A scoring map is provided that coverts glucose values to a
clinical relevance score. That is, the scoring map can convert
glucose values in one numerical scale/units (e.g., mg/dL) to
another scale/units that is based on a clinical relevance. The map
can be defined algorithmically by one or more mathematical
equations in some implementations. Further, in some
implementations, the map projects the coordinate space of 40-400
mg/dL into two separate coordinate spaces comprising above and
below a target range. The target range can be defined as an ideal
glucose value for a user, such as between 110 mg/dL, although it is
understood that other values can be used or that instead of a
value, as range is used, such as 80-120 mg/dL. The map converts one
numerical scale/units to other scale/units (e.g. from mg/dL glucose
to GVI score). In some implementations, the numerical range of the
clinical relevance scale is from 1.0 to 10.0 and represents the
increasing clinical significance away from target, although it is
understood that other scales can be used instead, such as 0.0 to
1.0 or 1 to 100.
[0089] The mapping can be non-linear in the space of glucose
concentration in some implementations. For example, clinical
symptoms can get somewhat exponentially worse the further a patient
drifts from target. Further, the mapping can be different for above
versus below target. For example, it is believed that a glucose
level in humans of 50 mg/dL below a target is very different (e.g.
significantly clinically more severe) than 50 mg/dL above a target
range, where the target is 105 mg/dL, for example.
[0090] In some implementations, the score map in the clinical
relevance scale can be linear--in contrast to the glucose
concentration scale. That is, the glucose values are mapped to the
clinical relevance scale so that each unit in the clinical
relevance scale changes along the entire scale at approximately the
same rate as the increase in clinical significance. However, in
alternative implementations, the map range can be logarithmic; for
example, similar to the decibels and Richter scales where every
integer unit increase is ten times worse.
[0091] Every glucose value within a specified date range--if any
date range is provided-can then be converted into units of clinical
relevance according to the clinical relevance scoring map.
[0092] Once converted, a statistical algorithm can be applied to
the values in units of clinical relevance to generate a composite
clinical relevance score. The algorithm can take one or more of the
sum, mean, average standard deviation, etc., of the values. For
example, in some implementations, the composite score can be the
mean score of all of the values within the specified date
range.
[0093] The results of the mapped score can then be processed and
outputted. The output can include a numerical score, such as a
composite high/low mean score of all values within a specified time
range, a combined mean score of all values within a specified time
range, and/or one or more graphs over time of the composite and/or
combined scores.
[0094] FIG. 8 is a graphical representation of a combined score
output displayed on a user interface of device 14, 16, 18, 20 in
accordance with some implementations. Here, the score is on a scale
of 1 to 10 along the y-axis over time on the x-axis. A numerical
score that is the mean of the scores illustrated in the graph is
displayed to the right of the graph.
[0095] FIG. 9 is a graphical representation of a composite score
output displayed on a user interface of device 14, 16, 18, 20 in
accordance with some implementations. Here, the graph provides
clinical relevance away from target in both high and low
directions. Further, separate high and low numerical scores
representative of the mean of all high scores and all low scores,
respectively, are provided on to the right of the graph.
[0096] In some implementations, scores can also be bucketed into
five minute epochs over a modal day for any number of days desired.
From this sum or average for each epoch can be obtained and plotted
over a day.
[0097] In some implementations, the map is designed so that scores
range from 0 to 10. A 0 score can indicate very good glycemic
variability, and a 10 score can indicate very poor glycemic
variability.
[0098] In some implementations, the score is normalized to have
equivalent clinical relevance for high and low blood glucose
ranges. For example, a score of 6.5 for a high only blood glucose
reading has and equivalent clinical relevance of a score of 6.5 for
a low only blood glucose reading. Likewise, a score for a
composite/combined blood glucose reading has the same meaning as a
score of 6.5 for both high low and low only blood glucose
readings.
Retrospective Analysis of Real-Time Generated Analyte Data
[0099] In some implementations, system 100 can re-analyze real-time
measured analyte data retrospectively to provide greater insight in
managing a health condition, such as retrospectively analyzing
glucose data to manage diabetes.
[0100] A non-limiting example is a patient with type-2 diabetes
going through basal insulin titration. In the morning, the patient
may need to decide whether to increase, decrease, or maintain
insulin rates. The patent can use system 100, which includes a
continuous glucose monitor, such as the Dexcom G4.RTM. Platinum
continuous glucose monitoring system and initiates a re-analysis of
historical glucose information, such as the past days', weeks' or
months' glucose information. The initiation can be performed by a
user selecting a menu item displayed on a user interface of one or
more of display device 14, 16, 18 20, for example. The system 100
reanalyzes the historical glucose information and changes any
historical trend information to reflect greater accuracy from a
retrospective analysis of the data. The retrospectively analyzed
data can be used by the patient to adjust his or her basal insulin
administration protocols.
[0101] Further, the retrospectively analyzed data can be further
processed to identify possible events and provide event markers on
a glucose trend graph for a user to visualize. For example, if the
user's glucose drops every Tuesday at 10am in a consistent pattern,
a retrospective analysis can prompt the user to ask whether he
exercises during that time period and store the user's answer to
the prompt.
[0102] System 100 can also programically analyze data after a
predetermined amount of time, such as at the end of each day, and
provide a message to the user with information based on the data
analysis. For instance, a push notification, or local notification,
can be automatically displayed on the user interface of device 14,
16, 18, 20 at predetermined times with the percentage of glucose
values that were within a specified glucose range that day. It is
believed that doing so can provide motivation to the user to
maintain his or her glucose levels within the specified range.
Automatic Detection of Missed Insulin Administration
[0103] System 100 can also be used to detect missed insulin and
provide a timely notification to the patient/user for the
prevention of hyperglycemia, in accordance with some
implementations. It is believed that high positive rates of change
(3-8 mg/dL/min) occur infrequently and are almost always associated
with missed insulin administration. When sustained high positive
rates of change are detected (e.g., 3-8 mg/dL/min over 10-15
minutes duration) with system 100, a specific alarm can be provided
on display 14, 16, 18, 20 alerting the user to the possibility that
they may have missed an insulin administration. This could occur as
a result of inattention or distraction, e.g. a "missed meal bolus".
In insulin pump therapy, missed meal boluses often occur when the
patient/user sets the bolus amount but forgets to apply the final
confirmation necessary to initiate delivery of insulin. Similarly,
patients administering insulin by injection can also forget to give
insulin at mealtime to cover the carbohydrate content of a meal.
However, missed insulin can also occur as a result of an insulin
pump failure, e.g., an occlusion in the insulin tubing or cannula.
Finally, missed insulin can occur as well in situations in which a
patient/user assumes that he/she has been given a "diet" drink
(e.g., cola, lemonade etc.), but due to error, has been given a
high carbohydrate content beverage instead. Under these
circumstances, the patient/user would typically not give insulin
and then experience a rapid rise in glucose due to the error.
Pattern Detection on Troublesome Meals
[0104] System 100 can be used to make event entry and download for
reports more useful to the patient, physician, nurse, educator and
dietician, in accordance with some implementations.
[0105] Calculating bolus insulin for mealtime is often complicated
to a user. One difficulty can be estimating the number of
carbohydrates in a meal. If the estimation by the patient is
inaccurate, the corresponding insulin dose will be off which may
result in hypo or hyperglycemia. When patients retrospectively
analyze his or her data, for example, it can be difficult to now
review a problem meal and draw any useful insights given the data
that is available with just carbohydrate logging. For instance, a
patient may ask themselves "What was the meal?", "Were the carbs
estimated correct?", "Was the glycemic index different?", "Did I
take my insulin too early or too late?", "Did I inject the correct
amount of insulin?"
[0106] Most people only eat 12-15 different meals. By having system
100 look for problems by specific meal (e.g. came asada burrito vs.
2 slices of pizza) system 100 can programically highlight meals
that have a pattern of poor control and give an insight to the user
that they may be mis-estimating the number of carbs in a given
meal. This data becomes actionable. The following is an exemplary
implementation that may be programically implemented using system
100.
[0107] Part 1: Meal events. Rather than having event entry input
the number if carbs for each meal and have the user estimate carbs
every meal, have a list of meals to choose from. Typical users only
eat 12-20 different meals most of the time. The selection can start
with breakfast1, breakfast2, lunch1, lunch2, etc. and allow the
user to name the meal more specifically on display device 20 and
download that information to another display device, such as
display device 16, which would change the meal. Each meal would
have information relevant to the meal such as carbohydrates,
glycemic index, etc. stored under that meal. The user when logging
a meal simply selects the meal they ate.
[0108] Part 2: Meal event setup. Meal setup can be done any of
display device 14, 16, 18, 20. If device 14, 16, 18, 20 has access
to the Internet, the setup problem can be connected to a food
database that can allow the user to select a common meal and
download accurate information about the meal reducing the need for
carb counting. The user can setup a list of 10, 20 or more common
meals they eat frequently which configures a menu on the receiver
with the meal name.
[0109] Part 3: Pattern analysis. The analysis software in system
100 determines poor control around specific meals and reports
issues relating to them providing insight to the user that they may
be misestimating or mistiming meal insulin bolus by providing an
alert to the user using user interface of device 14, 16, 18,
20.
Pattern Recognition Of Glucose Trends Based on Location and
Duration of Insulin Pump Infusion Site Wear
[0110] Some implementations of system 100 programically provide
information to a user about how sites and duration of wear of
insulin infusion pumps influence glucose control of the user. Here,
system 100 can prompt a user about the location of an insulin
infusion site upon priming the insulin pump for use, for example.
The system 100 can then track the duration of the use of the
insulin pump. Upon a request from the user, the system 100 can
programically analyze the user's glucose readings using a
continuous glucose sensor worn by the patient over the time period
that the insulin pump was worn and provide output to the user as to
the user's glucose control. The user can then use this information
to determine if certain locations and/or durations of wearing the
insulin pump may provide different levels of glucose control in the
user.
[0111] Various implementations of the subject matter described
herein may be realized in digital electronic circuitry, integrated
circuitry, specially designed ASICs (application specific
integrated circuits), computer hardware, firmware, software, and/or
combinations thereof. The circuitry may be affixed to a printed
circuit board (PCB), or the like, and may take a variety of forms,
as noted. These various implementations may include implementation
in one or more computer programs that are executable and/or
interpretable on a programmable system including at least one
programmable processor, which may be special or general purpose,
coupled to receive data and instructions from, and to transmit data
and instructions to, a storage system, at least one input device,
and at least one output device.
[0112] These computer programs (also known as programs, software,
software applications, or code) include machine instructions for a
programmable processor, and may be implemented in a high-level
procedural and/or object-oriented programming language, and/or in
assembly/machine language. As used herein, the term
"machine-readable medium" refers to any non-transitory computer
program product, apparatus and/or device (e.g., magnetic discs,
optical disks, memory, Programmable Logic Devices (PLDs)) used to
provide machine instructions and/or data to a programmable
processor, including a machine-readable medium that receives
machine instructions.
[0113] To provide for interaction with a user, the subject matter
described herein may be implemented on a computer having a display
device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal
display) monitor) for displaying information to the user and a
keyboard and a pointing device (e.g., a mouse or a trackball) by
which the user may provide input to the computer. Other kinds of
devices may be used to provide for interaction with a user as well;
for example, feedback provided to the user may be any form of
sensory feedback (e.g., visual feedback, auditory feedback, or
tactile feedback); and input from the user may be received in any
form, including acoustic, speech, or tactile input.
[0114] The subject matter described herein may be implemented in a
computing system that includes a back-end component (e.g., as a
data server), or that includes a middleware component (e.g., an
application server), or that includes a front-end component (e.g.,
a client computer having a graphical user interface or a Web
browser through which a user may interact with an implementation of
the subject matter described herein), or any combination of such
back-end, middleware, or front-end components. The components of
the system may be interconnected by any form or medium of digital
data communication (e.g., a communication network). Examples of
communication networks include a local area network ("LAN"), a wide
area network ("WAN"), and the Internet.
[0115] Although a few variations have been described in detail
above, other modifications are possible. For example, while the
descriptions of specific implementations of the current subject
matter discuss analytic applications, the current subject matter is
applicable to other types of software and data services access as
well. Moreover, although the above description refers to specific
products, other products may be used as well. In addition, the
logic flows depicted in the accompanying figures and described
herein do not require the particular order shown, or sequential
order, to achieve desirable results. As used herein, the term
"based on" also refers to "based on at least." Other
implementations may be within the scope of the following
claims.
[0116] While the disclosure has been illustrated and described in
detail in the drawings and foregoing description, such illustration
and description are to be considered illustrative or exemplary and
not restrictive. The disclosure is not limited to the disclosed
embodiments. Variations to the disclosed embodiments can be
understood and effected by those skilled in the art in practicing
the claimed disclosure, from a study of the drawings, the
disclosure and the appended claims.
[0117] All references cited herein are incorporated herein by
reference in their entirety. To the extent publications and patents
or patent applications incorporated by reference contradict the
disclosure contained in the specification, the specification is
intended to supersede and/or take precedence over any such
contradictory material.
[0118] Unless otherwise defined, all terms (including technical and
scientific terms) are to be given their ordinary and customary
meaning to a person of ordinary skill in the art, and are not to be
limited to a special or customized meaning unless expressly so
defined herein. It should be noted that the use of particular
terminology when describing certain features or aspects of the
disclosure should not be taken to imply that the terminology is
being re-defined herein to be restricted to include any specific
characteristics of the features or aspects of the disclosure with
which that terminology is associated. Terms and phrases used in
this application, and variations thereof, especially in the
appended claims, unless otherwise expressly stated, should be
construed as open ended as opposed to limiting. As examples of the
foregoing, the term `including` should be read to mean `including,
without limitation,` including but not limited to,' or the like;
the term `comprising` as used herein is synonymous with
`including,` containing,' or `characterized by,` and is inclusive
or open-ended and does not exclude additional, unrecited elements
or method steps; the term `having` should be interpreted as `having
at least;` the term `includes` should be interpreted as `includes
but is not limited to;` the term `example` is used to provide
exemplary instances of the item in discussion, not an exhaustive or
limiting list thereof; adjectives such as `known`, `normal`,
`standard`, and terms of similar meaning should not be construed as
limiting the item described to a given time period or to an item
available as of a given time, but instead should be read to
encompass known, normal, or standard technologies that may be
available or known now or at any time in the future; and use of
terms like `preferably,` preferred,"desired,' or `desirable,` and
words of similar meaning should not be understood as implying that
certain features are critical, essential, or even important to the
structure or function of the invention, but instead as merely
intended to highlight alternative or additional features that may
or may not be utilized in a particular embodiment of the invention.
Likewise, a group of items linked with the conjunction `and` should
not be read as requiring that each and every one of those items be
present in the grouping, but rather should be read as `and/or`
unless expressly stated otherwise. Similarly, a group of items
linked with the conjunction `or` should not be read as requiring
mutual exclusivity among that group, but rather should be read as
`and/or` unless expressly stated otherwise.
[0119] Where a range of values is provided, it is understood that
the upper and lower limit, and each intervening value between the
upper and lower limit of the range is encompassed within the
embodiments.
[0120] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations may be expressly set forth
herein for sake of clarity. The indefinite article "a" or "an" does
not exclude a plurality. A single processor or other unit may
fulfill the functions of several items recited in the claims. The
mere fact that certain measures are recited in mutually different
dependent claims does not indicate that a combination of these
measures cannot be used to advantage. Any reference signs in the
claims should not be construed as limiting the scope.
[0121] It will be further understood by those within the art that
if a specific number of an introduced claim recitation is intended,
such an intent will be explicitly recited in the claim, and in the
absence of such recitation no such intent is present. For example,
as an aid to understanding, the following appended claims may
contain usage of the introductory phrases "at least one" and "one
or more" to introduce claim recitations. However, the use of such
phrases should not be construed to imply that the introduction of a
claim recitation by the indefinite articles "a" or "an" limits any
particular claim containing such introduced claim recitation to
embodiments containing only one such recitation, even when the same
claim includes the introductory phrases "one or more" or "at least
one" and indefinite articles such as "a" or "an" (e.g., "a" and/or
"an" should typically be interpreted to mean "at least one" or "one
or more"); the same holds true for the use of definite articles
used to introduce claim recitations. In addition, even if a
specific number of an introduced claim recitation is explicitly
recited, those skilled in the art will recognize that such
recitation should typically be interpreted to mean at least the
recited number (e.g., the bare recitation of "two recitations,"
without other modifiers, typically means at least two recitations,
or two or more recitations). Furthermore, in those instances where
a convention analogous to "at least one of A, B, and C, etc." is
used, in general such a construction is intended in the sense one
having skill in the art would understand the convention (e.g., "a
system having at least one of A, B, and C" would include but not be
limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). In those instances where a convention analogous to
"at least one of A, B, or C, etc." is used, in general such a
construction is intended in the sense one having skill in the art
would understand the convention (e.g., "a system having at least
one of A, B, or C" would include but not be limited to systems that
have A alone, B alone, C alone, A and B together, A and C together,
B and C together, and/or A, B, and C together, etc.). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
"A or B" will be understood to include the possibilities of "A" or
"B" or "A and B."
[0122] All numbers expressing quantities of ingredients, reaction
conditions, and so forth used in the specification are to be
understood as being modified in all instances by the term `about.`
Accordingly, unless indicated to the contrary, the numerical
parameters set forth herein are approximations that may vary
depending upon the desired properties sought to be obtained. At the
very least, and not as an attempt to limit the application of the
doctrine of equivalents to the scope of any claims in any
application claiming priority to the present application, each
numerical parameter should be construed in light of the number of
significant digits and ordinary rounding approaches.
[0123] Furthermore, although the foregoing has been described in
some detail by way of illustrations and examples for purposes of
clarity and understanding, it is apparent to those skilled in the
art that certain changes and modifications may be practiced.
Therefore, the description and examples should not be construed as
limiting the scope of the invention to the specific embodiments and
examples described herein, but rather to also cover all
modification and alternatives coming with the true scope and spirit
of the invention.
[0124] Methods and devices that are suitable for use in conjunction
with aspects of the preferred embodiments are disclosed in U.S.
Pat. No. 4,757,022; U.S. Pat. No. 4,994,167; U.S. Pat. No.
6,001,067; U.S. Pat. No. 6,558,321; U.S. Pat. No. 6,702,857; U.S.
Pat. No. 6,741,877; U.S. Pat. No. 6,862,465; U.S. Pat. No.
6,931,327; U.S. Pat. No. 7,074,307; U.S. Pat. No. 7,081,195; U.S.
Pat. No. 7,108,778; U.S. Pat. No. 7,110,803; U.S. Pat. No.
7,134,999; U.S. Pat. No. 7,136,689; U.S. Pat. No. 7,192,450; U.S.
Pat. No. 7,226,978; U.S. Pat. No. 7,276,029; U.S. Pat. No.
7,310,544; U.S. Pat. No. 7,364,592; U.S. Pat. No. 7,366,556; U.S.
Pat. No. 7,379,765; U.S. Pat. No. 7,424,318; U.S. Pat. No.
7,460,898; U.S. Pat. No. 7,467,003; U.S. Pat. No. 7,471,972; U.S.
Pat. No. 7,494,465; U.S. Pat. No. 7,497,827; U.S. Pat. No.
7,519,408; U.S. Pat. No. 7,583,990; U.S. Pat. No. 7,591,801; U.S.
Pat. No. 7,599,726; U.S. Pat. No. 7,613,491; U.S. Pat. No.
7,615,007; U.S. Pat. No. 7,632,228; U.S. Pat. No. 7,637,868; U.S.
Pat. No. 7,640,048; U.S. Pat. No. 7,651,596; U.S. Pat. No.
7,654,956; U.S. Pat. No. 7,657,297; U.S. Pat. No. 7,711,402; U.S.
Pat. No. 7,713,574; U.S. Pat. No. 7,715,893; U.S. Pat. No.
7,761,130; U.S. Pat. No. 7,771,352; U.S. Pat. No. 7,774,145; U.S.
Pat. No. 7,775,975; U.S. Pat. No. 7,778,680; U.S. Pat. No.
7,783,333; U.S. Pat. No. 7,792,562; U.S. Pat. No. 7,797,028; U.S.
Pat. No. 7,826,981; U.S. Pat. No. 7,828,728; U.S. Pat. No.
7,831,287; U.S. Pat. No. 7,835,777; U.S. Pat. No. 7,857,760; U.S.
Pat. No. 7,860,545; U.S. Pat. No. 7,875,293; U.S. Pat. No.
7,881,763; U.S. Pat. No. 7,885,697; U.S. Pat. No. 7,896,809; U.S.
Pat. No. 7,899,511; U.S. Pat. No. 7,901,354; U.S. Pat. No.
7,905,833; U.S. Pat. No. 7,914,450; U.S. Pat. No. 7,917,186; U.S.
Pat. No. 7,920,906; U.S. Pat. No. 7,925,321; U.S. Pat. No.
7,927,274; U.S. Pat. No. 7,933,639; U.S. Pat. No. 7,935,057; U.S.
Pat. No. 7,946,984; U.S. Pat. No. 7,949,381; U.S. Pat. No.
7,955,261; U.S. Pat. No. 7,959,569; U.S. Pat. No. 7,970,448; U.S.
Pat. No. 7,974,672; U.S. Pat. No. 7,976,492; U.S. Pat. No.
7,979,104; U.S. Pat. No. 7,986,986; U.S. Pat. No. 7,998,071; U.S.
Pat. No. 8,000,901; U.S. Pat. No. 8,005,524; U.S. Pat. No.
8,005,525; U.S. Pat. No. 8,010,174; U.S. Pat. No. 8,027,708; U.S.
Pat. No. 8,050,731; U.S. Pat. No. 8,052,601; U.S. Pat. No.
8,053,018; U.S. Pat. No. 8,060,173; U.S. Pat. No. 8,060,174; U.S.
Pat. No. 8,064,977; U.S. Pat. No. 8,073,519; U.S. Pat. No.
8,073,520; U.S. Pat. No. 8,118,877; U.S. Pat. No. 8,128,562; U.S.
Pat. No. 8,133,178; U.S. Pat. No. 8,150,488; U.S. Pat. No.
8,155,723; U.S. Pat. No. 8,160,669; U.S. Pat. No. 8,160,671; U.S.
Pat. No. 8,167,801; U.S. Pat. No. 8,170,803; U.S. Pat. No.
8,195,265; U.S. Pat. No. 8,206,297; U.S. Pat. No. 8,216,139; U.S.
Pat. No. 8,229,534; U.S. Pat. No. 8,229,535; U.S. Pat. No.
8,229,536; U.S. Pat. No. 8,231,531; U.S. Pat. No. 8,233,958; U.S.
Pat. No. 8,233,959; U.S. Pat. No. 8,249,684; U.S. Pat. No.
8,251,906; U.S. Pat. No. 8,255,030; U.S. Pat. No. 8,255,032; U.S.
Pat. No. 8,255,033; U.S. Pat. No. 8,257,259; U.S. Pat. No.
8,260,393; U.S. Pat. No. 8,265,725; U.S. Pat. No. 8,275,437; U.S.
Pat. No. 8,275,438; U.S. Pat. No. 8,277,713; U.S. Pat. No.
8,280,475; U.S. Pat. No. 8,282,549; U.S. Pat. No. 8,282,550; U.S.
Pat. No. 8,285,354; U.S. Pat. No. 8,287,453; U.S. Pat. No.
8,290,559; U.S. Pat. No. 8,290,560; U.S. Pat. No. 8,290,561; U.S.
Pat. No. 8,290,562; U.S. Pat. No. 8,292,810; U.S. Pat. No.
8,298,142; U.S. Pat. No. 8,311,749; U.S. Pat. No. 8,313,434; U.S.
Pat. No. 8,321,149; U.S. Pat. No. 8,332,008; U.S. Pat. No.
8,346,338; U.S. Pat. No. 8,364,229; U.S. Pat. No. 8,369,919; U.S.
Pat. No. 8,374,667; U.S. Pat. No. 8,386,004; and U.S. Pat. No.
8,394,021.
[0125] Methods and devices that are suitable for use in conjunction
with aspects of the preferred embodiments are disclosed in U.S.
Patent Publication No. 2003-0032874-A1; U.S. Patent Publication No.
2005-0033132-A1; U.S. Patent Publication No. 2005-0051427-A1; U.S.
Patent Publication No. 2005-0090607-A1; U.S. Patent Publication No.
2005-0176136-A1; U.S. Patent Publication No. 2005-0245799-A1; U.S.
Patent Publication No. 2006-0015020-A1; U.S. Patent Publication No.
2006-0016700-A1; U.S. Patent Publication No. 2006-0020188-A1; U.S.
Patent Publication No. 2006-0020190-A1; U.S. Patent Publication No.
2006-0020191-A1; U.S. Patent Publication No. 2006-0020192-A1; U.S.
Patent Publication No. 2006-0036140-A1; U.S. Patent Publication No.
2006-0036143-A1; U.S. Patent Publication No. 2006-0040402-A1; U.S.
Patent Publication No. 2006-0068208-A1; U.S. Patent Publication No.
2006-0142651-A1; U.S. Patent Publication No. 2006-0155180-A1; U.S.
Patent Publication No. 2006-0198864-A1; U.S. Patent Publication No.
2006-0200020-A1; U.S. Patent Publication No. 2006-0200022-A1; U.S.
Patent Publication No. 2006-0200970-A1; U.S. Patent Publication No.
2006-0204536-A1; U.S. Patent Publication No. 2006-0224108-A1; U.S.
Patent Publication No. 2006-0235285-A1; U.S. Patent Publication No.
2006-0249381-A1; U.S. Patent Publication No. 2006-0252027-A1; U.S.
Patent Publication No. 2006-0253012-A1; U.S. Patent Publication No.
2006-0257995-A1; U.S. Patent Publication No. 2006-0258761-A1; U.S.
Patent Publication No. 2006-0263763-A1; U.S. Patent Publication No.
2006-0270922-A1; U.S. Patent Publication No. 2006-0270923-A1; U.S.
Patent Publication No. 2007-0027370-A1; U.S. Patent Publication No.
2007-0032706-A1; U.S. Patent Publication No. 2007-0032718-A1; U.S.
Patent Publication No. 2007-0045902-A1; U.S. Patent Publication No.
2007-0059196-A1; U.S. Patent Publication No. 2007-0066873-A1; U.S.
Patent Publication No. 2007-0173709-A1; U.S. Patent Publication No.
2007-0173710-A1; U.S. Patent Publication No. 2007-0208245-A1; U.S.
Patent Publication No. 2007-0208246-A1; U.S. Patent Publication No.
2007-0232879-A1; U.S. Patent Publication No. 2008-0045824-A1; U.S.
Patent Publication No. 2008-0083617-A1; U.S. Patent Publication No.
2008-0086044-A1; U.S. Patent Publication No. 2008-0108942-A1; U.S.
Patent Publication No. 2008-0119703-A1; U.S. Patent Publication No.
2008-0119704-A1; U.S. Patent Publication No. 2008-0119706-A1; U.S.
Patent Publication No. 2008-0183061-A1; U.S. Patent Publication No.
2008-0183399-A1; U.S. Patent Publication No. 2008-0188731-A1; U.S.
Patent Publication No. 2008-0189051-A1; U.S. Patent Publication No.
2008-0194938-A1; U.S. Patent Publication No. 2008-0197024-A1; U.S.
Patent Publication No. 2008-0200788-A1; U.S. Patent Publication No.
2008-0200789-A1; U.S. Patent Publication No. 2008-0200791-A1; U.S.
Patent Publication No. 2008-0214915-A1; U.S. Patent Publication No.
2008-0228054-A1; U.S. Patent Publication No. 2008-0242961-A1; U.S.
Patent Publication No. 2008-0262469-A1; U.S. Patent Publication No.
2008-0275313-A1; U.S. Patent Publication No. 2008-0287765-A1; U.S.
Patent Publication No. 2008-0306368-A1; U.S. Patent Publication No.
2008-0306434-A1; U.S. Patent Publication No. 2008-0306435-A1; U.S.
Patent Publication No. 2008-0306444-A1; U.S. Patent Publication No.
2009-0018424-A1; U.S. Patent Publication No. 2009-0030294-A1; U.S.
Patent Publication No. 2009-0036758-A1; U.S. Patent Publication No.
2009-0036763-A1; U.S. Patent Publication No. 2009-0043181-A1; U.S.
Patent Publication No. 2009-0043182-A1; U.S. Patent Publication No.
2009-0043525-A1; U.S. Patent Publication No. 2009-0045055-A1; U.S.
Patent Publication No. 2009-0062633-A1; U.S. Patent Publication No.
2009-0062635-A1; U.S. Patent Publication No. 2009-0076360-A1; U.S.
Patent Publication No. 2009-0099436-A1; U.S. Patent Publication No.
2009-0124877-A1; U.S. Patent Publication No. 2009-0124879-A1; U.S.
Patent Publication No. 2009-0124964-A1; U.S. Patent Publication No.
2009-0131769-A1; U.S. Patent Publication No. 2009-0131777-A1; U.S.
Patent Publication No. 2009-0137886-A1; U.S. Patent Publication No.
2009-0137887-A1; U.S. Patent Publication No. 2009-0143659-A1; U.S.
Patent Publication No. 2009-0143660-A1; U.S. Patent Publication No.
2009-0156919-A1; U.S. Patent Publication No. 2009-0163790-A1; U.S.
Patent Publication No. 2009-0178459-A1; U.S. Patent Publication No.
2009-0192366-A1; U.S. Patent Publication No. 2009-0192380-A1; U.S.
Patent Publication No. 2009-0192722-A1; U.S. Patent Publication No.
2009-0192724-A1; U.S. Patent Publication No. 2009-0192751-A1; U.S.
Patent Publication No. 2009-0203981-A1; U.S. Patent Publication No.
2009-0216103-A1; U.S. Patent Publication No. 2009-0240120-A1; U.S.
Patent Publication No. 2009-0240193-A1; U.S. Patent Publication No.
2009-0242399-A1; U.S. Patent Publication No. 2009-0242425-A1; U.S.
Patent Publication No. 2009-0247855-A1; U.S. Patent Publication No.
2009-0247856-A1; U.S. Patent Publication No. 2009-0287074-A1; U.S.
Patent Publication No. 2009-0299155-A1; U.S. Patent Publication No.
2009-0299156-A1; U.S. Patent Publication No. 2009-0299162-A1; U.S.
Patent Publication No. 2010-0010331-A1; U.S. Patent Publication No.
2010-0010332-A1; U.S. Patent Publication No. 2010-0016687-A1; U.S.
Patent Publication No. 2010-0016698-A1; U.S. Patent Publication No.
2010-0030484-A1; U.S. Patent Publication No. 2010-0036215-A1; U.S.
Patent Publication No. 2010-0036225-A1; U.S. Patent Publication No.
2010-0041971-A1; U.S. Patent Publication No. 2010-0045465-A1; U.S.
Patent Publication No. 2010-0049024-A1; U.S. Patent Publication No.
2010-0076283-A1; U.S. Patent Publication No. 2010-0081908-A1; U.S.
Patent Publication No. 2010-0081910-A1; U.S. Patent Publication No.
2010-0087724-A1; U.S. Patent Publication No. 2010-0096259-A1; U.S.
Patent Publication No. 2010-0121169-A1; U.S. Patent Publication No.
2010-0161269-A1; U.S. Patent Publication No. 2010-0168540-A1; U.S.
Patent Publication No. 2010-0168541-A1; U.S. Patent Publication No.
2010-0168542-A1; U.S. Patent Publication No. 2010-0168543-A1; U.S.
Patent Publication No. 2010-0168544-A1; U.S. Patent Publication No.
2010-0168545-A1; U.S. Patent Publication No. 2010-0168546-A1; U.S.
Patent Publication No. 2010-0168657-A1; U.S. Patent Publication No.
2010-0174157-A1; U.S. Patent Publication No. 2010-0174158-A1; U.S.
Patent Publication No. 2010-0174163-A1; U.S. Patent Publication No.
2010-0174164-A1; U.S. Patent Publication No. 2010-0174165-A1; U.S.
Patent Publication No. 2010-0174166-A1; U.S. Patent Publication No.
2010-0174167-A1; U.S. Patent Publication No. 2010-0179401-A1; U.S.
Patent Publication No. 2010-0179402-A1; U.S. Patent Publication No.
2010-0179404-A1; U.S. Patent Publication No. 2010-0179408-A1; U.S.
Patent Publication No. 2010-0179409-A1; U.S. Patent Publication No.
2010-0185065-A1; U.S. Patent Publication No. 2010-0185069-A1; U.S.
Patent Publication No. 2010-0185070-A1; U.S. Patent Publication No.
2010-0185071-A1; U.S. Patent Publication No. 2010-0185075-A1; U.S.
Patent Publication No. 2010-0191082-A1; U.S. Patent Publication No.
2010-0198035-A1; U.S. Patent Publication No. 2010-0198036-A1; U.S.
Patent Publication No. 2010-0212583-A1; U.S. Patent Publication No.
2010-0217557-A1; U.S. Patent Publication No. 2010-0223013-A1; U.S.
Patent Publication No. 2010-0223022-A1; U.S. Patent Publication No.
2010-0223023-A1; U.S. Patent Publication No. 2010-0228109-A1; U.S.
Patent Publication No. 2010-0228497-A1; U.S. Patent Publication No.
2010-0240975-A1; U.S. Patent Publication No. 2010-0240976 C1; U.S.
Patent Publication No. 2010-0261987-A1; U.S. Patent Publication No.
2010-0274107-A1; U.S. Patent Publication No. 2010-0280341-A1; U.S.
Patent Publication No. 2010-0286496-A1; U.S. Patent Publication No.
2010-0298684-A1; U.S. Patent Publication No. 2010-0324403-A1; U.S.
Patent Publication No. 2010-0331656-A1; U.S. Patent Publication No.
2010-0331657-A1; U.S. Patent Publication No. 2011-0004085-A1; U.S.
Patent Publication No. 2011-0009727-A1; U.S. Patent Publication No.
2011-0024043-A1; U.S. Patent Publication No. 2011-0024307-A1; U.S.
Patent Publication No. 2011-0027127-A1; U.S. Patent Publication No.
2011-0027453-A1; U.S. Patent Publication No. 2011-0027458-A1; U.S.
Patent Publication No. 2011-0028815-A1; U.S. Patent Publication No.
2011-0028816-A1; U.S. Patent Publication No. 2011-0046467-A1; U.S.
Patent Publication No. 2011-0077490-A1; U.S. Patent Publication No.
2011-0118579-A1; U.S. Patent Publication No. 2011-0124992-A1; U.S.
Patent Publication No. 2011-0125410-A1; U.S. Patent Publication No.
2011-0130970-A1; U.S. Patent Publication No. 2011-0130971-A1; U.S.
Patent Publication No. 2011-0130998-A1; U.S. Patent Publication No.
2011-0144465-A1; U.S. Patent Publication No. 2011-0178378-A1; U.S.
Patent Publication No. 2011-0190614-A1; U.S. Patent Publication No.
2011-0201910-A1; U.S. Patent Publication No. 2011-0201911-A1; U.S.
Patent Publication No. 2011-0218414-A1; U.S. Patent Publication No.
2011-0231140-A1; U.S. Patent Publication No. 2011-0231141-A1; U.S.
Patent Publication No. 2011-0231142-A1; U.S. Patent Publication No.
2011-0253533-A1; U.S. Patent Publication No. 2011-0263958-A1; U.S.
Patent Publication No. 2011-0270062-A1; U.S. Patent Publication No.
2011-0270158-A1; U.S. Patent Publication No. 2011-0275919-A1; U.S.
Patent Publication No. 2011-0290645-A1; U.S. Patent Publication No.
2011-0313543-A1; U.S. Patent Publication No. 2011-0320130-A1; U.S.
Patent Publication No. 2012-0035445-A1; U.S. Patent Publication No.
2012-0040101-A1; U.S. Patent Publication No. 2012-0046534-A1; U.S.
Patent Publication No. 2012-0078071-A1; U.S. Patent Publication No.
2012-0108934-A1; U.S. Patent Publication No. 2012-0130214-A1; U.S.
Patent Publication No. 2012-0172691-A1; U.S. Patent Publication No.
2012-0179014-A1; U.S. Patent Publication No. 2012-0186581-A1; U.S.
Patent Publication No. 2012-0190953-A1; U.S. Patent Publication No.
2012-0191063-A1; U.S. Patent Publication No. 2012-0203467-A1; U.S.
Patent Publication No. 2012-0209098-A1; U.S. Patent Publication No.
2012-0215086-A1; U.S. Patent Publication No. 2012-0215087-A1; U.S.
Patent Publication No. 2012-0215201-A1; U.S. Patent Publication No.
2012-0215461-A1; U.S. Patent Publication No. 2012-0215462-A1; U.S.
Patent Publication No. 2012-0215496-A1; U.S. Patent Publication No.
2012-0220979-A1; U.S. Patent Publication No. 2012-0226121-A1; U.S.
Patent Publication No. 2012-0228134-A1; U.S. Patent Publication No.
2012-0238852-A1; U.S. Patent Publication No. 2012-0245448-A1; U.S.
Patent Publication No. 2012-0245855-A1; U.S. Patent Publication No.
2012-0255875-A1; U.S. Patent Publication No. 2012-0258748-A1; U.S.
Patent Publication No. 2012-0259191-A1; U.S. Patent Publication No.
2012-0260323-A1; U.S. Patent Publication No. 2012-0262298-A1; U.S.
Patent Publication No. 2012-0265035-A1; U.S. Patent Publication No.
2012-0265036-A1; U.S. Patent Publication No. 2012-0265037-A1; U.S.
Patent Publication No. 2012-0277562-A1; U.S. Patent Publication No.
2012-0277566-A1; U.S. Patent Publication No. 2012-0283541-A1; U.S.
Patent Publication No. 2012-0283543-A1; U.S. Patent Publication No.
2012-0296311-A1; U.S. Patent Publication No. 2012-0302854-A1; U.S.
Patent Publication No. 2012-0302855-A1; U.S. Patent Publication No.
2012-0323100-A1; U.S. Patent Publication No. 2013-0012798-A1; U.S.
Patent Publication No. 2013-0030273-A1; U.S. Patent Publication No.
2013-0035575-A1; U.S. Patent Publication No. 2013-0035865-A1; U.S.
Patent Publication No. 2013-0035871-A1; U.S. Patent Publication No.
2005-056552-A1; and U.S. Patent Publication No. 2005-182451-A1.
[0126] Methods and devices that are suitable for use in conjunction
with aspects of the preferred embodiments are disclosed in U.S.
application Ser. No. 09/447,227 filed on Nov. 22, 1999 and entitled
"DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS"; U.S.
application Ser. No. 12/828,967 filed on Jul. 1, 2010 and entitled
"HOUSING FOR AN INTRAVASCULAR SENSOR"; U.S. application Ser. No.
13/461,625 filed on May 1, 2012 and entitled "DUAL ELECTRODE SYSTEM
FOR A CONTINUOUS ANALYTE SENSOR"; U.S. application Ser. No.
13/594,602 filed on Aug. 24, 2012 and entitled "POLYMER MEMBRANES
FOR CONTINUOUS ANALYTE SENSORS"; U.S. application Ser. No.
13/594,734 filed on Aug. 24, 2012 and entitled "POLYMER MEMBRANES
FOR CONTINUOUS ANALYTE SENSORS"; U.S. application Ser. No.
13/607,162 filed on Sep. 7, 2012 and entitled "SYSTEM AND METHODS
FOR PROCESSING ANALYTE SENSOR DATA FOR SENSOR CALIBRATION"; U.S.
application Ser. No. 13/624,727 filed on Sep. 21, 2012 and entitled
"SYSTEMS AND METHODS FOR PROCESSING AND TRANSMITTING SENSOR DATA";
U.S. application Ser. No. 13/624,808 filed on Sep. 21, 2012 and
entitled "SYSTEMS AND METHODS FOR PROCESSING AND TRANSMITTING
SENSOR DATA"; U.S. applicatiion Ser. No. 13/624,812 filed on Sep.
21, 2012 and entitled "SYSTEMS AND METHODS FOR PROCESSING AND
TRANSMITTING SENSOR DATA"; U.S. application Ser. No. 13/732,848
filed on Jan. 2, 2013 and entitled "ANALYTE SENSORS HAVING A
SIGNAL-TO-NOISE RATIO SUBSTANTIALLY UNAFFECTED BY NON-CONSTANT
NOISE"; U.S. application Ser. No. 13/733,742 filed on Jan. 3, 2013
and entitled "END OF LIFE DETECTION FOR ANALYTE SENSORS"; U.S.
application Ser. No. 13/733,810 filed on Jan. 3, 2013 and entitled
"OUTLIER DETECTION FOR ANALYTE SENSORS"; U.S. application Ser. No.
13/742,178 filed on Jan. 15, 2013 and entitled "SYSTEMS AND METHODS
FOR PROCESSING SENSOR DATA"; U.S. application Ser. No. 13/742,694
filed on Jan. 16, 2013 and entitled "SYSTEMS AND METHODS FOR
PROVIDING SENSITIVE AND SPECIFIC ALARMS"; U.S. application Ser. No.
13/742,841 filed on Jan. 16, 2013 and entitled "SYSTEMS AND METHODS
FOR DYNAMICALLY AND INTELLIGENTLY MONITORING A HOST'S GLYCEMIC
CONDITION AFTER AN ALERT IS TRIGGERED"; and U.S. application Ser.
No. 13/747,746 filed on Jan. 23, 2013 and entitled "DEVICES,
SYSTEMS, AND METHODS TO COMPENSATE FOR EFFECTS OF TEMPERATURE ON
IMPLANTABLE SENSORS".
[0127] The above description presents the best mode contemplated
for carrying out the present invention, and of the manner and
process of making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it
pertains to make and use this invention. This invention is,
however, susceptible to modifications and alternate constructions
from that discussed above that are fully equivalent. Consequently,
this invention is not limited to the particular embodiments
disclosed. On the contrary, this invention covers all modifications
and alternate constructions coming within the spirit and scope of
the invention as generally expressed by the following claims, which
particularly point out and distinctly claim the subject matter of
the invention. While the disclosure has been illustrated and
described in detail in the drawings and foregoing description, such
illustration and description are to be considered illustrative or
exemplary and not restrictive.
[0128] All references cited herein are incorporated herein by
reference in their entirety. To the extent publications and patents
or patent applications incorporated by reference contradict the
disclosure contained in the specification, the specification is
intended to supersede and/or take precedence over any such
contradictory material.
[0129] Unless otherwise defined, all terms (including technical and
scientific terms) are to be given their ordinary and customary
meaning to a person of ordinary skill in the art, and are not to be
limited to a special or customized meaning unless expressly so
defined herein. It should be noted that the use of particular
terminology when describing certain features or aspects of the
disclosure should not be taken to imply that the terminology is
being re-defined herein to be restricted to include any specific
characteristics of the features or aspects of the disclosure with
which that terminology is associated. Terms and phrases used in
this application, and variations thereof, especially in the
appended claims, unless otherwise expressly stated, should be
construed as open ended as opposed to limiting. As examples of the
foregoing, the term `including` should be read to mean `including,
without limitation,` including but not limited to,' or the like;
the term `comprising` as used herein is synonymous with
`including,` containing,' or `characterized by,` and is inclusive
or open-ended and does not exclude additional, unrecited elements
or method steps; the term `having` should be interpreted as `having
at least;` the term `includes` should be interpreted as `includes
but is not limited to;` the term `example` is used to provide
exemplary instances of the item in discussion, not an exhaustive or
limiting list thereof; adjectives such as `known`, `normal`,
`standard`, and terms of similar meaning should not be construed as
limiting the item described to a given time period or to an item
available as of a given time, but instead should be read to
encompass known, normal, or standard technologies that may be
available or known now or at any time in the future; and use of
terms like `preferably,` preferred,"desired,' or `desirable,` and
words of similar meaning should not be understood as implying that
certain features are critical, essential, or even important to the
structure or function of the invention, but instead as merely
intended to highlight alternative or additional features that may
or may not be utilized in a particular embodiment of the invention.
Likewise, a group of items linked with the conjunction `and` should
not be read as requiring that each and every one of those items be
present in the grouping, but rather should be read as `and/or`
unless expressly stated otherwise. Similarly, a group of items
linked with the conjunction `or` should not be read as requiring
mutual exclusivity among that group, but rather should be read as
`and/or` unless expressly stated otherwise.
[0130] Where a range of values is provided, it is understood that
the upper and lower limit, and each intervening value between the
upper and lower limit of the range is encompassed within the
embodiments.
[0131] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations may be expressly set forth
herein for sake of clarity. The indefinite article `a` or `an` does
not exclude a plurality. A single processor or other unit may
fulfill the functions of several items recited in the claims. The
mere fact that certain measures are recited in mutually different
dependent claims does not indicate that a combination of these
measures cannot be used to advantage. Any reference signs in the
claims should not be construed as limiting the scope.
[0132] It will be further understood by those within the art that
if a specific number of an introduced claim recitation is intended,
such an intent will be explicitly recited in the claim, and in the
absence of such recitation no such intent is present. For example,
as an aid to understanding, the following appended claims may
contain usage of the introductory phrases `at least one` and `one
or more` to introduce claim recitations. However, the use of such
phrases should not be construed to imply that the introduction of a
claim recitation by the indefinite articles `a` or `an` limits any
particular claim containing such introduced claim recitation to
embodiments containing only one such recitation, even when the same
claim includes the introductory phrases `one or more` or `at least
one` and indefinite articles such as `a` or `an` (e.g., `a` and/or
`an` should typically be interpreted to mean `at least one` or `one
or more`); the same holds true for the use of definite articles
used to introduce claim recitations. In addition, even if a
specific number of an introduced claim recitation is explicitly
recited, those skilled in the art will recognize that such
recitation should typically be interpreted to mean at least the
recited number (e.g., the bare recitation of `two recitations,`
without other modifiers, typically means at least two recitations,
or two or more recitations). Furthermore, in those instances where
a convention analogous to `at least one of A, B, and C, etc.` is
used, in general such a construction is intended in the sense one
having skill in the art would understand the convention (e.g., `a
system having at least one of A, B, and C` would include but not be
limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). In those instances where a convention analogous to
`at least one of A, B, or C, etc.` is used, in general such a
construction is intended in the sense one having skill in the art
would understand the convention (e.g., `a system having at least
one of A, B, or C` would include but not be limited to systems that
have A alone, B alone, C alone, A and B together, A and C together,
B and C together, and/or A, B, and C together, etc.). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
`A or B` will be understood to include the possibilities of `A` or
13' or `A and B.`
[0133] All numbers expressing quantities of ingredients, reaction
conditions, and so forth used in the specification are to be
understood as being modified in all instances by the term `about.`
Accordingly, unless indicated to the contrary, the numerical
parameters set forth herein are approximations that may vary
depending upon the desired properties sought to be obtained. At the
very least, and not as an attempt to limit the application of the
doctrine of equivalents to the scope of any claims in any
application claiming priority to the present application, each
numerical parameter should be construed in light of the number of
significant digits and ordinary rounding approaches.
[0134] Furthermore, although the foregoing has been described in
some detail by way of illustrations and examples for purposes of
clarity and understanding, it is apparent to those skilled in the
art that certain changes and modifications may be practiced.
Therefore, the description and examples should not be construed as
limiting the scope of the invention to the specific embodiments and
examples described herein, but rather to also cover all
modification and alternatives coming with the true scope and spirit
of the invention.
* * * * *