U.S. patent application number 15/155674 was filed with the patent office on 2016-11-17 for devices, systems, and methods related to analyte monitoring and management.
The applicant listed for this patent is Abbott Diabetes Care Inc.. Invention is credited to Kim Cullen, Lynn Dixon, Jonathan Fern, Timothy S. Gasperak, Gary A. Hayter, Mark P. Jesser, Jai Karan, Kim Ladin, Marc B. Taub, Matthew T. Vogel, Charles Wei.
Application Number | 20160331287 15/155674 |
Document ID | / |
Family ID | 44834515 |
Filed Date | 2016-11-17 |
United States Patent
Application |
20160331287 |
Kind Code |
A1 |
Fern; Jonathan ; et
al. |
November 17, 2016 |
Devices, Systems, and Methods Related to Analyte Monitoring and
Management
Abstract
Analyte monitoring devices, systems, and methods are provided
that relate to: enabling different application features on a data
processing device for analyte monitoring devices with different
analyte monitoring features; programming analyte monitoring devices
in advance; personalizing an analyte monitoring device; graphically
representing a remaining insulin level in a user body; and
graphically representing analyte measurement related data for
on-demand readings; protecting access to feature of an analyte
monitoring device.
Inventors: |
Fern; Jonathan; (Alameda,
CA) ; Jesser; Mark P.; (Austin, TX) ; Dixon;
Lynn; (Fremont, CA) ; Karan; Jai; (Fremont,
CA) ; Wei; Charles; (Fremont, CA) ; Vogel;
Matthew T.; (Oakland, CA) ; Gasperak; Timothy S.;
(Berkeley, CA) ; Cullen; Kim; (San Francisco,
CA) ; Ladin; Kim; (Campbell, CA) ; Taub; Marc
B.; (Mountain View, CA) ; Hayter; Gary A.;
(Oakland, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Diabetes Care Inc. |
Alameda |
CA |
US |
|
|
Family ID: |
44834515 |
Appl. No.: |
15/155674 |
Filed: |
May 16, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14954457 |
Nov 30, 2015 |
9339219 |
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15155674 |
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13091557 |
Apr 21, 2011 |
9198623 |
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14954457 |
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61327023 |
Apr 22, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150358 20130101;
A61B 5/743 20130101; A61B 5/0022 20130101; A61B 5/7475 20130101;
A61B 5/742 20130101; A61B 2560/045 20130101; A61B 5/7435 20130101;
A61B 5/14546 20130101; G16H 40/67 20180101; A61B 5/14532 20130101;
A61B 5/746 20130101; G06F 19/00 20130101; A61B 5/72 20130101; A61B
2560/0295 20130101 |
International
Class: |
A61B 5/145 20060101
A61B005/145; A61B 5/15 20060101 A61B005/15; A61B 5/00 20060101
A61B005/00 |
Claims
1-20. (canceled)
21. An analyte monitoring device, comprising: a housing; a strip
port coupled to the housing; a processor coupled to the housing;
and memory operably coupled to the housing and electrically coupled
to the first processor, wherein the memory includes instructions
stored therein for programming an analyte monitoring device in
advance, the instructions comprising: instructions for receiving,
with a processor on an analyte monitoring device, programming
instructions for operating the analyte monitoring device in a first
mode beginning at a future point in time, wherein the future point
in time is based on an occurrence of an event; instructions for
enabling, with the processor, the operation of the analyte
monitoring device in a second mode before the future point in time;
and instructions for enabling, with the processor, the operation of
the analyte monitoring device in the first mode beginning at the
future point in time.
22. The analyte monitoring device of claim 21, wherein the event is
a future clinical visit.
23. The analyte monitoring device of claim 22, wherein the future
point in time is a predetermined amount of time before the clinical
visit.
24. The analyte monitoring device of claim 23, wherein the
operation of the analyte monitoring device in the first mode is
enabled for a predetermined duration of time.
25. The analyte monitoring device of claim 21, wherein the
operation of the analyte monitoring device in the first mode
comprises performing analyte measurements and recording the analyte
measurements, and operating the analyte monitoring device in the
second mode comprises performing analyte measurements without
recording the analyte measurements.
26. The analyte monitoring device of claim 21, wherein the
operation of the analyte monitoring device in the first mode
comprises operating in a first data gathering mode, and wherein the
operation of the analyte monitoring device in the second mode
comprises operating in a second data gathering mode.
27. The analyte monitoring device of claim 21, wherein the future
point in time is a predetermined amount of time before the
event.
28. The analyte monitoring device of claim 21, wherein the
operation of the analyte monitoring device in the first mode is
enabled for a predetermined duration of time.
29. The analyte monitoring device of claim 21, wherein the
operation in the first mode comprises activating additional user
interfaces, reminders, or alarms that are different than in the
second mode.
30. The analyte monitoring device of claim 21, wherein the analyte
is glucose.
31. The analyte monitoring device of claim 21, wherein the event is
the programming of the analyte monitoring device.
32. The analyte monitoring device of claim 31, wherein the future
point in time is a predetermined amount of time after the
programming of the device.
33. The analyte monitoring device of claim 21, wherein the
operation in the first mode and second mode comprises operating the
analyte monitoring device with different configuration
settings.
34. The analyte monitoring device of claim 21, wherein the
programming instructions are received via the internet.
35. The analyte monitoring device of claim 21, wherein the
programming instructions are received via a remote data processing
device operatively coupled to the analyte monitoring device.
36. The analyte monitoring device of claim 21, wherein the event is
a future data condition obtained by the analyte monitoring device,
and the future point in time is at an occurrence of the future data
condition.
37. The analyte monitoring device of claim 36, wherein the future
data condition is an occurrence of a measurement reading.
38. The analyte monitoring device of claim 36, wherein the future
data condition is a threshold measurement reading.
39. The analyte monitoring device of claim 36, wherein the future
data condition is a predetermined trending magnitude.
40. The analyte monitoring device of claim 36, wherein the future
data condition is an occurrence of a pattern.
41. The analyte monitoring device of claim 36, wherein the future
data condition is a user-entered condition.
42. The analyte monitoring device of claim 36, wherein the
operation of the analyte monitoring device in the first mode
comprises performing analyte measurements and recording the analyte
measurements, and operating the analyte monitoring device in the
second mode comprises performing analyte measurements without
recording the analyte measurements.
43. The analyte monitoring device of claim 36, wherein the
operation of the analyte monitoring device in the first mode
comprises operating in a first data gathering mode, and wherein the
operation of the analyte monitoring device in the second mode
comprises operating in a second data gathering mode.
44. The analyte monitoring device of claim 36, wherein the
operation of the analyte monitoring device in the first mode is
enabled for a predetermined duration of time.
45. The analyte monitoring device of claim 36, wherein operation in
the first mode comprises activating additional user interfaces,
reminders, or alarms that are different than in the second
mode.
46. The analyte monitoring device of claim 36, wherein the analyte
is glucose.
47. The analyte monitoring device of claim 36, wherein operation in
the first mode and second mode comprises operating the analyte
monitoring device with different configuration settings.
48. The analyte monitoring device of claim 36, wherein the
programming instructions are received via the internet.
49. The analyte monitoring device of claim 36, wherein the
programming instructions are received via a remote data processing
device operatively coupled to the analyte monitoring device.
50-126. (canceled)
Description
PRIORITY
[0001] This application claims the benefit of priority to U.S.
Provisional Patent Application No. 61/327,023, filed Apr. 22, 2010,
which is hereby incorporated by reference.
BACKGROUND
[0002] Analyte monitoring devices have been used as medical
diagnostic devices to determine a level of analyte from a sample.
One common application is blood glucose measurements for diabetics.
The diabetic typically pricks his or her finger using a lancet. A
droplet of exposed blood is applied to a sensor on a test strip
which is placed in the analyte monitoring device (in this case a
glucose meter). A reading appears on a display of the measuring
device indicating the blood glucose level of the diabetic. Analyte
monitoring devices may be used to receive analyte measurement
readings over a period of time for purposes of monitoring a
patient's status or progress.
BRIEF DESCRIPTION OF THE FIGURES
[0003] The subject matter of the present disclosure is best
understood from the following detailed description when read in
conjunction with the accompanying drawings. It is emphasized that,
according to common practice, the various features of the drawings
are not to-scale. On the contrary, the dimensions of the various
features are arbitrarily expanded or reduced for clarity. Included
are the following:
[0004] FIGS. 1A-1C illustrates a block diagram representing an
overview of a user interface flow for an analyte monitoring device,
according to some embodiments
[0005] FIG. 2 illustrates a home screen, according to certain
embodiments.
[0006] FIG. 3A illustrates a flowchart for personalizing an analyte
monitoring device, according to certain embodiments.
[0007] FIG. 3B illustrates an example block diagram for a method
that is performed when the instruction are executed by the
processor, according to certain embodiments.
[0008] FIGS. 4A-4B illustrate a remote data processing device
having RD software that enables it to operate with one type of
analyte monitoring device but not another type of analyte
monitoring device.
[0009] FIG. 4C illustrates a remote data processing device
receiving RD software from an analyte monitoring device that
enables the data processing device to operate with multiple types
of analyte monitoring devices, according to certain
embodiments.
[0010] FIG. 4D illustrates device 455 operably connected to any one
of the analyte monitoring devices 401, 402, and 455, according to
certain embodiments.
[0011] FIG. 4E illustrates a block diagram for a method of enabling
different application features on a data processing device for
analyte monitoring devices with different analyte monitoring
features, according to certain embodiments.
[0012] FIG. 5 illustrates a block diagram of a system including an
analyte monitoring device and remote data processing device,
according to some embodiments.
[0013] FIG. 6 illustrates an analyte monitoring device used with a
remote sensor, according to some embodiments.
[0014] FIG. 7A illustrates a Snapshot report for a specific time
frame (e.g., a two week period as shown), according to certain
embodiments.
[0015] FIG. 7B illustrates a Logbook report, according to certain
embodiments.
[0016] FIG. 7C illustrates a Daily Statistics Report, according to
certain embodiments.
[0017] FIG. 7D illustrates a Meal Event Averages report, according
to certain embodiments.
[0018] FIG. 7E illustrates a Modal Day report, according to certain
embodiments.
[0019] FIG. 7F illustrates a Meter Settings report, according to
certain embodiments.
[0020] FIG. 8 illustrates an example user interface for
personalizing an analyte monitoring device with a remote data
processing device, according to certain embodiments.
[0021] FIG. 9 illustrates an analyte monitoring device configured
with a personalized background image, according to certain
embodiments.
[0022] FIGS. 10A-10B illustrate an example graphical user interface
element that functions as a fill-level indicator, according to some
embodiments.
[0023] FIGS. 11A-11B illustrate an example graphical user interface
element representing insulin remaining in a body, according to some
embodiments.
[0024] FIG. 12A-12B illustrate a graphical element representing
insulin in the body, according to certain embodiments.
[0025] FIG. 13A illustrates a plot for continuous glucose
measurements.
[0026] FIG. 13B illustrates a plot of magnitudes for on-demand
measurements for the same glucose pattern.
[0027] FIG. 13C illustrates a plot of magnitudes and rate-of-change
data, according to certain embodiments.
[0028] FIG. 14 illustrates a plot using forward and backward
prediction errors to provide a line between plots, according to
certain embodiments.
DETAILED DESCRIPTION
[0029] Before the subject matter of the present disclosure is
described, it is to be understood that the present disclosure is
not limited to particular aspects described, as such may, of
course, vary. It is also to be understood that the terminology used
herein is for the purpose of describing particular aspects only,
and is not intended to be limiting, since the scope of the present
disclosure will be limited only by the appended claims.
[0030] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limits of that range is also specifically disclosed. Each
smaller range between any stated value or intervening value in a
stated range and any other stated or intervening value in that
stated range is encompassed within the present disclosure. The
upper and lower limits of these smaller ranges may independently be
included or excluded in the range, and each range where either,
neither or both limits are included in the smaller ranges is also
encompassed within the present disclosure, subject to any
specifically excluded limit in the stated range. Where the stated
range includes one or both of the limits, ranges excluding either
or both of those included limits are also included in the present
disclosure.
[0031] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this present disclosure belongs.
Although any methods and materials similar or equivalent to those
described herein can be used in the practice or testing of the
subject matter of the present disclosure, some potential and
preferred methods and materials are now described. All publications
mentioned herein are incorporated herein by reference to disclose
and describe the methods and/or materials in connection with which
the publications are cited. It is understood that the present
disclosure supercedes any disclosure of an incorporated publication
to the extent there is a contradiction.
[0032] It must be noted that as used herein and in the appended
claims, the singular forms "a", "an", and "the" include plural
referents unless the context clearly dictates otherwise. Thus, for
example, reference to "a feature" includes a plurality of such
features and reference to "the feature" includes reference to one
or more features and equivalents thereof known to those skilled in
the art, and so forth.
[0033] The publications discussed herein are provided solely for
their disclosure prior to the filing date of the present
application. Nothing herein is to be construed as an admission that
the present disclosure is not entitled to antedate such
publication. Further, the dates of publication provided may be
different from the actual publication dates which may need to be
independently confirmed.
User Interface for the Analyte Monitoring Device
[0034] In the present disclosure, various block diagrams,
flowcharts, and graphical user interfaces (GUI) associated with an
analyte monitoring device are discussed and illustrated. It should
be understood that the specific embodiments discussed and shown are
exemplary and that other embodiments may be implemented without
compromising the underlying principles in the present disclosure.
For example, all features shown in the exemplary embodiments are
not necessarily required and may be combined, deleted, etc., in
some situations without compromising the underlying principles in
the present disclosure.
[0035] In some aspects, the analyte monitoring device stores
software programs and applications in, for example, Flash memory,
or other non-volatile memory. The software programs and
applications that are installed and stored in memory in the analyte
monitoring device provide for the user interface of the analyte
monitoring device. The analyte monitoring device includes a control
unit which may include any variety of processing devices--e.g.,
CPU, processor, microprocessor, microcontroller, etc. The control
unit executes the various software programs and applications to
provide the user interface to the analyte monitoring device.
[0036] In some aspects, the analyte monitoring device provides the
necessary hardware and software to acquire analyte test
measurements for a patient. The analyte monitoring device may
include a test strip port to receive test strips and analyze any
analyte samples present on the test strip. For example, the user
may insert a test strip into the test strip port and then apply a
sample of blood to the test strip so that the analyte monitoring
device can measure the glucose levels of the sample. In some
instances, the analyte monitoring device may receive analyte
readings from another device--e.g., from an implantable sensor for
glucose on demand (GoD) applications, and/or from continuous
glucose monitoring (CGM) devices. In some embodiments, an adapter
with one or more such capabilities may be coupled to the analyte
monitoring device to provide the device with such capabilities.
[0037] In some aspects of the present disclosure, a user interface
flow for an analyte monitoring device is provided. The user
interface flow comprises various graphical user interfaces
displayed on the analyte monitoring device and/or
features/functions/settings available or accessible to the user.
The user may navigate between various graphical user interfaces
and/or accessing various features and functions of the analyte
monitoring device.
[0038] It should be understood that the term "graphical user
interface" is used broadly herein to represent any graphical
interface element displayed on the display. For example, the
graphical user interface may comprise a graphical icon, element,
picture, video, text box, pop-up window, application window, home
screen, etc. Furthermore, it should be understood that one or more
GUIs may be implemented for various features, functions and/or
settings. Further, different GUIs may be combined in some instances
without compromising the underlying principles of the
disclosure.
[0039] The analyte monitoring device may include a landing (e.g., a
home screen) that is displayed on the display of the analyte
monitoring device and functions as a starting point or relative
starting point. From the home screen the user can navigate to any
of the various GUI's to perform or access various functions and
features of the device.
[0040] These branches of navigation may be accessed when the user
activates trigger elements on the device. The trigger elements may
be any variety of trigger elements--e.g., buttons, keys, toggle
switches, wheels, arrows, etc. The trigger elements may be physical
and tangible trigger elements located on the device (e.g., hardware
buttons or keys on the housing or keyboard, etc.) and/or may be
nontangible trigger elements (e.g., graphical user interface
elements) displayed on the device. It should also be understood
that the branches of navigation may be displayed on the home screen
(e.g., as icons) and triggered by corresponding physical and
tangible trigger elements on the housing of keyboard. For example,
in certain embodiments, a touchscreen display is implemented and
the trigger elements are icons displayed on the touchscreen. The
trigger element is activated by the user touching the corresponding
trigger element (e.g., icon). It should be understood that icons is
used broadly herein to represent any text, image, video, graphic,
etc. For example, the trigger element may be suggestive of its
function or feature--e.g., an image of a gear representing a
trigger element for accessing the setup menu, an arrow keys, check
boxes, toggle switches, buttons (e.g., with identifying text or
image inside), etc. It should be understood that the underlying
principles of the present disclosure are not limited to a
touchscreen implementation.
[0041] For example, FIGS. 1A-1C illustrate a block diagram
representing an overview of a user interface flow for an analyte
monitoring device, according to some embodiments. The block
diagrams shown in each of FIGS. 1A-1B connect at the reference
letters A.
[0042] Block diagram 100 is shown comprising a home screen 101 from
which the user may navigate (e.g., via a trigger element on a
touchscreen display or with buttons on the device) to logbook
screen 102, setup menu 103, extras menu 104, and reminder screen
116. From logbook 102, the user may access other feature and
functions, such as logging insulin 105, viewing log entry details
106, and viewing various charts and graphs 107. It should be
appreciated that other features and functions may be available from
logbook 102 in other embodiments.
[0043] Setup menu 103 enables a user to setup the device--e.g.,
adjust sound and graphics 108, set the time and date 109, set the
language 110, and perform control solution tests 111. Further, from
extras menu 104, the user may access various features and function
related to personalizing the device 112, viewing statistical data
113 (e.g., trends, target ranges, etc.), viewing/controlling food
data and settings 114, and viewing/controlling insulin related data
and settings 115 (or other drug related data).
[0044] From reminders 116, the user may navigate to various
features and function related to viewing and controlling various
reminders (and alerts in some instances).
[0045] FIG. 1 also shows navigation from a test screen 117. As
shown, after a test result 118 for a test measurement is generated,
the user may access various feature and functions from the test
result screen 118. It should be appreciated that, in some
instances, the user may be automatically taken to another feature
or function.
[0046] Again, it should be appreciated that the user interface flow
provided in FIG. 1 is exemplary and should not be construed as
limited to such example. Furthermore, for the sake of clarity and
brevity, not all user interface screens and features and functions
are described for FIG. 1. Further details regarding various example
user interfaces that may be implemented with analyte monitoring
systems is described in U.S. Provisional Patent Application No.
61/451,488, filed Mar. 10, 2011; 61/326,651, filed Apr. 21, 2010;
and 61/327,023, filed Apr. 22, 2010, the entireties of which are
incorporated herein by reference.
[0047] FIG. 2 illustrates a home screen, according to certain
embodiments. Home screen 200 is shown comprising various trigger
elements 201A-201F that can be activated by the user touching the
trigger element on the touchscreen of the analyte monitoring
device. For example, trigger element 201A navigates to a settings
screen; trigger element 201B navigates to a reminders screen;
trigger element 201C navigates to the extras screen; trigger
element 201D navigates to an insulin in body screen; trigger
element 201E is a feature that enables the user to turn a test
strip port light on and off; and trigger element 201F navigates to
a logbook screen.
[0048] When the meter is turned on, for example, the home screen
may be presented for the user to access various GUI's, features,
and functions of the device. In some instances, the home screen may
include one or more formats. For example, a date format may be
implemented and display the date and time on the home screen, such
as shown in FIG. 2. It should be understood that other formats may
be implemented. In some instances, as pointed out on page 5, a home
screen may be customized--e.g., with a background image or
customized text.
[0049] In some embodiments, the analyte monitoring device may
include a test port and provide the capability to perform test
measurements on a fluid sample. For example, a test strip may be
received by the test port and a sample applied to the test strip.
The analyte monitoring device performs a measurement reading on the
sample and displays and/or stores the reading on the device.
[0050] In some aspects, the analyte monitoring device enables the
user to add notes to provide a more comprehensive analysis at a
later time. For example, these customized notes may provide
additional details associated with measurement readings taken.
[0051] As stated before, the analyte monitoring device may
specifically relate to glucose monitoring of patients (e.g.,
diabetics) in both clinical and home use environments. Patients
that use long and/or short-acting insulin may use glucose
measurement readings to estimate if insulin is needed and how much
to use. The analyte monitoring device may include software programs
for performing insulin dosage calculations with the analyte
monitoring device. In some instances, the insulin calculation may
take into account factors in addition to a current measurement
reading or string of measurement readings. One or more of the
following additional factors may also be taken into account--e.g.,
threshold maximum and minimum values, trending of measurement
readings, times of tests (e.g., whether before and after meals
and/or time since last meal, and/or times from last insulin dosage
and/or amount of insulin remaining in the body), exercise, meals
and food intake (e.g., carbohydrate values, anticipated
carbohydrate values, bread units, serving size, etc.), etc. It
should be appreciated that other factors may also be taken into
account, and that the example factors are not limiting.
[0052] In some aspects, the analyte monitoring device may include
insulin calculation features that are available and presented to
the user. For example, in certain embodiments, the device may
include insulin dosage calculation. For example, the analyte
monitoring device may display various screens for entering user
inputs regarding such factors and calculation, and then perform the
calculation using those user inputs and displaying the calculated
result associated with the suggested amount of insulin for the
patient.
[0053] In some aspects, the analyte monitoring device may include
settings (and/or configurations) and reminders features that are
available and accessible to the user. For example, in some
instances, user interfaces may be implemented associated with
settings for the analyte monitoring device and reminders. In some
instances, settings allow the user to adjust settings related to
date and time, sounds and pictures, languages, control solution
tests, etc. A wide range of reminders may be implemented for
various purposes and should not be construed to be limited to these
specific examples. One or more types of reminders may be
implemented. For example, reminders relating to measurement tests
may be implemented--e.g., to remind the user to perform test
measurements at various times and/or upon occurrence of certain
events, etc. Certain events may include, for example, measurement
readings at or beyond threshold level, or projections of
measurement readings at or beyond a threshold level. For example,
reminders to take a measurement reading may be provided when a
measurement level crosses an upper and lower threshold value (e.g.,
the upper and lower bounds of a target range). As another example,
reminders to take a measurement reading may be provided when an
upper and lower threshold level are projected to be crossed. In
some instances, the reminder may not be provided until the time
when the upper or lower threshold level was projected to be
crossed. Furthermore, the reminders may be provided at various
times. For example, upon the occurrence of the event, the reminder
may be provided at a fixted time after the occurrence; at a user
configured time after the occurrence; at a time based on the
reader's actual projection that the threshold would have been
crossed; at a time equal to the time horizon of a configurable
projected alarm. In some instances, multiple thresholds may be
implemented with the reminders being provided at different times
for each. For example, a blood glucose threshold of 120 mg/dL may
trigger a reminder to take another measurement in 15 minutes;
another blood glucose threshold of 130 mg/dL may trigger a reminder
to take another measurement in 5 minutes; and yet another blood
glucose threshold of 150 mg/dL may trigger a reminder to take
another measurement in 1 minute.
[0054] Furthermore, reminders relating to medication may be
implemented--e.g., to remind the user to take medicine at various
times and/or upon occurrence of certain events. Still further,
reminders related to insulin may be implemented--e.g., to remind
the user to take insulin at various times and/or upon occurrence of
certain events. In some instances, additional and/or customizable
reminders may be implemented in the analyte monitoring device. In
some instances, the frequency (e.g., daily, once, etc) of the
reminder and/or a countdown timer may be set.
[0055] Additional details regarding alarms and reminders may be
found in U.S. Nonprovisional patent application Ser. No.
11/555,192, filed Oct. 31, 2006, the entirety of which is herein
incorporated by reference.
[0056] It should be understood that alarms may also be implemented
on the device and viewed/controlled by the user, in certain
embodiments. The reminders/alarms may take the form of audio,
visual, and/or haptic feedback (e.g., vibratory) reminders. For
instance, the reminder may be a particular GUI that pops up on the
display to remind the user of the particular reminder. The GUI may
encompass the display or be a smaller "window" that pops up over a
current GUI. The reminder could also include an audio and/or
vibratory reminder instead of, or in addition to, the GUI.
Furthermore, it should be appreciated that the various symbols or
icons may also be implemented in place of a pop up window or full
screen GUI. The user may also take various actions upon being
reminded--e.g., dismiss, snooze, confirm, etc.
[0057] Various patterns and messages may be implemented in certain
embodiments to provide additional information to the user and/or
physician. Patterns may include, for example, patterns in the data
acquired from the analyte monitoring device. For instance,
measurement reading patterns over various time periods and target
ranges may be identified. In some instances, the patterns may
relate to measurement reading patterns associated with various
events (e.g., meals, exercises, insulin administration, etc.).
[0058] Messages may be displayed on the analyte monitoring device
to inform the user of a wide variety of purposes. For example, in
some instances, the messages are used to convey identified patterns
to the user. For example, the user may receive a message via a
message icon such as a suggestive `envelope` icon, and may then
access the message and information regarding one or more patterns.
In some instances, the patterns and/or messages feature may be
activated and deactivated by the user and/or physician.
[0059] In some aspects of the present disclosure, the analyte
monitoring device may enable the user to personalize the analyte
monitoring device using the analyte monitoring device.
Personalization may include, for example, setting audio, visual,
and/or haptic feedback (e.g., vibratory) themes for the analyte
monitoring device and GUIs. For example, customized sounds, images
(e.g., background images, icons, etc.), video, vibration patterns,
etc. may be set by the user. In some instances, the user is
presented with default options that may be chosen. In some
instances, the user may upload various personalizations (e.g.,
images, sounds, etc.) to the device. In some embodiments, the
audio, visual, and/or vibratory theme may be presented during a
waiting period when performing a test measurement.
[0060] FIG. 3 illustrates a flowchart for personalizing an analyte
monitoring device, according to certain embodiments. A
personalization screen 300 is shown displaying six pre-installed
background images 301-306. In other embodiments, one or more
uploaded background images may be displayed as well. The
personalization screen 300 may be accessed in various
manners--e.g., via an extras menu on the home screen. A help
trigger element 307 is shown on the personalization screen 300. If
activated by the user, the trigger element 307 navigates to the
help screen 308 that provides additional information regarding the
personalization screen 300. Trigger element 309 navigates back to
the personalization screen 300. Upon selection of a pre-installed
background image--e.g., background image 301--a confirmation screen
310 is displayed that includes the background image 301 displayed
in the background. Upon user confirmation, the device is configured
with the background image 301 displayed. In other embodiments, the
device is configured to display the background image 301 when
waiting for a measurement result during a test measurement.
[0061] In certain embodiments, the personalizing of the analyte
monitoring device comprises configuring the analyte monitoring
device to display a user selected name--e.g., as a banner on the
background.
[0062] In certain embodiments, the analyte monitoring device
comprises a housing, a strip port coupled to the housing, an output
display coupled to the housing, a processor coupled to the housing,
and memory operably coupled to the housing and electrically coupled
to the first processor. The memory includes instructions stored
therein for personalizing the analyte monitoring device.
[0063] FIG. 3B illustrates an example block diagram for a method
that is performed when the instruction are executed by the
processor, according to certain embodiments.
[0064] At block 320, a user interface is displayed on the output
display. The user interface enables a user to personalize the
analyte monitoring device--e.g., to configure the analyte
monitoring device to display a user selected background image.
[0065] At block 325, the user selects a background image. In some
embodiments, a plurality of pre-installed background images is
displayed on the output display for the user to select from. In
other embodiments, the user may upload a separate background
image--e.g., from a storage device or from the internet, for
example.
[0066] At block 330, the device is configured to display the user
selected background image. In some embodiments, the background
image is displayed on the home screen, for example. In other
embodiments, the background image is displayed during a waiting
period for an analyte measurement.
[0067] In some aspects of the present disclosure, the analyte
monitoring device may enable the user to log food and/or view
logged food data with the analyte monitoring device. In some
instances, the capability to log food may be activated by the user
or physician to provide a more comprehensive view of user data. For
example, in some instances, the user may be provided with the
capability to log food after test measurements.
[0068] In some aspects, the analyte monitoring device provides the
capability to setup and/or adjust the settings of the insulin
calculation feature. In some instances, setup may include, for
example, one or more of the following: an introduction or short
tutorial that is presented to the user; a lock feature to lock the
calculator settings when complete; adjustment and/or setting of a
target range, adjustment and/or setting of a correction range,
adjustment and/or setting of a correction factor, adjustment and/or
setting of dose increments, adjustment and/or setting of a maximum
dose, adjustment and/or setting of a insulin duration; setup of a
meal calculator; setup of a servings calculator; setup of bread
units; setup of a carb calculator, etc. In some instances, the user
may be presented with a GUI for reviewing, confirming, and/or
editing the insulin calculation settings. In some instances, user
interfaces are provided for locking the calculator settings of the
analyte monitoring device.
[0069] In some aspects, the analyte monitoring device provides a
logbook feature to log various data. The data may include
measurement reading, data associated with the measurement readings,
various events (e.g., meals, exercises, medication, insulin, etc.),
etc., and may be recorded based on time and/or date of occurrence.
Various data may be logged and stored in the device for later
analysis and review. For example, in the user may be presented with
the option to log results after measurements are taken. Additional
notes and related information may be included and logged with the
measurement to provide a more comprehensive view of the logged
measurement. Furthermore, the user may access the logbook to review
the data logged and/or review analysis of the data logged (e.g.,
statistical data, trends, patterns, averages, etc.). In some
aspects, the analyte monitoring device may present the required
interface to log insulin dosages and/or medicine intake. The
insulin log may, for example, account for whether the insulin was
long acting or rapid acting, the amount administered, time
administered, etc.
[0070] In some embodiments, the device may be configured to
automatically display one or more interfaces upon a first start or
activation of the analyte monitoring device, according to some
embodiments. The first start may take into account, for example,
the language to be used, date, time, introduction or short
tutorial, etc. For instance, the analyte monitoring device may
prompt the user to enter, read, confirm, skip, etc., the
information provided.
[0071] In some aspects, the analyte monitoring device provides an
interface for setting carb data--e.g., setting carb ratios by time
of day for the calculator setup of the analyte monitoring device.
In some aspects, the analyte monitoring device provides an
interface for setting correction factors--e.g., associated with
setting correction factors by time of day, and setting correction
factors adjusted for high blood glucose readings, for calculator
setup of the analyte monitoring device.
[0072] In some instances, the analyte monitoring device may provide
a warning and possible remedy. For example, if a user has a low
blood sugar reading, the analyte monitoring device may display a
warning that the user's blood sugar is low, and that suggested
remedy may provide some relief--e.g., by taking a set amount of
carbs, by suggesting a food product, etc. Some interface may be
associated with setting units on the analyte monitoring device. In
some instances, different features may be assigned different units
independently.
[0073] In some instances, the analyte monitoring device may provide
an interface for the user to account for insulin already taken by
the user. In some instances, the analyte monitoring device will
take into account whether the user has any insulin remaining in
their body, and may include requests for user inputs to confirm
previous administration times, amounts, etc.
User Interface for a Remote Data Processing Device
[0074] In some aspects, the analyte monitoring device may be
communicatively coupled to a remote data processing device for
management purposes. Remote device may include, for example, a
personal computer, laptop, PDA, cellular phone, smartphone, set-top
box, etc. The remote device may include, for example, a control
unit including any variety of processor, microprocessor,
microcontroller, etc. The remote device may also include a memory
unit comprising non-volatile memory and volatile memory.
[0075] The term remote device is used herein to represent any
device that is external to the analyte monitoring device. The
remote device may require software to communicate and manage data
from the analyte monitoring device. This user interface software
(referred to herein as "remote device software" or "RD software" to
distinguish it from the user interface software running on the
analyte monitoring device) may be obtained from one or more methods
such as downloading from the web, CD-ROM, memory stick, etc.
[0076] In some embodiments, the analyte monitoring device includes
the RD software programs and/or applications to be run on the
remote device. In some instances, the RD software may be configured
to automatically launch when the analyte monitoring device is
coupled to the computer. For example, the analyte monitoring device
may include an installer program that is stored in non-volatile
memory and executed when the analyte monitoring device is coupled
to the remote device. The installer program may be executed when
the user couples the analyte monitoring device to the remote
device. The installer program may then initiate the launch of the
RD software on the remote device.
[0077] In some embodiments, the RD software is not stored in
non-volatile memory on the remote device. The RD software is stored
on the analyte monitoring device and used to launch the RD software
on the remote device is coupled to the analyte monitoring
device.
[0078] In some embodiments, the RD software may be downloaded and
stored in non-volatile memory on the remote device. For example,
the RD software may be downloaded via a network connection (e.g.,
via an internet connection), by storage device (e.g., CD-ROM,
memory stick, etc.), and/or downloaded from the analyte monitoring
device. In some instances, the RD software is capable of being run
even when the device is not coupled to the computer.
[0079] It should be understood that the RD software may be
compatible with various hardware systems (e.g., PC, MAC) and
various operating systems (e.g., Windows, MAC OS, Linux).
[0080] The analyte monitoring device may be communicatively coupled
to the remote device via wired technologies. Example wired
technologies may include, but are not limited to, the following
technologies, or family of technologies: USB, FireWire, SPI, SDIO,
RS-232 port, etc.
[0081] The analyte monitoring device may include, for example, a
communication connector unit to permit wired communication and
coupling to the remote device. The communication connector unit
provides the capability to communicate with a remote device having
an appropriate interface to operatively couple with the
communication connector. In some embodiments, the communication
connector is configured to communicate with a smartphone such as an
iPhone or Blackberry.
[0082] The communication connector unit may be any variety of
connection interfaces--e.g., male or female connection interfaces.
Using USB as an example, the communication connector may be any of
the variety of USB plugs or USB receptacles/ports. As USB
receptacles are typically located on computer and other devices, a
corresponding USB plug used as a communication connector unit will
enable the analyte monitoring device to be plugged directly into
the USB receptacle, avoiding the use of cables. In other instances,
the appropriate USB receptacle may be used on the analyte
monitoring device to enable communication using a USB cable
(similar to many other devices such as digital cameras, cellular
phones, smartphones, etc.).
[0083] It should be appreciated that the in some embodiments the
analyte monitoring device may be communicably coupled to the remote
device via wireless technology. In such instances, the analyte
monitoring device may include corresponding transmitters,
receivers, and/or transceivers. The analyte monitoring device may
be configured to wirelessly communicate using a technology
including, but not limited to, radio frequency (RF) communication,
Zigbee communication protocols, WiFi, infrared, wireless Universal
Serial Bus (USB), Ultra Wide Band (UWB), Bluetooth.RTM.
communication protocols, and cellular communication, such as code
division multiple access (CDMA) or Global System for Mobile
communications (GSM), etc.
[0084] The functionality of the RD software launched on the remote
device may include a variety of functions relating to, for example,
data acquisition; data management; management of features,
settings, configurations, etc., of the analyte monitoring device;
generation, saving, transmitting, and/or printing of reports,
management of updates (e.g., field updates to device firmware and
RD software); access to training content, web-based content,
web-based marketing; etc.
[0085] The RD software may be launched on a remote device and used
by the user (e.g., the patient) and/or a health care provider (HCP)
(e.g., physician, hospital staff, etc.). For example, the HCP
and/or patient may use the RD software on a remote device to
analyze the patient data, view and print reports, view and change
device settings, update device firmware and application software,
etc.
[0086] In some instances, the RD software may initiate a comparison
between the time date on the analyte monitoring device and that on
the remote device and/or remote time server accessed via an
internet connection from the remote device. The RD software may
account for discrepancies and take action accordingly. For example,
thresholds may be set (e.g., 5 minute difference) and if the
threshold is reached, the analyte monitoring device prompts the
user with a warning, question, indicator, etc., to acknowledge the
discrepancy and/or remedy the discrepancy (e.g., adjust the time on
one of the devices). In some instances, a similar comparison may be
performed by the RD software to account for other discrepancies
between the analyte monitoring device and remote device--e.g.,
discrepancies between data logs, data values, stored files, device
and/or user interface configurations and settings, etc. The
appropriate action can then be taken or requested.
[0087] Various defaults and customized configurations and settings
may be established for generating, printing, saving, exporting,
etc., reports. For example, the various formats for the report may
be established (e.g., layout, style, themes, color, etc.); various
file types to save the report as (e.g., PDF, Word document, Excel
spreadsheet, etc. In some instances, for example, the RD software
may provide the user with the ability to export tab-delimited text
files or XML exports of the meter data (e.g., including blood
glucose, ketones, carbs, insulin, and event tags, etc.). In some
instances, the RD software may enable the user to save, print,
and/or export preferences, including favorite reports, target blood
glucose ranges, auto save, auto print, color/black and white
printing, device/software update settings for multiple devices,
etc.
[0088] In some aspects, the RD software is used to control the
configuration of the device and data from the device. This control
may be utilized by the user and/or HCP. In some instances, the RD
software shall provide access to one or more informative documents,
trainings, tutorials, etc. For example, the RD software application
may provide links or to manufacturer sponsored websites intended
for any variety of purposes such as marketing and training
content.
[0089] In some aspects, the RD software may include an update
management function to help facilitate the detection, download, and
installation of updates (e.g., firmware, informatics application
updates, etc.) for the analyte meter device and/or the RD software.
The updates may be detected and downloaded automatically in some
instances (e.g., when an internet connection is active) and/or
detected and downloaded upon user confirmation or request. In some
instances, updates to the software shall also update its
installation files stored on the device. Moreover, in some
instances, when the device firmware is updated, required
labeling/user documentation is also updated on the device. In some
instances, when device firmware is updated, the existing device
settings and testing history (e.g., blood glucose, insulin, carb
data, etc.) is preserved.
[0090] FIGS. 4A-4B illustrate a remote data processing device
having RD software that enables it to operate with one type of
analyte monitoring device but not another type of analyte
monitoring device. Remote data processing device 400 has RD
software installed on it. The software loaded onto the device 400
via the internet 403 or a memory device 404.
[0091] In FIG. 4A, the device 400 is enabled by the RD software to
communicate with a coupled analyte monitoring device 401 but not
with a coupled analyte monitoring device 402. For example, device
402 may be a legacy device that requires different RD software. In
FIG. 4B, the device 400 is enabled by a different RD software to
operate with a coupled analyte monitoring device 402 but not with a
coupled analyte monitoring device 401.
[0092] FIG. 4C illustrates a remote data processing device
receiving RD software from an analyte monitoring device that
enables the data processing device to operate with multiple types
of analyte monitoring devices, according to certain embodiments.
Remote data processing device 450 is operably coupled to analyte
monitoring device that has RD software installed on it. When
connected, device 455 transfers the RD software to the device 450,
which stores the software therein for execution. Device 455 may be,
for example, a newer model of analyte monitoring device that has
the RD software installed on it to enable compatibility with other
types of analyte monitoring devices--e.g., legacy devices. In some
instances, this RD software may be loaded onto the device 400 via
the internet 403 or a memory device 404.
[0093] FIG. 4D illustrates device 455 operably connected to any one
of the analyte monitoring devices 401, 402, and 455, according to
certain embodiments. It should be appreciated that all three
devices are not necessarily connected at the same time, but are
shown that way for illustrative purposes. For example, after device
455 loads the RD software on the device 450, the device 450 may
operate with the analyte monitoring device 455. If the analyte
monitoring device 455 is disconnected and another type of analyte
monitoring device (e.g., device 401 or device 402) is connected,
then the device 450 may operate with the other type of device
(e.g., device 401 or device 402).
[0094] For example, in certain embodiments, all three devices 401,
402, and 455 may be able to perform blood glucose measurements,
while only device 455 is able to utilize advanced functions, such
as, but not limited to, insulin calculation (e.g., bolus and/or
basal), ketone body measurements, personalization of the device,
carb counting, etc.
[0095] FIG. 4E illustrates a block diagram for a method of enabling
different application features on a data processing device for
analyte monitoring devices with different analyte monitoring
features, according to certain embodiments.
[0096] At block 470 of method 400, an indication that a first
analyte monitoring device is communicatively coupled to a data
processing device is received. The first analyte monitoring device
includes a first plurality of analyte monitoring features.
[0097] At block 475, a first plurality of application features for
the first analyte monitoring device is determined. The first
plurality of application features is associated with the first
plurality of analyte monitoring features. For example, analyte
monitoring features may include a feature for performing blood
glucose measurements, and the associated first application features
may include a feature for displaying recorded blood glucose
measurements.
[0098] At block 480, the first plurality of application features is
enabled on the data processing device for the first analyte
monitoring device.
[0099] At block 485, an indication that a second analyte monitoring
device is communicatively coupled to the data processing device is
received. The second analyte monitoring device includes a second
plurality of analyte monitoring features. The second plurality of
analyte monitoring features includes at least one analyte
monitoring feature that is absent from the first plurality of
analyte monitoring features.
[0100] For example, the first analyte monitoring device may be
removed from the data processing device and the second analyte
monitoring device coupled to the data processing device. In such
case, the RD software initiates operation with the second analyte
monitoring device. In some embodiments, the current application may
stay active but replace any first device-specific data with second
device-specific data (e.g., imported data from the second device,
imported or saved profile information, etc.). In other embodiments,
the application may reset or restart for operation with the second
analyte monitoring device. Any application features from the first
plurality of application features that are absent in the second
plurality of application features are disabled.
[0101] In some embodiments, the data processing device may indicate
the device that is being operated using the RD software--e.g., by
activating and/or flashing the backlight of the operated device.
Other notifications may also be provided to make the user aware of
the proper device that is being operated with the software.
[0102] In some instances, the second analyte monitoring device may
be coupled to the data processing device while the first analyte
monitoring device is still coupled. In such case, the RD software
may be programmed to operate with one of the devices--e.g.,
maintain operation with the first device or begin operation with
the second device. This may be indicated, for example, by the
backlight on the "operated" device remaining lit while the
backlight on the "non-operated" device is not activated.
[0103] In yet other embodiments where two analyte monitoring
devices are simultaneous coupled to the data processing device, the
RD software opens a second application window for the second
analyte monitoring device that was added. For example, the second
application for the second analyte monitoring device runs
independent of, and simultaneously with, the first application
running for the first analyte monitoring device. The backlight of
the device corresponding to the "active" application window may be
lit, for example, to indicate the current analyte monitoring device
being "operated".
[0104] At block 485, a second plurality of application features for
the second analyte monitoring device is determined. The second
plurality of application features are associated with the second
plurality of analyte-monitoring features, and the second plurality
of application features includes at least one application feature
that is absent from the first plurality of application features. In
some embodiments, the at least one analyte monitoring feature that
is absent comprises insulin calculation; and the at least one
application feature that is absent comprises enabling customization
of device settings for insulin calculation. The insulin calculation
may be, for example, a bolus calculation or a basal calculation. In
other embodiments, the at least one analyte monitoring feature that
is absent comprises a ketone body measurement, and the at least one
application feature that is absent comprises displaying recorded
ketone body measurements.
[0105] At block 490, the second plurality of application features
is enabled on the data processing device for the second analyte
monitoring device. For example, the RD software may import the data
from the second
[0106] In some embodiments, application features from the first
plurality of application features that are absent in the second
plurality of application features are disabled.
[0107] In some embodiments, the first plurality of analyte
monitoring features and the second plurality of analyte monitoring
features may include a feature for performing blood glucose
measurements, and the first plurality of application features and
the second plurality of application features include a feature for
displaying recorded blood glucose measurements.
[0108] In some embodiments, methods may also include receiving an
indication that a third analyte monitoring device is
communicatively coupled to the data processing device. The third
analyte monitoring device includes a third plurality of analyte
monitoring features, and the third plurality of analyte monitoring
features include at least one analyte monitoring feature that is
absent from the first and second plurality of analyte monitoring
features. A third plurality of application features for the third
analyte monitoring device is determined. The third plurality of
application features are associated with the third plurality of
analyte-monitoring features, and the third plurality of application
features include at least one application feature that is absent
from the first and second plurality of application features. And,
the third plurality of application features is enabled on the data
processing device for the third analyte monitoring device.
[0109] Furthermore, in yet further embodiments, the application
features from the first plurality and second plurality of
application features that are absent in the third plurality of
application features are enabled.
[0110] In some aspects of the present disclosure, the analyte
monitoring device transfers software to the remote data processing
device to perform the methods of enabling different application
features on a data processing device for analyte monitoring devices
with different analyte monitoring features. For example, the
analyte monitoring device may comprises a housing, a strip port
coupled to the housing, a first processor coupled to the housing;
and memory coupled to the housing and electrically coupled to the
first processor. The memory includes the instructions stored
therein for transfer to and execution by a second processor on a
remote data processing device.
Exemplary Systems
[0111] FIG. 5 illustrates a block diagram of a system including an
analyte monitoring device and remote data processing device,
according to some embodiments. System 500 is shown to comprising
analyte monitoring device 501 communicably coupled to remote device
505. In some instances, as shown, remote device 505 may have
network access to a network 510 in which a second remote device 515
is shown coupled to. It should be understood that network 510 may
include one or more networks, including LANs, WANs, and/or the
internet.
[0112] Analyte monitoring device 501 is shown removably coupled to
remote device 505 via communication connector unit 422.
Communication connector unit, for example, includes a USB plug
which couples with a USB receptacle 507 in remote device 505.
Remote device 505 may include peripheral devices, such as printer,
keyboard, monitor, CD drive, etc. Remote device 505 may also
include, as shown, a network interface 530 which connects it to
network 510. Remote device 515 is also connected to network 510 and
may communicate with remote device 505 via network 510.
[0113] The following paragraphs describe system 500 during
operation, according to some embodiments. In some instances, the
analyte monitoring device described is a glucose monitoring device
which measures the glucose concentration level of a blood sample.
It should be understood that the description applies equally to
other analytes and to other forms of samples.
[0114] In use, analyte monitoring device 501 receives a test strip
525 for measuring an analyte level of a sample applied to test
strip 525. Test strip 525 is received at strip port unit 520.
Analyte monitoring device 501 performs a measurement computation on
the sample and the user can view the measurement reading on, for
example, a touchsreen display (not shown). The user may also be
presented with a menu on the touchscreen display to view and
select--e.g., menus for storing data, downloading data, performing
bolus calculations based on the measurement, etc.
[0115] The user may couple the analyte monitoring device 501 to
remote device 505 (e.g., a personal computer) via a communication
connector unit. For example, the user may decide to store the
measurement data and then choose to download stored test data
(including stored measurement readings) to a remote device 505.
[0116] Analyte monitoring device 501 may then be coupled to remote
device 505 via communication connector unit 422. Communication
connector unit 422 may, for example, include a USB plug which
couples to a USB receptacle 507 on remote device 505.
[0117] In some instances, the analyte monitoring device 501 may be
powered by the remote device 505 when coupled via the communication
connector unit 422. In such case, the user would couple the analyte
monitoring device 501 to the remote device 505 and then insert test
strip 525 into the strip port 520 to take a measurement reading. In
some instances, the analyte monitoring device includes its own
power source, such as button or AAA-size batteries, for example,
and is not powered by the remote device 505.
[0118] In some instances, the analyte monitoring device may be
"locked" or prevented from performing a test while coupled to the
remote device 505. For example, medical device regulations such as
high voltage isolation testing may be required if the analyte
monitoring device is configured to perform tests while coupled to a
remote device. Thus, "locking" or preventing the analyte monitoring
device from performing a test while coupled to the remote device
allows the analyte monitoring device to not be subjected to the
additional testing, if so desired.
[0119] In some aspects, the analyte monitoring device 501 may
initiate a user interface application (e.g., RD software) to
execute on the analyte monitoring device, and/or the remote device
505 when coupled to the remote device 505. The user interface
application may be stored in a memory unit on the analyte
monitoring device 501, for example. In some aspects, the user is
not required to have previously loaded software on the remote
device 505 to operate with the analyte monitoring device 501. In
some aspects, the analyte monitoring device may be configured to
initiate the user interface application automatically upon coupling
to the remote device. It should be understood that the user
interface application may be configured to be compatible with
various hardware systems (e.g., PC, MAC) and various operating
systems (e.g., Windows, MAC OS, Linux).
[0120] The user interface application may include, for example,
diabetes management related applications. The user interface
application may provide a variety of menus, selections, charts,
alarms, reminders, visual indicators, etc. For example, the user
may be presented with menus and options, such as whether to take a
measurement reading, to view stored measurement readings, to store
data, to download data, to perform bolus calculation based on the
measurement, etc.
[0121] The user interface program may, for example, allow the user
to perform the following steps: (1) create a replica of the test
data stored on the analyte monitoring device 501, on the remote
device 505; and (2) synchronize test data from the analyte
monitoring device 501 to the database on the remote device 505.
Meter settings and/or user settings/preferences from the analyte
monitoring device may also be included in the test data and
synchronized with the remote device. Date and time for the remote
device 505 and analyte monitoring device 501 may also be
synched.
[0122] To read test data from the analyte monitoring device 501 and
write it to the remote device 505, it is recognized herein that
data in the remote device may be organized into tables, which may
be organized into records, which may be broken down into predefined
fields. Similarly, at some level data will be organized into
records with a consistent field structure on the analyte monitoring
device 501. The user interface application may read test data from
the analyte monitoring device and write it out to tables on the
remote device 505. The user interface application may also read
data from table in the remote device 505 and write them out to the
analyte monitoring device 501. Various types of data conversion may
be used. For example, data residing in fields in the analyte
monitoring device may be converted from the format it exists in the
analyte monitoring device to a format compatible with the remote
device, and vice versa. The logical structure of the records in the
two systems may be different.
[0123] Remote device 505 may include peripheral devices, such as
printer, keyboard, monitor, CD drive, etc. Remote device 505
includes a network interface which connects it to network 510
(e.g., the internet). The user interface application may provide
the user with the option to view test data on the monitor, to store
test data on storage media (e.g., CD-ROM, memory card, etc.),
further analyze and/or manipulate test data, transmit data to
another device), and/or print out test data such as charts,
reports, etc., on the printer.
[0124] As shown, remote device 505 may also include a network
interface 530 (e.g., network interface card (NIC), modem, router,
RF front end, etc.) used to connect the remote device 505 to
network 510. For example, in some aspects, analyte monitoring
device 501 may couple via a USB connection to the remote device
which may be a personal computer or laptop connected to the
internet using a wireless modem and/or router. In some aspects,
analyte monitoring device 501 may couple via a micro USB connection
to a remote device 505 which is a smartphone having an RF front end
to access a mobile network. The user interface application may
provide a user interface for using the network connection of the
remote device 505--e.g., to forward test data to a physician,
hospital, health provider, and/or other third party located at a
second remote device 515 on network 510. Appropriate action may
then be taken by the receiving party at the second remote device
515.
[0125] Referring back to FIG. 5, the analyte monitoring device may
include a wireless communication unit, for example, which may
include, for example, a receiver and/or transmitter for
communicating with another device, e.g., remote device 505, a
medication delivery device, and/or a patient monitoring device
(e.g., a continuous glucose monitoring device or a health
management system, such as the CoPilot.TM. system available from
Abbott Diabetes Care Inc., Alameda, Calif.), etc. The wireless
communication unit may be configured to wirelessly communicate
using a technology including, but not limited to, radio frequency
(RF) communication, Zigbee communication protocols, WiFi, infrared,
wireless Universal Serial Bus (USB), Ultra Wide Band (UWB),
Bluetooth.RTM. communication protocols, and cellular communication,
such as code division multiple access (CDMA) or Global System for
Mobile communications (GSM), etc. In some aspects, the wireless
communication unit is configured for bi-directional radio frequency
(RF) communication with another device to transmit and/or receive
data to and from the analyte monitoring device 501.
[0126] In some aspects, the wireless communication unit may be used
to communicate with a remote device as described above for the
communication connector unit. In some aspects where the analyte
monitoring device includes a communication connector unit, the
wireless communication unit may replace or provide an optional
channel of communication for the functions provided by the
communication connector unit discussed above. Referring back to
FIG. 5, analyte monitoring device 501 may be coupled to remote
device 505 via a wireless communication unit and provide an
optional alternative communication channel with remote device 505.
In some aspects, analyte monitoring device 501 may not include a
communication connector unit 422, and instead only communicate with
the remote device 505 via a wireless communication unit present on
analyte monitoring device 501. In some aspects, the analyte
monitoring device is configured to receive a program update from a
remote device via the wireless communication unit.
[0127] In some aspects, the wireless communication module may be
configured to communicate with a smartphone (e.g., iPhone,
Blackberry, etc). It is typical for smartphones to include various
wireless technologies such as Wi-Fi, infrared, Bluetooth.RTM.,
etc.
[0128] In some aspects, the analyte monitoring device may be
configured to wirelessly communicate via the wireless communication
unit with a server device, e.g., using a common standard such as
802.11 or Bluetooth.RTM. RF protocol, or an IrDA infrared protocol.
The server device could be another portable device, such as a
Personal Digital Assistant (PDA) or notebook computer, or a larger
device such as a desktop computer, appliance, etc. In some aspects,
the server device has a display, such as a liquid crystal display
(LCD), as well as an input device, such as buttons, a keyboard,
mouse or touchscreen. With such an arrangement, the user can
control the meter indirectly by interacting with the user
interface(s) of the server device, which in turn interacts with the
meter across a wireless link.
[0129] In some aspects, the wireless communication module is used
to communicate with a remote sensor--e.g., a sensor configured for
implantation into a patient or user. Examples of sensors for use in
the analyte monitoring systems of the present disclosure are
described in U.S. Pat. No. 6,175,752; and U.S. patent application
Ser. No. 09/034,372, incorporated herein by reference. Additional
information regarding sensors and continuous analyte monitoring
systems and devices are described in U.S. Pat. No. 5,356,786; U.S.
Pat. No. 6,175,752; U.S. Pat. No. 6,560,471; U.S. Pat. No.
5,262,035; U.S. Pat. No. 6,881,551; U.S. Pat. No. 6,121,009; U.S.
Pat. No. 7,167,818; U.S. Pat. No. 6,270,455; U.S. Pat. No.
6,161,095; U.S. Pat. No. 5,918,603; U.S. Pat. No. 6,144,837; U.S.
Pat. No. 5,601,435; U.S. Pat. No. 5,822,715; U.S. Pat. No.
5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat. No. 6,120,676; U.S.
Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S. Pat. No.
6,338,790; U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997; U.S.
Pat. No. 6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No.
6,592,745; U.S. Pat. No. 5,628,890; U.S. Pat. No. 5,820,551; U.S.
Pat. No. 6,736,957; U.S. Pat. No. 4,545,382; U.S. Pat. No.
4,711,245; U.S. Pat. No. 5,509,410; U.S. Pat. No. 6,540,891; U.S.
Pat. No. 6,730,100; U.S. Pat. No. 6,764,581; U.S. Pat. No.
6,299,757; U.S. Pat. No. 6,461,496; U.S. Pat. No. 6,503,381; U.S.
Pat. No. 6,591,125; U.S. Pat. No. 6,616,819; U.S. Pat. No.
6,618,934; U.S. Pat. No. 6,676,816; U.S. Pat. No. 6,749,740; U.S.
Pat. No. 6,893,545; U.S. Pat. No. 6,942,518; U.S. Pat. No.
6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No. 5,262,305; U.S.
Pat. No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat. No.
6,746,582; U.S. Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S.
patent application Ser. No. 10/745,878 filed Dec. 26, 1003 entitled
"Continuous Glucose Monitoring System and Methods of Use"; and U.S.
Application No. 61/149,639 entitled "Compact On-Body Physiological
Monitoring Device and Methods Thereof", the disclosures of each
which are incorporated by reference herein.
[0130] In some instances, the analyte monitoring device is part of
a continuous analyte monitoring system, where a transcutaneously
implanted sensor may continually or substantially continually
measure an analyte concentration of a bodily fluid. Examples of
such sensors and continuous analyte monitoring devices include
systems and devices described in U.S. Pat. Nos. 6,175,752,
6,560,471, 5,262,305, 5,356,786, U.S. patent application Ser. No.
12/698,124 and U.S. provisional application No. 61/149,639 titled
"Compact On-Body Physiological Monitoring Device and Methods
Thereof", the disclosures of each of which are incorporated herein
by reference for all purposes.
[0131] Accordingly, in some aspects, the analyte monitoring device
may be configured to operate or function as a data receiver or
controller to receive analyte related data from a transcutaneously
positioned in vivo analyte sensor such as an implantable glucose
sensor. The analyte monitoring system may include a sensor, for
example an in vivo analyte sensor configured for continuous or
substantially continuous measurement of an analyte level of a body
fluid, a data processing unit (e.g., sensor electronics)
connectable to the sensor, and the analyte monitoring device
configured to communicate with the data processing unit via a
communication link (e.g., using the wireless communication module).
In aspects of the present disclosure, the sensor and the data
processing unit (sensor electronics) may be configured as a single
integrated assembly. In some aspects, the integrated sensor and
sensor electronics assembly may be configured as a compact, low
profile on-body patch device assembled in a single integrated
housing and positioned on a skin surface of the user or the patient
with a portion of the analyte sensor maintained in fluid contact
with a bodily fluid such as an interstitial fluid during the sensor
life time period (for example, sensor life time period including
about 5 days or more, or about 7 days or more, or about 14 days or
more, or in certain instances, about 30 days or more). In such
instances, the on-body patch device may be configured for, for
example, RF communication with the analyte monitoring device to
wirelessly provide monitored or detected analyte related data to
the analyte monitoring device based on a predetermined transmission
schedule or when requested from the analyte monitoring device.
Predetermined transmission schedule may be programmed or configured
to coincide with the analyte sample detection by the analyte sensor
(for example, but not limited to including once every minute, once
every 5 minutes, once every 15 minutes). Alternatively, the analyte
monitoring device may be programmed or programmable to acquire the
sampled analyte data (real time information and/or stored
historical data) in response to one or more requests transmitted
from the analyte monitoring device to the on-body patch device.
[0132] In some aspects, wireless communication module of the
analyte monitoring device includes an RF receiver and an antenna
that is configured to communicate with the data processing unit,
and the processor of the analyte monitoring device is configured
for processing the received data from the data processing unit such
as data decoding, error detection and correction, data clock
generation, and/or data bit recovery.
[0133] In operation, the analyte monitoring device in some aspects
is configured to synchronize with the data processing unit to
uniquely identify the data processing unit, based on, for example,
an identification information of the data processing unit, and
thereafter, to periodically receive signals transmitted from the
data processing unit associated with the monitored analyte levels
detected by the sensor.
[0134] In some aspects, the analyte monitoring device may also be
configured to operate as a data logger, interacting or
communicating with the on-body patch device by, for example,
periodically transmitting requests for analyte level information
from the on-body patch device, and storing the received analyte
level information from the on-body patch device in one or more
memory components.
[0135] In some aspects, when the analyte monitoring device is
positioned or placed in close proximity or within a predetermined
range of the on-body patch device, the RF power supply in the
analyte monitoring device may be configured to provide the
necessary power to operate the electronics in the on-body patch
device, and accordingly, the on-body patch device may be configured
to, upon detection of the RF power from the analyte monitoring
device, perform preprogrammed routines including, for example,
transmitting one or more signals to the analyte monitoring device
indicative of the sampled analyte level measured by the analyte
sensor. In one aspect, communication and/or RF power transfer
between the analyte monitoring device and the on-body patch device
may be automatically initiated when the analyte monitoring device
is placed in close proximity to the on-body patch device.
Alternatively, the analyte monitoring device may be configured such
that user intervention, such as a confirmation request and
subsequent confirmation by the user using, for example, the display
and/or input components of the analyte monitoring device, may be
required prior to the initiation of communication and/or RF power
transfer between the analyte monitoring device and the on-body
patch device. In a further aspect, the analyte monitoring device
may be user configurable between multiple modes, such that the user
may choose whether the communication between the analyte monitoring
device and on-body patch device is performed automatically or
requires a user confirmation.
[0136] FIG. 6 illustrates an analyte monitoring device used with a
remote sensor, according to some embodiments. Sensor 605 may be
configured for implantation (e.g., subcutaneous, venous, or
arterial implantation) into a patient. The sensor 605 is coupled to
sensor control unit 610 which is typically attached to the skin of
a patient. The sensor control unit 610 operates the sensor 605,
including, for example, providing a voltage across the electrodes
of the sensor 605 and collecting signals from the sensor 605. The
sensor control unit 610 may evaluate the signals from the sensor
605 and/or transmit the signals to wireless communication unit 423
on analyte monitoring device 501 for evaluation.
[0137] In some aspects, the wireless communication unit 423 is
configured to receive a signal from a remote sensor using
radio-frequency identification (RFID) technology. This
configuration may be used to provide glucose on demand
capabilities, in which case when a measurement reading is desired,
the analyte monitoring device is brought within close vicinity of
the implantable sensor. In some instances, RFID technology may be
used in continuous glucose monitoring (CGM) applications.
[0138] The analyte monitoring device 501 processes the signals from
the on-skin sensor control unit 610 to determine the concentration
or level of analyte in the subcutaneous tissue and may display the
current level of the analyte via display unit 421. Furthermore, the
sensor control unit 610 and/or the analyte monitoring device 501
may indicate to the patient, via, for example, an audible, visual,
or other sensory-stimulating alarm, when the level of the analyte
is at or near a threshold level. For example, if glucose is
monitored then an alarm may be used to alert the patient to a
hypoglycemic or hyperglycemic glucose level and/or to impending
hypoglycemia or hyperglycemia.
[0139] The analyte monitoring device 501 may perform a variety of
functions, including for example: modifying the signals from the
sensor 605 using calibration data and/or measurements from a
temperature probe (not shown); determining a level of an analyte in
the interstitial fluid; determining a level of an analyte in the
bloodstream based on the sensor measurements in the interstitial
fluid; determining if the level, rate of change, and/or
acceleration in the rate of change of the analyte exceeds or meets
one or more threshold values; activating an alarm system if a
threshold value is met or exceeded; evaluating trends in the level
of an analyte based on a series of sensor signals; therapy
management (e.g., determine a dose of a medication, etc.); and
reduce noise or error contributions (e.g., through signal averaging
or comparing readings from multiple electrodes); etc. The analyte
monitoring device may be simple and perform only one or a small
number of these functions or the analyte monitoring device may
perform all or most of these functions.
[0140] Analyte monitoring device 501 may communicate with a remote
device 505 via communication connector unit 422, and/or wireless
communication unit 423, and/or a second wireless communication unit
(not shown), as described earlier. It should also be understood
that the analyte monitoring device may be configured with one or
more wireless communication units.
Software on the Data Processing Device
[0141] In some aspects of the present disclosure, software is
loaded and launched on a remote data processing device to operate
with a coupled analyte monitoring device. The software may include
one or more GUI's for communicating with the analyte monitoring
device. It should be appreciated a GUI may be used to represent one
or more of graphical elements displayed on the display of the
remote device for interfacing with the user. Thus, "graphical user
interface" or "GUI" may encompass the entire display, an
application window, pop-up windows, menus, progress and status
bars, buttons, etc.
[0142] In some aspects of the present disclosure, the RD software
provides a meter mode to provide access to settings and functions
that are used to setup and control the analyte monitoring device.
The RD software may also provide a meter setup mode to guide the
user through the initial setup of the analyte monitoring device.
The RD software may provide a reports mode to provide access to
settings and function for creating, viewing, saving, and/or
printing various reports. In addition, the RD software may provide
a reports setup mode to guide a user through the initial reports
setup and creation process. The RD software may also provide the
function for users to export data from the analyte monitoring
device--e.g., as a tab-delimited file or other
spreadsheet-compatible format. In some instances, the RD software
may provide functions for providing help documents, tutorials, etc.
to the user. The RD software may provide functions for checking for
software update and for acquiring updates. For example, checks may
be automatically initiated and/or initiated by the user. In some
instances, the software updates may be checked for and acquired via
a network connection on the remote device.
[0143] In some embodiments, the RD software provides a user
interface to manage and/or control features related to the analyte
monitoring device. In some aspects, the RD software provides an
interface to manage and/or control features related to generated
reports. For example, the RD software provides a reports mode for
creating, editing, viewing, printing, and for performing any other
functions associated with report generation and management.
[0144] Different types of reports may be generated. For example,
FIGS. 7A-7F illustrate various types of reports, according to
certain embodiments. It should be appreciated that the reports
illustrated are exemplary and should not be interpreted as
limiting. For the sake of clarity and brevity, the various reports
are briefly described. Further details regarding various reports
that may be implemented with the software is described in U.S.
patent application Ser. No. 11/146,897, filed on Jun. 6, 2005, and
U.S. Provisional Application No. 61/451,488, filed Mar. 10, 2011;
and 60/577,064, filed Jun. 4, 2004, the entireties of which are
incorporated herein by reference.
[0145] Snapshot Report:
[0146] In some aspects of the present disclosure, a Snapshot report
is provided. The Snapshot report captures the overall condition of
the patient's health management (e.g., diabetes management). For
instance, the report may highlight the key metrics for the user's
activities over a specific time period. In some embodiments, the
Snapshot report may provide significant pieces of information
related to one or more of the following: utilization, glucose
levels, events (e.g., hypoglycemic events, ketone events,
Hyperglycemic events, etc.), trends, insulin and carbohydrate data,
notes taken, etc. Additional details related to the above-described
information may be found in U.S. Provisional Patent Application No.
61/451,488, filed on Mar. 10, 2011, the entirety of which is
incorporated herein by reference.
[0147] FIG. 7A illustrates a Snapshot report for a specific time
frame (e.g., a two week period as shown), according to certain
embodiments. Snapshot report 700 includes various pieces of analyte
monitoring related information displayed on one report. For
example, in the embodiment shown, a glucose section 701 and an
insulin and carbohydrates section 702 is provided. Glucose section
701 includes various data related to glucose measurements for the
given time period. For example, the glucose section 701 displays an
indication 703 for the percentage of tests that were above target,
within target, and below target; an indication 704 for standard
deviation; and other usage-related indications 705 (e.g., high,
low, and average values; total tests; average tests per day; days
without tests; hypo events; ketone events; etc.).
[0148] In the embodiment shown, indication 704 provides a graphical
representation of the standard deviation of actual blood glucose
measurements over the two-week time period with respect to an
average blood glucose value. The indication 704 also shows a
comparison to a target deviation range. In the embodiment shown,
the actual standard deviation of +/-69.7 is within the target
standard deviation of +/-100.7 from an average value of 201.
[0149] Historical trends 706 are also represented within the
glucose section 701. The historical trends 706 illustrate trends
for past blood glucose measurements. In the embodiment shown, the
time-period shown is different than the time period of the
snapshot. In other embodiments, the time period may be the same.
Other usage and event data may be provided for various time
periods, such as shown with indication 707.
[0150] Indications 708 and 709 are provided in the insulin and
carbohydrate section 702 to represent or display various insulin
and carbohydrate related data for the given time period.
Furthermore, a notes section 710 is also provided and conveys
various patterns or bits of information for the associated data set
for the specific time period. In some instances, the notes are
generated by the software based on the user's historical data. In
some instances, the notes are notes that have been entered by the
user.
[0151] Logbook Report:
[0152] In some aspects of the present disclosure, a Logbook report
is provided. A logbook report provides a detailed look at blood
glucose readings and, in some cases, other relevant data--e.g.,
insulin dosage, meals, notes, and ketone events--categorized by
time period (e.g., by day). For example, FIG. 7B illustrates a
Logbook report, according to certain embodiments. Logbook report
720 presents blood glucose readings in addition to information
related to carb, insulin, notes. In FIG. 7B, the logged glucose
readings for a selected time period (in this case 2-weeks) is
provided in the report. Only one page is shown that comprises data
for four days 721, 722, 723, and 724 along a time scale 725 for
each day. Each day is broken up in time to identify various
readings and other events (e.g., carb entries, insulin entries,
notes, etc.). Daily totals 726 are also provided along with
indications for measurements that are above or below target.
[0153] Daily Statistics Reports:
[0154] In some aspects of the present disclosure, a Daily
Statistics report is provided. The Daily Statistics report
highlights and details data for glucose readings within a single
day. The data may be used to assist in the identification of causes
of hypoglycemic events and other abnormalities, for example. For
example, FIG. 7C illustrates a Daily Statistics Report, according
to certain embodiments. The Daily Statistics Report 730 includes
plotted glucose data 731 for times throughout the day. The target
range 732 is indicated with shading to provide a quick and easy way
to see when the readings are within or outside the target range.
Additional recorded information (e.g., carbs, insulin, notes, and
ketones) are provided on the graph below each associated reading to
remain in the same time-frame context.
[0155] Meal Event Averages Reports:
[0156] In some aspects of the present disclosure, a Meal Event
Averages report is provided. A Meal Event Averages report
communicates the rise and fall in glucose levels relative to meals.
For example, FIG. 7D illustrates a Meal Event Averages report,
according to certain embodiments. Meal Event Averages report 740
presents glucose data before and after meals, over a set
timeframe--e.g., in the morning 741, midday 742, and evening 743. A
graph is shown, for example, that includes both a pre-meal target
range and a post-meal target range in relation to a time a meal
occurred. The user's glucose readings are provided on the graph to
indicate the user's glucose readings before and after the meal. The
graph may be divided into incremental time periods.
[0157] Pre-meal insulin and carb information are also provided on
the report in charts 744 for each timeframe 741,742,743 for each
day of the given time period (e.g., two week time period). In
addition, other associated information is provided, such as the
number of carbs associated with that meal, the amount of insulin
(e.g., fast-acting and/or long-acting insulin) taken, etc., may be
provided in report 740
[0158] Modal Day Reports:
[0159] In some aspects of the present disclosure, a Modal Day
report is provided. A Modal Day report communicates the trend in
glucose levels based across a time period, such as a typical or
average day. For example, the embodiment shown in FIG. 7E
illustrates a Modal Day report, according to certain embodiments.
Modal Day report 750 includes visualization 751 for the trend of
average glucose levels across a typical day. Areas containing
averages that fall above or below target may be color-coded, as
illustrate by different shading in ranges 752,753,754. Tabular data
755 is also provided below the visualization 751 to provide
relevant statistics for each time period shown in the visualization
751.
[0160] The modal day reports may also include information that
represents distribution of the measurement related data. For
example, the report may indicate the percentage of measurements
that were within a target range, the percentage of measurements
that were above the target range, and the percentage of
measurements below the target range. As another example, the number
of measurements falling within a percentile range for the
measurements taken may be indicated in the report--e.g., the number
of measurements falling within the top twenty fifth percentile,
bottom twenty fifth percentile, etc.
[0161] Meter Settings Report:
[0162] In some aspects, a Meter Settings Report is provided. The
Meter Settings Report provides the user with a quick synopsis of
pertinent meter settings. Some meter settings may be related to the
glucose data--e.g., settings of glucose targets, thresholds,
insulin calculation, correction factors, etc. For example, FIG. 7F
illustrates a meter settings report, according to certain
embodiments. Meter Settings Report 760 comprises sections for
profile settings 761, glucose target settings 762, extra settings
(e.g., insulin related settings) 763, note settings 764, and
reminder settings 765.
[0163] It should be appreciated that other reports may also be
provided. Additional example reports may include, but are not
limited to, Calendar reports (e.g., 30 or 90 day summaries); Usage
reports that provide details about the meter utilization to
indicate user engagement; Hypoglycemic Events Reports that focus on
the hypoglycemic events that occurred in a specific time frame;
etc.
Personalization of an Analyte Monitoring Device Using a Remote Data
Processing Device
[0164] In some aspects of the present disclosure, a remote data
processing device is used to personalize an analyte monitoring
device. The remote device may include software that enables a user
to personalize an analyte meter that is coupled to the remote
device.
[0165] FIG. 8 illustrates an example user interface for
personalizing an analyte monitoring device with a remote data
processing device, according to certain embodiments. User interface
800 includes various pre-installed background images 801 that may
be selected by a user for display on the analyte monitoring device.
The selected background image may be, for example, displayed on the
home screen in some instances. In other instances, the analyte
monitoring device may be configured to display the background image
during a waiting period during a test measurement. As shown, the
user has selected the piano image 801A (e.g., the user may be a
piano player) for display on the analyte monitoring device. Upon
selection, the selected background image 801A is displayed on the
analyte monitoring device at the appropriate time and screen, as
shown in FIG. 9. FIG. 9 illustrates an analyte monitoring device
configured with a personalized background image, according to
certain embodiments. After the user selection (and confirmation in
some instances) shown in FIG. 8, the analyte monitoring device 900
includes the selected background image 801A displayed on the
background of the home screen. In other embodiments, the background
image 801A is only shown during a waiting period during a test
measurement.
[0166] Methods for personalizing an analyte monitoring device with
a remote data processing device may comprise receiving an
indication that an analyte monitoring device is communicatively
coupled to the remote data processing device; and displaying a user
interface on the remote data processing device that enables a user
to personalize the analyte monitoring device. For example, the user
may be able to configure the analyte monitoring device to display a
user selected background image. The methods may further comprise
receiving input for a user selected background image, and
configuring the analyte monitoring device to display the user
selected background image.
[0167] In some embodiments, the methods comprise displaying a
plurality of pre-installed background images on an output display
of the remote data processing device so that the user may select
one. In some instances, the user may select a different background
image that is stored on a memory device or located on the internet,
for example, and then uploaded to the device.
[0168] In some instances, the methods may comprise personalizing
the analyte monitoring device by configuring the analyte monitoring
device to display a user selected name. In some instances, user
input may be entered from the remote data processing device. In
other instances, the user input may be entered from the analyte
monitoring device.
Time Based Advanced Programming of an Analyte Monitoring Device
[0169] In some aspects, one or more configuration settings and/or
user interface settings for the analyte monitoring device may be
pre-programmed prior to a future clinical visit and be based on a
time period relative to a future event (e.g., a future visit, such
as the next future visit). The analyte monitoring device may then
be pre-programmed, for example, by the HCP during a current
clinical visit by the patient, for a time period in the future
based on a future event such as the next clinical visit by the
patient. For example, the HCP may pre-program the device for two
weeks prior to a future clinical visit.
[0170] In some embodiments, the time period begins in the future
from the time when the device is pre-programmed. In some instances,
the time period begins more than one day after the day the device
is pre-programmed, including a time period beginning more than 2
days after the day the device is pre-programmed, for example a time
period beginning more than one week after the device is
pre-programmed.
[0171] Thus, if the time between visits is too long of a time
period to gather data, the HCP may set a future time period based
on the next clinical visit. For example, if a patient is at a
current clinical visit and the next clinical visit is three months
later, but three months of data is more than the HCP desires, the
HCP may pre-program the device for an appropriately desired time
period prior to the next clinical visit--e.g., 2 weeks, 1 month,
etc.
[0172] In some embodiments, the pre-programming of the device
includes beginning to gather data at the specified time period. For
example, prior to the beginning of the time period, the user may
still use the glucose monitor to monitor his glucose without data
being gathered.
[0173] In other embodiments, the pre-programming of the device
includes pre-programming the device to enter a different data
gathering mode when the time period begins. Thus, the device
switches to a different data gathering mode when the time period
begins. For instances, after the patient leaves the office, the
patient will continue with his usual glucose monitoring schedule
until the time period established prior to the next scheduled
visit. When the time period is reached, the glucose monitor with
the advanced programming routine will "switch" the mode of
operation and provide additional UI, reminder, and alarm based on
the time based advanced programming. The patient may then follow
the prescribed reminders and alarms to collect the additional data
that the doctor wanted right before the clinical visit in order to
better facilitate diagnosis and optimize treatment.
[0174] The analyte monitoring device may be pre-programmed to
account for a variety of configuration settings and/or user
interface settings. This may include instructions or aids for the
user (e.g., summary checklists for all the various glucose readings
to be obtained in the time period, various reminders and alarms
(e.g., reminders to take glucose readings), thresholds, user
interface elements, or any other configuration setting and/or user
interface settings such as the ones described herein.
[0175] The advanced programming of this data "gathering" mode
switch can be done at the clinic, for example, as part of the HCP
providing new recommendations for the self management routine. In
some embodiments, the RD software is used to manage data analysis
and therapy change in the clinic (e.g., to pre-program the device)
and can be used to provide a more user friendly tool to program the
device. For example, the HCP may plug the analyte monitoring device
into a computer causing the RD software application to launch on
the computer, subsequently pre-programming the device via the
computer. In some embodiments, the time based advanced programming
can be done on the analyte monitoring device itself, through the
corresponding configuration graphical user interface presented on
the device.
[0176] The time period may be preprogrammed into the device as well
as any attributes of the data gathering mode that is to be entered
during the time period. The time period may include, for example,
starting and ending dates in the future, only a starting date in
the future, etc. The attributes of the data gathering mode may, for
example, include the adding of three more SMBG readings 2 hours
after each meal, at approximately 10 am, 2 pm, and 9 pm. The
attributes may include other relevant thresholds for UI, alarms,
and/or reminders that make up the data gathering mode (e.g.,
reminder only, reminder+alarm, daily checklist, weekly checklist,
etc.). Furthermore, in some instances, the time of the next
clinical visit may be entered. The time period may, for example, in
such case, identify the time period prior to the date entered for
the next clinical visit.
[0177] It should be appreciated that in some embodiments, more than
one future time period may be pre-programmed if desired.
Condition Based Advanced Programming of an Analyte Monitoring
Device
[0178] In some aspects, one or more configuration settings and/or
user interface settings for the analyte monitoring device may be
pre-programmed prior to a future clinical visit and be based on a
future data condition obtained by the analyte monitoring device
prior to the next clinical visit. The discussion above for time
based advanced programming applies here to condition based advanced
programming, except that the trigger for the entry into the
pre-programmed mode is based on the occurrence of a future
condition rather than a future time period relative to a future
event (e.g., the next clinical visit).
[0179] The data condition may be any variety of conditions related
to the data taken by the analyte monitoring device. For example,
the data condition may be associated with, but not limited to,
measurement readings, thresholds, trends, patterns, other events
(e.g., meal events, carb level thresholds, exercise events, state
of health, etc.), etc. In some instances, the events may be
user-entered.
[0180] For example, if a HCP finds that a pattern exists where
whenever the patient has a pre-prandial glucose of less than 110
mg/dL (e.g., not every meal, but frequently occurring), the patient
has a tendency to go low 3 hours after the meal. The HCP may decide
to, for example, recommend the patient adjust the bolus calculator
recommended meal bolus readings whenever a pre-meal SMBG is below
110 mg/dL, and at the same time pre-program the device to turn on
this data gathering feature. If future condition occurs, the device
then enters the pre-programmed data gathering mode. The
pre-programmed data gathering mode may include configuration
settings and/or user interface settings that, for example, provide
the user with reminders, alarms, instructions, etc. For example,
upon occurrence of the future condition, the data collection mode
ay be activated, reminders sent to the patient on what to do (e.g.,
lower insulin by 2-5%), and alarm the patient regularly to check
SMBG after that meal at regular intervals (e.g., 2, 3, 4, and 5
hours after the meal) in order to detect and mitigate potential
lows). In some embodiments, the patient would have the option to
turn off one or more settings (e.g., the interval alarms described
above, etc.). In some embodiments, the settings will be locked so
the user cannot change any of the settings.
[0181] When the patient leaves the office, for example, he may
continue with his normal monitoring schedule and routine and
attempt to follow the new dosing algorithm for these meal boluses
when his pre-meal BG falls below 110 mg/dL. The condition based
pre-programming will be activated upon occurrence of the condition
and assist the user, for example, to obtain the additional data.
This additional data may then be review by the HCP during the next
visit and analyzed to evaluate the new routine.
[0182] One or more attributes of the condition based advanced
programming may be entered (e.g., via the RD software application
launched on a remote device, and/or on the user interface of the
analyte monitoring device itself). The detected condition that will
trigger the activation of the data gathering mode may be
preprogrammed into the device. In some instances, one or more of
the following example attributes may be entered: the duration of
the data collection activation after the detected condition may
also be entered (e.g., number of minutes, hours, days, weeks,
etc.); an SMBG reminder schedule and/or other reminder schedule
(e.g., one time, recurring every hour, x-hours, daily, weekly,
etc.); SMBG alarm schedule and/or other alarm schedule (e.g., one
time, recurring every hour, x-hours, daily, weekly, etc.), etc.
Graphical Representation of Insulin on Board
[0183] In some aspects, the analyte monitoring device may be
configured to graphically represent the amount of insulin remaining
in the user's body. Knowing the insulin on board helps to avoid
bolus stacking or overlapping of multiple boluses taken by the
user. The graphical representation provides a different and more
intuitive way to display and present the insulin on board to the
user than by presenting a numerical value.
[0184] A graphical user interface element may be presented on the
display of the analyte monitoring device to indicate the insulin on
board (IOB or Bolus on Board). In some embodiments, the insulin on
board is represented as a "gauge" to provide the user with an
indication as to the amount of insulin remaining in the body. The
exact value is not required but rather a general indication as to
how much insulin remains. In some instances, the graphical user
interface element includes markers to indicate a maximum and
minimum amount of insulin along with an indication element of the
current amount of insulin remaining in the body (indicated at or
between the maximum and minimum).
[0185] For example, in some embodiments, the current amount of
insulin remaining in the body is represented by a fill-level of the
graphical user interface element (i.e., the indication element is
the filling). The graphical interface element is thus a fill-level
indicator. The graphical element is provided and the amount that
the graphical element is filled represents the amount or percentage
of insulin remaining in the body. For example, if the graphical
element is completely unfilled, then no insulin remains. If the
graphical element is completely filled, then 100% of the insulin
remains. The user can easily and quickly identify the approximate
percentage that the graphical element is filled and thus obtain an
approximate understanding of the amount or percentage remaining in
the body. FIGS. 10A-10B illustrate an example graphical user
interface element that functions as a fill-level indicator,
according to some embodiments. Bar 1001 is shown approximately 100%
filled and represents the amount of insulin remaining in the body
after a bolus was delivered. Bar 1002 is shown approximately 30%
filled indicating approximately 30% insulin on board remaining from
the amount previously delivered. In the embodiment shown, a bar is
shown, however it should be understood that other shapes (e.g.,
triangles, circles, etc.) and orientations (vertical, horizontal,
etc.) may be implemented.
[0186] In some embodiments, the graphical user interface element
includes markers indicating a maximum and minimum, and the current
amount of insulin remaining in the body is indicated by an
indicator element between the maximum and minimum graphical
indications. The indicator element may be, for example, an arrow
pointing to a point between the maximum and minimum. Where the
indicator element resides relative to the maximum and minimum
indications provides the user with an approximate percentage or
value remaining in the body. It should be understood that other
forms of indicator elements may be used such as a line, dot, star,
icon, or any other form of graphic. For example, the level in the
bar in FIGS. 10A-10B may be represented by a single line, and not
necessarily "filled".
[0187] FIGS. 11A-11B illustrate an example graphical user interface
element representing insulin remaining in a body, according to some
embodiments. Gauge 2001 is shown approximately 100% filled and
represents the amount of insulin remaining in the body after a
bolus was delivered. Gauge 2002 is shown approximately 30% filled
indicating approximately 30% insulin on board remaining from the
amount previously delivered. In some instances, additional
identifying markers may be present in the graphical user interface
to indicate divisions, approximate values, thresholds, etc. For
instance, as shown in FIGS. 11A-11B, three additional identifying
markers are present to indicate divisions by quarters (i.e., 25%
full, 50% full, and 75% full).
[0188] In some aspects of the present disclosure, methods for
graphically represent a remaining insulin level in a user body are
provided. The methods comprise displaying a first marker on the
output display to indicate a maximum amount of insulin; displaying
a second marker on the output display to indicate a minimum amount
of insulin; and displaying a indication element on the output
display to indicate a current amount of insulin in the user body,
wherein the positional relation of the indication element to the
first and second markers is approximately proportional to the
percentage of insulin remaining in the body.
[0189] In some embodiments, the indication element may be, for
example, a fill-level of a graphical element, wherein the second
marker is at one end of the graphical element and corresponds to a
zero percent fill-level, and wherein the first marker is at an
opposite end of the graphical element and corresponds to a one
hundred percent fill-level.
[0190] In some embodiments, the graphical element is body-shaped,
and wherein the second marker is at a foot-end of the body-shaped
graphical element, and wherein the first maker is at a head-end of
the body-shaped graphical element. For example, FIGS. 12A and 12B
illustrate a graphical element representing insulin in the body,
according to certain embodiments. Graphical element 1200 is a
body-shaped graphical element wherein the element is filled from
the foot end 1202 to the head end 1201 of the element. The
percentage of the element filled is proportional to the percentage
of insulin remaining in the body.
[0191] In other embodiments, the indication element is an arrow
pointing to a position at or between the first marker and the
second marker. In some instances, the methods comprise displaying
one or more identifying markers between the first marker and second
marker to represent divisions, approximate values, or
thresholds.
Line Graph Data Representation for Glucose-on-Demand Systems
[0192] In some aspects, the analyte monitoring device may be
configured without memory for storing measured glucose values. For
example, an on-body unit may not record measurements, and the user
initiates a read when a measurement reading is desired. For
example, analyte monitoring related data may be provided during an
on-demand reading. Such analyte monitoring related data may include
magnitude data, as well as rate-of-change data, for the on-demand
measurement.
[0193] In some aspects of the present disclosure, methods of
providing a graphical representation of such on-demand readings are
provided. The methods may include outputting a graphical
representation of the analyte monitoring related data that includes
graphical elements plotted at locations corresponding to the
magnitude values of the on-demand readings. Furthermore, the
graphical elements visually represent the rate-of-change data for
each on-demand reading. For example, in some embodiments, the
graphical element may be an arrow that is plotted at the
corresponding magnitude value on a chart. The direction or
orientation of the arrow may indicate the rate-of-change of that
specific on-demand reading. For example, an upward pointing arrow
may indicate an upward trend. Further, the degree of incline of the
upward pointing arrow may indicate the degree of the upward trend.
Similarly, downward pointing arrows may represent a downward trend.
In some instances, the arrows may match the arrows presented on the
user interface of the analyte monitoring device. In other
embodiments, a color or size of the graphical element may indicate
the direction and/or degree of rate-of-change.
[0194] FIG. 13A illustrates a plot for continuous glucose
measurements. FIG. 13B illustrates a plot of magnitudes for
on-demand measurements for the same glucose pattern. As shown, FIG.
13B does not provide the user with much information in addition to
the actual glucose value readings. Trending and other patterns are
not discernable. In FIG. 13C, magnitude data of the on-demand
measurements are provided in addition to rate-of-change data. As
shown, an arrow is illustrated at each on-demand reading and the
location of the arrow represents the magnitude of the reading.
Furthermore, the direction of the arrow correlates to the
rate-of-change of the reading at that instant. Furthermore, the
degree of the arrow conveys the degree of the rate-of-change--e.g.,
with steeper pointing upward arrows and downward arrows correlating
to a larger rate-of-change in the corresponding direction. Thus, in
FIG. 13C, the user is able to discern whether glucose values are
stable, rising, or falling.
[0195] In another aspect, the glucose rate of change information
and the timing between glucose values is used to determine rules
for when a line is drawn on the graph connecting subsequent glucose
values. For example, if two values are taken in close proximity
(e.g., less than 30 minutes apart) and the rate-of-change observed
at the time of the first reading indicated a rising trend and the
second glucose value was greater than the first, then the points
may be connected by a line. The line may be, for example, dotted,
color coded, or otherwise represented to indicate to the user that
it is a "fit" to the data and does not represent additional
measured glucose values. Alternatively, an autoregressive approach
is used to connect the points when there is sufficient data density
and when the subsequent glucose value falls within the range
predicted by the autoregressive mode.
[0196] In some embodiments, a standard spline technique is used to
connect the dots with curves instead of straight lines. Other model
based approaches are also possible--e.g., that use both glucose and
glucose rates to produce a continuous profile. For example, a
standard stochastic state observer may be used to predict forward
from one point and/or predict backward from the next point. In this
way, it may provide the prediction error forward and backward. The
forward and backward predication curves between the two points may
be combined as one weighted prediction error. For example, the
prediction error may be represented by the following equation:
F(t)=[P.sup.+(t)*(1/E.sup.+(t)) 2+P.sup.-(t)*(1/E.sup.-(t))
2]/[(1/E.sup.+(t)) 2+(1/E.sup.-(t)) 2]
[0197] Wherein F(t) is the resulting line, P.sup.+(t) is the
forward prediction line; P.sup.- (t) is the backward prediction
line; E.sup.+(t) is the forward prediction error; E.sup.-(t) is the
backward prediction error.
[0198] FIG. 14 illustrates a plot using such a prediction error,
according to certain embodiments. As shown, data for on-demand
readings 1401 and 1402 are provided on a graph 1400. Forward
prediction line P.sup.+(t) and backward prediction line P.sup.-(t),
and corresponding forward prediction error E.sup.+(t) and backward
prediction error E.sup.-(t) are used to provide resulting line 1403
between the two points 1401 and 1402. If the error E.sup.+(t) or
E.sup.-(t) exceeds a predetermined threshold, for example 10 mg/dL
or 30 mg/dL, then a line connecting the points won't be drawn but
rather the gap will be left.
Protection of Access to Features on an Analyte Monitoring
Device
[0199] In some aspects, the analyte monitoring device may be
configured to prevent the user from accessing specific features of
the analyte monitoring device. The user may be blocked access from
specific features for any variety of reasons, such as proficiency
of the subject matter related to the feature, non-applicability of
the feature to the patient, etc. For example, many advanced
features such as bolus calculators and basal titration algorithms
require a user to be proficient in knowledge and management of
their disease state in order to be used safely and effectively. The
user may not have the required knowledge or training to use such
features properly.
[0200] In some aspects, the analyte monitoring device may be
configured with software protection mechanisms to ensure the user
does not have access to specific features. In some instances, the
software protection mechanisms may be implemented to confirm that
the user is qualified to use the feature. The software protection
mechanism may implement a test to certify that the user is
qualified to use the feature. In some instances, the software
protection mechanism may present the user with a series of one or
more questions that demonstrates the user is proficient in the
subject matter related to the feature to be unlocked. For example,
a protection screen that allows access to a bolus calculator
feature may check that a user understands carb counting (e.g., by
asking them to answer one or more questions on the number of carbs
in a slice of bread), and/or correction factor (e.g., by asking one
or more questions related to correction factor), etc. In some
instances, the question may be presented in a multiple choice
format. In order to provide additional protection against an
unqualified user trying to access a feature by randomly guessing
answers, the functionality can be locked out after a number of
attempts, and unlocked by password, special key, etc.
[0201] In some instances, the HCP may confirm the user is qualified
to use the feature and unlock access to the feature. For example,
the HCP may possess the appropriate password or key necessary to
unlock the feature.
[0202] It should be understood that techniques introduced herein
can be implemented by programmable circuitry programmed or
configured by software and/or firmware, or they can be implemented
entirely by special-purpose "hardwired" circuitry, or in a
combination of such forms. Such special-purpose circuitry (if any)
can be in the form of, for example, one or more
application-specific integrated circuits (ASICS), programmable
logic devices (PLDs), field-programmable gate arrays (FPGAs),
etc.
[0203] Software or firmware implementing the techniques introduced
herein may be stored on a machine-readable storage medium and may
be executed by one or more general-purpose or special-purpose
programmable microprocessors. A "machine-readable medium", as the
term is used herein, includes any mechanism that can store
information in a form accessible by a machine (a machine may be,
for example, a computer, network device, cellular phone, personal
digital assistant (PDA), manufacturing took, any device with one or
more processors, etc.). For example, a machine-accessible medium
includes recordable/non-recordable media (e.g., read-only memory
(ROM); random access memory (RAM); magnetic disk storage media;
optical storage media; flash memory devices; etc.), etc. The term
"logic", as used herein, can include, for example, special purpose
hardwired circuitry, software and/or firmware in conjunction with
programmable circuitry, or a combination thereof.
[0204] The preceding merely illustrates the principles of the
present disclosure. It will be appreciated that those skilled in
the art will be able to devise various arrangements which, although
not explicitly described or shown herein, embody the principles of
the present disclosure and are included within its spirit and
scope. Furthermore, all examples and conditional language recited
herein are principally intended to aid the reader in understanding
the principles of the present disclosure and the concepts
contributed by the inventors to furthering the art, and are to be
construed as being without limitation to such specifically recited
examples and conditions. Moreover, all statements herein reciting
principles, aspects, and aspects of the present disclosure as well
as specific examples thereof, are intended to encompass both
structural and functional equivalents thereof. Additionally, it is
intended that such equivalents include both currently known
equivalents and equivalents developed in the future, i.e., any
elements developed that perform the same function, regardless of
structure. The scope of the present disclosure, therefore, is not
intended to be limited to the exemplary aspects shown and described
herein. Rather, the scope and spirit of present disclosure is
embodied by the appended claims.
* * * * *