U.S. patent application number 15/007672 was filed with the patent office on 2016-07-28 for handheld diabetes manager with a flight mode.
This patent application is currently assigned to Roche Diabetes Care, Inc.. The applicant listed for this patent is Roche Diabetes Care, Inc.. Invention is credited to Mark G. MEARS, Mark NIERZWICK, Phillip E. PASH, Vincent R. RIZZO, Bettina STEINER, Kristen M. WESTERFIELD.
Application Number | 20160213291 15/007672 |
Document ID | / |
Family ID | 48695182 |
Filed Date | 2016-07-28 |
United States Patent
Application |
20160213291 |
Kind Code |
A1 |
MEARS; Mark G. ; et
al. |
July 28, 2016 |
Handheld Diabetes Manager With A Flight Mode
Abstract
A handheld diabetes manager has a flight mode that cooperatively
interacts with an external medical device and includes a port
configured to receive a test strip for blood glucose measurement, a
blood glucose measurement module operable with the test strip, a
communications module and a user interface module. The
communications module selectively communicates wirelessly with an
external medical device. The user interface module communicates
with the blood glucose measurement module and the communications
module and operates to provide a graphical user interface on a
display of the diabetes manager. The graphical user interface
includes a screen with a flight mode option. When the flight mode
option is enabled and the external medical device is paired and
currently communicating with the diabetes manager, the user
interface module interacts with the communication module to send a
command to the external medical device to turn off wireless
communication of the external medical device.
Inventors: |
MEARS; Mark G.; (Westfield,
IN) ; NIERZWICK; Mark; (Fishers, IN) ; PASH;
Phillip E.; (Indianapolis, IN) ; RIZZO; Vincent
R.; (Indianapolis, IN) ; STEINER; Bettina;
(Indianapolis, IN) ; WESTERFIELD; Kristen M.;
(Fortville, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Roche Diabetes Care, Inc. |
Indianapolis |
IN |
US |
|
|
Assignee: |
Roche Diabetes Care, Inc.
Indianapolis
IN
|
Family ID: |
48695182 |
Appl. No.: |
15/007672 |
Filed: |
January 27, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13661156 |
Oct 26, 2012 |
9264129 |
|
|
15007672 |
|
|
|
|
61581149 |
Dec 29, 2011 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/1723 20130101;
A61M 2205/3569 20130101; H04B 7/26 20130101; H04W 84/20 20130101;
A61B 5/7435 20130101; G16H 40/67 20180101; A61B 5/0002 20130101;
H04B 15/02 20130101; G16H 20/17 20180101; A61M 2205/3592 20130101;
F04C 2270/0421 20130101; A61M 2205/3584 20130101; A61B 5/14532
20130101; G01N 33/66 20130101; G16H 40/63 20180101; H04W 4/50
20180201; G05B 15/02 20130101; A61M 2230/201 20130101; A61M
2205/502 20130101; G06F 19/3468 20130101; A61B 2562/0295 20130101;
A61M 2205/505 20130101; A61M 5/14244 20130101; A61M 2205/35
20130101 |
International
Class: |
A61B 5/145 20060101
A61B005/145; A61B 5/00 20060101 A61B005/00; G06F 19/00 20060101
G06F019/00; H04B 15/02 20060101 H04B015/02 |
Claims
1-26. (canceled)
27. A handheld diabetes manager having a flight mode and
cooperatively interacts with an external medical device,
comprising: a housing; a port formed in the housing and configured
to receive a test strip for blood glucose measurement; a blood
glucose measurement module residing in the housing and
cooperatively operable with a test strip inserted in the port for
blood glucose measurement; a communications module configured to
selectively communicates via a wireless data link with an external
medical device to receive status data pertaining to the operation
of the external medical device, the external medical device being
physically separated from the handheld diabetes manager; a display
integrated into the housing; and a user interface module in data
communication with the communications module and programmed to
generate a graphical user interface on the display of the handheld
diabetes manager, wherein the graphical user interface includes a
travel screen that allows a user to enable or disable a flight mode
of the handheld diabetes manager and interact with the
communications module to disable communication with the external
medical device when the flight mode is enabled; wherein the user
interface module is implemented by computer readable instructions
executed by a processor in the handheld diabetes manager.
28. The diabetes manager of claim 27 further comprises a bolus
advice module configured to receive blood glucose measurements from
the blood glucose measurement module and programmed, in response to
an input, to compute an insulin recommendation for a patient based
in part on the blood glucose measurements.
29. The diabetes manager of claim 28 wherein the user interface
module presents a notification that bolus information may be
outdated when a user inputs a request for bolus advice information
and the flight mode is enabled.
30. The diabetes manager of claim 29, wherein when the flight mode
is enabled, pairing with new devices is disabled and corresponding
buttons are grayed out in a connectivity screen.
31. The diabetes manager of claim 30, wherein when the flight mode
is enabled, managing of paired devices is disabled and
corresponding buttons are grayed out in a connectivity screen.
32. The diabetes manager of claim 31, wherein when the flight mode
is enabled and the handheld diabetes manager is paired and
currently communicating with the external medical devices, the
handheld diabetes manager sends a command to the external medical
device to turn off wireless communication.
33. The diabetes manager of claim 32, wherein a failure warning is
displayed if the external medical device sends an error message in
response to the command to turn off wireless communication.
34. The diabetes manager of claim 33, wherein when the flight mode
is enabled and the handheld diabetes manager is either not paired
with the external medical device or paired but currently not
communicating with the external medical device, the handheld
diabetes manager disables wireless communication of the
communications module.
35. The diabetes manager of claim 34, wherein the external medical
device is one of an insulin pump or a continuous glucose monitoring
device.
36. A handheld diabetes manager having a flight mode and
cooperatively interacts with an external medical device,
comprising: a housing; a port formed in the housing and configured
to receive a test strip for blood glucose measurement; a blood
glucose measurement module residing in the housing and
cooperatively operable with a test strip inserted in the port for
blood glucose measurement; a bolus advice module configured to
receive blood glucose measurements from the blood glucose
measurement module and programmed, in response to an input, to
compute an insulin recommendation for a patient based in part on
the blood glucose measurements; a communications module configured
to selectively communicate via a wireless data link with an
external medical device, wherein the external medical device being
physically separated from the handheld diabetes manager; a travel
module programmed to cooperatively operate with the communications
module to effectuate a flight mode; a display integrated into the
housing; and a user interface module in data communication with the
travel module and programmed to generate a graphical user interface
on a display of the diabetes manager, wherein the graphical user
interface includes a travel screen that allows a user to
selectively enable or disable a flight mode, and wherein the user
interface module presents, in response to user input to access
bolus advice and while the flight mode is enabled, a notification
on the display, wherein the notification indicates that an insulin
recommendation from the bolus advice module may be based on data
that is outdated; wherein the bolus advise module, the travel
module and the user interface module are implemented by computer
readable instructions executed by a processor in the handheld
diabetes manager.
37. The diabetes manager of claim 36, wherein the external medical
device is one of an insulin pump or a continuous glucose monitoring
device.
38. The diabetes manager of claim 36, wherein when the flight mode
is enabled, pairing with new devices is disabled and corresponding
buttons are grayed out in a connectivity screen.
39. The diabetes manager of claim 36, wherein when the flight mode
is enabled, managing of paired devices is disabled and
corresponding buttons are grayed out in a connectivity screen.
40. The diabetes manager of claim 36, wherein when the flight mode
is enabled and the handheld diabetes manager is paired and
currently communicating with the external medical devices, the
handheld diabetes manager sends a command to the external medical
device to turn off wireless communication.
41. The diabetes manager of claim 40, wherein a failure warning is
displayed if the external medical device sends an error message in
response to the command to turn off wireless communication.
42. The diabetes manager of claim 36, wherein when the flight mode
is enabled and the handheld diabetes manager is either not paired
with the external medical device or paired but currently not
communicating with the external medical device, the handheld
diabetes manager disables wireless communication of the
communications module.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. Ser. No. 13/661,156
filed Oct. 26, 2012 which claims the benefit of U.S. provisional
application 61/581,149 filed on Dec. 29, 2011. The disclosure of
the above application is incorporated herein by reference in its
entirety.
FIELD
[0002] The present disclosure relates to a handheld diabetes
manager that has a flight mode for an external medical device, such
as an insulin pump, communicating with the diabetes manager.
BACKGROUND
[0003] Diabetes mellitus, often referred to as diabetes, is a
chronic condition in which a person has elevated blood glucose
levels that result from defects in the body's ability to produce
and/or use insulin. There are three main types of diabetes. Type 1
diabetes usually strikes children and young adults, and may be
autoimmune, genetic, and/or environmental. Type 2 diabetes accounts
for 90-95% of diabetes cases and is linked to obesity and physical
inactivity. Gestational diabetes is a form of glucose intolerance
diagnosed during pregnancy and usually resolves spontaneously after
delivery.
[0004] Diabetes is managed primarily by controlling the level of
glucose in the bloodstream. This level is dynamic and complex, and
is affected by multiple factors including the amount and type of
food consumed, and the amount of insulin (which mediates transport
of glucose across cell membranes) in the blood. Blood glucose
levels are also sensitive to exercise, sleep, stress, smoking,
travel, illness, menses, and other psychological and lifestyle
factors unique to individual patients. The dynamic nature of blood
glucose and insulin, and all other factors affecting blood glucose,
often require a person with diabetes to forecast blood glucose
levels. Therefore, therapy in the form of insulin or oral
medications, or both, can be timed to maintain blood glucose levels
in an appropriate range.
[0005] Management of diabetes is time-consuming for patients
because of the need to consistently obtain reliable diagnostic
information, follow prescribed therapy, and manage lifestyle on a
daily basis. Diagnostic information, such as blood glucose, is
typically obtained from a capillary blood sample with a lancing
device and is then measured with a handheld blood glucose meter.
Interstitial glucose levels may be obtained from a continuous
glucose sensor worn on the body. Prescribed therapies may include
insulin, oral medications, or both. Insulin can be delivered with a
syringe, an ambulatory infusion pump, or a combination of both.
With insulin therapy, determining the amount of insulin to be
injected can require forecasting meal composition of fat,
carbohydrates and proteins along with effects of exercise or other
physiologic states. The management of lifestyle factors such as
body weight, diet, and exercise can significantly influence the
type and effectiveness of a therapy.
[0006] Management of diabetes involves large amounts of diagnostic
data and prescriptive data acquired in a variety of ways: from
medical devices, from personal healthcare devices, from
patient-recorded logs, from laboratory tests, and from healthcare
professional recommendations. Medical devices include patient-owned
bG meters, continuous glucose monitors, ambulatory insulin infusion
pumps, diabetes analysis software, and diabetes device
configuration software. Each of these systems generates and/or
manages large amounts of diagnostic and prescriptive data. Personal
healthcare devices include weight scales, blood pressure cuffs,
exercise machines, thermometers, and weight management software.
Patient recorded logs include information relating bG levels,
meals, exercise and lifestyle. Lab test results include HbA1C,
cholesterol, triglycerides, and glucose tolerance. Healthcare
professional recommendations include prescriptions, diets, test
plans, therapy changes and other information relating to the
patient's treatment.
[0007] The present teachings are directed to a handheld diabetes
manager that includes a user interface with a travel mode for an
external medical device, such as an insulin pump, communicating
with the diabetes manager.
SUMMARY
[0008] This section provides a general summary of the disclosure,
and is not a comprehensive disclosure of its full scope or all of
its features.
[0009] The present teachings provide a handheld diabetes manager
that has a flight mode that cooperatively interacts with an
external medical device and includes a port configured to receive a
test strip for blood glucose measurement, a blood glucose
measurement module cooperatively operable with the test strip, a
communications module and a user interface module. The
communications module selectively communicates wirelessly with the
external medical device. The user interface module is in data
communication with the blood glucose measurement module and the
communications module and operates to provide a graphical user
interface on a display of the diabetes manager. The graphical user
interface includes a screen with a flight mode option. When the
flight mode option is enabled and the external medical device is
paired and currently communicating with the diabetes manager, the
user interface module interacts with the communication module to
send a command to the external medical device to turn off wireless
communication of the external medical device.
[0010] The present teachings provide a handheld diabetes manager
that has a flight mode that cooperatively interacts with an
external medical device and includes a port configured to receive a
test strip for blood glucose measurement, a blood glucose
measurement module cooperatively operable with a test strip
inserted in the port for blood glucose measurement, a bolus advice
module, a communications module, a travel module and a user
interface module. The bolus advice module is configured to receive
blood glucose measurements from the blood glucose measurement
module and operates, in response to an input, to compute an insulin
recommendation for a patient based in part on the blood glucose
measurements. The communications module selectively communicates
via a wireless data link with an external medical device. The
travel module cooperatively operates with the communications module
to effectuate a flight mode. The user interface module is in data
communication with the travel module and operates to provide a
graphical user interface on a display of the diabetes manager. The
graphical user interface includes a travel screen that allows a
user to selectively enable or disable a flight mode. The user
interface module presents, in response to user input to access
bolus advice and while the flight mode is enabled, a notification
on the display that an insulin recommendation from the bolus advice
module may be based on data that is outdated.
[0011] The present teachings also provide an alternative embodiment
wherein the flight mode option is enabled by sending a flight mode
command to the external medical device during a periodic listening
window of the external medical device. Periodic listening windows
of the external medical device are associated with corresponding
periodic beacons from the external medical device to the diabetes
manager. In response to the flight mode command from the diabetes
manager, the external medical device enters a listening only mode
having periodic listening windows without sending beacons.
[0012] Further areas of applicability will become apparent from the
description provided herein. The description and specific examples
in this summary are intended for purposes of illustration only and
are not intended to limit the scope of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The drawings described herein are for illustrative purposes
only of selected embodiments and not all possible implementations,
and are not intended to limit the scope of the present
disclosure.
[0014] FIG. 1 shows a patient with a continuous glucose monitoring
(CGM) patch, an ambulatory durable insulin infusion pump, an
ambulatory non-durable insulin infusion pump, and a diabetes
manager;
[0015] FIG. 2 shows a diabetes management system used by patients
and clinicians to manage diabetes;
[0016] FIG. 3 is a functional block diagram of a diabetes manager
according to the present teachings;
[0017] FIG. 4 is a block diagram illustrating a user interface with
a travel module for a diabetes manager according to the present
teachings;
[0018] FIG. 5 is an activity diagram illustrating behavior flow for
managing a flight mode according to the present teachings;
[0019] FIG. 6 illustrates a representative flight mode screen
according to the present teachings;
[0020] FIG. 7 illustrates a representative screen indicating that
flight mode is turned on according to the present teachings;
[0021] FIG. 8A illustrates an exemplary main menu screen of a
diabetes manager according to the present teachings;
[0022] FIG. 8B illustrates a representative screen illustrating a
bolus warning when the flight mode is turned on according to the
present teachings;
[0023] FIG. 8C illustrates a representative screen showing a
detailed screen for bolus advice according to the present
teachings;
[0024] FIG. 8D illustrates a representative screen showing a bolus
advice warning when the flight mode is turned on according to the
present teachings;
[0025] FIG. 9 illustrates a representative screen showing device
connectivity according to the present teachings; and
[0026] FIG. 10 is an activity diagram illustrating an alternative
embodiment for managing a flight mode according to the present
teachings.
[0027] Corresponding reference numerals indicate corresponding
parts throughout the several views of the drawings.
DETAILED DESCRIPTION
[0028] The following description is merely illustrative in nature
and is in no way intended to limit the disclosure, its application,
or uses. For purposes of clarity, the same reference numbers will
be used in the drawings to identify similar elements. As used
herein, the phrase at least one of A, B, and C should be construed
to mean a logical (A or B or C), using a non-exclusive logical
"or". It should be understood that steps within a method may be
executed in different order without altering the principles of the
present disclosure.
[0029] Referring now to FIG. 1, a person with diabetes 100 using
various medical devices is illustrated. Persons with diabetes
include persons with metabolic syndrome, persons with pre-diabetes,
type 1 diabetes, type 2 diabetes, and gestational diabetes, and are
collectively referred to as a patient. Healthcare providers for
diabetes are diverse and include nurses, nurse practitioners,
physicians, diabetes nurse educators, nutritionists and
endocrinologists and are collectively referred to as a
clinician.
[0030] During a healthcare consultation, the patient 100 typically
shares with the clinician a variety of patient data including blood
glucose measurements, continuous glucose monitor data, amounts of
insulin infused, amounts of food and beverages consumed, exercise
schedules, and other lifestyle information. The clinician may
obtain additional patient data that includes measurements of HbA1C,
cholesterol levels, triglycerides, blood pressure, and weight of
the patient 100. The patient data can be recorded manually or
electronically on a handheld diabetes management device 104 having
a display 103, a diabetes analysis software executed on a personal
computer (PC not shown), and/or a web-based diabetes analysis site
(not shown). The clinician can analyze the patient data manually or
electronically using the diabetes management device 104, the
diabetes analysis software and/or the web-based diabetes analysis
site. After analyzing the patient data and reviewing adherence of
the patient 100 to previously prescribed therapy, the clinician can
decide whether to modify the therapy for the patient 100.
[0031] Referring now to FIG. 1, the patient 100 can use a
continuous glucose monitoring (CGM) device or CGM patch 200, an
ambulatory non-durable insulin infusion pump 202 or an ambulatory
durable insulin infusion pump 204 (hereinafter insulin pump 202 or
204), and the handheld diabetes management device 104 (hereinafter
the diabetes manager or meter 104). The CGM patch 200 includes a
body mount, a reusable component and a subcutaneous sensor to sense
and monitor the amount of glucose in interstitial fluid of the
patient 100 and communicates corresponding data to the diabetes
manager 104.
[0032] The diabetes manager 104 can perform various tasks including
measuring and recording blood glucose levels, determining an amount
of insulin to be administered to the patient 100 via the insulin
pump 202 or 204, receiving patient data via a user interface,
archiving the patient data, etc. The diabetes manager 104
periodically receives glucose levels of the patient 100 from the
CGM patch 200, or data from which glucose levels of the patient 100
may be computed. The diabetes manager 104 transmits instructions to
the insulin pump 202 or 204, which delivers insulin to the patient
100. Insulin can be delivered in a scheduled manner in the form of
a basal dose, which maintains a predetermined insulin dose to the
patient 100. Additionally, insulin can be delivered in the form of
a bolus dose, which raises the amount of insulin delivered to the
patient 100 by a determined amount.
[0033] Generally, and referring now to FIG. 2, a diabetes
management system 300 used by the patient 100 and the clinician can
include one or more of the following devices: the diabetes manager
104, the continuous glucose monitor (CGM patch) 200, the insulin
pump 202 or 204, a mobile device 302, the PC 106 with diabetes
analysis and/or configuration software, and other healthcare
devices 304. The diabetes manager 104 can be configured as a system
hub that communicates with the devices of the diabetes management
system 300. Alternatively, the mobile device 302 can serve as the
system hub. Communication between the devices in the diabetes
management system 300 can be performed using wireless interfaces
(e.g., Bluetooth) and/or wireline interfaces (e.g., USB).
Communication protocols used by these devices can include protocols
compliant with the IEEE 11073 standard, as extended using
guidelines provided by Continua.RTM. Health Alliance Design
Guidelines. Further, healthcare records systems such as
Microsoft.RTM. HealthVault.TM. and Google.TM. Health can be used by
the patient 100 and clinician to exchange information.
[0034] The diabetes manager 104 can receive glucose readings from
one or more sources (e.g., from the CGM patch 200). The CGM patch
200 regularly monitors the interstitial glucose level of the
patient 100. The CGM patch 200 periodically communicates glucose
levels to the diabetes manager 104. The diabetes manager 104 and
the CGM patch 200 communicate wirelessly using generally a wireless
protocol, such as, for example, the standard Bluetooth Low Energy
wireless protocol. Any other suitable wireless protocol can be used
instead.
[0035] Additionally, the diabetes manager 104 includes a blood
glucose meter (BGM) and a port that communicates with the BGM (not
shown). The port can receive a blood glucose measurement strip 306.
The patient 100 deposits a sample of blood on the blood glucose
measurement strip 306. The BGM analyzes the sample and measures the
blood glucose level in the sample. The blood glucose level measured
from the sample is used to determine the amount of insulin to be
administered to the patient 100 using, for example, the insulin
pump 202, 204.
[0036] The diabetes manager 104 also communicates with the insulin
pump 202 or 204. The insulin pump 202 or 204 can be configured to
receive instructions from the diabetes manager 104 to deliver a
predetermined amount of insulin to the patient 100 in the form of
basal dose or bolus dose. Additionally, the insulin pump 202 or 204
can receive other information including meal and/or exercise
schedules of the patient 100. The insulin pump 202 or 204 or the
diabetes manager 104 can determine the amount of insulin to
administer based on the additional information as a basal dose or
bolus dose.
[0037] The insulin pump 202 or 204 can also communicate data to the
diabetes manager 104 via wireless communication module including,
for example, a pump transceiver or a communications radio. The data
can include amounts of insulin delivered to the patient 100,
corresponding times of delivery, and pump status. The diabetes
manager 104 and the insulin pump 202 or 204 can communicate using a
wireless communication protocol such as Bluetooth. Other wireless
communication protocols can also be used.
[0038] In addition, the diabetes manager 104 can communicate with
the other healthcare devices 304. For example, the other healthcare
devices 304 can include a blood pressure meter, a weight scale, a
pedometer, a fingertip pulse oximeter, a thermometer, etc. The
other healthcare devices 304 obtain and communicate personal health
information of the patient 100 to the diabetes manager 104 through
wireless, USB, or other interfaces. The other healthcare devices
304 may use communication protocols compliant with ISO/IEEE 11073
extended using guidelines from Continua.RTM. Health Alliance. The
diabetes manager 104 can communicate with the other healthcare
devices 304 using interfaces including Bluetooth, USB, etc.
Further, the devices of the diabetes management system 300 can
communicate with each other via the diabetes manager 104.
[0039] The diabetes manager 104 can communicate with the PC 106
using Bluetooth, USB, or other wireless interfaces. A diabetes
management software running on the PC 106 includes an
analyzer-configurator that stores configuration information of the
devices of the diabetes management system 300. The configurator has
a database to store configuration information of the diabetes
manager 104 and the other devices. The configurator can communicate
with users through standard web or computer screens in non-web
applications. The configurator transmits user-approved
configurations to the devices of the diabetes management system
300. The analyzer retrieves data from the diabetes manager 104,
stores the data in a database, and outputs analysis results through
standard web pages or computer screens in non-web based
applications.
[0040] The diabetes manager 104 can communicate with the mobile
device 302 using Bluetooth or another suitable wireless
communication protocol. The mobile device 302 may include a
cellular phone, a pager, or a personal digital assistant (PDA). The
diabetes manager 104 can send messages to an external network
through the mobile device 302. The mobile device 302 can transmit
messages to the external network upon receiving requests from the
diabetes manager 104.
[0041] Referring now to FIG. 3, the diabetes manager 104 includes a
blood glucose measuring (BGM) module 400, a communication module
402, a user interface module 404, various user interface elements
406, a processing module 408, a memory 410, and a power module 412.
The user interface module 404 and the processing module 408 can be
implemented by an application processing module 409. The BGM module
400 includes a blood glucose measuring engine that analyzes samples
provided by the patient 100 on the blood glucose measurement strip
306 and measures the amount of blood glucose in the samples. The
communication module 402 can include a transceiver and/or multiple
radios that communicate with different devices of the diabetes
management system 300. The user interface module 404 interfaces the
diabetes manager 104 to various user interface elements 406 that
the patient 100 can use to interact with the diabetes manager 104.
For example, the user interface elements 406 can include a
touchscreen or other display, touchscreen or other keys, switches,
a speaker, a microphone, a secure digital (SD) card port, a USB
port, etc. (not shown).
[0042] The processing module 408 processes data received from the
BGM module 400, the communication module 402, and the user
interface module 404. The processing module 408 uses memory 410 for
processing and storing data. The memory 410 can include volatile
and nonvolatile memory. The processing module 408 outputs data to
and receives data from the user interface elements 406 via the user
interface module 404. The processing module 408 outputs data to and
receives data from the devices of the diabetes management system
300 via the communication module 402. The power module 412 supplies
power to the components of the diabetes manager 104. The power
module 412 can include a rechargeable battery. The battery can be
charged via the USB port of the diabetes manager 104 using an
adapter that plugs into a wall outlet or using a cable that plugs
into a PC.
[0043] Referring to FIG. 4, a logical navigation architecture of
the user interface module for handheld diabetes manager 104 is
illustrated. The following modules can be integrated in the
navigation architecture of the handheld diabetes manager 104: a
startup module 150, a home module 152, a meter module 154, a bolus
advice module 156, a "my data" module 158, a system settings module
160, a device connectivity module 162, a travel module 164, a pump
module 166 and a data module 140. The data module 140 includes
databases, settings and configurations, and acts as a central hub
that communicates with the other modules to store and provide
information regarding data, settings, configuration related to the
other modules. In some embodiments, some of the modules can be
removed or inactivated or additional modules can be added. For
example, the pump module 166 may be removed or inactivated in
models of the handheld diabetes manager 104 for non-pump users. In
other modules, a continuous glucose monitoring module (CGM) 168 can
be added, as illustrated in dashed lines.
[0044] As briefly outlined in reference to FIG. 4, the handheld
diabetes manager 104 of the present teachings integrates in a
single handheld device various functions, controls, calculations,
tests and reports that, in prior art devices, are typically split
among different specialized devices, such as single-purpose bG
meters, single-purpose remote devices for insulin pumps and other
similar single or limited-purpose diabetes managers. Integrating
the multiple tasks and functions of the plurality of modules of the
handheld diabetes manager 104 of the present teachings requires a
user interface that does not simply superpose various functions in
an additive manner, but anticipates behaviors and use case
scenarios that are unique and emerge from the interaction of the
multiplicity of modules when all these modules are integrated in
the same handheld device. Such interactions arise not just from the
hardware aspects of the device, but from the various possibilities
or use scenarios that a user may subject the device based on the
user-perceived and/or actual capabilities of the device. For
example, although portability is common to many prior art diabetes
devices, portability and use in restricted or semi-restricted
environments, such as during air travel, requires anticipation of
alternative use case or use scenarios to avoid conflicts, without
totally disabling the device. In the following example, the term
pump is used interchangeably for an insulin pump, a micropump, and
insulin patch with a CGM device or a combination, unless
differentiation is required.
[0045] In the context of the user interface for the handheld
diabetes manager 104, a use case is an observable result based upon
an action by a user. A use case describes the behavior and
navigation along a primary or alternate path including any standard
business rules for diabetes management and is graphically
represented in an activity or behavior diagram, as shown, for
example, in FIG. 5.
[0046] Referring to FIG. 4, the present teachings are directed
generally to the travel module 164 of the user interface.
Generally, the travel module 164 interacts with the meter module
154, the bolus advice module 156 and pump module 166 (and/or the
CGM module 168). The travel module 164 can be accessed, for
example, via a travel/flight mode button 688 of a main menus screen
660, shown in FIG. 8A and described below. The bolus advice module
156 receives blood glucose measurements from the blood glucose
measurement module 400 (FIG. 3) and determines various insulin
recommendations in the form of a bolus for a patient based in part
on the blood glucose measurements, meals, lifestyle factors, health
events, etc.
[0047] Referring to FIG. 5, an activity diagram of behavioral flow
for the travel module 164 is illustrated. From a home screen or a
main screen 660 (FIG. 8A), the flight mode button 688 (FIG. 8A) can
be selected to display flight mode screen (block 500) that includes
a button to start flight mode, a button to stop flight mode and a
button to go back. Pressing the start flight mode button (block
502), the wireless communication with an external medical device,
such as the insulin pump 202, 204 or CGM 200 that is paired with
the diabetes manager 104 and currently communicating with the
diabetes manager 104, will be stopped. Specifically, if the insulin
pump 202, 204 is paired and currently communicating with the
diabetes manager 104, the diabetes manager 104 will send a command
via the communications module 402 (block 504) to the insulin pump
202, 204 (or other external medical device) to turn off the pump's
wireless radio or transceiver and stop the communication. When the
diabetes manager 104 sends a command to the pump 202, 204 to turn
the radio off and in response an error is received from the pump
202, 204, a warning message that the flight mode failed at the pump
will be displayed 202, 204. The diabetes manager 104 will also
disable the diabetes manager's 104 own wireless communication, such
as turn off Bluetooth radio, for example. If the diabetes manager
104 is not set up to communicate with an external medical device,
pressing the start flight mode button (block 502) will simply
disable the diabetes manager's 104 own wireless communication. The
diabetes manager 104 displays a screen with a notification that the
travel/flight mode is on (block 508). If the diabetes manager 104
is paired with the pump 202, the notification also includes a
"paired to pump" text message. Additionally, the start flight mode
button (block 502) is disabled and grayed out and the stop flight
mode button is enabled (block 510). Pressing a confirming or OK
button (block 506) returns the diabetes manager 104 to the previous
screen (block 520).
[0048] With continued reference to FIG. 5, pressing the stop flight
mode button (block 510) while flight mode is enabled, enables the
wireless communication and displays a screen with the notification
that the travel/flight mode is off (block 512). If the insulin pump
202, 204 is paired with the diabetes manager 104, a notification
that the travel/flight mode is off and that the pump is paired will
be displayed (block 514). Pressing an OK button (block 516) from
the travel mode screens (blocks 512 and 514) displays the previous
screen (block 520). Pressing a back button (block 518) from the
flight mode screen (block 500) will also display the previous
screen (block 520).
[0049] Referring to FIG. 8A, a main menu screen 660 can display
time and date information, and various status icons, such as, for
example a temperature icon 662, sound icon 664 (including vibrate
mode), battery status icon 668 and flight mode icon 670. Some
status icons are only displayed when they are enabled or active.
For example, if flight mode is enabled, the flight mode icon 670 is
displayed. Similarly, the sound and sound/vibrate icons 664 are
displayed when the corresponding functions are enabled. The
temperature icon 662 is displayed when the diabetes manager 104
detects that the temperature is outside a bG test warning
temperature or a bG test lockout range, as defined by a code key
for the test strip 306. The battery icon 668 displays the current
charge condition of the battery. The main menu screen 660 includes
various buttons (mechanical or touch buttons) that can be activated
by touch or stylus or other selector device to display a
corresponding detailed screen. The button labeled meter 672
represents a graphical user interface for the meter module 154 and
interfaces with the BGM module 400. The button labeled pump 676
illustrates a graphical user interface for an external medical
device, in this case a pump, as shown in the pump module 166 (FIG.
4) and in FIG. 2 at 202 and 204. The pump button 676 is used to
represent graphically any such external medical device, with the
insulin infusion pumps 202, 204 and the CGM patch 200 being
exemplary external medical devices.
[0050] With continued reference to FIG. 8A, the main menu screen
660 can include a bolus button 674 corresponding to the bolus
advice module 156, a "my data" button 678 corresponding to the "my
data" module 158, a communications button 680 corresponding to the
"device connectivity" (or communications) module 162, and a
settings button 682 corresponding to the system setting module 160.
The main menu screen 660 can also include a status button 684, and
a quick notes button 686. A flight mode button 688 and a help
button 690 (indicated as a question mark) can be presented and
accessed by swiping the screen along its length to shift the
buttons on the main menu screen 660. Some of the preceding set of
buttons may go out of view as a result.
[0051] Referring now to FIGS. 6-9, pressing the flight mode button
688 from the main menu screen 660 (FIG. 8A) displays a flight mode
screen 600 (FIG. 6) indicating the current status of the flight
mode. The flight mode screen 600 includes a "flight mode" heading
602, a "flight mode on" button 604 and a "flight mode off" button
606. If flight mode is enabled, pressing the flight mode on button
604 displays a flight mode on screen 630 (FIG. 7). The flight mode
on screen 630 can display a "meter information" heading 632, a
flight mode on icon and text at 634 and a text message that meter
communication is disabled at 636. Pressing an OK button 638
displays the main menu screen 660. Similarly, if flight mode is not
enabled, a screen indicating that the flight mode is off will be
displayed (not shown). From the main menu screen 660, pressing the
bolus button 674, displays a bolus advice screen. When bolus advice
has been programmed in the diabetes manager 104 and set to on
status (bolus advice on), the bolus advice screen 720 of FIG. 8C is
displayed. Screen 720 includes a heading 722 labeled bolus input
with a bolus on icon and temperature icon, and various
bolus-related buttons that when pressed display more detailed
screens. These buttons include a bG test button 726, a meal time
button 728, a carbohydrates button 730, a health events button 732,
a basal insulin button 734, and note button 736. Pressing a
confirming button 738 displays the previous screen. Pressing a
bolus button 740 while in flight mode will display a warning screen
742 (FIG. 8D) with the message that bolus information may be out of
date. Similarly, pressing the meter button 672 from the main menu
screen 660 while in flight mode will display a warning screen 742
(FIG. 8D) with the message that bolus information may be out of
date.
[0052] Referring to FIG. 8B, pressing the bolus button 674 while in
flight mode displays a screen 700 having a meter information
heading 702 and displaying a bolus warning message at 704 and a
text message 706 that there is no communication with the pump and
that the bolus history may be out of date. Pressing an OK button
708 displays the previous screen. The warning screens 700 and 742
of FIGS. 8B and 8D may be also displayed from other screens when
the user attempts to access information related to the current
status of the bolus and bolus history.
[0053] When the flight mode is on, the pump button 676 in the main
screen 660, and in any other detailed or status screen where it may
be displayed, is disabled and grayed out. Additionally, in flight
mode, connectivity to a PC and pairing with devices, and
corresponding connectivity buttons are disabled. For example, in
the device connectivity screen 750 of FIG. 9, a "manage paired
devices" button 758 is disabled and grayed out. Similarly, a pair
new devices button 754 for pairing new devices is also disabled and
grayed out. Other buttons, such as a connect settings button 756
and a "connect to PC" button 752 can remain enabled in the
connectivity screen 750. The device connectivity screen 750 is
displayed, for example, by pressing the communications button 680
of the main menu screen 660. Additionally, when the flight mode is
on, only status screens with bG status information are displayed.
Any status screens that include pump (or other external medical
device) status are either not displayed or the pump information is
suppressed or grayed out.
[0054] Referring to FIG. 10, an alternative embodiment for managing
a flight mode is diagrammatically illustrated. In this embodiment,
the handheld diabetes manager 104 can communicate with an external
medical device 200A, such as an insulin pump 202, 204 or a CGM
patch 200 using radio frequency signals at periodic intervals.
Specifically, during usual, non-flight mode, the external medical
device 200A and the diabetes manager 104 can communicate with
signals (beacon or notification or advertisement signals) 800
initiated and emitted by the external medical device 200A at
periodic intervals of time t.sub.1. The external medical device
200A then listens for a response or message from the diabetes
manager 104 during a short, predetermined listening interval or
window. Accordingly, the diabetes manager 104 can communicate with
the external medical device 200A during the external medical
device's listening period after a beacon 800 is sent. If the
listening window associated with a specific beacon is missed, the
diabetes manger 104 can communicate with the external medical
device 200A during the next listening window. This arrangement
conserves power in the external medical device 200A, which
typically has greater power constraints than the diabetes manager
104.
[0055] To enter flight mode, the diabetes manager sends a command
or message 802 to the external medical device 200A to enter a
flight or airplane mode during its regular listening window. The
external medical device 200A is programmed such that upon receiving
the message 802 it enters a flight mode that includes listening
only windows 804 at periodic intervals t.sub.2 that are typically
greater than the regular interval t.sub.1. No beacons 800 are
transmitted while the external medical device 200A is in flight
mode. When it is determined that flight mode can be safely exited,
the diabetes manager 104 sends a command 806 to the external
medical device 200A during one of its listening windows and
instructs the external medical device 200A to resume a regular
non-flight mode. Alternatively, a specific time interval after
which the external medical device 200A can exit the flight mode can
be sent to the external medical device 200A together with the
initial command 802 to enter the flight mode. Typically, the
interval for exiting flight mode is set for the known duration of
the flight and possibly an additional safety interval. After
exiting the flight mode, the external medical device 200A then
resumes the transmission of beacons 800 at regular periodic
intervals t.sub.1.
[0056] As used herein, the term module may refer to, be part of, or
include an Application Specific Integrated Circuit (ASIC); an
electronic circuit; a combinational logic circuit; a field
programmable gate array (FPGA); a processor (shared, dedicated, or
group) that executes code; other suitable components that provide
the described functionality; or a combination of some or all of the
above, such as in a system-on-chip. The term module may include
memory (shared, dedicated, or group) that stores code executed by
the processor.
[0057] The term code, as used above, may include software,
firmware, and/or microcode, and may refer to programs, routines,
functions, classes, and/or objects. The term shared, as used above,
means that some or all code from multiple modules may be executed
using a single (shared) processor. In addition, some or all code
from multiple modules may be stored by a single (shared) memory.
The term group, as used above, means that some or all code from a
single module may be executed using a group of processors. In
addition, some or all code from a single module may be stored using
a group of memories.
[0058] The apparatuses and methods described herein may be
implemented by one or more computer programs executed by one or
more processors. The computer programs include processor-executable
instructions that are stored on a non-transitory tangible
computer-readable medium. The computer programs may also include
stored data. Non-limiting examples of the non-transitory tangible
computer readable medium are nonvolatile memory, magnetic storage,
and optical storage.
[0059] The broad teachings of the disclosure can be implemented in
a variety of forms. Therefore, while this disclosure includes
particular examples, the scope of the disclosure should not be so
limited since other modifications will become apparent to the
skilled practitioner upon a study of the drawings, the
specification, and the following claims.
* * * * *