U.S. patent application number 14/592689 was filed with the patent office on 2015-04-30 for device and method for automatic data acquisition and/or detection.
This patent application is currently assigned to Abbott Diabetes Care Inc.. The applicant listed for this patent is Abbott Diabetes Care Inc.. Invention is credited to Scott Dalton, John R. Galasso.
Application Number | 20150120323 14/592689 |
Document ID | / |
Family ID | 39690831 |
Filed Date | 2015-04-30 |
United States Patent
Application |
20150120323 |
Kind Code |
A1 |
Galasso; John R. ; et
al. |
April 30, 2015 |
Device and Method for Automatic Data Acquisition and/or
Detection
Abstract
Methods and devices for providing diabetes management including
automatic time acquisition protocol is provided.
Inventors: |
Galasso; John R.; (Saint
Helena, CA) ; Dalton; Scott; (Berkeley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Diabetes Care Inc. |
Alameda |
CA |
US |
|
|
Assignee: |
Abbott Diabetes Care Inc.
Alameda
CA
|
Family ID: |
39690831 |
Appl. No.: |
14/592689 |
Filed: |
January 8, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14216872 |
Mar 17, 2014 |
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14592689 |
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13858562 |
Apr 8, 2013 |
8676601 |
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14216872 |
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13400026 |
Feb 17, 2012 |
8417545 |
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13858562 |
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12031664 |
Feb 14, 2008 |
8121857 |
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13400026 |
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60890154 |
Feb 15, 2007 |
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Current U.S.
Class: |
705/2 |
Current CPC
Class: |
G16H 40/67 20180101;
A61B 5/14532 20130101; G16H 40/40 20180101; G16H 40/63 20180101;
A61B 5/0205 20130101; G16H 50/20 20180101; A61B 5/0002 20130101;
G16H 20/17 20180101; A61B 2562/0295 20130101 |
Class at
Publication: |
705/2 |
International
Class: |
G06F 19/00 20060101
G06F019/00 |
Claims
1. (canceled)
2. A machine-executed method of continuous analyte monitoring for a
host to facilitate management of the host's blood glucose level,
the method comprising: receiving a first input from a
timekeeping/scheduling module executed by an electronic device, the
first input including information about an upcoming event;
receiving a second input from a continuous analyte monitoring (CAM)
device including analyte concentration data of the host; processing
the first and second inputs by analyzing an event or an operational
mode associated with either of the timekeeping/scheduling module or
the CAM device; and producing an output by synchronizing the event
or the operational mode of at least one of the
timekeeping/scheduling module and the CAM device with the other of
the timekeeping/scheduling module and the CAM device.
3. The method of claim 2, wherein the output is to the
timekeeping/scheduling module to schedule an event.
4. The method of claim 2, wherein the event is to eat, to obtain a
reference glucose value, or to inject insulin.
5. The method of claim 2, wherein the wherein the output is sent to
a user, a caretaker, a parent, a guardian, or a healthcare
professional.
6. The method of claim 2, wherein the output is a recommendation
provided via screen prompt.
7. The method of claim 2, wherein the output is a change in the
operating mode of the electronic device.
8. The method of claim 7, wherein the operating mode is a vibrate
mode or a silent mode.
9. The method of claim 2, wherein the processing comprises
analyzing a user's blood glucose data.
10. The method of claim 2, wherein the event is insertion of a new
continuous analyte sensor or to eat.
11. The method of claim 2, wherein the output is a
recommendation.
12. The method claim 11, wherein the recommendation is a therapy,
to call a caretaker, to send data to a caretaker, to send data to a
doctor, to eat a meal, to replace a sensor, to calibrate a sensor,
to check blood glucose, to upload or sync data to a cloud computing
system.
13. The method of claim 2, wherein the recommendation is provided
via screen prompt.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/216,872 filed Mar. 17, 2014, which is a
continuation of U.S. patent application Ser. No. 13/858,562 filed
Apr. 8, 2013, now U.S. Pat. No. 8,676,601, which is a continuation
of U.S. patent application Ser. No. 13/400,026 filed Feb. 17, 2012,
now U.S. Pat. No. 8,417,545, which is a continuation of U.S. patent
application Ser. No. 12/031,664 filed Feb. 14, 2008, now U.S. Pat.
No. 8,121,857, which claims priority under .sctn.35 U.S.C. 119(e)
to U.S. provisional patent application No. 60/890,154 filed Feb.
15, 2007, entitled "Device and Method for Automatic Data
Acquisition and/or Detection", the disclosures of each of which are
incorporated herein by reference for all purposes.
BACKGROUND
[0002] In diabetes management, there exist devices which allow
diabetic patients to measure the blood glucose levels. One such
device is a hand-held electronic meter such as blood glucose meters
such as Freestyle.RTM. blood glucose monitoring system available
from Abbott Diabetes Care Inc., of Alameda, Calif. which receives
blood samples via enzyme-based test strips. Typically, the patient
lances a finger or alternate body site to obtain a blood sample,
applies the drawn blood sample to the test strip, and the strip is
inserted into a test strip opening or port in the meter housing.
The blood glucose meter converts a current generated by the
enzymatic reaction in the test strip to a corresponding blood
glucose value which is displayed or otherwise provided to the
patient to show the level of glucose at the time of testing.
[0003] Such periodic discrete glucose testing helps diabetic
patients to take any necessary corrective actions to better manage
diabetic conditions. Presently available glucose meters have
limited functionalities (for example, providing the glucose value
measured using the test strip and storing the data for subsequent
recall or display) and do not provide any additional information or
capability to assist patients in managing diabetes.
SUMMARY
[0004] In accordance with the various embodiments of the present
disclosure, there are provided methods and devices for detecting a
predefined parameter associated with an operational condition of an
analyte monitoring device, transmitting a request for time
information in response to the predefined parameter detection, and
receiving time information in response to the transmitted
request.
[0005] These and other objects, features and advantages of the
present disclosure will become more fully apparent from the
following detailed description of the embodiments, the appended
claims and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a block diagram illustrating a therapy management
system for practicing one embodiment of the present disclosure;
[0007] FIG. 2 is a block diagram of a fluid delivery device of FIG.
1 in one embodiment of the present disclosure;
[0008] FIG. 3 is a flowchart illustrating the time zone detection
procedure in the therapy management system in one embodiment of the
present disclosure;
[0009] FIG. 4 is a flowchart illustrating the time zone detection
procedure in the therapy management system in another embodiment of
the present disclosure;
[0010] FIG. 5 is a flowchart illustrating the device
synchronization procedure in the therapy management system in one
embodiment of the present disclosure;
[0011] FIG. 6 is a flowchart illustrating device condition
notification function in the therapy management system in one
embodiment of the present disclosure;
[0012] FIG. 7 is a flowchart illustrating automatic time
information detection function incorporated in a medical device
such as a blood glucose meter in one embodiment of the present
disclosure;
[0013] FIG. 8 is a flowchart illustrating automatic time
information detection function incorporated in a medical device
such as a blood glucose meter in another embodiment of the present
disclosure; and
[0014] FIGS. 9A-9C illustrate embodiments of automatic expiration
detection function on blood glucose meter test strips in accordance
with one embodiment of the present disclosure.
DETAILED DESCRIPTION
[0015] As described below, within the scope of the present
disclosure, there are provided user interface features associated
with the operation of the various components or devices in a
therapy management system such as automatic time change based
functions, automatic expiration date detection on test strips, for
example, synchronization of the components in the therapy
management system, user interface changes based on the user
configuration, notification functions for programmable events
associated with the therapy management, and voice enabled
communication between devices in the therapy management system.
[0016] FIG. 1 is a block diagram illustrating a therapy management
system for practicing one embodiment of the present disclosure.
Referring to FIG. 1, the therapy management system 100 includes an
analyte monitoring system 110 operatively coupled to a fluid
delivery device 120, which may be in turn, operatively coupled to a
remote terminal 140. As shown in the Figure, the analyte monitoring
system 110 is, in one embodiment, coupled to the patient 130 so as
to monitor or measure the analyte levels of the patient. Moreover,
the fluid delivery device 120 is coupled to the patient using, for
example, an infusion set and tubing connected to a cannula (not
shown) that is placed transcutaneously through the skin of the
patient so as to infuse medication such as, for example, insulin,
to the patient.
[0017] Referring to FIG. 1, the analyte monitoring system 110 in
one embodiment may include one or more analyte sensors
subcutaneously positioned such that at least a portion of the
analyte sensors are maintained in fluid contact with the patient's
analytes. The analyte sensors may include, but are not limited to
short term subcutaneous analyte sensors or transdermal analyte
sensors, for example, which are configured to detect analyte levels
of a patient over a predetermined time period, and after which, a
replacement of the sensors is necessary.
[0018] The one or more analyte sensors of the analyte monitoring
system 110 is coupled to a respective one or more of a data
transmitter unit which is configured to receive one or more signals
from the respective analyte sensors corresponding to the detected
analyte levels of the patient, and to transmit the information
corresponding to the detected analyte levels to a receiver device,
and/or fluid delivery device 120. That is, over a communication
link, the transmitter units may be configured to transmit data
associated with the detected analyte levels periodically, and/or
intermittently and repeatedly to one or more other devices such as
the fluid delivery device 120 and/or the remote terminal 140 for
further data processing and analysis.
[0019] In one aspect, each of the one or more receiver devices of
the analyte monitoring system 110 and the fluid delivery device 120
includes a user interface unit which may include a display unit, an
audio output unit such as, for example, a speaker, or any other
suitable user interface mechanism for displaying or informing the
user of such devices.
[0020] The transmitter units of the analyte monitoring system 110
may in one embodiment be configured to transmit the analyte related
data substantially in real time to the fluid delivery device 120
and/or the remote terminal 140 after receiving it from the
corresponding analyte sensors such that the analyte level such as
glucose level of the patient 130 may be monitored in real time. In
one aspect, the analyte levels of the patient may be obtained using
one or more of discrete blood glucose testing devices such as blood
glucose meters that employ glucose test strips, or continuous
analyte monitoring systems such as continuous glucose monitoring
systems. In a further embodiment, the analyte monitoring system 110
may include a blood glucose meter such as FreeStyle.RTM. and
Precision meters available from Abbott Diabetes Care Inc., of
Alameda Calif. The blood glucose meter may be used to calibrate the
sensors in the analyte monitoring system 110. Exemplary analyte
systems that may be employed are described in, for example, U.S.
Pat. Nos. 6,134,461, 6,175,752, 6,121,611, 6,560,471, 6,746,582,
and elsewhere, the disclosures of which are herein incorporated by
reference.
[0021] Analytes that may be monitored, determined or detected in
the analyte monitoring system 110 include, for example, acetyl
choline, amylase, amyln, bilirubin, cholesterol, chorionic
gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,
fructosamine, glucose, glutamine, growth hormones, hormones,
ketones, lactate, measures for oxidative stress (such as 8-iso
PGF2gamma), peroxide, prostate-specific antigen, prothrombin, RNA,
thyroid stimulating hormone, and troponin. The concentration of
drugs, such as, for example, antibiotics (e.g., gentamicin,
vancomycin, and the like), biguanides, digitoxin, digoxin, drugs of
abuse, GLP-1, insulin, PPAR agonists, sulfonylureas, theophylline,
thiazolidinediones, and warfarin, may also be determined.
[0022] Moreover, within the scope of the present disclosure, the
transmitter units of the analyte monitoring system 110 may be
configured to directly communicate with one or more of the remote
terminal 140 or the fluid delivery device 120. Furthermore, within
the scope of the present disclosure, additional devices may be
provided for communication in the analyte monitoring system 110
including additional receiver/data processing units, remote
terminals (such as a physician's terminal and/or a bedside terminal
in a hospital environment, for example).
[0023] In addition, within the scope of the present disclosure, one
or more of the analyte monitoring system 110, the fluid delivery
device 120 and the remote terminal 140 may be configured to
communicate over a wireless data communication link such as, but
not limited to radio frequency (RF) communication link,
Bluetooth.RTM. communication link, infrared communication link, or
any other type of suitable wireless communication connection
between two or more electronic devices, which may further be
uni-directional or bi-directional communication between the two or
more devices. Alternatively, the data communication link may
include wired cable connections such as, for example, but not
limited to RS232 connection, USB connection, or serial cable
connection.
[0024] The fluid delivery device 120 may include in one embodiment,
but not limited to, an external infusion device such as an external
insulin infusion pump, an implantable pump, a pen-type insulin
injector device, a patch pump, an inhalable infusion device for
nasal insulin delivery, or any other type of suitable delivery
system. In addition, the remote terminal 140 in one embodiment may
include for example, a desktop computer terminal, a data
communication enabled kiosk, a laptop computer, a handheld
computing device such as a personal digital assistant (PDAs), or a
data communication enabled mobile telephone.
[0025] Referring back to FIG. 1, in one embodiment, the analyte
monitoring system 110 includes a strip port configured to receive a
test strip for capillary blood glucose testing. In one aspect, the
glucose level measured using the test strip may in addition, be
configured to provide periodic calibration of the analyte sensors
of the analyte monitoring system 110 to assure and improve the
accuracy of the analyte levels detected by the analyte sensors.
[0026] Referring yet again to FIG. 1, in one embodiment of the
present disclosure, the fluid delivery device 120 may be configured
to include a voice signal activation/generation unit for voice
communication with the remote terminal 140 configured as a voice
device such as a mobile telephone, a voice enabled personal digital
assistant, a Blackberry device, or the like. For example, in one
embodiment, the communication between the fluid delivery device 120
and the remote terminal 140 may be voice based such that the
information or data output to the user from the fluid delivery
device 120 is configured to be transmitted to the user's telephone.
In turn, the fluid delivery device 120 may additionally be
configured to receive voice commands from the remote terminal 140
configured as a telephone or any other voice signal communication
device (such as personal computers or PDAs with voice signal
capabilities).
[0027] In this manner, in one embodiment, the user interface of the
fluid delivery device 120 may be configured with the voice signal
activation/generation unit such that, output information for the
user is converted into a voice signal and transmitted to the voice
signal enabled remote terminal 140. For example, when the fluid
delivery device 120 detects an alarm condition, the fluid delivery
device 120 is configured to initiate a telephone call to the user's
telephone (remote terminal 140), and when the user picks up the
telephone line, the user is provided with a voice signal
representing the alarm condition.
[0028] In a further embodiment, for certain predetermined patient
conditions, the fluid delivery device 120 may be configured to
initiate a telephone call directly to a preprogrammed telephone
number of a health care physician, a local hospital, or emergency
medical care facilities, in addition to or instead of initiating a
telephone call to the user of the fluid delivery device 120.
[0029] In addition, within the scope of the present disclosure,
interaction and programming of the fluid delivery device 120 may be
exclusively or partially exclusively performed over the user's
telephone in voice communication with the fluid delivery device
120. That is, when the user wishes to calculate a carbohydrate
bolus in the fluid delivery device 120, the user may dial a
predetermined number using the user's telephone (remote terminal
140) to connect with the fluid delivery device 120, and the user
may provide voice commands to the fluid delivery device 120 via the
telephone connection between the user's telephone (remote terminal
140) and the fluid delivery device 120.
[0030] FIG. 2 is a block diagram of a fluid delivery device of FIG.
1 in one embodiment of the present disclosure. Referring to FIG. 2,
the fluid delivery device 120 in one embodiment includes a
processor 210 operatively coupled to a memory unit 240, an input
unit 220, a display unit 230, an output unit 260, and a fluid
delivery unit 250. In one embodiment, the processor 210 includes a
microprocessor that is configured to and capable of controlling the
functions of the fluid delivery device 120 by controlling and/or
accessing each of the various components of the fluid delivery
device 120. In one embodiment, multiple processors may be provided
as safety measure and to provide redundancy in case of a single
processor failure. Moreover, processing capabilities may be shared
between multiple processor units within the fluid delivery device
120 such that pump functions and/or control may be performed faster
and more accurately.
[0031] Referring back to FIG. 2, the input unit 220 operatively
coupled to the processor 210 may include a jog dial key pad
buttons, a touch pad screen, or any other suitable input mechanism
for providing input commands to the fluid delivery device 120. More
specifically, in case of a jog dial input device, or a touch pad
screen, for example, the patient or user of the fluid delivery
device 120 will manipulate the respective jog dial or touch pad in
conjunction with the display unit 230 which performs as both a data
input and output unit. The display unit 230 may include a touch
sensitive screen, an LCD screen, or any other types of suitable
display unit for the fluid delivery device 120 that is configured
to display alphanumeric data as well as pictorial information such
as icons associated with one or more predefined states of the fluid
delivery device 120, or graphical representation of data such as
trend charts and graphs associated with the insulin infusion rates,
trend data of monitored glucose levels over a period of time, or
textual notification to the patients.
[0032] In one embodiment, the alphanumeric representation displayed
on the display unit 230 may be configured to be modified by the
user of the fluid delivery device such that the size of the
displayed number or character may be adjusted to suit the user's
visual needs. For example, in one embodiment, the user may apply
font size adjustment request via the input unit 220 to instruct the
processor 210 to modify the size of the displayed number or
character on the display unit 230. In one aspect, the font size may
be increased or decreased for each character, value or word
displayed on the display unit 230. Alternatively, the font size
adjustment may be applied globally to all output settings, for
example, under the control of the processor 210 such that the user
setting of the size adjustment may be configured to apply to
substantially all displayed values or characters on the display
unit 230 of the fluid delivery device 120 (FIG. 1).
[0033] Moreover, referring back to FIG. 2, in a further aspect of
the present disclosure, the relative size adjustment of the
displayed character or value may be determined by the processor 210
so that the relative size adjustment may be implemented to the
output display on the display unit 230. In this manner, depending
upon the type or configuration of the display unit 230 (whether bit
map or icon type display), in one embodiment, the display size
adjustment may be implemented within the predetermined size
restrictions for the respective value or character. For example, a
10% relative increase in the font size for display area designated
for insulin dosage level may correspond to a 5% relative increase
in the size of the display area designated for the insulin delivery
time display. In one embodiment, the processor 210 may be
configured to determine the relative size modification for each
area of the display unit 230 based on the user inputted size
adjustment values to appropriately apply the relative size
differential adjustment.
[0034] In a further aspect, the processor 210 may be configured to
temporarily increase the font size displayed on the display unit
230 based on the user input commands such that the user requested
size modification on the display unit 230 may be implemented only
for the displayed screen at the time the user input commands for
size adjustment is received by the processor 210. In this manner,
the processor may be configured to revert to the previously
programmed display size settings for the display unit 230 when the
user is no longer viewing the particular displayed screen from
which the user has requested font size adjustment.
[0035] In addition, the user interface of the receiver unit of the
analyte monitoring system 110 (FIG. 1) may be configured with
similar size adjustment capabilities so as to allow the user to
instruct the controller or processor of the analyte monitoring
system 110 to appropriately adjust the size of the displayed
character or value on the display unit of the analyte monitoring
system 110.
[0036] In a further embodiment, the display unit 230 may be
configured to display an indication or marker for the type of
insulin or other medication being used by the fluid delivery device
120 such as, for example, Symlin and Byetta. Such a marker may, in
one embodiment, be associated with a predefined icon or character
for display on the display unit 230. In addition, within the scope
of the present disclosure, the information associated with the
displayed marker or indication may be stored in the memory unit 240
so that the user may retrieve this information as desired. In
addition, an indication or a marker for shift work may be
programmed in the fluid delivery device 120 (FIG. 1) such that
shift workers using the fluid delivery device 120 may align days
and nights upon command based on the markers.
[0037] For example, if a user worked nightshifts on Mondays and
Tuesdays and dayshifts on Thursdays and Fridays, this daily work
pattern information may be stored, identified or marked in the
fluid delivery device 120 to provide additional data management
functionalities and a more robust therapy analysis. For example,
meal times such as breakfasts, for example, at 8 pm on Monday and 9
pm on Tuesday (during the nightshifts) may be aligned with the
breakfasts at 7 am on Thursday and 8 am on Friday. In this manner,
the user may conveniently access meal (e.g., breakfast) related
data and associated therapy information in conjunction with the
operation of the fluid delivery device 120. This may assist the
user in improving upon the user's diet such as the daily food
intake.
[0038] Referring to FIG. 2, the output unit 260 operatively coupled
to the processor 210 may include an audible alarm or alarms
including one or more tones and/or preprogrammed or programmable
tunes or audio clips, or vibratory alert features having one or
more pre-programmed or programmable vibratory alert levels.
[0039] In addition, in one embodiment of the present disclosure,
each alert event or alarm event may be programmed with combined
notification features such that, depending upon the level of
importance associated with each alert or alarm, a combination of
vibratory, audible, or displayed indications may be provided to the
user using the display unit 230 in combination with the output unit
260.
[0040] For example, the processor 210 may be configured to provide
combined vibratory and increasingly audible alerts on the output
unit 260 in addition to intermittently flashing background light on
the display unit 230 for one or more predetermined alarms that
require immediate user attention. An example may include unexpected
pressure increase in the infusion tubing which may indicate an
occlusion or other undesirable condition that the user should be
immediately notified. The processor 210 may be configured such that
the alarm or alert may be automatically reasserted within a
predetermined time period in the event the associated alarm or
alert condition has not been cleared by the user. In addition, each
alert/alarm feature may be individually programmed to include a
wide selection of tones, audible levels, vibratory strength, and
intensity of visual display.
[0041] In a further aspect, the fluid delivery device 120 may be
configured to provide an alarm or alert indication associated with
a change in temperature. That is, when the fluid delivery device
120 which contains the insulin (for example, in a reservoir)
experiences a rise or drop in temperature, such change in the
temperature may have an adverse effect on the insulin contained
within the device 120. Accordingly, a temperature sensor may be
coupled to the processor 210 of the fluid delivery device 120 to
detect the operating condition of the fluid delivery device 120 and
to notify the user of changes in the temperature, when, for
example, the temperature change reaches a predetermined threshold
level that may potentially have an adverse impact upon the efficacy
of the insulin being delivered.
[0042] Also shown in FIG. 2 is the fluid delivery unit 250 which is
operatively coupled to the processor 210 and configured to deliver
the insulin doses or amounts to the patient from the insulin
reservoir or any other types of suitable containment for insulin to
be delivered (not shown) in the fluid delivery device 120 via an
infusion set coupled to a subcutaneously positioned cannula under
the skin of the patient.
[0043] Referring yet again to FIG. 2, the memory unit 240 may
include one or more of a random access memory (RAM), read only
memory (ROM), or any other type of data storage unit that is
configured to store data as well as program instructions for access
by the processor 210 and execution to control the fluid delivery
device 120 and/or to perform data processing based on data received
from the analyte monitoring system 110, the remote terminal 140,
the patient 130 or any other data input source.
[0044] FIG. 3 is a flowchart illustrating the time zone detection
procedure in the therapy management system in one embodiment of the
present disclosure. Referring to FIG. 3, the fluid delivery device
120 (FIG. 1) may be configured to transmit a location position
request (310) to for example, a global positioning system (GPS).
Thereafter, the location information is received (320) by the
processor 210 of the fluid delivery device 120. The processor 210
is further configured to determine whether the location information
has changed (330). That is, the processor 210 in one embodiment is
configured to compare the receive location information which may
include a current time zone information associated with the
location of the fluid delivery device 120, with the previously
stored and operating time zone information in the fluid delivery
device 120 in operation.
[0045] Referring back, if it is determined that the location
information has not changed, then the routine terminates. On the
other hand, if it is determined that the fluid delivery device
location information has changed, then, the location change
information is output (340) to the user on the display unit 230,
for example. Thereafter, the processor 210 may be configured to
generate a user prompt or notification to modify the time zone
information (350) of the fluid delivery device 120 such that it is
updated to the new location where the fluid delivery device 120 is
operating.
[0046] For example, when the fluid delivery device 120 is
programmed with predetermined basal profiles and/or bolus functions
that are time based and associated with an internal clock of the
fluid delivery device 120, it may be desired to modify some or all
of the time based insulin delivery profiles programmed in the fluid
delivery device 120 so as to correspond to the location of the
fluid delivery device 120. More specifically, if a user is
traveling from a first location to a second location in which one
or more time zones are traversed, e.g., by way of example from San
Francisco to Paris, given the time difference, the meal times, and
sleep times, for example, will change. In this case, it may be
desirable to modify the preprogrammed time based insulin delivery
profiles so that they are synchronized with the user events such as
meals and sleep times.
[0047] Referring back to FIG. 3, in one embodiment, the user
responds to the time based programming change prompt provided by
the processor 210, then the processor 210 may be configured in one
embodiment, to propagate the time change associated with the
preprogrammed insulin delivery profile and notify the user to
confirm the changes, prior to implementing the modification to the
delivery profiles and any associated alerts or notifications. For
example, in the case where the user has programmed to be alerted at
a particular time of day, e.g., noon each day, for a bolus
determination prior to lunch, the processor 210 in one embodiment
is configured to either modify the internal clock of the fluid
delivery device 120 or alternatively, modify the programmed alert
for bolus determination so as to correspond to the new location of
the user and the fluid delivery device 120.
[0048] In another embodiment, the fluid delivery device 120 may be
configured to include a time zone detection unit, such as for
example, the processor 210 may be configured to communicate with a
geographical location change detection mechanism (e.g., an atomic
clock) operatively coupled to the processor 210 for performing the
time zone detection procedure as described above in conjunction
with FIG. 3. In addition, the analyte monitoring system 110 may be
configured to include a time zone detection unit as described above
to automatically or based on a preprogrammed procedure, detect any
location change associated with the analyte monitoring system 110.
In this manner, the analyte monitoring system 110 may be configured
to automatically or based on a preprogrammed procedure, implement
modifications to functions associated with the operation of the
analyte monitoring system 110 that are temporally associated with
the time of day information.
[0049] FIG. 4 is a flowchart illustrating the time zone detection
procedure in the therapy management system in another embodiment of
the present disclosure. Referring to FIG. 4, the fluid delivery
device 120 (FIG. 1) may be configured to transmit a location
position request (410) to for example, a global positioning system
(GPS). Thereafter, the location information is received (420) by
the processor 210 of the fluid delivery device 120. The processor
210 is further configured to determine whether the location
information has changed (430). That is, the processor 210 in one
embodiment is configured to compare the receive location
information which may include a current time zone information
associated with the location of the fluid delivery device 120, with
the previously stored and operating time zone information in the
fluid delivery device 120 in operation.
[0050] Referring back, if it is determined that the location
information has not changed, then the routine terminates. On the
other hand, if it is determined that the fluid delivery device
location information has changed, then, the processor 210 in one
embodiment is configured to retrieve one or more time based
programmed functions (440) from the memory unit 240 of the fluid
delivery device 120, for example.
[0051] Thereafter, the processor 210 may be further configured to
modify the retrieved time based preprogrammed functions in
accordance with the location change information received (450).
Then, the modified retrieved functions are provided to the user
(460) on the display unit 230, for example, to request confirmation
of the time based adjustments, prior to the processor 210 executing
the modified retrieved functions.
[0052] In addition, in one embodiment of the present disclosure,
the fluid delivery device 120 may be configured to detect for
daylight savings time and the processor 210 may be configured to
either automatically execute the time change in the internal clock
of the fluid delivery device, and/or provide a user notification to
accept such time based change so that the operation of the fluid
delivery device 120 performing time based programs are updated with
any time based change in the insulin delivery system 120 operating
environment.
[0053] Within the scope of the present disclosure, the fluid
delivery device 120 may be configured to receive location
information from any positioning system which provides updated time
information based on location. The fluid delivery device 120 may be
configured with a positioning transceiver that is configured to
transmit location information requests to a satellite network, for
example, and to receive the location information therefrom.
[0054] Alternatively, the fluid delivery device 120 may be
configured to update its location information locally upon
synchronization with another device operating in the local (or at
the new location). This may include a host computer terminal
connectable to the fluid delivery device 120 such as, for example,
the remote terminal 140 (FIG. 1), the analyte monitoring system
110, or any other electronic device operating in the new location
with communication capabilities with the fluid delivery device 120
such as a cellular telephone, a personal digital assistant, and the
like.
[0055] In addition, within the scope of the present disclosure, the
procedure and processes described in conjunction with FIGS. 3-4
associated with location change information and corresponding
modification to the time based preprogrammed functions in the fluid
delivery device 120 may be provided to the analyte monitoring
system 110 such that the analyte monitoring system 110 is also
configured to receive new location information and correspondingly
perform modifications to any time based preprogrammed
functions.
[0056] FIG. 5 is a flowchart illustrating the device
synchronization procedure in the therapy management system in one
embodiment of the present disclosure. Referring to FIG. 5, in one
embodiment the fluid delivery device 120 (FIG. 1) may be configured
to detect a synchronization request (510) from another device such
as the remote terminal 140 or the analyte monitoring system 110
(FIG. 1). Thereafter, data communication connection is established
(520) between the fluid delivery device 120 and the synchronization
requesting device. In one embodiment, the fluid delivery device 120
is configured to verify the authenticity or identity of the device
requesting synchronization, and upon synchronization approval, the
fluid delivery device 120 is configured to establish communication
with the synchronization requesting device.
[0057] In addition, within the scope of the present disclosure, the
fluid delivery device 120 may be configured to periodically or at a
predetermined time interval, establish communication connection
with another device for synchronization. Alternatively, the fluid
delivery device may be configured to attempt communication
connection when another device for synchronization is detected
within a predefined distance from the location of the fluid
delivery device 120.
[0058] Referring back to FIG. 5, the fluid delivery device 120 is
configured in one embodiment to transmit its programmed and
operating settings to the connected device (530), and the connected
device is configured to update and store the data received from the
fluid delivery device 120 based on predetermined conditions (540).
For example, the predetermined conditions may include a predefined
set of rules associated with the type of data from the fluid
delivery device 120 to be updated such as historical infusion
related information, programmed functions in the fluid delivery
device 120 such as bolus calculations, temporarily basal profiles,
programmed basal profiles, insulin usage level, and any other
information that is associated with the user.
[0059] In this manner, in one embodiment of the present disclosure,
periodic synchronization of the fluid delivery device 120 settings
and functions may be synchronized to another device so that when
the user replaces the fluid delivery device 120, the new or upgrade
fluid delivery device may be easily and readily programmed to the
user's specification. The synchronization described above may be
configured to be performed periodically at a regular interval such
as, once a week, once per day, when certain predefined criteria are
met such as when the devices are within a predetermined distance
from each other, and/or upon user command.
[0060] In addition, within the scope of the present disclosure, the
fluid delivery device 120 may be configured with any communication
protocol which would allow data transfer between the fluid delivery
device 120 and the synchronizing device. This may include, wired or
wireless communication including for example, Bluetooth.RTM.
protocol, 802.1x protocol, USB cable connection and the like.
[0061] FIG. 6 is a flowchart illustrating device condition
notification function in the therapy management system in one
embodiment of the present disclosure. Referring to FIG. 6 the fluid
delivery device 120 may be configured to detect a notification
condition (610). For example, the processor 210 may be configured
to detect such notification conditions at a preprogrammed time
interval (such as about every 24 hours, for example). Thereafter,
the programmed profile associated with the condition is retrieved
(620). An example of the programmed profile associated with the
condition includes a reminder to start an overnight fast for the
user.
[0062] Referring back to FIG. 6, the processor 210 in one
embodiment is further configured to generate a message associated
with the notification condition and/or the retrieved programmed
profile (630), and, the generated message is provided to the user
(640) on one or more of the display unit 230 or the output unit
260. In this manner, in one embodiment of the present disclosure,
the fluid delivery device 120 may be programmed with automatic
reminders for conditions to assist the user to improve insulin
therapy management.
[0063] In one embodiment, the notification condition detection may
be skipped and the processor 210 may be configured to retrieve the
appropriate programmed profile associated with notification
conditions based on the user programming of the fluid delivery
device 120. Additionally, while a reminder for overnight fast is
described as an example, any other therapy related reminders or
device operating condition reminders may be programmed for
execution by the processor 210 to remind the user. Examples of such
reminders include, but are not limited to, infusion set replacement
reminder, battery replacement reminder, data synchronization
reminder, insulin replenishment reminder, glucose testing reminder,
and the like. In addition, within the scope of the present
disclosure, the procedure described in conjunction with FIG. 6 may
be incorporated in the analyte monitoring system 110 for
programming suitable automatic reminders such as, for example,
sensor replacement reminder, sensor calibration reminder, and the
like.
[0064] FIG. 7 is a flowchart illustrating automatic time
information detection function incorporated in a medical device
such as a blood glucose meter of the analyte monitoring system 110
in one embodiment of the present disclosure. Referring to FIG. 7,
when the medical device active state is detected (710) for example,
by the user initiated power on procedure of the medical device such
as a blood glucose meter, a routine is called by the processor of
the medical device to automatically initiate time acquisition
protocol. That is, upon power on of the medical device, the device
is automatically configured to perform time acquisition protocol
to, among others, transmit request for time and/or date information
to available communication channels, and upon receiving the
information, to store, update and/or otherwise set and/or display
the received or acquired time/date information in the medical
device (720-740).
[0065] Referring back to FIG. 7, in one embodiment, the time
information is received at step 730, and thereafter, the received
time information is stored and/or displayed on a display unit of
the medical device. In one aspect, the medical device is configured
to update all previously stored time associated data (for example,
blood glucose readings taken at certain times of the day (or week,
month, or any other time period)). More specifically, in one
embodiment, when the medical device such as the blood glucose meter
is activated by the user, the processor or controller of the
glucose meter is configured to enable or activate time/date
receiver (for example, a communication component such as a radio
frequency transceiver coupled to the processor of the glucose
meter). The time/date receiver in one embodiment is configured to
seek or acquire automatically, upon activation, time and date
information from one or more available communication networks
within range. For example, the time/date receiver may be configured
to detect the time/date information from one or more radio
frequencies on public, government, or private airwaves using AM
band short frequency or FM band long wave frequency. Alternatively,
as discussed above, current local time/date information may be
received from global positioning satellites, as well as cellular
telephone networks such as GSM, CDMA, AMPS, and the like within
range of the time/date receiver in the medical device.
Additionally, WiFi network may be used to receive the time/data
information, if available and within range.
[0066] In this manner, in one embodiment, the medical device such
as a blood glucose meter, may be configured to automatically
acquire time information that is continuously broadcast on a
frequency in which the antenna and the receiver of the blood
glucose meter are configured to operate. Upon obtaining and
verifying the time and date information, the internal clock
function or component is updated or adjusted with the acquired
time/date information and displayed to the user, for example.
[0067] In a further embodiment, the medical device such as a blood
glucose meter may be configured to use GMT time as the reference
time for all log entry (for example, for each blood glucose test
performed) timestamps associated with each data stored in the
medical device. Thereafter, the medical device may be configured to
convert the stored GMT based time information for each log entry
stored in the medical device to the local time based on the
location of the medical device.
[0068] FIG. 8 is a flowchart illustrating automatic time
information detection function incorporated in a medical device
such as a blood glucose meter in another embodiment of the present
disclosure. Referring to FIG. 8, in one embodiment, the automatic
time acquisition protocol is initiated based on a detection of one
or more changed or preconfigured parameters associated with the
medical device and/or the user of the medical device (810). For
example, the device parameter may include a preconfigured time for
periodically checking for time and date information (such as every
24 hours, 48 hours, or based on a programmed calendar such as to
compensate for daylight savings time change).
[0069] Alternatively, the device parameter may include an
environmental condition change associated with the medical device
or the user, such as a detection of the medical device location
such as during travel by air or a vehicle. That is, in one
embodiment, the medical device may be configured to include an
altimeter which is coupled to the processor of the medical device
to detect a change in altitude of the medical device location for
example, when the user of the medical device is traveling by air.
In such a case, the medical device may be configured to initiate
the time acquisition protocol to confirm or verify the time and
date information of the medical device (820-840).
[0070] Further, the medical device may include an accelerometer
which may be configured to initiate the automatic time acquisition
protocol on the medical device when a predetermined threshold level
of acceleration force is reached. Within the scope of the present
disclosure, other parameters may be used in conjunction with the
medical device to trigger the automatic time acquisition protocol
on the medical device (820-840) such that, without user
intervention, prompting, or initiating, the medical device is
configured to automatically initiate time and date information
acquisition routine. In addition, the functionality of the
automatic time and date information acquisition may be incorporated
in other medical devices such as infusion pumps, continuous glucose
monitoring devices, heart rate monitors, and the like that are
configured to maintain a time associated log of physiological data
(such as glucose levels, insulin infusion rates, cardiac signal
levels and so on) of a patient or a user.
[0071] FIGS. 9A-9C illustrate embodiments of automatic expiration
detection function on blood glucose meter test strips in accordance
with one embodiment of the present disclosure. Presently, test
strips for use with blood glucose meters are sold or made available
in containers that include the expiration date information of the
test strips contained therein. For diabetic patients or healthcare
providers using glucose meters, it is important to check the
expiration information of the test strip before testing for glucose
levels so that the obtained results are accurate.
[0072] Referring to FIGS. 9A-9C, in one embodiment, test strips may
be configured with predefined parameters to allow automatic
expiration date detection of the test strip. In one aspect,
resistance values are provided on the test strips such that when
the test strip is inserted into the strip port of the blood glucose
meter, the meter is configured to compare the detected resistance
value to a stored value of resistance, and determine whether the
inserted test strip has expired or not. More specifically, in one
embodiment, using the resistance value on the test strip, the
expiration date information may be coded, and the meter may be
configured to detect the resistance value of the test strip and
determine whether the test strip has expired.
[0073] In one aspect, the resistance value on the test strip may be
controlled with the ink formulation on the wake up bar and/or
patterns provided thereon. Silver, gold, carbon or any other
suitable conductive material may be used to increase the resistance
as may be desired. The blood glucose meter may be configured such
that the strip port includes a current connector and predetermined
control lines that may be configured to measure the resistance
values coded on the test strips. More specifically, in one
embodiment, the expiration dates may be coded using the resistance
value on the wake-up bar in a logical sequence such as follows:
TABLE-US-00001 Resistance Value Expiration Date 300-310 kOhm Q1 of
odd year 315-320 kOhm Q2 of odd year . . . 350-360 kOhm Q1 of even
year
[0074] Referring to FIGS. 9A-9C, it can be seen that the wavy lines
may increase in thickness or length to change the resistance on the
test strip. Furthermore, the pads on the test strip are shown to
make contact with the wake-up bar on the strip port. By way of an
example, FIG. 9A illustrates 300 KOhm trace width, FIG. 9B
illustrates 315 KOhm trace width, and FIG. 9C illustrates 350 KOhm
trace width, each associated with a predefined expiration date as
described above.
[0075] In this manner, in one embodiment of the present disclosure,
expiration date of test strips may be automatically detected so
that the user is notified of expired date of a given test strip
before it used to test for blood glucose levels. Moreover, while
the automatic expiration detection is described in conjunction with
test strip and blood glucose meters, within the scope of the
present disclosure, other medical device or consumable items with
expiration dates may benefit from the technique described
herein.
[0076] Accordingly, a method in one aspect of the present
disclosure includes detecting a predefined parameter associated
with an operational condition of a medical device such as, for
example, but not limited to a blood glucose meter, an analyte
monitoring device such as continuous glucose monitoring device, or
an infusion pump, transmitting a request for time information in
response to the predefined parameter detection, and receiving time
information in response to the transmitted request.
[0077] The method in one aspect may include storing the received
time information.
[0078] In a further aspect, the method may include updating one or
more stored data based on the received time information.
[0079] In still another aspect, the method may include retrieving
one or more stored data associated with stored time related
information, and updating the retrieved one or more stored data
based on the received time information, and further, storing the
updated retrieved one or more stored data.
[0080] The retrieved one or more stored data may include one or
more of a blood glucose measurement value, monitored analyte level
data, calibration schedule data, or analyte sensor insertion time
data.
[0081] Further, transmitting the request for time information may
be automatically performed in response to the predefined parameter
detection.
[0082] In still another aspect, the method may include displaying
the received time information.
[0083] The method may also include receiving confirmation of the
received time information.
[0084] The time information may include one or more of a time of
day information and date information, or other temporal and/or
geographical information such as time zone information, location
information, GMT data, and the like.
[0085] A medical device in accordance with another aspect of the
present disclosure includes one or more processing units, and a
memory for storing instructions which, when executed by the one or
more processing units, causes the one or more processing units to
detect a predefined parameter associated with an operational
condition of the medical device, to transmit a request for time
information in response to the predefined parameter detection, and
to receive time information in response to the transmitted
request.
[0086] The memory for storing instructions which, when executed by
the one or more processing units, may cause the one or more
processing units to store the received time information.
[0087] The memory for storing instructions which, when executed by
the one or more processing units, may cause the one or more
processing units to update one or more stored data based on the
received time information.
[0088] The memory for storing instructions which, when executed by
the one or more processing units, may cause the one or more
processing units to retrieve one or more stored data associated
with stored time related information, and to update the retrieved
one or more stored data based on the received time information.
[0089] Also, the memory for storing instructions which, when
executed by the one or more processing units, may cause the one or
more processing units to store the updated retrieved one or more
stored data.
[0090] In one embodiment, the medical device may include an analyte
monitoring device, such as a blood glucose meter, a continuous
glucose monitoring device, an integrated continuous glucose
monitoring device and blood glucose meter, or a controller unit in
communication with one or more of the blood glucose meter, the
continuous glucose monitoring device or the integrated continuous
glucose monitoring device and blood glucose meter.
[0091] For example, in one aspect, the medical device may include
an in vitro blood glucose meter. Alternatively, the medical device
may include a receiver unit or a controller unit in a continuous
glucose monitoring system 110 (FIG. 1), which may additionally
incorporate a strip port and the corresponding electronic circuitry
for processing blood samples from an in vitro test strip.
[0092] In still another aspect, the medical device may include an
infusion device for infusing medication such as insulin, for
example an external infusion pump, an implantable infusion pump, an
inhalable medication dispensing unit, or a medication injection
device.
[0093] The retrieved one or more stored data includes one or more
of a blood glucose measurement value, monitored analyte level data,
calibration schedule data, or analyte sensor insertion time data,
or any other time associated data such as, for example, a
medication delivery schedule such as programmed basal profiles in
infusion pumps.
[0094] Also, the memory for storing instructions which, when
executed by the one or more processing units, may cause the one or
more processing units to automatically transmit the request for
time information in response to the predefined parameter
detection.
[0095] The device may include a display unit operatively coupled to
the one or more processing units, to display the received time
information.
[0096] The memory for storing instructions which, when executed by
the one or more processing units, may cause the one or more
processing units to receive confirmation of the received time
information.
[0097] The one or more of the processing units may include a
communication unit configured to transmit the request for time
information or to receive time information in response to the
transmitted request, or both.
[0098] The communication unit may be configured to transmit or
receive information using one or more of a Bluetooth.RTM.
communication protocol, an RF communication protocol, an infrared
communication protocol, a Zigbee.RTM. communication protocol, an
802.1x communication protocol, or a wireless personal area network
protocol.
[0099] A medical device in yet another embodiment may include means
for detecting a predefined parameter associated with an operational
condition of a medical device, means for transmitting a request for
time information in response to the predefined parameter detection,
and means for receiving time information in response to the
transmitted request.
[0100] A therapy management system in one embodiment of the present
disclosure includes an infusion device including a processing unit
configured to perform data processing, and a user interface unit
operatively coupled to a processing unit, where the processing unit
is configured to detect a location information associated with the
infusion device for output to the user interface unit.
[0101] The location information in one embodiment is time
based.
[0102] In one aspect, the location information is associated with a
local time information based on the location of the infusion
device, where the location information may be received from a
global positioning system (GPS) or from another device, such as a
mobile telephone, a GPS enabled personal digital assistant, which
has received that information from a global positioning system.
[0103] In one aspect, a clock unit may be operatively coupled to
the processing unit, where the clock unit is configured to
dynamically adjust the location information based on the location
of the infusion device.
[0104] In a further embodiment, the clock unit may include an
atomic clock.
[0105] The processor unit may be configured to generate a
notification associated with the detected location information for
output to the user interface unit, where the notification may be
output to the user interface unit as one or more of a date
information and time information associated with the location of
the infusion device.
[0106] The processing unit may be configured to retrieve one or
more programmed procedures associated with time, where the one or
more programmed procedures may include one or more basal profiles,
a programmed bolus determination schedule, a time based condition
alert.
[0107] The time based condition alert may include one or more of a
time based reminder associated with the operation of the infusion
device. Further, the time based condition alert may include one or
more of a time based reminder associated with the condition of the
infusion device user.
[0108] In a further aspect, the processor unit may be configured to
automatically adjust one or more time based functions associated
with the operation of the infusion device based on the detected
location information.
[0109] A method in accordance with another embodiment includes
detecting a change in the location information of a therapy
management device, comparing the detected change with a stored
location information, and executing one or more processes
associated with the operation of the therapy management device
based on the detected change.
[0110] The detected change in the location information may include
one of a time zone change, a time standard change, a date change,
or combinations thereof.
[0111] The one or more processes may include generating a
notification associated with the detected change in the location
information.
[0112] Further, the one or more processes may include modifying one
or more programmed time based functions of the therapy management
device and which may include one or more of a programmed time based
alert, a programmed time based fluid delivery determination; a
programmed time based fluid delivery profile, or a programmed time
based operational condition of the therapy management device.
[0113] In still another aspect, the therapy management device may
include one or more of an infusion device or an analyte monitoring
unit.
[0114] A therapy management system in accordance with still another
embodiment of the present disclosure includes an infusion device,
and a communication unit operatively coupled to the infusion device
over a wireless data network, the communication device configured
to transmit a request for synchronization to the infusion device,
where the infusion device may be configured to transmit one or more
data to the communication unit in response to the received
synchronization request.
[0115] The wireless data network may be based on one or more of a
Bluetooth.RTM. communication protocol, an RF communication
protocol, an infrared communication protocol, a Zigbee.RTM.
communication protocol, an 802.1x communication protocol, or a
wireless personal area network such as ANT protocol.
[0116] In a further aspect, the wireless data network may include
one or more of a wireless local area network, or a WiFi
network.
[0117] The communication unit may be configured to periodically
transmit the synchronization request at a predetermined time
interval.
[0118] Further, the infusion device may be configured to verify the
received synchronization request before transmitting the one or
more data to the communication unit.
[0119] The transmitted one or more data to the communication unit
may be encrypted, and also, the communication unit may be
configured to decrypt the received one or more encrypted data.
[0120] The transmitted one or more data may include one or more
information associated with the stored user profile of the infusion
device, an operating parameter of the infusion device, or infusion
delivery information.
[0121] The communication unit may include one or more of an analyte
monitoring unit, a personal digital assistant, a mobile telephone,
a computer terminal, a server terminal or an additional infusion
device.
[0122] A system for communicating with an infusion device in still
another embodiment of the present disclosure includes a voice
enabled device and an infusion device configured to communicate
with the voice enabled device using one or more voice signals.
[0123] In one aspect, the voice enabled device may include one or
more of a telephone set, a mobile telephone, a voice of IP
(Internet Protocol) telephone, a voice enabled computing device, or
a voice enabled computer terminal.
[0124] The infusion device may be configured to initiate a voice
enabled communication to the voice enabled device. For example, the
infusion device may be integrated with mobile telephone
components.
[0125] In one aspect, the voice enabled communication may include a
telephone call.
[0126] The infusion device may be configured to receive one or more
voice commands from the voice enabled device, where the infusion
device may be configured to process the one or more voice commands
to execute one or more associated functions of the infusion device
operation.
[0127] The one or more associated functions include a bolus dosage
determination, a programmable notification, or a temporarily basal
dosage determination.
[0128] A method in accordance with yet still another embodiment of
the present disclosure includes initiating a voice signal based
communication from an infusion device, and transmitting a voice
signal associated with the operation of the infusion device.
[0129] The method may also include receiving a voice signal based
request over a communication network, and executing one or more
functions associated with the operation of the infusion device
based on the received voice signal based request.
[0130] The voice signal based communication may include a telephone
call.
[0131] A therapy management kit in accordance with still yet
another embodiment includes an infusion device including a
processing unit configured to perform data processing, and a user
interface unit operatively coupled to a processing unit, where the
processing unit is configured to detect a location information
associated with the infusion device for output to the user
interface unit.
[0132] The kit may further include a clock unit operatively coupled
to the processing unit, where the clock unit is configured to
dynamically adjust the location information based on the location
of the infusion device.
[0133] The clock unit may include an atomic clock.
[0134] In a further aspect, the kit may also include a voice
enabled device, where the infusion device may be further configured
to communicate with the voice enabled device using one or more
voice signals.
[0135] In one aspect, the voice enabled device may include one or
more of a telephone set, a mobile telephone, a voice of IP
(Internet Protocol) telephone, a voice enabled computing device, or
a voice enabled computer terminal.
[0136] The various processes described above including the
processes performed by the processor 210 in the software
application execution environment in the fluid delivery device 120
as well as any other suitable or similar processing units embodied
in the analyte monitoring system 120 and the remote terminal 140,
including the processes and routines described in conjunction with
FIGS. 3-8, may be embodied as computer programs developed using an
object oriented language that allows the modeling of complex
systems with modular objects to create abstractions that are
representative of real world, physical objects and their
interrelationships. The software required to carry out the
inventive process, which may be stored in the memory unit 240 (or
similar storage devices in the analyte monitoring system 110 or the
remote terminal 140) of the processor 210, may be developed by a
person of ordinary skill in the art and may include one or more
computer program products.
[0137] In addition, all references cited above herein, in addition
to the background and summary of the invention sections, are hereby
incorporated by reference into the detailed description of the
preferred embodiments as disclosing alternative embodiments and
components.
[0138] Various other modifications and alterations in the structure
and method of operation of this invention will be apparent to those
skilled in the art without departing from the scope and spirit of
the invention. Although the invention has been described in
connection with specific preferred embodiments, it should be
understood that the invention as claimed should not be unduly
limited to such specific embodiments. It is intended that the
following claims define the scope of the present disclosure and
that structures and methods within the scope of these claims and
their equivalents be covered thereby.
* * * * *