U.S. patent application number 16/032017 was filed with the patent office on 2018-11-15 for health management devices and methods.
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 Daniel Milfred Bernstein, Jean-Pierre Cole, Martin J. Fennell, Namvar Kiaie, Michael Love, Steve Scott, Mark Kent Sloan, Jared Watkin.
Application Number | 20180325434 16/032017 |
Document ID | / |
Family ID | 40137214 |
Filed Date | 2018-11-15 |
United States Patent
Application |
20180325434 |
Kind Code |
A1 |
Bernstein; Daniel Milfred ;
et al. |
November 15, 2018 |
Health Management Devices and Methods
Abstract
Methods and devices and systems including a communication module
operatively coupled to a data collection module for communicating
the stored analyte related data after the analyte related data is
stored in the data collection module over a predetermined time
period, and a user interface unit configured to communicate with
the communication module to receive from the communication module
the stored analyte related data in the data collection module over
the predetermined time period, and to output information associated
with the monitored analyte level, where the user interface unit is
configured to operate in a prospective analysis mode including
substantially real time output of information associated with the
monitored analyte level, or a retrospective analysis mode including
limited output of information during the predetermined time period
wherein no information related to the monitored analyte level is
output during the predetermined time period, are provided.
Inventors: |
Bernstein; Daniel Milfred;
(El Granada, CA) ; Watkin; Jared; (Danville,
CA) ; Fennell; Martin J.; (Concord, CA) ;
Sloan; Mark Kent; (Redwood City, CA) ; Love;
Michael; (Pleasanton, CA) ; Kiaie; Namvar;
(Danville, CA) ; Cole; Jean-Pierre; (Tracy,
CA) ; Scott; Steve; (Pleasanton, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Diabetes Care Inc. |
Alameda |
CA |
US |
|
|
Assignee: |
Abbott Diabetes Care Inc.
Alameda
CA
|
Family ID: |
40137214 |
Appl. No.: |
16/032017 |
Filed: |
July 10, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14094719 |
Dec 2, 2013 |
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16032017 |
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12143731 |
Jun 20, 2008 |
8597188 |
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14094719 |
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60945579 |
Jun 21, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 40/67 20180101;
A61B 5/002 20130101; G16H 20/10 20180101; A61B 2560/0276 20130101;
G16H 10/40 20180101; A61B 5/14542 20130101; A61B 2560/0252
20130101; A61B 2560/045 20130101; G16H 50/20 20180101; G16H 40/63
20180101; A61B 5/0017 20130101; G06F 19/00 20130101; G06F 19/3418
20130101; A61B 5/0031 20130101; A61B 2560/0223 20130101; A61B
5/14532 20130101; A61B 5/14865 20130101; G06Q 50/22 20130101; A61B
5/14546 20130101; G08C 17/02 20130101; A61B 2560/0456 20130101;
G06Q 50/24 20130101 |
International
Class: |
A61B 5/145 20060101
A61B005/145; G08C 17/02 20060101 G08C017/02; G16H 10/40 20180101
G16H010/40; G06F 19/00 20180101 G06F019/00; G06Q 50/22 20180101
G06Q050/22; G16H 50/20 20180101 G16H050/20; G16H 40/63 20180101
G16H040/63; A61B 5/00 20060101 A61B005/00; A61B 5/1486 20060101
A61B005/1486 |
Claims
1. (canceled)
2. A method comprising: inhibiting access to analyte sensor data
indicative of measured analyte concentration levels in a host, when
a command is received to place in a blind mode one or more of an
interface and a sensor system configured to measure the analyte
concentration level in the host; forwarding the analyte sensor data
to an analyte processing system; and deriving analyte concentration
values using the analyte sensor data, wherein the inhibiting access
to the analyte sensor data prevents one or more of the interface
and the sensor system from displaying a numerical representation of
the analyte concentration values derived using the analyte sensor
data stored in memory therein.
3. The method of claim 2, wherein the interface comprises a
processor and a display for displaying the analyte sensor data, and
wherein the interface couples to the sensor system via a first
encrypted connection and further couples through a second encrypted
connection to the analyte processing system.
4. The method of claim 2, further comprising: receiving, from the
analyte processing system, the command to place in the blind mode
at least one of the interface and the sensor system.
5. The method of claim 2, further comprising accessing a remote
processing system using the interface, the remote processing system
having computer instructions configured to cause the inhibiting
access to the analyte sensor data.
6. The method of claim 2, further comprising registering the sensor
system for a particular use, the registering comprising associating
the sensor system with a file pertaining the particular use.
7. The method of claim 6, wherein the registering further comprises
one or more of clearing data from persistent memory of the sensor
system, setting a clock of the sensor system or placing the sensor
system in the blind or an unblind mode.
8. The method of claim 6, wherein the inhibiting is performed when
the sensor system is set to the blind mode, and wherein the
inhibiting access to the analyte sensor data is not performed when
the sensor is in the unblind mode.
9. An apparatus comprising: at least one processor; and at least
one memory including code which when executed by the at least one
processor provides operations comprising: inhibiting access to
analyte sensor data indicative of measured analyte concentration
levels in a host, when a command is received to place in a blind
mode one or more of an interface and a sensor system configured to
measure the analyte concentration level in the host; forwarding the
analyte sensor data to an analyte processing system; and deriving
analyte concentration values using the analyte sensor data, wherein
the inhibiting access to the analyte sensor data prevents one or
more of the interface and the sensor system from displaying a
numerical representation of the analyte concentration values
derived using the analyte sensor data stored in memory therein.
10. The apparatus of claim 9, wherein the interface comprises a
processor and a display for displaying the analyte sensor data, and
wherein the interface is configured to couple to the sensor system
via a first encrypted connection and is further configured to
couple through a second encrypted connection to the analyte
processing system.
11. The apparatus of claim 9, further configured to receive, from
the analyte processing system, the command to place in the blind
mode at least one of the interface and the sensor system.
12. The apparatus of claim 9, wherein the operations further
comprise accessing a remote processing system using the interface,
the remote processing system having computer instructions
configured to cause the inhibiting access to the analyte sensor
data.
13. The apparatus of claim 9, wherein the operations further
comprise registering the sensor system for a particular use, the
registering comprising associating the sensor system with a file
pertaining the particular use.
14. The apparatus of claim 13, wherein the registering further
comprises one or more of clearing data from persistent memory of
the sensor system, setting a clock of the sensor system or placing
the sensor system in the blind or an unblind mode.
15. The apparatus of claim 13, wherein the inhibiting is performed
when the sensor system is set to the blind mode, and wherein the
inhibiting access to the analyte sensor data is not performed when
the sensor is in the unblind mode.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/094,719 filed Dec. 2, 2013, which is a
continuation of U.S. patent application Ser. No. 12/143,731 filed
Jun. 20, 2008, now U.S. Pat. No. 8,597,188, which claims priority
to U.S. Provisional Application No. 60/945,579 filed Jun. 21, 2007,
entitled "Health Management Devices and Methods" and assigned to
the assignee of the present application, Abbott Diabetes Care Inc.,
the disclosures of each of which are incorporated by reference for
all purposes.
BACKGROUND
[0002] The detection of the level of analytes, such as glucose,
lactate, oxygen, and the like, in certain individuals is vitally
important to their health. For example, the monitoring of glucose
is particularly important to individuals with diabetes. Diabetics
may need to monitor glucose levels to determine when insulin is
needed to reduce glucose levels in their bodies or when additional
glucose is needed to raise the level of glucose in their
bodies.
[0003] Accordingly, of interest are devices that allow a user to
test for one or more analytes.
SUMMARY
[0004] In accordance with embodiments of the present disclosure,
there is provided analyte monitoring methods and system for
prospective or retrospective data analysis and processing including
an in vivo analyte monitoring system comprising an analyte sensor
and a module to collect analyte data from the sensor for use by a
first user, a data management system to manipulate analyte data at
a remote site, the analyte data transferred to the data management
system from the in vivo system, where the system is configured for
use by at least a second user, and further where there is provided
a patient privacy system to limit or restrict data access by the
type of users.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 shows a block diagram of an embodiment of a data
monitoring and management system according to the present
disclosure;
[0006] FIG. 2 shows a block diagram of an embodiment of the
transmitter unit of the data monitoring and management system of
FIG. 1;
[0007] FIG. 3 shows a block diagram of an embodiment of the
receiver/monitor unit of the data monitoring and management system
of FIG. 1;
[0008] FIG. 4 shows a schematic diagram of an embodiment of an
analyte sensor according to the present disclosure;
[0009] FIGS. 5A-5B show a perspective view and a cross sectional
view, respectively of another embodiment an analyte sensor;
[0010] FIGS. 6-10 illustrate exemplary blood glucose meters and
test strips and using the same;
[0011] FIG. 11 illustrates in vitro data transfer to a health care
provider (HCP) via Universal Serial Bus (USB) connection to a
computing device such as a personal computer (PC) in one
embodiment;
[0012] FIG. 12 illustrates prospective calibration of an assessor
(AS) data, and unblinded assessor (AS) data in one embodiment;
[0013] FIG. 13 illustrates prospective calibration of the assessor
(AS) data, unblinded data and associated analysis and an RF module
in one embodiment;
[0014] FIG. 14 illustrates unblinded, retrospective data and
associated analysis and a USB connection in one embodiment;
[0015] FIG. 15 illustrates unblinded, prospective data and
associated analysis and a wireless adapter in one embodiment;
and
[0016] FIG. 16 shows a table of exemplary embodiments and
respective features in one embodiment.
DETAILED DESCRIPTION
[0017] Before the present disclosure is described, it is to be
understood that this disclosure is not limited to particular
embodiments 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 embodiments only, and is not intended to
be limiting, since the scope of the present disclosure will be
limited only by the appended claims.
[0018] 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 limit of that range and any other stated or intervening
value in that stated range, is encompassed within the disclosure.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges as also encompassed
within the 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 disclosure.
[0019] 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.
[0020] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present disclosure.
[0021] The figures shown herein are not necessarily drawn to scale,
with some components and features being exaggerated for
clarity.
[0022] Generally, embodiments of the present disclosure relate to
methods and devices for detecting at least one analyte such as
glucose in body fluid. Embodiments relate to the continuous and/or
automatic in vivo monitoring of the level of one or more analytes
using a continuous analyte monitoring system that includes an
analyte sensor at least a portion of which is to be positioned
beneath a skin surface of a user for a period of time and/or the
discrete monitoring of one or more analytes using an in vitro blood
glucose ("BG") meter and an analyte test strip. Embodiments include
combined or combinable devices, systems and methods and/or
transferring data between an in vivo continuous system and a BG
meter system.
[0023] Accordingly, embodiments include analyte monitoring devices
and systems that include an analyte sensor--at least a portion of
which is positionable beneath the skin of the user--for the in vivo
detection, of an analyte, such as glucose, lactate, and the like,
in a body fluid. Embodiments include wholly implantable analyte
sensors and analyte sensors in which only a portion of the sensor
is positioned under the skin and a portion of the sensor resides
above the skin, e.g., for contact to a transmitter, receiver,
transceiver, processor, etc. The sensor may be, for example,
subcutaneously positionable in a patient for the continuous or
periodic monitoring of a level of an analyte in a patient's
interstitial fluid. For the purposes of this description,
continuous monitoring and periodic monitoring will be used
interchangeably, unless noted otherwise.
[0024] The sensor response may be correlated and/or converted to
analyte levels in blood or other fluids. In certain embodiments, an
analyte sensor may be positioned in contact with interstitial fluid
to detect the level of glucose, which detected glucose may be used
to infer the glucose level in the patient's bloodstream. Analyte
sensors may be insertable into a vein, artery, or other portion of
the body containing fluid. Analyte sensors that do not require
bodily fluid contact are also contemplated. Embodiments of the
analyte sensors may be configured for monitoring the level of the
analyte over a time period which may range from minutes, hours,
days, weeks, or longer.
[0025] Of interest are analyte sensors, such as glucose sensors,
that are capable of in vivo detection of an analyte for about one
hour or more, e.g., about a few hours or more, e.g., about a few
days of more, e.g., about three or more days, e.g., about five days
or more, e.g., about seven days or more, e.g., about several weeks
or at least one month. Future analyte levels may be predicted based
on information obtained, e.g., the current analyte level at time
t.sub.o, the rate of change of the analyte, etc. Predictive alarms
may notify the user of a predicted analyte level that may be of
concern in advance of the user's analyte level reaching the future
level. This provides the user an opportunity to take corrective
action.
[0026] FIG. 1 shows a data monitoring and management system such
as, for example, an analyte (e.g., glucose) monitoring system 100
in accordance with certain embodiments. Embodiments of the subject
disclosure are further described primarily with respect to glucose
monitoring devices and systems, and methods of glucose detection,
for convenience only and such description is in no way intended to
limit the scope of the disclosure. It is to be understood that the
analyte monitoring system may be configured to monitor a variety of
analytes at the same time or at different times.
[0027] Analytes that may be monitored include, but are not limited
to acetyl choline, amylase, bilirubin, cholesterol, chorionic
gonadotropin, creatine kinase (e.g., CK-MB), creatine, creatinine,
DNA, fructosamine, glucose, glutamine, growth hormones, hormones,
ketone bodies, lactate, 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), digitoxin, digoxin, drugs of
abuse, theophylline, and warfarin, may also be monitored. In those
embodiments that monitor more than one analyte, the analytes may be
monitored at the same or different times.
[0028] The analyte monitoring system 100 includes a sensor 101, a
data processing unit or control unit 102 connectable to the sensor
101, and a primary receiver unit 104 which is configured to
communicate with the data processing unit 102 via a communication
link 103. In certain embodiments, the primary receiver unit 104 may
be further configured to transmit data to a data processing
terminal 105 to evaluate or otherwise process or format data
received by the primary receiver unit 104. The data processing
terminal 105 may be configured to receive data directly from the
data processing unit 102 via a communication link which may
optionally be configured for bi-directional communication. Further,
the data processing unit 102 may include a transmitter or a
transceiver to transmit and/or receive data to and/or from the
primary receiver unit 104 and/or the data processing terminal 105
and/or optionally the secondary receiver unit 106.
[0029] Also shown in FIG. 1 is an optional secondary receiver unit
106 which is operatively coupled to the communication link and
configured to receive data transmitted from the data processing
unit 102. The secondary receiver unit 106 may be configured to
communicate with the primary receiver unit 104, as well as the data
processing terminal 105. The secondary receiver unit 106 may be
configured for bi-directional wireless communication with each of
the primary receiver unit 104 and the data processing terminal 105.
As discussed in further detail below, in certain embodiments the
secondary receiver unit 106 may be a de-featured receiver as
compared to the primary receiver, i.e., the secondary receiver may
include a limited or minimal number of functions and features as
compared with the primary receiver unit 104. As such, the secondary
receiver unit 106 may include a smaller (in one or more, including
all, dimensions), compact housing or embodied in a device such as a
wrist watch, arm band, etc., for example. Alternatively, the
secondary receiver unit 106 may be configured with the same or
substantially similar functions and features as the primary
receiver unit 104. The secondary receiver unit 106 may include a
docking portion to be mated with a docking cradle unit for
placement by, e.g., the bedside for night time monitoring, and/or a
bi-directional communication device. A docking cradle may recharge
a power supply.
[0030] Only one sensor 101, data processing unit 102 and data
processing terminal 105 are shown in the embodiment of the analyte
monitoring system 100 illustrated in FIG. 1. However, it will be
appreciated by one of ordinary skill in the art that the analyte
monitoring system 100 may include more than one sensor 101 and/or
more than one data processing unit 102, and/or more than one data
processing terminal 105. Multiple sensors may be positioned in a
patient for analyte monitoring at the same or different times. In
certain embodiments, analyte information obtained by a first
positioned sensor may be employed as a comparison to analyte
information obtained by a second sensor. This may be useful to
confirm or validate analyte information obtained from one or both
of the sensors. Such redundancy may be useful if analyte
information is contemplated in critical therapy-related decisions.
In certain embodiments, a first sensor may be used to calibrate a
second sensor.
[0031] The analyte monitoring system 100 may be a continuous
monitoring system, or semi-continuous, or a discrete monitoring
system. In a multi-component environment, each component may be
configured to be uniquely identified by one or more of the other
components in the system so that communication conflict may be
readily resolved between the various components within the analyte
monitoring system 100. For example, unique IDs, communication
channels, and the like, may be used.
[0032] In certain embodiments, the sensor 101 is physically
positioned in or on the body of a user whose analyte level is being
monitored. The sensor 101 may be configured to at least
periodically sample the analyte level of the user and convert the
sampled analyte level into a corresponding signal for transmission
by the data processing unit 102. The data processing unit 102 is
coupleable to the sensor 101 so that both devices are positioned in
or on the user's body, with at least a portion of the analyte
sensor 101 positioned transcutaneously. The data processing unit
may include a fixation element such as adhesive or the like to
secure it to the user's body. A mount (not shown) attachable to the
user and mateable with the unit 102 may be used. For example, a
mount may include an adhesive surface. The data processing unit 102
performs data processing functions, where such functions may
include but are not limited to, filtering and encoding of data
signals, each of which corresponds to a sampled analyte level of
the user, for transmission to the primary receiver unit 104 via the
communication link 103. In one embodiment, the sensor 101 or the
data processing unit 102 or a combined sensor/data processing unit
may be wholly implantable under the skin layer of the user.
[0033] In certain embodiments, the primary receiver unit 104 may
include an analog interface section including an RF receiver and an
antenna that is configured to communicate with the data processing
unit 102 via the communication link 103, and a data processing
section for processing the received data from the data processing
unit 102 such as data decoding, error detection and correction,
data clock generation, data bit recovery, etc., or any combination
thereof.
[0034] In operation, the primary receiver unit 104 in certain
embodiments is configured to synchronize with the data processing
unit 102 to uniquely identify the data processing unit 102, based
on, for example, an identification information of the data
processing unit 102, and thereafter, to periodically receive
signals transmitted from the data processing unit 102 associated
with the monitored analyte levels detected by the sensor 101.
[0035] Referring again to FIG. 1, the data processing terminal 105
may include a personal computer, a portable computer such as a
laptop or a handheld device (e.g., personal digital assistants
(PDAs), telephone such as a cellular phone (e.g., a multimedia and
Internet-enabled mobile phone such as an iPhone or similar phone),
mp3 player, pager, and the like), drug delivery device, each of
which may be configured for data communication with the receiver
via a wired or a wireless connection. Additionally, the data
processing terminal 105 may further be connected to a data network
(not shown) for storing, retrieving, updating, and/or analyzing
data corresponding to the detected analyte level of the user.
[0036] The data processing terminal 105 may include an infusion
device such as an insulin infusion pump or the like, which may be
configured to administer insulin to patients, and which may be
configured to communicate with the primary receiver unit 104 for
receiving, among others, the measured analyte level. Alternatively,
the primary receiver unit 104 may be configured to integrate an
infusion device therein so that the primary receiver unit 104 is
configured to administer insulin (or other appropriate drug)
therapy to patients, for example, for administering and modifying
basal profiles, as well as for determining appropriate boluses for
administration based on, among others, the detected analyte levels
received from the data processing unit 102. An infusion device may
be an external device or an internal device (wholly implantable in
a user).
[0037] In certain embodiments, the data processing terminal 105,
which may include an insulin pump, may be configured to receive the
analyte signals from the data processing unit 102, and thus,
incorporate the functions of the primary receiver unit 104
including data processing for managing the patient's insulin
therapy and analyte monitoring. In certain embodiments, the
communication link 103 as well as one or more of the other
communication interfaces shown in FIG. 1, may use one or more of:
an RF communication protocol, an infrared communication protocol, a
Bluetooth.RTM. enabled communication protocol, an 802.11x wireless
communication protocol, or an equivalent wireless communication
protocol which would allow secure, wireless communication of
several units (for example, per HIPAA requirements), while avoiding
potential data collision and interference.
[0038] FIG. 2 shows a block diagram of an embodiment of a data
processing unit of the data monitoring and detection system shown
in FIG. 1. User input and/or interface components may be included
or a data processing unit may be free of user input and/or
interface components. In certain embodiments, one or more
application-specific integrated circuits (ASIC) may be used to
implement one or more functions or routines associated with the
operations of the data processing unit (and/or receiver unit) using
for example one or more state machines and buffers. Referring to
the Figure, the data processing unit 102 in one embodiment includes
an analog interface 201 configured to communicate with the sensor
101 (FIG. 1), a user input 202, and a temperature measurement
section 203, each of which is operatively coupled to a processor
204 such as a central processing unit (CPU).
[0039] As can be seen in the embodiment of FIG. 2, the sensor 101
(FIG. 1) includes four contacts, three of which are
electrodes--work electrode (W) 210, reference electrode (R) 212,
and counter electrode (C) 213, each operatively coupled to the
analog interface 201 of the data processing unit 102. This
embodiment also shows optional guard contact (G) 211. Fewer or
greater electrodes may be employed. For example, the counter and
reference electrode functions may be served by a single
counter/reference electrode, there may be more than one working
electrode and/or reference electrode and/or counter electrode, and
so on. The processor shown in FIG. 2 may be equipped with
sufficient memory to store the data of interest (such as analyte
data) for extended periods of time ranging from one to several
samples to the number of samples obtained for an entire wear period
of several days to weeks. In one aspect, the memory may be included
as part of the processor 204. In another embodiment, a separate
memory unit such as a memory chip, random access memory (RAM) or
any other storage device for storing for subsequent retrieval data.
The electronics of the on-skin sensor control unit and the sensor
are operated using a power supply 207, e.g., a battery.
Additionally, as can be seen from the Figure, clock 208 is provided
to, among others, supply real time information to the processor
204. In one embodiment, a unidirectional input path is established
from the sensor 101 (FIG. 1) and/or manufacturing and testing
equipment to the analog interface 201 of the data processing unit
102, while a unidirectional output is established from the output
of the RF transmitter 206 of the data processing unit 102 for
transmission to the primary receiver unit 104. In this manner, a
data path is shown in FIG. 2 between the aforementioned
unidirectional input and output via a dedicated link 209 from the
analog interface 201 to serial communication section 205,
thereafter to the processor 204, and then to the RF transmitter
206. Also shown is a leak detection circuit 214 coupled to the
guard contact (G) 211 and the processor 204 in the data processing
unit 102. The leak detection circuit 214 in accordance with one
embodiment of the present invention may be configured to detect
leakage current in the sensor 101 to determine whether the measured
sensor data are corrupt or whether the measured data from the
sensor 101 is accurate.
[0040] FIG. 3 is a block diagram of an embodiment of a
receiver/monitor unit such as the primary receiver unit 104 of the
data monitoring and management system shown in FIG. 1. The primary
receiver unit 104 includes one or more of: a blood glucose test
strip interface 301, an RF receiver 302, an input 303, a
temperature detection section 304, and a clock 305, each of which
is operatively coupled to a processing and storage section 307. The
primary receiver unit 104 also includes a power supply 306
operatively coupled to a power conversion and monitoring section
308. Further, the power conversion and monitoring section 308 is
also coupled to the receiver processor 307. Moreover, also shown
are a receiver serial communication section 309, and an output 310,
each operatively coupled to the processing and storage unit 307.
The receiver may include user input and/or interface components or
may be free of user input and/or interface components.
[0041] In certain embodiments, the test strip interface 301
includes a glucose level testing portion to receive a blood (or
other body fluid sample) glucose test or information related
thereto. For example, the interface may include a test strip port
to receive a glucose test strip. The device may determine the
glucose level of the test strip, and optionally display (or
otherwise notice) the glucose level on the output 310 of the
primary receiver unit 104. Any suitable test strip may be employed,
e.g., test strips that only require a very small amount (e.g., one
microliter or less, e.g., 0.5 microliter or less, e.g., 0.1
microliter or less), of applied sample to the strip in order to
obtain accurate glucose information, e.g. FreeStyle.RTM. blood
glucose test strips from Abbott Diabetes Care Inc. Glucose
information obtained by the in vitro glucose testing device may be
used for a variety of purposes, computations, etc. For example, the
information may be used to calibrate sensor 101, confirm results of
the sensor 101 to increase the confidence thereof (e.g., in
instances in which information obtained by sensor 101 is employed
in therapy related decisions), and the like.
[0042] In further embodiments, the data processing unit 102 and/or
the primary receiver unit 104 and/or the secondary receiver unit
106, and/or the data processing terminal/infusion section 105 may
be configured to receive the blood glucose value wirelessly (or via
a wire as shown in FIG. 12) over a communication link from, for
example, a blood glucose meter. In further embodiments, a user
manipulating or using the analyte monitoring system 100 (FIG. 1)
may manually input the blood glucose value using, for example, a
user interface (for example, a keyboard, keypad, voice commands,
and the like) incorporated in one or more of the data processing
unit 102, the primary receiver unit 104, secondary receiver unit
106, or the data processing terminal/infusion section 105.
[0043] Additional detailed description of embodiments of test
strips, blood glucose (BG) meters and continuous monitoring systems
and data management systems that may be employed are provided in
but not limited to: U.S. Pat. No. 6,175,752; U.S. Pat. No.
6,560,471; U.S. Pat. No. 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.
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No. 7,811,231 entitled "Continuous Glucose Monitoring System and
Methods of Use", and elsewhere, the disclosures of each which are
incorporated herein by reference for all purposes.
[0044] FIG. 4 schematically shows an embodiment of an analyte
sensor in accordance with the present disclosure. This sensor
embodiment includes electrodes 401, 402 and 403 on a base 404.
Electrodes (and/or other features) may be applied or otherwise
processed using any suitable technology, e.g., chemical vapor
deposition (CVD), physical vapor deposition, sputtering, reactive
sputtering, printing, coating, ablating (e.g., laser ablation),
painting, dip coating, etching, and the like. Materials include but
are not limited to aluminum, carbon (such as graphite), cobalt,
copper, gallium, gold, indium, iridium, iron, lead, magnesium,
mercury (as an amalgam), nickel, niobium, osmium, palladium,
platinum, rhenium, rhodium, selenium, silicon (e.g., doped
polycrystalline silicon), silver, tantalum, tin, titanium,
tungsten, uranium, vanadium, zinc, zirconium, mixtures thereof, and
alloys, oxides, or metallic compounds of these elements.
[0045] The sensor may be wholly implantable in a user or may be
configured so that only a portion is positioned within (internal) a
user and another portion outside (external) a user. For example,
the sensor 400 may include a portion positionable above a surface
of the skin 410, and a portion positioned below the skin. In such
embodiments, the external portion may include contacts (connected
to respective electrodes of the second portion by traces) to
connect to another device also external to the user such as a
transmitter unit. While the embodiment of FIG. 4 shows three
electrodes side-by-side on the same surface of base 404, other
configurations are contemplated, e.g., fewer or greater electrodes,
some or all electrodes on different surfaces of the base or present
on another base, some or all electrodes stacked together,
electrodes of differing materials and dimensions, etc.
[0046] FIG. 5A shows a perspective view of an embodiment of an
electrochemical analyte sensor 500 having a first portion (which in
this embodiment may be characterized as a major portion)
positionable above a surface of the skin 510, and a second portion
(which in this embodiment may be characterized as a minor portion)
that includes an insertion tip 530 positionable below the skin,
e.g., penetrating through the skin and into, e.g., the subcutaneous
space 520, in contact with the user's biofluid such as interstitial
fluid. Contact portions of a working electrode 501, a reference
electrode 502, and a counter electrode 503 are positioned on the
portion of the sensor 500 situated above the skin surface 510.
Working electrode 501, a reference electrode 502, and a counter
electrode 503 are shown at the second section and particularly at
the insertion tip 530. Traces may be provided from the electrode at
the tip to the contact, as shown in FIG. 5A. It is to be understood
that greater or fewer electrodes may be provided on a sensor. For
example, a sensor may include more than one working electrode
and/or the counter and reference electrodes may be a single
counter/reference electrode, etc.
[0047] FIG. 5B shows a cross sectional view of a portion of the
sensor 500 of FIG. 5A. The electrodes 510, 502 and 503, of the
sensor 500 as well as the substrate and the dielectric layers are
provided in a layered configuration or construction. For example,
as shown in FIG. 5B, in one aspect, the sensor 500 (such as the
sensor 101 FIG. 1), includes a substrate layer 504, and a first
conducting layer 501 such as carbon, gold, etc., disposed on at
least a portion of the substrate layer 504, and which may provide
the working electrode. Also shown disposed on at least a portion of
the first conducting layer 501 is a sensing layer 508.
[0048] A first insulation layer such as a first dielectric layer
505 is disposed or layered on at least a portion of the first
conducting layer 501, and further, a second conducting layer 509
may be disposed or stacked on top of at least a portion of the
first insulation layer (or dielectric layer) 505. As shown in FIG.
5B, the second conducting layer 509 may provide the reference
electrode 502, and in one aspect, may include a layer of
silver/silver chloride (Ag/AgCl), gold, etc.
[0049] A second insulation layer 506 such as a dielectric layer in
one embodiment may be disposed or layered on at least a portion of
the second conducting layer 509. Further, a third conducting layer
503 may provide the counter electrode 503. It may be disposed on at
least a portion of the second insulation layer 506. Finally, a
third insulation layer 507 may be disposed or layered on at least a
portion of the third conducting layer 503. In this manner, the
sensor 500 may be layered such that at least a portion of each of
the conducting layers is separated by a respective insulation layer
(for example, a dielectric layer). The embodiment of FIGS. 5A and
5B show the layers having different lengths. Some or all of the
layers may have the same or different lengths and/or widths.
[0050] In certain embodiments, some or all of the electrodes 501,
502, 503 may be provided on the same side of the substrate 504 in
the layered construction as described above, or alternatively, may
be provided in a co-planar manner such that two or more electrodes
may be positioned on the same plane (e.g., side-by side (e.g.,
parallel) or angled relative to each other) on the substrate 504.
For example, co-planar electrodes may include a suitable spacing
there between and/or include dielectric material or insulation
material disposed between the conducting layers/electrodes.
Furthermore, in certain embodiments, one or more of the electrodes
501, 502, 503 may be disposed on opposing sides of the substrate
504. In such embodiments, contact pads may be on the same or
different sides of the substrate. For example, an electrode may be
on a first side and its respective contact may be on a second side,
e.g., a trace connecting the electrode and the contact may traverse
through the substrate.
[0051] As noted above, analyte sensors may include an
analyte-responsive enzyme to provide a sensing component or sensing
layer. Some analytes, such as oxygen, can be directly
electrooxidized or electroreduced on a sensor, and more
specifically at least on a working electrode of a sensor. Other
analytes, such as glucose and lactate, require the presence of at
least one electron transfer agent and/or at least one catalyst to
facilitate the electrooxidation or electroreduction of the analyte.
Catalysts may also be used for those analytes, such as oxygen, that
can be directly electrooxidized or electroreduced on the working
electrode. For these analytes, each working electrode includes a
sensing layer (see for example sensing layer 508 of FIG. 5B)
proximate to or on a surface of a working electrode. In many
embodiments, a sensing layer is formed near or on only a small
portion of at least a working electrode.
[0052] The sensing layer includes one or more components designed
to facilitate the electrochemical oxidation or reduction of the
analyte. The sensing layer may include, for example, a catalyst to
catalyze a reaction of the analyte and produce a response at the
working electrode, an electron transfer agent to transfer electrons
between the analyte and the working electrode (or other component),
or both.
[0053] A variety of different sensing layer configurations may be
used. In certain embodiments, the sensing layer is deposited on the
conductive material of a working electrode. The sensing layer may
extend beyond the conductive material of the working electrode. In
some cases, the sensing layer may also extend over other
electrodes, e.g., over the counter electrode and/or reference
electrode (or counter/reference is provided).
[0054] A sensing layer that is in direct contact with the working
electrode may contain an electron transfer agent to transfer
electrons directly or indirectly between the analyte and the
working electrode, and/or a catalyst to facilitate a reaction of
the analyte. For example, a glucose, lactate, or oxygen electrode
may be formed having a sensing layer which contains a catalyst,
such as glucose oxidase, lactate oxidase, or laccase, respectively,
and an electron transfer agent that facilitates the
electrooxidation of the glucose, lactate, or oxygen,
respectively.
[0055] In other embodiments the sensing layer is not deposited
directly on the working electrode. Instead, the sensing layer 508
may be spaced apart from the working electrode, and separated from
the working electrode, e.g., by a separation layer. A separation
layer may include one or more membranes or films or a physical
distance. In addition to separating the working electrode from the
sensing layer the separation layer may also act as a mass transport
limiting layer and/or an interferent eliminating layer and/or a
biocompatible layer.
[0056] In certain embodiments which include more than one working
electrode, one or more of the working electrodes may not have a
corresponding sensing layer, or may have a sensing layer which does
not contain one or more components (e.g., an electron transfer
agent and/or catalyst) needed to electrolyze the analyte. Thus, the
signal at this working electrode may correspond to background
signal which may be removed from the analyte signal obtained from
one or more other working electrodes that are associated with
fully-functional sensing layers by, for example, subtracting the
signal.
[0057] In certain embodiments, the sensing layer includes one or
more electron transfer agents. Electron transfer agents that may be
employed are electroreducible and electrooxidizable ions or
molecules having redox potentials that are a few hundred millivolts
above or below the redox potential of the standard calomel
electrode (SCE). The electron transfer agent may be organic,
organometallic, or inorganic. Examples of organic redox species are
quinones and species that in their oxidized state have quinoid
structures, such as Nile blue and indophenol. Examples of
organometallic redox species are metallocenes such as ferrocene.
Examples of inorganic redox species are hexacyanoferrate (III),
ruthenium hexamine etc.
[0058] In certain embodiments, electron transfer agents have
structures or charges which prevent or substantially reduce the
diffusional loss of the electron transfer agent during the period
of time that the sample is being analyzed. For example, electron
transfer agents include but are not limited to a redox species,
e.g., bound to a polymer which can in turn be disposed on or near
the working electrode. The bond between the redox species and the
polymer may be covalent, coordinative, or ionic. Although any
organic, organometallic or inorganic redox species may be bound to
a polymer and used as an electron transfer agent, in certain
embodiments the redox species is a transition metal compound or
complex, e.g., osmium, ruthenium, iron, and cobalt compounds or
complexes. It will be recognized that many redox species described
for use with a polymeric component may also be used, without a
polymeric component.
[0059] One type of polymeric electron transfer agent contains a
redox species covalently bound in a polymeric composition. An
example of this type of mediator is poly(vinylferrocene). Another
type of electron transfer agent contains an ionically-bound redox
species. This type of mediator may include a charged polymer
coupled to an oppositely charged redox species. Examples of this
type of mediator include a negatively charged polymer coupled to a
positively charged redox species such as an osmium or ruthenium
polypyridyl cation. Another example of an ionically-bound mediator
is a positively charged polymer such as quaternized poly(4-vinyl
pyridine) or poly(1-vinyl imidazole) coupled to a negatively
charged redox species such as ferricyanide or ferrocyanide. In
other embodiments, electron transfer agents include a redox species
coordinatively bound to a polymer. For example, the mediator may be
formed by coordination of an osmium or cobalt 2,2'-bipyridyl
complex to poly(1-vinyl imidazole) or poly(4-vinyl pyridine).
[0060] Suitable electron transfer agents are osmium transition
metal complexes with one or more ligands, each ligand having a
nitrogen-containing heterocycle such as 2,2'-bipyridine,
1,10-phenanthroline, 1-methyl, 2-pyridyl biimidazole, or
derivatives thereof. The electron transfer agents may also have one
or more ligands covalently bound in a polymer, each ligand having
at least one nitrogen-containing heterocycle, such as pyridine,
imidazole, or derivatives thereof. One example of an electron
transfer agent includes (a) a polymer or copolymer having pyridine
or imidazole functional groups and (b) osmium cations complexed
with two ligands, each ligand containing 2,2'-bipyridine,
1,10-phenanthroline, or derivatives thereof, the two ligands not
necessarily being the same. Some derivatives of 2,2'-bipyridine for
complexation with the osmium cation include but are not limited to
4,4'-dimethyl-2,2'-bipyridine and mono-, di-, and
polyalkoxy-2,2'-bipyridines, such as
4,4'-dimethoxy-2,2'-bipyridine. Derivatives of 1,10-phenanthroline
for complexation with the osmium cation include but are not limited
to 4,7-dimethyl-1,10-phenanthroline and mono, di-, and
polyalkoxy-1,10-phenanthrolines, such as
4,7-dimethoxy-1,10-phenanthroline. Polymers for complexation with
the osmium cation include but are not limited to polymers and
copolymers of poly(1-vinyl imidazole) (referred to as "PVI") and
poly(4-vinyl pyridine) (referred to as "PVP"). Suitable copolymer
substituents of poly(1-vinyl imidazole) include acrylonitrile,
acrylamide, and substituted or quaternized N-vinyl imidazole, e.g.,
electron transfer agents with osmium complexed to a polymer or
copolymer of poly(1-vinyl imidazole).
[0061] Embodiments may employ electron transfer agents having a
redox potential ranging from about -200 mV to about +200 mV versus
the standard calomel electrode (SCE). The sensing layer may also
include a catalyst which is capable of catalyzing a reaction of the
analyte. The catalyst may also, in some embodiments, act as an
electron transfer agent. One example of a suitable catalyst is an
enzyme which catalyzes a reaction of the analyte. For example, a
catalyst, such as a glucose oxidase, glucose dehydrogenase (e.g.,
pyrroloquinoline quinone (PQQ), dependent glucose dehydrogenase,
flavine adenine dinucleotide (FAD) dependent glucose dehydrogenase,
or nicotinamide adenine dinucleotide (NAD) dependent glucose
dehydrogenase), may be used when the analyte of interest is
glucose. A lactate oxidase or lactate dehydrogenase may be used
when the analyte of interest is lactate. Laccase may be used when
the analyte of interest is oxygen or when oxygen is generated or
consumed in response to a reaction of the analyte.
[0062] The sensing layer may also include a catalyst which is
capable of catalyzing a reaction of the analyte. The catalyst may
also, in some embodiments, act as an electron transfer agent. One
example of a suitable catalyst is an enzyme which catalyzes a
reaction of the analyte. For example, a catalyst, such as a glucose
oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone
(PQQ), dependent glucose dehydrogenase or oligosaccharide
dehydrogenase, flavine adenine dinucleotide (FAD) dependent glucose
dehydrogenase, nicotinamide adenine dinucleotide (NAD) dependent
glucose dehydrogenase), may be used when the analyte of interest is
glucose. A lactate oxidase or lactate dehydrogenase may be used
when the analyte of interest is lactate. Laccase may be used when
the analyte of interest is oxygen or when oxygen is generated or
consumed in response to a reaction of the analyte.
[0063] In certain embodiments, a catalyst may be attached to a
polymer, cross linking the catalyst with another electron transfer
agent (which, as described above, may be polymeric. A second
catalyst may also be used in certain embodiments. This second
catalyst may be used to catalyze a reaction of a product compound
resulting from the catalyzed reaction of the analyte. The second
catalyst may operate with an electron transfer agent to electrolyze
the product compound to generate a signal at the working electrode.
Alternatively, a second catalyst may be provided in an
interferent-eliminating layer to catalyze reactions that remove
interferents.
[0064] Certain embodiments include a Wired Enzyme.TM. sensing layer
(Abbott Diabetes Care Inc.) that works at a gentle oxidizing
potential, e.g., a potential of about +40 mV. This sensing layer
uses an osmium (Os)-based mediator designed for low potential
operation and is stably anchored in a polymeric layer. Accordingly,
in certain embodiments the sensing element is redox active
component that includes (1) Osmium-based mediator molecules
attached by stable (bidente) ligands anchored to a polymeric
backbone, and (2) glucose oxidase enzyme molecules. These two
constituents are crosslinked together.
[0065] A mass transport limiting layer (not shown), e.g., an
analyte flux modulating layer, may be included with the sensor to
act as a diffusion-limiting barrier to reduce the rate of mass
transport of the analyte, for example, glucose or lactate, into the
region around the working electrodes. The mass transport limiting
layers are useful in limiting the flux of an analyte to a working
electrode in an electrochemical sensor so that the sensor is
linearly responsive over a large range of analyte concentrations
and is easily calibrated. Mass transport limiting layers may
include polymers and may be biocompatible. A mass transport
limiting layer may provide many functions, e.g., biocompatibility
and/or interferent-eliminating, etc.
[0066] In certain embodiments, a mass transport limiting layer is a
membrane composed of crosslinked polymers containing heterocyclic
nitrogen groups, such as polymers of polyvinylpyridine and
polyvinylimidazole. Embodiments also include membranes that are
made of a polyurethane, or polyether urethane, or chemically
related material, or membranes that are made of silicone, and the
like.
[0067] A membrane may be formed by crosslinking in situ a polymer,
modified with a zwitterionic moiety, a non-pyridine copolymer
component, and optionally another moiety that is either hydrophilic
or hydrophobic, and/or has other desirable properties, in an
alcohol-buffer solution. The modified polymer may be made from a
precursor polymer containing heterocyclic nitrogen groups. For
example, a precursor polymer may be polyvinylpyridine or
polyvinylimidazole. Optionally, hydrophilic or hydrophobic
modifiers may be used to "fine-tune" the permeability of the
resulting membrane to an analyte of interest. Optional hydrophilic
modifiers, such as poly(ethylene glycol), hydroxyl or polyhydroxyl
modifiers, may be used to enhance the biocompatibility of the
polymer or the resulting membrane.
[0068] A membrane may be formed in situ by applying an
alcohol-buffer solution of a crosslinker and a modified polymer
over an enzyme-containing sensing layer and allowing the solution
to cure for about one to two days or other appropriate time period.
The crosslinker-polymer solution may be applied to the sensing
layer by placing a droplet or droplets of the solution on the
sensor, by dipping the sensor into the solution, or the like.
Generally, the thickness of the membrane is controlled by the
concentration of the solution, by the number of droplets of the
solution applied, by the number of times the sensor is dipped in
the solution, or by any combination of these factors. A membrane
applied in this manner may have any combination of the following
functions: (1) mass transport limitation, i.e. reduction of the
flux of analyte that can reach the sensing layer, (2)
biocompatibility enhancement, or (3) interferent reduction.
[0069] The description herein is directed primarily to
electrochemical sensors for convenience only and is in no way
intended to limit the scope of the disclosure. Other sensors and
sensor systems are contemplated. Such include, but are not limited
to, optical sensors, colorimetric sensors, and sensors that detect
hydrogen peroxide to infer glucose levels, potentiometric sensors,
coulometric sensors, or oxygen sensors.
[0070] For example, a hydrogen peroxide-detecting sensor may be
constructed in which a sensing layer includes enzyme such as
glucose oxides, glucose dehydrogenase, or the like, and is
positioned proximate to the working electrode. The sending layer
may be covered by a membrane that is selectively permeable to
glucose. Once the glucose passes through the membrane, it is
oxidized by the enzyme and reduced glucose oxidase can then be
oxidized by reacting with molecular oxygen to produce hydrogen
peroxide.
[0071] Certain embodiments include a hydrogen peroxide-detecting
sensor constructed from a sensing layer prepared by crosslinking
two components together, for example: (1) a redox compound such as
a redox polymer containing pendent Os polypyridyl complexes with
oxidation potentials of about +200 mV vs. SCE, and (2) periodate
oxidized horseradish peroxidase (HRP). Such a sensor functions in a
reductive mode; the working electrode is controlled at a potential
negative to that of the Os complex, resulting in mediated reduction
of hydrogen peroxide through the HRP catalyst.
[0072] In another example, a potentiometric sensor can be
constructed as follows. A glucose-sensing layer is constructed by
crosslinking together (1) a redox polymer containing pendent Os
polypyridyl complexes with oxidation potentials from about -200 mV
to +200 mV vs. SCE, and (2) glucose oxidase. This sensor can then
be used in a potentiometric mode, by exposing the sensor to a
glucose containing solution, under conditions of zero current flow,
and allowing the ratio of reduced/oxidized Os to reach an
equilibrium value. The reduced/oxidized Os ratio varies in a
reproducible way with the glucose concentration, and will cause the
electrode's potential to vary in a similar way.
[0073] A sensor may also include an active agent such as an
anticlotting and/or antiglycolytic agent(s) disposed on at least a
portion a sensor that is positioned in a user. An anticlotting
agent may reduce or eliminate the clotting of blood or other body
fluid around the sensor, particularly after insertion of the
sensor. Examples of useful anticlotting agents include heparin and
tissue plasminogen activator (TPA), as well as other known
anticlotting agents. Embodiments may include an antiglycolytic
agent or precursor thereof. Examples of antiglycolytic agents are
glyceraldehyde, fluoride ion, and mannose.
[0074] Sensors may be configured to require no system calibration
or no user calibration. For example, a sensor may be factory
calibrated and may not require further calibration during the life
of the sensor. In certain embodiments, calibration may be required,
but may be done without user intervention, i.e., may be automatic.
In those embodiments in which calibration by the user is required,
the calibration may be according to a predetermined schedule or may
be dynamic, i.e., the time for which may be determined by the
system on a real-time basis according to various factors, such as
but not limited to glucose concentration and/or temperature and/or
rate of change of glucose, etc.
[0075] Calibration may be accomplished using an in vitro test strip
(or other reference), e.g., a small sample test strip such as a
test strip that requires less than about 1 microliter of sample
(for example FreeStyle.RTM. blood glucose monitoring test strips
from Abbott Diabetes Care Inc.). For example, test strips that
require less than about 1 nanoliter of sample may be used. In
certain embodiments, a sensor may be calibrated using only one
sample of body fluid per calibration event. For example, a user
need only lance a body part one time to obtain sample for a
calibration event (e.g., for a test strip), or may lance more than
one time within a short period of time if an insufficient volume of
sample is firstly obtained. Embodiments include obtaining and using
multiple samples of body fluid for a given calibration event, where
glucose values of each sample are substantially similar. Data
obtained from a given calibration event may be used independently
to calibrate or combine with data obtained from previous
calibration events, e.g., averaged including weighted averaged,
etc., to calibrate. In certain embodiments, a system need only be
calibrated once by a user, where recalibration of the system is not
required.
[0076] Analyte systems may include an optional alarm system that,
e.g., based on information from a processor, warns the patient of a
potentially detrimental condition of the analyte. For example, if
glucose is the analyte, an alarm system may warn a user of
conditions such as hypoglycemia and/or hyperglycemia and/or
impending hypoglycemia, and/or impending hyperglycemia. An alarm
system may be triggered when analyte levels approach, reach or
exceed a threshold value. An alarm system may also, or
alternatively, be activated when the rate of change, or
acceleration of the rate of change, in analyte level increase or
decrease approaches, reaches or exceeds a threshold rate or
acceleration. A system may also include system alarms that notify a
user of system information such as battery condition, calibration,
sensor dislodgment, sensor malfunction, etc. Alarms may be, for
example, auditory and/or visual. Other sensory-stimulating alarm
systems may be used including alarm systems which heat, cool,
vibrate, or produce a mild electrical shock when activated.
[0077] The subject disclosure also includes sensors used in
sensor-based drug delivery systems. The system may provide a drug
to counteract the high or low level of the analyte in response to
the signals from one or more sensors. Alternatively, the system may
monitor the drug concentration to ensure that the drug remains
within a desired therapeutic range. The drug delivery system may
include one or more (e.g., two or more) sensors, a processing unit
such as a transmitter, a receiver/display unit, and a drug
administration system. In some cases, some or all components may be
integrated in a single unit. A sensor-based drug delivery system
may use data from the one or more sensors to provide necessary
input for a control algorithm/mechanism to adjust the
administration of drugs, e.g., automatically or semi-automatically.
As an example, a glucose sensor may be used to control and adjust
the administration of insulin from an external or implanted insulin
pump.
[0078] In certain embodiments, a continuous glucose ("CG")
monitoring system (for example a FreeStyle Navigator.RTM.
continuous glucose monitoring system or certain components thereof)
may be used to assess diabetes and treatment options, e.g.,
assessed by a health care provider ("HCP") device. Such an
assessment may occur at initial phases of, or at the beginning of
diagnosis or onset of, diabetic condition. A CG system may be
provided to a user to monitor glucose levels for a period of time,
e.g., about one day to about one month or more, e.g., about a few
days to about a few weeks, e.g., about 1-2 weeks. The information
gathered by the CG system may be reviewed retrospectively by an
HCP, e.g., stored in an HCP device memory and communicated to
(including transferred to) HCP, to assess the next steps of
treating and/or monitoring the user's glucose levels to control
diabetes. These CG systems may generally be referred to as
"assessor" ("AS") systems. Generally, a CG system is an in vivo
system, e.g., that a user may borrow/rent/otherwise obtain whenever
they are collecting glucose data.
[0079] In certain embodiments, an HCP may use AS system data
obtained from a user to assess whether the user would benefit from
using an in vitro meter (test strip and meter, including an
integrated glucose monitoring system). The HCP may then prescribe
such a system for the user. Of course, an HCP may determine that
the user continue to use an in vivo system or that no additional
glucose monitoring is required. In many embodiments, an HCP may
determine (and prescribe) a short assay time/small sample size in
vitro system, and a user may monitor their glucose levels using
such a system. Accordingly, after using an AS system to monitor
glucose levels for a period of time, an HCP may, after reviewing
the AS data obtained during this time, recommend that the user to
continue to monitor glucose levels using an in vitro system.
Typically (though not always) the user may use the in vitro system
as the primary and sole source of glucose monitoring, i.e., the AS
system need not be used by the user any longer, or may be used
periodically.
[0080] In certain embodiments, a given AS system may be used to
monitor glucose levels of a first person, an HCP may review the
data therefrom, and the AS system may then be used by at least a
second person (excluding the analyte sensor).
[0081] As noted above, an HCP may recommend (and prescribe) an in
vitro system for a user if AS data reviewed by the HCP after being
used for a period of time indicates that such a system would be
beneficial for the user/patient.
[0082] Embodiments include devices which allow diabetics or users
evaluating whether they have diabetes to measure the blood (or
other bodily fluid) glucose levels, e.g., hand-held electronic
meters (blood glucose meters), e.g., such as Freestyle or Precision
blood glucose monitoring systems available from Abbott Diabetes
Care Inc., of Alameda, Calif. which receives blood samples via
enzyme-based test strips. Typically, a user inserts a test strip
into a meter and lances a finger or alternate body site to obtain a
blood sample. The drawn sample is applied to the test strip and the
meter reads the strip and determines analyte concentration, which
is then conveyed to the user. For example, a blood glucose meter
may convert 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. Such periodic discrete glucose
testing helps diabetic patients to take any necessary corrective
actions to better manage diabetic conditions.
[0083] Test strips for use with such in vitro systems may be
adapted to measure the concentration of an analyte in any volume of
sample, including but not limited to small volumes of sample, e.g.,
about 1 microliter or less sample, for example about 0.5
microliters or less, for example about 0.3 microliters or less, for
example about 0.1 microliters or less. In some embodiments, the
volume of sample may be as low as about 0.05 microliters or as low
as about 0.03 microliters. Strips may be configured so that an
accurate analyte measurement may be obtained using a volume of
sample that wholly or partially fills a sample chamber of a strip.
In certain embodiments, a test may only start when sufficient
sample has been applied to a strip, e.g., as detected by a detector
such as an electrode. An in vitro system may be programmed to allow
re-application of additional sample if insufficient sample is
firstly applied, e.g., the time to reapply sample may range from
about 10 seconds to about 2 minutes, e.g., from about 30 seconds to
about 60 seconds.
[0084] Strips may be side fill, front fill, top fill or corner
fill, or any combination thereof. Test strips may be
calibration-free, e.g., minimal input (if any) is required of a
user to calibrate. In certain embodiments, no calibration test
strips may be employed. In such embodiments, the user need not take
any action for calibration, i.e., calibration is invisible to a
user.
[0085] As noted above, strips are used with meters. In certain
embodiments, meters may be integrated meters, i.e., a device which
has at least one strip and at least a second element, such as a
meter and/or a skin piercing element such as a lancet or the like,
in the device. In some embodiments, a strip may be integrated with
both a meter and a lancet, e.g., in a single housing. Having
multiple elements together in one device reduces the number of
devices needed to obtain an analyte level and facilitates the
sampling process. For example, embodiments may include a housing
that includes one or more analyte test strips, a skin piercing
element and a processor for determining the concentration of an
analyte in a sample applied to the strip. A plurality of strips may
be retained in a magazine in the housing interior and, upon
actuation by a user, a single strip may be dispensed from the
magazine so that at least a portion extends out of the housing for
use.
[0086] Test strips may be short test time test strips. For example,
test times may range from about 1 second to about 20 seconds, e.g.,
from about 3 seconds to about 10 seconds, e.g., from about 3
seconds to about 7 seconds, e.g., about 5 seconds or about 3
seconds.
[0087] Exemplary meters and test strips and using the same are
shown in FIGS. 6-10.
[0088] In certain embodiments, the glucose levels obtained by the
AS system may not be displayed or otherwise communicated to a user
in real time, i.e., the user of the system will be blinded to the
data obtained--at least in real time. Stated otherwise, no glucose
results are shown on the AS system. The AS data will thus be
retrospective providing blind data, and will include a device
(wired or wireless) so that an HCP device may download
retrospective continuous glucose monitoring system data from the AS
system for review and analysis. In certain embodiments, the AS
system will not be calibrated in real time, e.g., will not include
(or will not include a functional or the strip port will be
blocked) strip port to accept a calibration test strip. An in vitro
system may be used concurrently with the system, and the data
obtained by the in vitro system reviewed and used in the review
and/or processing of AS data. For example, the in vitro data may be
used to retrospectively calibrate the CG data, e.g., at a remote
site such as an HCP site, and as shown, for example, in FIG.
11.
[0089] Referring to FIG. 11, in one aspect, a user wears and uses
an AS system that includes an in vivo analyte sensor (not shown)
coupled to an AS data processing unit (transmitter) worn (in this
embodiment) on the user's arm, and an AS receiver unit to receive
information from the AS data processing unit (wired or wirelessly).
A blood glucose ("BG") or in vitro meter (used interchangeably) is
also used and is configured to transfer data to a remote site such
as shown here an HCP PC terminal (either wirelessly or otherwise).
Also included is a data management system ("DMS"). There is no data
transfer connection between the in vitro meter and the AS system,
data transfer exists between the AS system and a DMS, such as a
PC-based DMS.
[0090] In the particular embodiment of FIG. 11, in vitro data is
transferred to the HCP PC terminal via USB connection. The PC
terminal may be at the user's location, at which the data may then
be accessed by the HCP (e.g., via a network connection, server
connection or otherwise), or downloaded to a computing device at
the remote location. Once the HCP collects AS data (which may be
transferred to the HCP as raw data or may be processed at least in
certain respects), the data may be reviewed and/or further
processed. For example, the AS data may be calibrated using the
collected in vitro data. The calibrated AS data may then be
reviewed and/or processed further. For example, reports may be
generated. A data management system may be employed, e.g., such as
the CoPilot.TM. data management system available from Abbott
Diabetes Care Inc., or analogous system. The HCP PC terminal may
generate and review reports produced using the AS data.
[0091] Accordingly, in certain embodiments an HCP attaches the AS
processing unit with transmitter to the user at the HCP office and
provides a reusable receiver unit to the user. The user may wear
and collect data with the AS receiver and transmitter for about one
or more days, e.g., about 2-30 days, e.g., about 3-7 days, e.g.,
about 5-7 days. The user performs BG tests on their in vitro meter
at appropriate times, e.g., at 1, 2, 10, 24 and/or 72 hours after
AS sensor insertion in certain embodiments. The user brings the AS
receiver unit and in vitro meter to the HCP office and the HCP
connects the in vitro meter via a USB cable (or otherwise including
wirelessly) to a computing device such as the PC terminal and
downloads the in vitro data from the meter's memory. The AS
receiver wirelessly (or otherwise) transmits data to the PC. The
HCP may view the AS and/or BG information using a DMS loaded and
running on the HCP PC terminal.
[0092] In one aspect, the data obtained by the in vitro meter
includes a time stamp based, for example, from an internal clock.
The in vitro meter in one aspect may be synchronized with the clock
of the PC terminal so that when the time stamped blood glucose
values are received from the in vitro meter, the time of day
information associated with each blood glucose test and the
resulting blood glucose values are time synchronized with the
corresponding analyte data in the PC terminal for further
processing and analysis. In this manner, improved accuracy may be
obtained. Further, the transmitted blood glucose values from the in
vitro meter may also be associated with the unique identifier of
the in vitro meter. In this manner, each blood glucose value
derived or obtained from the in vitro meter will identify the
corresponding in vitro meter based on its unique identifier.
[0093] In this manner, in one aspect, the user may be provided with
limited or no real time data from the AS receiver during the time
the glucose data is collected from the user. As such, user behavior
or health care or treatment based decisions are limited or avoided
by not allowing the user to view the on-going continuous glucose
level monitored by the AS sensor and collected by the AS system. In
one aspect, the AS system may be configured to provide limited
output information to the user during the data collection modes,
such as an indication that the AS system is functioning properly
(for example, with periodic audible alerts, visual displays
indicating system integrity, and the like). Other information may
likewise be displayed or output on the AS receiver to the user such
as, for example, the time of day information, the duration of the
data collection elapsed, and so on.
[0094] Certain embodiments include prospective calibration of AS
data, and unblinded AS data. An exemplary embodiment of such a
system is shown in FIG. 12. This embodiment includes an AS data
processing unit that includes a transmitter worn and used by a
user, an AS receiving unit, an in vitro meter capable of
transferring data to the AS system, (herein shown using a wired
connection, but wireless may also be used), and a DMS. Accordingly,
in this embodiment, glucose results of the AS system are
communicated to the user in real-time, e.g., audibly and/or
visually such as on a display. There is unidirectional transfer of
data from the in vitro blood glucose meter to the AS receiver,
e.g., using a USB cable or the like. In certain embodiments, the
transfer of data may be bidirectional so the BG meter could (for
example) display the most recent CG data. This would greatly
enhance the value of the BG meter (to be able to display glucose
data without the pain of drawing the blood), and more generally the
BG meter may be used as a display unit for medical data besides
just BG. For example, this may be included in a Data Logger
embodiment. The embodiment of FIG. 12 can be configured to show or
not show ("blind") CG data since it uses prospective data.
[0095] Accordingly, in certain embodiments an HCP attaches the AS
processing unit with transmitter to a user at the HCP office and
provides a loaner or reusable AS receiver. The user may wear and
collect data with the AS receiver and transmitter for about one or
more days, e.g., about 2-30 days, e.g., about 3-7 days, e.g., about
5-7 days. The user performs BG tests on their in vitro meter at
appropriate times, e.g., at 10, 24 and 72 hours after AS sensor
insertion in certain embodiments. When the user performs a BG test
on their in vitro meter, the user couples (wired or wirelessly) the
meter to the AS receiver. The AS receiver may be calibrated using
this transferred BG data. The user brings the AS receiver and in
vitro meter to the HCP office. The AS receiver wirelessly (or
otherwise) transmits data to the PC. The HCP may view the AS and/or
BG information using a DMS.
[0096] Certain embodiments include prospective calibration of AS
data, unblinded data and an RF module. An exemplary embodiment of
such a system is shown in FIG. 13. This embodiment includes an AS
data processing unit that includes a transmitter worn and used by a
user, an AS receiving unit, an in vitro meter capable of
transferring data to the AS system, herein shown using a wired
connection, (but wireless may also be used), an RF module, and a
DMS. Accordingly, in this embodiment glucose results of the AS
system are communicated to the user in real-time, e.g., audibly
and/or visually such as on a display. As shown, there is
unidirectional transfer of data from the in vitro blood glucose
meter to the AS receiver, e.g., using RF and a wireless adaptor
coupled to the in vitro meter. However, there may be bidirectional
transfer of data that permits the in vitro meter to display AS data
(i.e., the in vitro meter including functionality to output the
continuous analyte sensor data).
[0097] Accordingly, in certain embodiments an HCP attaches the AS
processing unit with transmitter to a user at the HCP office and
provides a loaner or reusable AS receiver. The user may wear and
collect data with the AS receiver and transmitter for about one or
more days, e.g., about 2-30 days, e.g., about 3-7 days, e.g., about
5-7 days. The user performs BG tests on their in vitro meter at
appropriate times, e.g., at 10, 24 and 72 hours after AS sensor
insertion in certain embodiments. When the user performs a BG test
on their in vitro meter, the wireless adapter will have to be
coupled to the meter and the BG test data may be wirelessly sent to
the AS receiver. The collected data in the AS receiver may be
calibrated using this transferred BG data. The user brings the AS
receiver and in vitro meter to the HCP office. The AS receiver
wirelessly (or otherwise) transmits data to the PC. The HCP may
view the AS data and/or BG information using a DMS.
[0098] Certain embodiments include unblinded, retrospective data
and a USB cable. An exemplary embodiment of such a system is shown
in FIG. 14. This embodiment includes a Data Logger, a USB cable, a
serial cable to Data Logger and an enhanced BG meter having
continuous glucose monitoring functionalities. Accordingly, in this
embodiment continuous glucose monitoring capabilities are accorded
with the in vitro meter, which includes a mini usb port. A user
wears the Data Logger and may view the retrospective data obtained
by the Data Logger on the in vitro meter. There is unidirectional
transfer (wired or wireless) of data from Data Logger to the BG
meter--or may be bidirectional to allow calibration of the CG data
with BG data as well as to display CG data on the BG meter.
[0099] Accordingly, in certain embodiments an HCP attaches an in
vivo sensor and Data Logger to a user at the HCP office. The user
may wear and collect data with the Data Logger (for example,
provided in the AS transmitter coupled to the in vivo sensor) for
about one or more days, e.g., about 2-30 days, e.g., about 3-7
days, e.g., about 5-7 days. The user connects the USB cable from
the Data Logger to the BG meter to download results. The user
brings the BG meter to the HCP site and transits data, e.g., via
usb cable, from the BG meter to the HCP PC or computer terminal.
The HCP may view the Data Logger and/or BG information using a
DMS.
[0100] Certain embodiments include unblinded, prospective data and
a wireless adapter. An exemplary embodiment of such a system is
shown in FIG. 15. This embodiment includes a BG meter, an RF module
and a Data Logger. The BG meter is an enhanced BG meter having
continuous glucose monitoring functionalities and a USB port. A
user wears a Data Logger and can view prospective data of the Data
Logger on the BG meter. There is bidirectional transfer (wired or
wireless) of data from Data Logger to the BG meter.
[0101] Accordingly, in certain embodiments an HCP attaches an in
vivo sensor and Data Logger to a user at the HCP office. The user
may wear and collect data with the Data Logger and transmitter for
about one or more days, e.g., about 2-30 days, e.g., about 3- 7
days, e.g., about 5-7 days. The user connects the wireless adapter
to the BG meter to download results. The user brings the BG meter
to the HCP site and transits data, e.g., via the wireless adapter,
from the BG meter to the HCP pc. HCP may view the Data Logger
and/or BG information using a DMS.
[0102] In certain embodiments, an AS receiver unit may be embedded
in a BG meter. That is, the BG meter may be configured to directly
communicate with the AS transmitter and to receive/store data from
the AS transmitter and collect the monitored glucose levels from
the in vivo sensor.
[0103] While in the embodiments described above, specific
implementation of data communication including wired or cabled and
wireless, and data processing is described, within the scope of the
present disclosure, other data communication techniques may be used
including wired over a cable connection and/or wireless over a
communication link such as RF communication link, infrared
communication link, Bluetooth.RTM. communication link, and the
like, as well as networked data communication over data networks
such as, but not limited to local area network, wide area network,
metropolitan area network and the like, using data protocols such
as, but not limited to TCP/IP, Internet Protocol version 4 (IPv4),
Internet Protocol version 6 (IPv6), wireless application protocol
(WAP), and the like.
[0104] FIG. 16 shows a table of exemplary embodiments and
respective features that may be included. Any feature may be
combined with any other embodiment, and/or features may be removed
and/or added from/to any embodiment.
[0105] In one aspect, a data management system may generate a
variety of reports, including 3 and/or 5 and/or 7 day reports of AS
data and/or BG data. In certain embodiments, all or substantially
all data processing is performed by the DMS, e.g., calibration of
AS data, data analysis, mining, aggregation, filtering, and other
suitable or desirable data processing functions including for
example, therapy based analysis.
[0106] Data may be encrypted/decrypted and/or password protected
for communication or transfer over one or more data networks or
using one or more data communication protocol described above, for
example. Additionally, data integrity and validation may be
performed, for example, for detecting and/or correcting errors in
the transmitted data using, for example, but not limited to, cyclic
redundancy code (CRC), Manchester encoding/decoding, and the like.
The AS system may include a unique identifier which may be known at
the remote site (e.g., by the HCP system), to ensure data is
correctly attributed to the correct user at the HCP site.
Embodiments include various patient privacy protections, e.g., in
accordance with The Health Insurance Portability and Accountability
Act (HIPAA). In other words, systems herein may be HIPAA
compliant.
[0107] In certain embodiments, data may be directly, e.g.,
automatically, transferred into a user's medical records
(electronic record), billing data, etc. e.g., from the DMS.
Embodiments include those capable to complete seamless downloads to
electronic medical records systems. In certain embodiments, a
reimbursement code may be automatically determined by the system
for the HCP, e.g., Medical and/or Medicaid and/or various state
codes. Determining such codes may be time consuming and complex. An
analyte system that performs this task would be a great benefit to
HCPs and users. For example, a reimbursement code may be determined
by a system such as a DMS and displayed audibly and/or visually on
a user interface display. The code may be automatically entered
into a patient's records and/or reimbursement files and
"paperwork". Embodiments include those capable to complete seamless
identification of reimbursement code(s) and/or download such to one
or more compatible electronic systems. Accordingly, certain
embodiments are self-documenting.
[0108] As noted above, embodiments are configured to ensure patient
privacy, e.g., are HIPAA compliant. For example, as described above
some embodiments include components that may be used by more than
one individual. Patient data may be patient identification (ID)
identified and all patient data from a first user may be
automatically deleted from the system or one or more system
components when the system is configured for a second user, e.g.,
by an HCP. For example, an AS data processing unit and/or receiving
unit may require an initialization procedure for each use or user,
e.g., performed by an HCP or the user, which requires entry of a
password or other unique patient identifier. Patient specific data
may be automatically deleted or the initializer may be prompted to
delete during initialization of the CG system. Likewise, patient
specific data may be scrambled, encrypted, or otherwise rendered
indiscernible. Patient data may be deleted based on a time schedule
in certain embodiments.
[0109] The AS systems and methods may be applicable for Type I and
Type II diabetics, newly diagnosed diabetics, patients experiencing
diabetic condition, post surgery glycemic control and the like. The
AS systems and methods may be used in conjunction with multiple
users or patients, for data analysis or therapy management.
[0110] The components of the embodiments herein may be combined in
a single housing or may be separate. Further, embodiments may be
re-usable, such that, they may be used by a plurality of users. In
certain embodiments, DMS may be a PC based application, e.g., a
Windows application.
[0111] Embodiments may include a module that (1) supports
bidirectional or unidirectional RF (or infrared "IR", or
Bluetooth.RTM.) communication between the module and a CG
transmitter unit and/or Data Logger, and/or (2) communicates to a
BG meter via a wired connection (such as a cable or set of
contacts), (3) communicates to a data processing terminal such as a
PC (e.g., unit 105) via RF, IR or a wired cable, and/or contains a
microprocessor (CPU) to handle all of the communication and data
processing tasks.
[0112] For example, a module may serve as a communications hub
between a BG meter, a PC and a CG transmitter or Data Logger,
thereby enabling CG-BG calibration, the display of CG data on the
BG meter, data transfer to a DMS, and data collection for
retrospective or prospective analysis. By having this capability,
the overall system is very cost effective and easy to use since the
display and BG capabilities of the BG meter aren't duplicated
elsewhere in the system, and the overall system would have complete
CG functionality without adding any significant extra cost to the
base HCP meter.
[0113] Accordingly, an analyte monitoring device such as an
assessor in one embodiment may include a data collection module for
receiving and storing analyte data over a predetermined time period
from a subject, a user interface unit coupled to the data
collection module for providing one or more indication related to
the analyte data, a control unit coupled to the data collection
module and the user interface unit to control, at least in part the
operation of the data collection module and the user interface
unit, and a communication module coupled to the control unit for
communicating one or more signals associated with the analyte data
to a remote location, where the user interface unit is configured
to operate in a prospective analysis mode including substantially
real time output of the analyte level received by the data
collection module, and a retrospective analysis mode including
limited output of information to the subject during the
predetermined time period, and further where the communication
module is configured to communicate with the remote location after
the analyte data is received and stored in the data collection
module over the predetermined time period.
[0114] The device may include a strip port operatively coupled to
the control unit for receiving a blood glucose test strip.
[0115] The communication module in one embodiment may be configured
to communicate with the remote location using one or more of a USB
cable connection, a serial cable connection, an RF communication
protocol, an infrared communication protocol, a Bluetooth.RTM.
communication protocol, or an 802.11x communication protocol.
[0116] The user interface unit may be configured to not display any
information related to the received analyte data in the
retrospective analyte mode.
[0117] In one aspect, the limited output of information during the
retrospective analysis mode may include output to the user
interface unit of one or more of the analyte monitoring device
operational status information, a time of day information, a user
profile information, or the elapsed duration of the predetermined
time period.
[0118] The data collection module may include one or more of a data
storage device or a memory device, where the memory device may be a
random access memory.
[0119] In another aspect, the data collection module may be
configured to delete the stored analyte data after transferring the
analyte data to the remote location.
[0120] The remote location may include a data processing terminal
such as an HCP PC terminal.
[0121] In a further aspect, during the prospective analysis mode,
the user interface unit may be configured to visually output real
time information related to the received analyte data of the
subject, where the visual output may include one or more of a
graphical output, a numerical output, or a text output.
[0122] The stored analyte data in the data collection module may be
uncalibrated.
[0123] The communicated one or more signals associated with the
analyte data to the remote location may include uncalibrated
analyte data.
[0124] In a further aspect, the communication module may be
configured to receive one or more calibration information, where
the calibration information may include blood glucose data.
[0125] Also, the control unit may be configured to calibrate the
received and stored analyte data based on the received calibration
information to generate calibrated analyte data, where the data
collection module may be configured to store the calibrated analyte
data.
[0126] Further, the communication module may be configured to
transmit the calibrated analyte data to the remote location.
[0127] A method in another embodiment may include storing analyte
data over a predetermined time period received from a subject,
providing one or more indication related to the received analyte
data on a user interface unit, including operating the user
interface unit in a prospective analysis mode including
substantially real time output of the analyte level received by the
data collection module, and a retrospective analysis mode including
limited output of information to the subject during the
predetermined time period, and communicating one or more signals
associated with the analyte data to a remote location after the
analyte data is received and stored over the predetermined time
period.
[0128] The method in another aspect may include receiving a blood
glucose test data.
[0129] The method may also include communicating with the remote
location using one or more of a USB cable connection, a serial
cable connection, an RF communication protocol, an infrared
communication protocol, a Bluetooth.RTM. communication protocol, or
an 802.11x communication protocol.
[0130] The method may include not displaying any information
related to the received analyte data in the retrospective analyte
mode.
[0131] The limited output of information during the retrospective
analysis mode may include outputting one or more of an operational
status information, a time of day information, a user profile
information, or the elapsed duration of the predetermined time
period.
[0132] In still another aspect, the method may include deleting the
stored analyte data after transferring the analyte data to the
remote location.
[0133] Also, during the prospective analysis mode, the method may
include visually outputting real time information related to the
received analyte data of the subject, where the visual output may
include one or more of a graphical output, a numerical output, or a
text output.
[0134] In another aspect, the stored analyte data may be
uncalibrated.
[0135] The method may include transmitting uncalibrated analyte
data to the remote location.
[0136] Further, the method in yet another aspect may include
receiving one or more calibration information, where the
calibration information may include blood glucose data.
[0137] In yet a further aspect, the method may include calibrating
the received and stored analyte data based on the received
calibration information to generate calibrated analyte data.
[0138] The method may also include storing the calibrated analyte
data.
[0139] Additionally, the method may include transmitting the
calibrated analyte data to the remote location.
[0140] In yet a further aspect, the in vitro blood glucose meter
may be configured to output or otherwise display the analyte sensor
data, where the blood glucose meter includes a memory unit such as
random access memory or other similar storage unit to store the
analyte sensor data (which may be a one minute analyte related data
over a time period of one to seven days, for example). Other time
periods for the storage of analyte related data may be contemplated
including, for example, longer than seven days, and further, the
each analyte related data may be a five minute data or 10 minute
data, for example.
[0141] In another aspect, the clocks in the in vitro blood glucose
meter and the receiver unit (FIG. 1) may be time synchronized
initially or during use, or periodically, such that the blood
glucose value obtained by the in vitro blood glucose meter has a
time corresponding analyte sensor data from the analyte sensor 101
(FIG. 1).
[0142] Various other modifications and alterations in the structure
and method of operation of the present disclosure will be apparent
to those skilled in the art without departing from the scope and
spirit of the present disclosure. Although the present disclosure
has been described in connection with specific embodiments, it
should be understood that the present disclosure 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.
* * * * *