U.S. patent application number 16/942265 was filed with the patent office on 2021-06-17 for analyte monitoring system with audible feedback.
The applicant listed for this patent is Intuity Medical, Inc.. Invention is credited to Raul ESCUTIA, Robin S. GAFFNEY, Kelley J. LIPMAN, Paul D. REYNOLDS, Matthew M. SHEMLUCK.
Application Number | 20210177361 16/942265 |
Document ID | / |
Family ID | 1000005419532 |
Filed Date | 2021-06-17 |
United States Patent
Application |
20210177361 |
Kind Code |
A1 |
LIPMAN; Kelley J. ; et
al. |
June 17, 2021 |
ANALYTE MONITORING SYSTEM WITH AUDIBLE FEEDBACK
Abstract
Described here are devices, systems, and methods for analyte
measurement. The analyte measurement devices and systems may be
configured to produce a prompt that may convey information,
instructions and/or encouragement to a user. In some variations,
analyte measurement devices may be configured to change a prompt
based on the replacement or addition of components of/to the
device. In some instances, a prompt may be an auditory prompt
and/or a visual prompt. In some variations, a system may comprise
an analyte measurement device comprising a housing, a speaker, and
a control unit. The housing may comprise a releasable housing
portion comprising an identifier that is associated with a prompt.
In some variations, a system may comprise an analyte measurement
device and a skin that may releasably attach to the analyte
measurement device and may comprise an identifier that is
associated with a prompt.
Inventors: |
LIPMAN; Kelley J.;
(Livermore, CA) ; GAFFNEY; Robin S.; (Redwood
City, CA) ; ESCUTIA; Raul; (Sunnyvale, CA) ;
SHEMLUCK; Matthew M.; (San Francisco, CA) ; REYNOLDS;
Paul D.; (Palo Alto, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Intuity Medical, Inc. |
Fremont |
CA |
US |
|
|
Family ID: |
1000005419532 |
Appl. No.: |
16/942265 |
Filed: |
July 29, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14311114 |
Jun 20, 2014 |
10729386 |
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16942265 |
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61838171 |
Jun 21, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/15113 20130101;
A61B 5/150801 20130101; A61B 5/14546 20130101; A61B 5/157 20130101;
A61B 5/150389 20130101; A61B 2560/0431 20130101; A61B 5/15153
20130101; A61B 5/15163 20130101; A61B 2562/08 20130101; A61B
2560/029 20130101; A61B 5/4845 20130101; A61B 2560/0443 20130101;
A61B 5/15117 20130101; A61B 5/742 20130101; A61B 5/150022 20130101;
A61B 5/150854 20130101; A61B 90/98 20160201; A61B 2560/0406
20130101; A61B 5/150503 20130101; A61B 5/14532 20130101; A61B
5/7405 20130101; A61B 5/150793 20130101; H04R 1/028 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/151 20060101 A61B005/151; A61B 5/157 20060101
A61B005/157; A61B 5/15 20060101 A61B005/15; A61B 90/98 20060101
A61B090/98; A61B 5/145 20060101 A61B005/145 |
Claims
1. A system comprising: an analyte measurement device comprising: a
housing, wherein the housing comprises a releasable housing portion
and wherein the releasable housing portion comprises an auditory
identifier that is associated with an auditory prompt set; a
speaker; a control unit, wherein the control unit is configured to
detect the auditory identifier, set the auditory prompt set
associated with the detected auditory identifier as an active
prompt set, and instruct the speaker to output at least one
auditory prompt from the active prompt set.
2. The system of claim 1 wherein the system further comprises a
plurality of releasable housing portions.
3. The system of claim 2 wherein each of the releasable housing
portions is associated with an auditory prompt set comprising at
least one auditory prompt that differs from at least one auditory
prompt associated with the other releasable housing portions of the
plurality of releasable housing portions.
4. The system of claim 1 wherein the control unit comprises a
processor.
5. The system of claim 1 wherein the control unit comprises a
memory unit.
6. The system of claim 5 wherein the auditory prompt set associated
with the releasable housing portion is stored on the memory
unit.
7. The system of claim 1 wherein the auditory prompt set associated
with the releasable housing portion is stored on the releasable
housing portion.
8. The system of claim 1 wherein the auditory prompt set associated
with the releasable housing portion is stored on a server.
9. The system of claim 1 wherein the control system comprises a
speech unit and wherein instructing the speaker to output at least
one auditory prompt from the active prompt set comprises
transmitting a signal associated with the at least one auditory
prompt from the speech unit to the speaker.
10. The system of claim 1 wherein the analyte measurement device
further comprises a display.
11. The system of claim 1 wherein the analyte measurement device
further comprises a microphone.
12. The system of claim 1 wherein the analyte measurement device is
an integrated meter.
13. The system of claim 1 wherein the system further comprises a
cartridge.
14-26. (canceled)
27. A method for assisting a user in measuring an analyte using an
analyte measurement device, the method comprising: outputting, via
a speaker of the analyte measurement device, an auditory prompt
that warns a user of an impending lance with a skin penetration
member by indicating an expiring time period until the lance
occurs, and an auditory prompt that alerts the user that the
analyte measurement device has acquired a usable sample.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 61/838,171, filed on Jun. 21, 2013, which is
hereby incorporated by reference in its entirety.
FIELD
[0002] The present invention relates to devices and methods for
monitoring an analyte in a fluid sample (e.g. blood glucose) and
providing visual and/or auditory feedback to a user of the
devices.
BACKGROUND
[0003] Diabetes is a widespread condition, affecting millions
worldwide. In the United States alone, an estimated 23.6 million
people, or 7.8% of the population, have the condition. Diabetes
accounts for an estimated $174 billion annually in direct and
indirect medical costs. Depending on the type (Type 1, Type 2, and
the like), diabetes may be associated with one or more symptoms
such as fatigue, blurred vision, and unexplained weight loss, and
may further be associated with one more complications such as
hypoglycemia, hyperglycemia, ketoacidosis, neuropathy, and
nephropathy.
[0004] To help delay or prevent these undesirable complications, it
may be necessary for people with diabetes to monitor one or more
blood analyte levels, such as blood glucose. Glucose testing allows
a patient to ensure that his or her blood glucose is at a safe
level, which in turn may help monitor the effectiveness of diet,
medication, and exercise in controlling the patient's diabetes, and
may also help reduce the risk of developing one or more
diabetes-related conditions (e.g., blindness, kidney damage and
nerve damage). Many of the currently available glucose meters,
however, require numerous components and complicated steps to
complete a test, and may result in a frustrating or otherwise
negative user experience (which may reduce the likelihood of user
compliance). As such, it may be desirable to produce safe and
effective analyte concentration meters that may make sampling
discrete and easier for the user.
BRIEF SUMMARY
[0005] Described here are analyte measurement devices and systems
for providing feedback to a user. In some variations, an analyte
measurement device may be configured to produce a plurality of
auditory prompts to a user, and these prompts may convey
information, instructions, and/or encouragement to a user. In some
variations, the analyte measurement device may be able to change a
set of auditory prompts outputted by the analyte measurement
device. In some of these variations, a system may comprise an
analyte measurement device comprising a housing, a speaker and a
control unit. In these variations, the housing may comprise a
releasable housing portion and the releasable housing portion may
comprise an auditory identifier that is associated with an auditory
prompt set. The control unit may be configured to detect the
auditory identifier, set the auditory prompt set associated with
the detected auditory identifier as an active prompt set, and
instruct the speaker to output at least one auditory prompt from
the active prompt set. In some variations, the control unit may
comprise a processor and/or a memory unit.
[0006] In some variations the system may further comprise a
plurality of releasable housing portions. In some of these
variations, each of the releasable housing portions may be
associated with an auditory prompt set comprising at least one
auditory prompt that differs from at least one auditory prompt
associated with the other releasable housing portions of the
plurality of releasable housing portions. In some embodiments, the
auditory prompt set associated with a releasable housing portion
may be stored on the memory unit. In other embodiments, the
auditory prompt set associated with the releasable housing portion
may be stored on the releasable housing portion or on a server. The
control unit may also comprise a speech unit and instructing the
speaker to output at least one auditory prompt from the active
prompt set may comprise transmitting a signal associated with the
at least one auditory prompt from the speech unit to the speaker.
In some variations, the analyte measurement devices described here
may further comprise a display and/or a microphone. In some
embodiments, the analyte measurement device may be an integrated
meter. In some variations, the system may further comprise a
cartridge.
[0007] In some embodiments, a system may comprise an analyte
measurement device comprising a housing, a speaker, a control unit,
and a skin. In these variations, the skin may be configured to
releasably attach to the housing and may comprise an auditory
identifier that may be associated with an auditory prompt set. The
control unit may be configured to detect the auditory identifier,
set the auditory prompt set associated with the detected auditory
identifier as an active prompt set, and instruct the speaker to
output at least one auditory prompt from the active prompt set. In
some variations, the control unit may comprise a processor and/or a
memory unit.
[0008] In some variations the system may further comprise a
plurality of skins. In some of these variations, each skin may be
associated with an auditory prompt set comprising at least one
auditory prompt that differs from at least one auditory prompt
associated with the other skins of the plurality of skins. In some
embodiments, the auditory prompt set associated with a skin may be
stored on the memory unit. In other embodiments, the auditory
prompt set associated with the skin may be stored on the skin or on
a server. The control unit may also comprise a speech unit and
instructing the speaker to output at least one auditory prompt from
the active prompt set may comprise transmitting a signal associated
with the at least one auditory prompt from the speech unit to the
speaker. In some variations, the analyte measurement devices
described here may further comprise a display and/or a microphone.
In some embodiments, the analyte measurement device may be an
integrated meter. In some variations, the system may further
comprise a cartridge.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1A-1B depict a front view, and a perspective bottom
view, respectively of a variation of an analyte measurement device
as described here. FIG. 1C depicts a perspective view of a
cartridge that may be used with an analyte measurement device
described here.
[0010] FIG. 2A depicts a perspective view of a cartridge. FIG. 2B
depicts an exploded view of a sampling arrangement contained in a
cartridge.
[0011] FIGS. 3A and 3B depict block diagrams of variations of the
analyte measurement devices described here.
[0012] FIG. 4 depicts a schematic representation of a server
system.
[0013] FIGS. 5A and 5B depict front views of a variation of the
analyte measurement devices described here.
[0014] FIGS. 6A and 6B depict front views of a variation of the
analyte measurement devices described here.
[0015] FIG. 7A depicts a perspective view of a variation of an
analyte measurement device described here comprising an additional
housing portion. FIG. 7B depicts a back view of a variation of an
analyte measurement device comprising a removable housing portion.
FIG. 7C depicts a back view of an analyte measurement device with
the back cover removed.
[0016] FIGS. 8A and 8B depict a front view and perspective view
respectively of a variation of the analyte measurement devices
described here with a skin. FIGS. 8C and 8D depict top perspective
views of a variation of the analyte measurement devices described
here without a skin, and with a skin, respectively.
DETAILED DESCRIPTION
[0017] Described here are analyte measurement systems and devices,
and methods of using the same. Generally, the devices described
here comprise an analyte measurement device configured to audibly
communicate with a user. In some embodiments, the analyte
measurement devices audibly and/or visually communicate with the
user by outputting prompts or receiving commands. In some
variations, the analyte measurement devices may be configured with
an auditory and/or visual output based on one or more removable
components of the analyte measurement device. In these variations,
the systems may comprise an analyte measurement device and one or
more removable components (e.g., a removable portion of a housing,
a cartridge, a skin, or the like).
Analyte Measurement Devices
[0018] Generally, the analyte measurement devices described here
are configured to perform one or more steps of an analyte
measurement operation in which the concentration of one or more
analytes in a fluid sample is measured. For example, an analyte
measurement device may be configured to perform one or more of the
following operations: collect a fluid sample from a sampling site,
transport the fluid sample to an analysis site, and analyze the
fluid sample. When the analyte measurement device is configured to
collect a fluid sample from a sampling site, the device may be
configured to collect a fluid sample from any suitable sampling
site. Examples of suitable sampling sites include, but are not
limited to, one or more body sites (e.g., fingers, toes, other skin
surfaces, or the like) or one or more artificial containers (e.g.,
a vial holding a control solution or a body fluid sample). The
fluid sample may comprise any suitable fluid, such as, for example,
one or more solutions (e.g., a control solution), mixtures, body
fluids (e.g., blood, saliva, or the like), combinations thereof and
the like. Analysis of a fluid sample may include determining the
concentration of one or more analytes in the sample, such as one or
more hormones, proteins, enzymes, toxins, drugs, other molecules,
or the like. In some variations, the analyte measurement devices
described here may be configured to measure the glucose
concentration of one or more blood samples or other
glucose-containing solutions.
[0019] In some variations, an analyte measurement device as
described here may be fully integrated, in that the device may
contain all of the components necessary for collecting,
transporting, and analyzing a fluid sample. For example, the
systems described here may comprise one or more of the devices
described in U.S. patent application Ser. No. 13/566,886, filed
Aug. 3, 2012 and titled "DEVICES AND METHODS FOR BODY FLUID
SAMPLING AND ANALYSIS," U.S. Pat. No. 7,004,928, filed Apr. 23,
2002 and titled "AUTONOMOUS, AMBULATORY ANALYTE MONITOR OR DRUG
DELIVERY DEVICE," and U.S. Pat. No. 8,012,103 and titled "CATALYSTS
FOR BODY FLUID SAMPLE EXTRACTION," the contents of each of which
are hereby incorporated by reference in their entirety. It should
also be appreciated that the analyte measurement devices described
here may be configured to perform only a subset of the collecting,
transporting, and analyzing operations associated with analysis of
a fluid sample.
[0020] For example, the analyte measurement device may comprise a
fully integrated meter. The meter may comprise a meter housing and
one or more cartridges, which will be described in more detail
below. In some variations, the meter may be configured to collect
and analyze a plurality of fluid samples. For example, in some
variations, a cartridge may comprise one or more cells, some or all
of which may contain one or more sampling arrangements for
collecting a fluid sample, as described in more detail below. The
meter may be further configured to audibly, visually or otherwise
provide one or more results from the sample analysis. Some portions
of the meter may be reusable, while other portions of the meter may
be disposable. For example, in some variations, the meter housing
is reusable while the cartridge is disposable. In these variations,
new cartridges may be inserted into or otherwise engage with a
meter housing to conduct a new series of tests. In other
variations, both the meter housing and the cartridge may be
disposable.
[0021] FIGS. 1A-1C show an illustrative variation of an exemplary
integrated meter (100). Specifically, FIGS. 1A and 1B show a front
view and a bottom perspective view, respectively, of a meter
housing (118), while FIG. 1C shows a perspective view of the
cartridge (102). While shown in FIG. 1C as being stored in a sealed
or sealable pouch (116), the cartridge (102) may be stored in any
suitable container, and may be removed prior to use. As shown in
FIGS. 1A and 1B, the meter housing (118) may comprise a door (104)
with a cartridge-engagement projection (105), a cartridge-receiving
chamber (106) or cavity, a cartridge ejection button (113), a
display (108), buttons (110), a port (112), and a tower (114). The
meter need not include each of these features, and it should be
appreciated that the meter may comprise any combination of these
features. The meter (100) may further comprise one or more imaging
systems (not shown), and internal mechanisms or components (e.g.,
memory, circuitry, actuators, batteries, vacuum pumps, sensors,
combinations thereof, etc.) for operating the meter and/or
facilitating a testing procedure.
[0022] A cover or door (104) may be opened to reveal a
cartridge-receiving chamber (106), as shown in FIG. 1B. A cartridge
(102) may be placed inside of cartridge-receiving chamber (106),
and the door (104) may be closed to temporarily enclose the
cartridge (102) within the meter housing (118). When placed inside
of the meter housing, one or more portions of the cartridge (102)
may engage one or more components of the meter housing (118). In
some variations, the meter housing (118) may comprise one or more
features that may facilitate self-alignment of the cartridge (102)
as it is placed in the cartridge-receiving chamber (106). For
example, in some variations the cartridge (102) may comprise a
recess (not shown). When the cartridge (102) is placed inside of
the cartridge-receiving chamber (106), a portion of the tower (114)
may fit within or otherwise engage the recess of the cartridge
(102). This engagement may help to hold the cartridge (102) in
place relative to meter housing (118). Conversely, in some
variations, the cartridge (102) may comprise one or more
projections (not shown) that may engage one or more recesses (not
shown) in the cartridge-receiving chamber (106) or other portion of
the meter housing (118). Additionally or alternatively, one or more
magnets may hold the cartridge in place relative to the meter
housing. A cartridge need not be placed inside of a meter housing
(e.g., via a cartridge-receiving chamber) to engage the meter
housing. For example, in some variations, a cartridge may attach to
or otherwise engage one or more external surfaces of a meter
housing.
[0023] Any suitable cartridge may be used with the meters. For
example, in some variations, the meter may comprise one or more of
the cartridges described in U.S. patent application Ser. No.
11/529,614, titled "MULTI-SITE BODY FLUID SAMPLING AND ANALYSIS
CARTRIDGE," and U.S. Pat. No. 8,231,832, titled "ANALYTE
CONCENTRATION DETECTION DEVICES AND METHODS," the contents of each
of which is hereby incorporated by reference in its entirety. A
suitable variation of a cartridge that may be used with the meter
described above is illustrated in FIG. 2A. As shown there, the
cartridge (200) may house or otherwise hold one or more sampling
arrangements (202). These sampling arrangements (202) may comprise
one or more components for collecting, transporting, and/or
reacting with a fluid sample. For example, in some variations, the
sampling arrangement may comprise a penetration member for piecing,
penetrating or otherwise puncturing a sampling site during a
testing procedure. In variations where the cartridge (200)
comprises a plurality of sampling arrangements (202), each sampling
arrangement (202) may be utilized to conduct a separate test on a
different fluid sample. The sampling arrangement may further
comprise a hub or other structure for moving the penetration member
relative to the cartridge. Additionally, the sampling arrangement
(202) may comprise a quantification member (not shown), which may
react with the fluid sample to produce a measurable response (e.g.,
an electrochemical or photometric response) that may be indicative
of one or more properties of the fluid sample. In variations where
the cartridge (200) is configured to be disposable, new cartridges
may be swapped in to provide unused (e.g., unfired) sampling
arrangements. Any reactions that occur between sampling arrangement
and the fluid sample may be quantified or measured by one or more
portions of the cartridge or the meter housing (e.g., an imaging
system). In some variations, one or more portions of the cartridge
may be reusable. For example, a cartridge containing one or more
unused sampling arrangements may be loaded into the cartridge to
allow the meter to conduct additional testing procedures. While the
meter (100) is discussed above as having a cartridge, the meter
need not.
[0024] FIG. 2B depicts an exploded view of a sampling arrangement
(202). Shown there are a hub (204), a skin penetration member
(206), a quantification member (208) (e.g., a pad), a cap (210),
and a spring (212). The hub (204) may comprise a latch (214), pivot
bars (216), and a micropatterned surface (218). In this variation,
the hub (204) may hold the skin penetration member (206) such that
an interior bore (220) of the skin penetration member (206) is in
fluid communication with the micropatterned surface (218). The
quantification member (208) may be placed on the micropatterned
surface (218) and a cap (210) may be placed at least partially over
the quantification member (208) to hold the quantification member
(208) in place against the micropatterned surface (218). The cap
(210) may comprise an aperture (222) through which the
quantification member (208) may be viewed by an imaging system
(e.g., light source and detector) to determine the concentration of
an analyte in a sample. While spring (212) is depicted as a
torsional spring, any mechanism capable of moving the skin
penetration member may be utilized (e.g., linear spring, leaf
spring, conical spring, mechanically-driven arm, sliding actuator
etc.).
[0025] The meter housing (118) may be configured to house a speaker
and/or a microphone (not shown) and a control unit (not shown),
although it should be appreciated that the speaker, microphone,
and/or control unit may in some instances be partially housed in
the housing (118), may be externally attached to the housing (118),
or may be part of a separate device (i.e., headphones, cellular
phone, computer, tablet, etc.) that communicates with the meter
either wirelessly or through a wired connection. As depicted in
FIG. 1A, the meter housing (118) may additionally comprise a
display (108) (e.g., for visually providing information to a user),
buttons (110) (e.g., for powering on/off the device, inputting
information into the device, etc.) and a port (112) (e.g., through
which a fluid sample may be collected), such as those described in
U.S. patent application Ser. No. 13/566,886, which was previously
incorporated by reference in its entirety. Additionally or
alternatively, the meter (100) may in some instances further
comprise one or more imaging systems (not shown), and internal
mechanisms or components (e.g., memory, circuitry, actuators,
batteries, vacuum pumps, sensors, combinations thereof, etc.) for
operating the meter (100) and/or facilitating testing of a fluid
sample The analyte measurement devices described here need not
include each of these features, and variations of these devices may
comprise any combination of these features.
[0026] As mentioned above, the analyte measurement devices
described here are generally configured to provide some form of
feedback (auditory, visual, tactile, etc.) to a user. Generally,
the analyte measurement devices described here may comprise a
control unit comprising a memory unit (which can include one or
more computer-readable storage mediums), one or more processors
(CPU's), and a speech unit. The one or more processors may execute
various software programs and/or sets of instructions stored in the
memory unit to perform various functions for the device and to
process data. In some examples, the memory unit, processor and
speech unit may be implemented on a single chip. In other examples,
they can be implemented on separate chips. Depending on the desired
functionality of the device, the device may further comprise any
number of components, including but not limited to, circuitry of
any kind (e.g., RF circuitry, audio circuitry, display circuitry,
lighting circuitry, integrated circuits, etc.), a speaker, a
microphone, a tactile output generator (e.g., a vibrational
element), a display (including a touch-sensitive display system),
one or more external ports, etc. The device may include all of the
above listed components, or any sub combination of the components.
Additionally, the various components described may be implemented
across two or more devices (e.g., an analyte measurement device and
a cellular phone), of which one or more may include a home
computer, or a remote server accessed by a local area network or by
the internet. In an example where two or more devices are used, the
devices can communicate with each other to facilitate operation of
the devices. The communication may or may not be encrypted.
[0027] The analyte measurement devices may also be configured to
receive, compile, store, and access data. In some variations, the
analyte measurement device may be configured to access and/or
receive data from different sources. The analyte measurement device
may be configured to receive data directly entered by a user and/or
it may be configured to receive data from separate devices (e.g. a
cellular phone, tablet, computer, etc.) and/or from a storage
medium (flash drive, memory card, etc.). The analyte measurement
device may receive the data through a network connection, as
discussed in more detail below, or through a physical connection
with the device or storage medium (e.g. through USB or any other
type of port). The analyte measurement device may compile the data
using a processor and may store the data on a memory unit within
the access device, or it may transmit the data to an external
server for storage. Furthermore, the analyte measurement device may
later access the stored data using the processor.
[0028] The analyte measurement device may be configured to receive
various types of data. For example, the analyte measurement device
may be configured to receive a user's personal data (e.g., gender,
weight, birthday, age, height, diagnosis date, anniversary date
using the device, etc.), a user's testing history (e.g., number of
tests completed, time each test was completed, date each test was
completed, pre or post prandial test markings, how many tests a
user has completed consecutively, etc.), a user's results history
(e.g., glucose level at time test was taken), a user's diet
information (e.g., what a user had to eat each day, number of
alcoholic beverages, amount of carbohydrates consumed, etc.), a
user's exercise information (e.g., if a user exercised, when the
user exercised, duration of exercise, what type of exercise the
user completed (e.g. biking, swimming, running, etc.), exertion
level of the exercise (e.g., low, medium, high), a user's heart
rate during exercise, etc.), general health information of other
similarly situated patients (e.g., typical test results for a
similar user at a similar time of day, average of test results for
a similar user after exercise, etc.), or any other information that
may be relevant to a user's treatment. In some variations, the
analyte measurement device may be configured to create, receive,
and/or store user profiles. A user profile may contain any of the
user specific information previously described. Additionally, the
analyte measurement device may be configured to receive general
information useful in determining when testing occurs (e.g., time
of day, date, location) as is described in more detail in U.S.
patent application Ser. No. 12/457,332, titled "MEDICAL DIAGNOSTIC
DEVICES AND METHODS," the content of which is hereby incorporated
by reference in its entirety. While the above mentioned information
may be received by the analyte measurement device, in some
embodiments the analyte measurement device may be configured to
calculate any of the above data from information it has received
using software stored on the device itself, or externally.
[0029] In some embodiments, the analyte measurement device may be
configured to identify patterns in user behavior, use the
identified patterns to predict future user behavior, and provide
prompts to the user relating to the identified patterns, as is
described in more detail in U.S. patent application Ser. No.
12/457,332, titled "MEDICAL DIAGNOSTIC DEVICES AND METHODS," which
was previously incorporated by reference in its entirety. In some
instances, the analyte measurement device may use the patterns to
help warn about, or prevent the occurrence of one or more glucose
events. A glucose event may occur any time a user's glucose is
above or below an expected level or is outside a specified range.
In some embodiments, a glucose event may be a hypoglycemic event or
a hyperglycemic event. In some variations, the analyte measurement
device may be configured to compare the user's personal data,
testing history, diet information, exercise information, or any
other relevant information, to a user's historical data (e.g. prior
test data, user's historical trends, etc.), data preloaded onto the
analyte measurement device that has been compiled from external
sources (e.g. medical studies), or data received from a separate
device (e.g., historical data or data compiled from external
sources), as is described in more detail below. In some instances,
the warning or notification may include instructions to perform a
test, seek medical attention, and/or to eat or drink something.
[0030] The analyte measurement device may be configured to
calculate the likelihood of a glucose event based on data it has
received and may provide an alert or prompt to a user based on its
calculation. In some variations, the method of alerting a user of a
glucose event may comprise receiving user information, identifying
the user information as a stimulus for a glucose event (e.g.,
exercise, alcohol consumption, sugar consumption, heavy meals,
etc.), calculating a likelihood of occurrence of the glucose event,
determining when the glucose event will occur, and alerting or
prompting the user in advance of the glucose event based on the
determination of when the glucose event will occur. The reporting
of a risk, if any, may be based upon whether the risk calculation
meets or exceeds a certain threshold, or certain criteria.
[0031] For example, some users may experience a higher risk of a
glucose event after intense exercise (e.g., high intensity for 60
minutes, moderate intensity for 90 minutes, low intensity for 120
minutes) or after consuming a certain number or amount of alcoholic
beverages (e.g. 5 glasses of wine, 4.5 ounces of vodka, etc.). The
user may input information about his exercise regimen or alcohol
consumption into the analyte measurement device or a separate
device communicating with the analyte measurement device. The
analyte measurement device may identify the information as a
stimulus for a glucose event based on data preloaded onto the
analyte measurement device, data received from a separate device,
and/or a user's historical data, and may mark the information as a
stimulus. The analyte measurement device may compare the user's
information to the preloaded, received, and/or historical data to
calculate a likelihood of occurrence of the glucose event. If there
is a high probability that a glucose event may occur, the analyte
measurement device may use the preloaded, received, and/or
historical data to determine when the event is likely to occur
(e.g., 12 hours after exercising, 4 hours after consuming alcohol,
etc.), and may alert or prompt the user at an appropriate time
(e.g., 11 hours after exercising, 3 hours and 45 minutes after
consuming alcohol, etc.), as is described in more detail below.
[0032] In some embodiments, calculating the likelihood of the
occurrence of a glucose event may comprise comparing the user's
information with the user's historical information (e.g. prior test
result, historical average, historical trend, predictive value,
etc.) assigning a probability of a glucose event occurring based on
the comparison, determining if the probability is larger than a
threshold value, and if so, determining that alerting or prompting
a user is necessary. In other embodiments, calculating the
likelihood of the occurrence of a glucose event may comprise
comparing the user's information with the health information of
other patients, for example, similarly situated patients (e.g.,
patients of similar age, weight, patterns, etc.). In yet other
embodiments, calculating the likelihood of the occurrence of a
glucose event may comprise comparing the user's information with
both the user's historical information and the health information
of similarly situated patients, assigning a probability to each
comparison, and averaging the probabilities. While a simple average
is described, a more complex weighting scheme may be utilized. For
example, in some embodiments, the comparison of the user's
information with the user's historical information may be weighted
more heavily than the comparison of the user's information with the
health information of similarly situated patients. In still other
variations, calculating the likelihood of the occurrence of a
glucose event may comprise comparing many different factors (e.g.,
duration of exercise, intensity of exercise, last meal, and age)
with the same factors in multiple data sets (e.g., historical data,
similarly situated patient data, etc.) and assigning each factor a
different weight to determine a final probability.
[0033] In some examples, determining when the glucose event will
occur may also comprise comparing the user's information with the
user's historical information or the health information of
similarly situated patients. This comparison may provide
information about how much time may elapse between the stimulus and
the glucose event (i.e. a response time). The response times may
also be averaged or assigned weights.
[0034] FIGS. 3A and 3B show block diagrams of variations of another
analyte measurement device (300). As shown in FIG. 3A, the analyte
measurement device (300) may comprise a speaker (302) configured to
produce a sound output, and a control unit (304) configured to
control the sound output of the speaker (302). The control unit
(304) may include electronics capable of outputting audio signals
to the speaker (302). For example, in the variations shown in FIGS.
3A and 3B, the control unit (304) may comprise a processor (306), a
speech unit (308), and a memory unit (310). The memory unit (310)
can include high-speed random access memory and non-volatile
memory, such as one or more magnetic disk storage devices, flash
memory devices, or other non-volatile solid-state memory devices.
In the variation depicted in FIG. 3A, the memory unit (310) may be
configured to store data relating to a plurality of sound outputs
for the speaker (302), the processor (306) may be configured to
select a specific sound output from the plurality of sound outputs,
and the speech unit (308) may be configured to convert the data
relating to the sound output into a signal that may be transmitted
to the speaker (302), or a wireless audio transmitter, e.g. IR,
Bluetooth, wireless USB protocol, WiFi IEEE 802.11x protocols, 2.4
GHz or 5 GHz transmissions. The speaker (302) may then convert the
signal to human-audible sound waves. The data relating to the sound
output may comprise any audio file, for example, sample sound
files, a library of sounds, recorded data files, sound files that
may be used together to form composite speech, or any other type of
audible indicia file. In some variations, the analyte measurement
device (300) may include a headset jack instead of, or in addition
to, a speaker (302). The headset jack may provide an interface
between the speech unit (308) and removable audio output devices,
such as output-only headphones, an external speaker, or a headset
with both an output (e.g. a headphone for one or both ears) and an
input (e.g., a microphone.)
[0035] In some variations, the analyte measurement device (300) may
also comprise a vibrational element (314), for example, a vibrating
motor or the like, such that the analyte measurement device may
provide tactile feedback to a user. The tactile feedback may be
provided to the user through the housing (118), the port (112), or
any other component of the device capable of transmitting
vibration. In this variation, the memory unit (310) may be
configured to store data relating to a plurality of vibrational
patterns, and the processor (306) may be configured to select a
specific pattern from the plurality of vibrational patterns and
communicate with an actuator configured to activate and deactivate
the vibrational element.
[0036] In some variations, the analyte measurement device (300) may
also be configured to produce a visual output to communicate
information to a user. As shown in FIG. 3A, the analyte measurement
device (300) may comprise a display (318) configured to produce a
visual output, and a control unit (304) configured to control the
visual output of the display (318). The display (318) may use LCD
(liquid crystal display) technology, LPD (light emitting polymer
display) technology, and/or LED (light emitting diode) or OLED
(organic LED) technology, although other display technologies can
be used in other examples. As mentioned above, the display (318)
may also use touch sensing technology, including but not limited
to, capacitive, resistive, infrared and surface acoustic wave
technologies, other proximity sensor arrays, or other elements for
determining one or more points of contact with the display (318),
such that the display (318) may also act as a touchscreen. The
control unit (304) may include electronics capable of outputting
visual signals to the display (318). In the variation depicted in
FIGS. 3A and 3B, the memory unit (310) may be configured to store
data relating to a plurality of visual outputs for the display
(318) and the processor (306) may be configured to select a
specific visual output from the plurality of visual outputs and
communicate with the display (318) such that the selected specific
visual output appears on the display (318). While the display (318)
is depicted in FIGS. 3A and 3B as an integrated display, the
analyte measurement device (300) may not comprise a display (318)
and a separate interface may be used to display information (e.g.,
a cellular phone, computer, tablet, etc.).
[0037] In some embodiments, the analyte measurement device (300)
may also be configured to detect and respond to audible commands.
As depicted in FIG. 3B, the analyte measurement device (300) may
comprise a microphone (312) configured to detect sound, and a
control unit (304) configured to interpret and control how the
detected sound is utilized by the analyte measurement device (300).
The control unit (304) may include electronics capable of detecting
sound and converting it into instructions for the device. For
example, the control unit (304) may comprise a processor (306), a
speech unit (308), and a memory unit (310). The microphone (312)
may be configured to detect an audible command and convert it into
a data signal, the speech unit (308) may be configured to convert
the data signal into instructional data for the analyte measurement
device, the memory unit (312) may be configured to store
instructional data relating to a plurality of instructions, and the
processor (306) may be configured to select a specific instruction
from a plurality of instructions stored on the memory unit (312)
and implement it. In some embodiments, the analyte measurement
device (300) may include a headset jack instead of, or in addition
to, a microphone (310). The headset jack may provide an interface
between the speech unit (308) and removable audio input devices,
such as an external microphone or a headset with both an output
(e.g. a headphone for one or both ears) and an input (e.g., a
microphone).
[0038] In some variations, the analyte measurement device may
communicate with and provide auditory, visual, or other information
to a separate user device. For example, FIG. 3B depicts a variation
of an analyte measurement device (300) comprising RF (radio
frequency) circuitry (316). The RF circuitry (316) may receive and
send RF signals. The RF circuitry (316) may convert electrical
signals to/from electromagnetic signals and communicate with
communications networks and other communications devices via the
electromagnetic signals. The RF circuitry (316) may comprise
well-known circuitry for performing these functions, including but
not limited to an antenna system, an RF transceiver, one or more
amplifiers, a tuner, one or more oscillators, a digital signal
processor, a CODEC chipset, a subscriber identity module (SIM)
card, memory, and so forth. The RF circuitry (316) may communicate
with networks, such as the network (406) illustrated in the
exemplary communication system (400) depicted in FIG. 4.
[0039] FIG. 4 depicts an exemplary system (400) for sending and
receiving auditory, visual, or other information between user
devices (402, 404). The first user device (402) may be an analyte
measurement device, such as the analyte measurement device (300)
depicted in FIGS. 3A-3B, and the second user device (404) may
include any of a variety of devices, such as a cellular telephone
(e.g., smartphone), tablet computer, laptop computer, desktop
computer, portable media player, wearable digital device (e.g.,
digital glasses, wristband, wristwatch, brooch, armbands, etc.),
television, set top box (e.g., cable box, video player, video
streaming device, etc.), gaming system, or the like. While two user
devices (402, 404) are depicted, any number of user devices (402,
404) could be included in the system (400).
[0040] The user devices (402, 404) may transmit data (e.g. user
data, test data, audible prompts, visual prompts, etc.) to the
server system (408) through the network (406). The network (406)
may include any of a variety of networks, such as a cellular
telephone network, WiFi network, wide area network, local area
network, the Internet, or the like. The user devices (402, 404) may
communicate with the network (406) by wireless communication. The
wireless communication may use any of plurality of communication
standards, protocols and technologies, including but not limited
to, Global System for Mobile Communications (GSM), Enhanced Data
GSM Environment (EDGE), high-speed downlink packet access (HSDPA),
high-speed uplink packet access (HSUPA), Evolution, Data-Only
(EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), long term
evolution (LTE), near field communication (NFC), wideband code
division multiple access (W-CDMA), code division multiple access
(CDMA), time division multiple access (TDMA), Bluetooth, Wireless
Fidelity (WiFi) (e.g., IEEE 802.11a, IEEE 802.11b, IEEE 802.11g
and/or IEEE 802.11n), voice over Internet Protocol (VoIP), Wi-MAX,
a protocol for e-mail (e.g., Internet message access protocol
(IMAP) and/or post office protocol (POP)), instant messaging (e.g.,
extensible messaging and presence protocol (XMPP), Session
Initiation Protocol for Instant Messaging and Presence Leveraging
Extensions (SIMPLE), Instant Messaging and Presence Service
(IMPS)), and/or Short Message Service (SMS), or any other suitable
communication protocol. In some variations, the user devices (402,
404) may directly communicate with each other without transmitting
data through the network (406) (e.g., through NFC, Bluetooth, WiFi,
and the like.)
[0041] The server system (408) may include a server, storage
devices (including cloud based storage), databases, and the like
and can be used in conjunction with the user devices (402, 404) to
transmit data. For example, in variations in which one of the user
devices (402) is one of the analyte measurement devices (300)
depicted in FIGS. 3A-3B, the user device (402) may receive
information from a user, optionally process the information,
transmit some or all of the entered and/or processed information to
the server system (408), receive information from the server system
(408), and output an auditory, visual, or tactile prompt from the
device (402). The user device (402) may optionally transmit
information to the second user device (404) which may also output
an auditory, visual, or tactile prompt. In some embodiments, both
user devices (402, 404) may receive information from the server
system (408), and output an auditory, visual, or tactile prompt. In
some variations, the server system (408) may process and/or store
the information. In some instances, the user device (402) may
receive and process information without the server system (408)
and/or the network (406) and may transmit information about an
auditory, visual, or tactile prompt to the server system (408) to
transmit to the second user device (404), which may receive the
information and output an auditory, visual, or tactile prompt. Any
type of information can be transmitted and the server system (408)
and the user devices (402, 404) may transmit information through
the network (406) as many times as necessary.
[0042] For the purposes of this application, a specific output and
any data or signal corresponding thereto will be referred to as a
"prompt." Likewise, for the purposes of this application, a
specific user input and any data or signal corresponding thereto
will be referred to as a "command." For example, a specific sound
output and any data or audio signals corresponding thereto will be
referred to as an "auditory prompt," a specific visual output and
any data corresponding thereto will be referred to as a "visual
prompt," and a specific auditory input and any data or audio
signals corresponding thereto will be referred to as an "auditory
command."
[0043] An auditory prompt may include speech, music, sounds,
combinations thereof, and the like, such as will be described in
more detail below. In some instances, the analyte measurement
device may be configured to produce auditory prompts that can
audibly guide users through one or more operations of the device.
For example, in variations where the analyte measurement device is
an integrated device, the analyte measurement device may be
configured to audibly guide a user through an entire sampling
process to obtain and analyze a fluid sample to determine a
concentration or other measurement of a target analyte. As an
example, some variations of the analyte measurement devices
described here may audibly inform a user that the device has been
woken from a sleep/powered off state, that the device is ready to
acquire a sample, that the device is acquiring a sample, that a
sample has been acquired (or in some instances, that an additional
sample needs to be applied to the device), and that the sample is
being analyzed. The analyte measurement device may then present the
results of the analysis (e.g., a concentration of blood glucose in
the sample).
[0044] A visual prompt may include text, graphics, symbols, or
combinations thereof, and the like, such as will be described in
more detail below. Similarly to the audible prompts discussed
above, in some instances the analyte measurement device may be
configured to produce visual prompts that can visually guide a user
through one or more operations of the device or otherwise convey
information about a user's testing history or results.
[0045] An auditory command may include speech or sounds, or a
combination thereof, and the like, such as will be described in
more detail below. A user may use auditory commands to instruct the
analyte measurement device to perform specified tasks.
Prompts
[0046] Typically, analyte monitors (such as glucose monitors)
visually communicate information to a user (e.g., via a display).
For example, the analyte monitors may visually display a
concentration of an analyte in a sample (e.g., a glucose reading),
or may visually display prompts that instruct the user to take one
or more actions associated with an analyte measurement operation
(e.g., insert a test strip or other test media, apply a sample to
the test media, wait for analysis). This type of visual
communication normally consists of simple text appearing on the
display. The analyte measurement devices described here may be
configured to provide information visually and/or audibly to a user
(e.g., via the display (318) or the speaker (302) of the device
(300) shown in FIG. 3A) in a customized manner. Generally,
presenting information audibly may promote or otherwise facilitate
the use of the analyte measurement devices by users with vision
problems, as auditory prompts may allow a vision-impaired user to
perform actions with the device (e.g., to complete the analysis of
an analyte) without needing assistance from another user.
Additionally, presenting information (visually, audibly, or
otherwise) in a customized manner, as will be discussed in more
detail below, may provide a more enjoyable user experience and may
therefore increase user compliance (e.g., whether the user tests as
directed).
[0047] Generally, the analyte measurement devices described here
may be configured to output one or more prompts during use of the
device. Typically, a prompt may be outputted in response to an
action taken by a user or on a scheduled basis. For example, in
some variations an analyte measurement device may provide a prompt
when the device is powered on or otherwise awoken from a low-power
sleep state. The prompt may provide a greeting, may inform a user
of the current time, or the like. When a user initiates an analyte
measurement operation (e.g., a testing sequence), the analyte
measurement device may output one or more prompts that may guide
the user through one or more steps of the analyte measurement
operation. For example, a prompt may instruct a user to insert a
test strip into the device, to place a sampling site such as a
finger on a test port, to apply or reapply a sample to a test port,
combinations thereof and the like. Prompts may also instruct a user
as to the status of the analyte measurement operation (e.g., a
prompt may inform a user that the device is obtaining a sample or
is analyzing the sample) or the results of the analyte measurement
operation (e.g., the concentration of a given analyte in the
sample). The analyte measurement devices may also be configured to
output multiple prompts at the same time. For example, the analyte
measurement devices may be configured to output both an auditory
prompt and a visual prompt in response to a single action taken by
a user or on a scheduled basis.
[0048] Turning to FIGS. 5A-5B, in some variations, one or more
prompts (502) may be dependent on a specific time, date,
measurement, or use of the device (500). The analyte measurement
device (500) may be configured to receive, compile, store, and/or
access data, as is described above in more detail. In some
variations, the analyte measurement device (500) may incorporate
this data in the given prompts (502). FIG. 5A depicts an example of
a variation of the devices (500) described here outputting a prompt
(502) that may be dependent on the time of day. As seen there, the
device (500) may be configured to recognize the time of day (e.g.,
morning) and to output a prompt or prompts (502) that correlate
with it (e.g., a rising sun, "good morning"). The device (500) may
be configured to recognize any time of day (e.g., lunch time,
evening, night, hours during which the user is at work, hours at
which the user is sleeping, etc.) and may output prompts that
correlate with the recognized time. In other variations, a device
may output a prompt (502) on certain days of the week (e.g., "Happy
Friday," graphic of calendar with day of week or date), or certain
days of the year (e.g., "Happy birthday!", graphic of birthday
cake, display age with balloons). In some instances, a prompt (502)
may be dependent on the user's testing frequency. For example, as
described above in more detail, the analyte measurement device
(500) may be configured to record the number of analyte measurement
operations performed by a user during a given span of time and the
corresponding results, and create a data set that can later be
referenced by the device. The analyte measurement device (500) may
be configured to output a prompt (502) that provides the user with
information about his/her testing history and results. For example,
the analyte measurement device (500) may output a prompt (502) that
informs a user of his/her compliance with an expected testing
regimen (or lack thereof), that encourages the user to better
comply with the regimen, that informs a user of how many tests
he/she has completed (consecutively, this week, total, etc.), and
the like.
[0049] For example, if a user is complying with the expected
testing regimen (e.g., consecutively or consistently testing at
prescribed times), the prompt (502) may praise the user (e.g.,
"You're doing great! Keep it up!", "Way to go! You've tested 4 days
in a row!", a graphic of a medal with a numerical indication of
compliance, graphic of a check mark, etc.). Conversely, if the user
is not complying with the expected testing regiment, the prompt
(502) may inform the user of this ("You haven't been testing 2
times a day as prescribed by Dr. Simmons. Maybe you should test
more often", graphic of a sick patient, graphic of an "X",
etc.).
[0050] Similarly, the prompts (502) may depend on the results of
one or more analyte measurement operations, as is depicted in FIG.
5B. For example, if a concentration or the concentrations measured
during the analyte measurement operations is consistently within a
prescribed range (e.g., for three consecutive tests, two out of
three consecutive tests, or the like), the prompt (502) may praise
the user (e.g., "Your results look great", graphic of a smiley
face, etc.). If a concentration or the concentrations measured is
consistently outside of a prescribed range (e.g., for three
consecutive tests, two out of three consecutive tests, or the
like), the prompt (502) may encourage the user to test more
frequently, to consult a physician or to change the user's diet
(e.g., "You may want to test more often," "You may want to speak to
Dr. Simmons about your test regimen", a graphic of a doctor on the
telephone, a graphic of a piece of candy, etc.). If a user
consistently tests at certain times throughout the day and the user
fails to test at a time previously identified as a regular testing
time, the prompt (502) may remind the user to test ("Did you forget
to test today?", graphic of an analyte measurement device flashing
on the display with a question mark, etc.). If the time a user
tests is consistently outside of a prescribed or historically
calculated range, the prompt (502) may remind the user to test
before the prescribed or historically calculated range passes
(e.g., "Don't forget to test at 2 pm", graphic of a set clock and
an exclamation mark, etc.).
[0051] Moreover, one or more of the prompts (502) may depend on the
results of a determination of when a glucose event may occur, as is
discussed in detail above. For example, a prompt (502) may inform a
user of the likelihood of a glucose event occurring (e.g., "80%",
graphic of a partially filled thermometer with a scale from 1-100%,
etc.). In some variations, the prompt (502) may inform a user that
a glucose event may occur imminently (e.g., "You may begin to feel
dizzy", a graphic of a hospital, etc.) and/or that immediate action
is required (e.g., "Please test immediately", "Please eat
carbohydrates", a graphic of a user testing, a graphic of a
suggested food, etc.). In some variations, the prompt (502) may
inform a user that a potentially glucose event may occur in the
future (e.g., "You may have low blood sugar in 2 hours", "graphic
of clock with an exclamation point, etc.) and/or suggest an action
the user may wish to take in the future (e.g., "Please test again
in 1 hour", "Please eat a snack in 30 minutes", a graphic of a
clock with an analyte testing device, etc.).
[0052] While the prompts (502) are described as being output to/on
the analyte measurement device (500) itself, in some variations,
the prompts may be output on a separate device (504) in
communication with the analyte measurement device, as is described
above in detail with respect to FIG. 4. For example, a user may
interact with an analyte measurement device (500) in some capacity
(e.g., turn the device on, turn the device off, begin a test
sequence, finish a test sequence, etc.) and a prompt (502) may be
output on one or more separate devices (504) (e.g., a cellular
phone, computer, tablet, etc.). In some variations, a prompt (502)
may be output on a separate device (504) that is used or can be
accessed by another person (e.g., a computer at the user's doctor's
office, a cellular phone of a relative or caretaker, etc.). In
other variations, a prompt (502) may be output on a separate device
(504) that is used or can be accessed by the user (e.g., the user's
cellular phone, the user's computer, the user's headphones (for
audible prompts) etc.). In some embodiments, a prompt (502) may be
output on both the analyte measurement device (500) and a separate
device (504), as is depicted in FIG. 5A. Additionally, in some
embodiments, the analyte measurement device (500) may be in
communication with applications that are running on or are stored
on a separate device (504), and may be able to receive and/or send
data to/from the applications on the separate device (504). For
example, in an embodiment in which a prompt (502) may be output to
inform the user that a glucose event may occur now or in the
future, the analyte measurement device (500) may communicate with
an alarm clock application running or stored on a separate device
(504) and may program the alarm clock to sound at a later time to
output the prompt (502).
Commands
[0053] Generally, the analyte measurement devices described here
may be configured to receive one or more commands during use of the
device. Typically, a command may be given by a user and received by
the device. For example, in some variations, a user may give a
command after the device is powered on or otherwise awoken from a
low-power sleep state. The command may provide instructions to the
device or may otherwise communicate an action the user desires the
device complete. For example, a user may provide an audible command
(e.g., "Wake-up", "Turn-off", "Begin Test", etc.), the device may
receive the audible command, and the device may respond by
completing the user's desired instruction (e.g., waking-up from
low-power sleep state, turning-off, beginning a test sequence,
etc.). In some variations, the user may provide an audible command
requesting information about the user and/or his/her current or
historical test results (e.g., "What is my blood sugar?", "What was
my blood sugar on Tuesday?"), the device may receive the command,
access the requested information, and respond with a prompt
comprising the information requested by the user. In some
embodiments, the requested information may comprise information
about the status of the testing sequence or any other information
that may be of interest to a user.
Auditory Prompts
[0054] As mentioned above, the analyte measurement device may
output an auditory prompt in response to an action taken by the
user (e.g. starting a test sequence) or on a scheduled basis (e.g.
a reminder to test at a certain time every day). Auditory prompts
may also be used to read on-screen menus and options, to guide a
user through setting or changing one or more options (e.g., setting
a device clock, setting an alarm or reminder, controlling a vacuum
pump or display backlight). Table 1 below provides a plurality of
examples of auditory prompts that may be outputted by the analyte
measurement devices described here.
TABLE-US-00001 TABLE 1 Auditory prompt Possible Triggering Action
Examples Auditory prompt configured to Device is powered on/awoken
"Welcome to POGO .RTM." alert user that device is in an from
low-power sleep state "Good morning, Jane" operational state and/or
provide "The time is 3:21 pm" a greeting "The device is ready for
use" Auditory prompt to instruct User activates a analyte "Please
apply your user to position a sampling site measurement operation
finger to the test port" (e.g., a finger) relative to a sample
acquisition portion of the device (e.g., a test port) Auditory
prompt to indicate The analyte measurement "Prepare for sampling:
3. 2. 1." that sampling or lancing will device determines that the
occur (e.g., the device will sampling site is positioned penetrate
the skin and/or relative to a sample acquisition extract a sample)
portion Auditory prompt to instruct The analyte measurement "POGO
.RTM. is obtaining a user to maintain sampling site device has
pierced or sample, please hold your finger position and/or provide
status lanced the sampling site on the test port." of sampling
Auditory prompt to alert a user The analyte measurement "Sample
Acquired." that a usable sample has been device determines that
acquired. a sample has been acquired Auditory prompt to alert a
user The analyte measurement "Please apply additional to apply
additional sample to device determines that a sample." the device
(e.g., if the device sufficient sample size has not determines that
an insufficient yet been acquired volume of fluid has been captured
by the device) Auditory prompt to alert a user The analyte
measurement "Your blood glucose is 126 that a result has been
obtained device has completed an mg/mmol." and/or measured values
analyte measurement operation
Visual Prompts
[0055] Also as mentioned above, the analyte measurement device may
output a visual prompt in response to an action taken by the user
(e.g. starting a test sequence) or on a scheduled basis (e.g. a
reminder to test at a certain time every day). Visual prompts may
also be used to guide a user through a test sequence (as is
described above in Table 1 with respect to auditory prompts).
Visual prompts that guide a user through a test sequence may
comprise any visual representation of the steps of the test
sequence. For example, simple text may appear on a display
explaining what the user should do or a graphical representation of
the steps may appear (e.g., a graphic of a finger applied to the
test port when a user should apply his/her finger to the test
port).
[0056] Other types of visual prompts are also contemplated. In some
embodiments a light source (e.g., LED) may illuminate a component
of the device. For example, a component (the display, a bezel of
the display, the test port, the buttons, etc.) may flash or change
colors. In some embodiments, the color the component is illuminated
may vary based on a user's testing history. For example, if a user
has not missed any tests in his/her expected testing regimen, the
component may illuminate green. If a user has missed between 0
tests and a selected set-point (e.g. 3 tests, 4 tests, etc.), the
component may illuminate yellow. If a user has missed more than a
selected set-point of tests, the component may illuminate red.
Illumination of the component may be tied to any of a number of
variables (e.g., missed tests as described above, time since last
test, etc.), and any appropriate set-point (e.g., 3 tests, 3 days
since last test, etc.). The set-point may be pre-programed into the
device, input by the user, input by a doctor, or received by the
device from an external source. The component may also begin to
flash or pulse based on a user's testing history or it may both be
illuminated a specified color and flash or pulse.
[0057] In some embodiments, visual prompts may be utilized to
convey data about a user's testing patterns, trends, and/or
results. For example, in some instances, a visual prompt may
comprise a graphic that may move or otherwise change positions
based on a specified variable (e.g., time, testing frequency,
testing consistency, amount of sample received, status of analyte
measuring operation, etc.). For example, a graphic may be displaced
along the x-axis, the y-axis, or both the x and y axes
consecutively or concurrently to convey a change in a specified
variable. In some embodiments, a graphic may rotate to indicate a
change in a specified variable, or its size or depicted volume may
increase or decrease. In other embodiments, a graphic's movement
may comprise a combination of displacement, rotation, and
volumetric changes.
[0058] In some variations, the graphic may change based on the
cumulative results of many tests (e.g., number of tests completed
in a specific time frame, number of tests with results within a
desired range, number of tests completed consecutively, number of
days with completed tests within desired range, etc.). For example,
each time a user finishes a test, the graphic may be modified to
reflect the cumulative result of all of the completed tests. In
some instances, the graphic may be modified such that it moves from
a first pre-test position to a second post-test position. The
movement of the graphic from the first pre-test position to the
second post-test position may convey information to the user about
the user's testing patterns or results. For example, FIG. 6A is an
illustrative example of an analyte measurement device (600)
outputting such a visual prompt (602). The visual prompt (602)
comprises a mountain (608) with a hiker depicted in a first
position (604) and a second position (606). In this example, the
mountain (608) may be a graphical representation of the number of
tests a user must complete during a set time frame (e.g. 1 day, 2
weeks, etc.) to be fully compliant with the user's regimen. The
hiker in the first position (604) may graphically indicate how many
tests the user has completed thus far during the set time frame and
may appear before a user begins a test sequence. After the user
completes the test sequence, the hiker in the second position (606)
may appear to indicate to the user that he/she is closer to
completing all of the tests necessary to be compliant during the
set time frame. In some embodiments, the hiker's displacement from
the first position to the second position may appear on the screen
such that the hiker appears to be moving. Additionally, it should
be appreciated that while the hiker is moving in both the x-axis
and the y-axis, the graphics may be configured to move in any
direction or to rotate. The graphics may also be configured to move
along a rotational path. In some embodiments, the graphic may only
move horizontally and vertically and may not rotate, while in other
embodiments the graphics may rotate and move in any direction (e.g.
along a linear path, rotational path, a zig-zag path, etc.).
[0059] In some instances, the graphic may change based on data
collected during a single test (e.g., time since test sequence
began, number of steps of test sequence completed/remaining, amount
of sample collected, etc.). For example, the device may output an
active visual prompt as the graphic may change in real-time while
the analyte measurement device is completing an analyte measurement
operation. As an example, the active visual prompt may comprise a
cat drinking water from a bowl and expanding in volume while the
device collects a sample from a user. The cat's volume may be
indicative of the amount of sample the device has collected and the
cat may finish drinking water and move away from the bowl when the
device collects a sufficient sample volume. Another example of an
active visual prompt (614) is depicted in FIG. 6B. The visual
prompt (614) may comprise a graphic that moves along a specified
trajectory as an analyte measurement operation is occurring.
Specifically, the graphic may be at the beginning of its specified
trajectory or path when the user begins the analyte measurement
operation, it may be displaced such that it is at the midpoint of
its specified trajectory when the analyte measurement operation is
half-way completed, and it may be displaced such that it is at the
end of its specified trajectory when the analyte measurement
operation is complete. For example, FIG. 6B depicts a racecar (612)
exiting a ramp (610) and completing a rotation in the air. In this
example, the racecar (612) may appear on the device (600) when a
user begins a testing sequence. The racecar (612) may move
vertically and horizontally along a specified trajectory while the
testing sequence is taking place such that the racecar's (612)
movement tracks the progress of the testing sequence. For example,
the racecar (612) may begin exiting the ramp (610) when the user
begins the test sequence, the racecar (612) may have rotated 180
degrees when the user is half-way through the test sequence, and
the racecar (612) may appear to be landing when the test sequence
is complete. The above embodiments are merely examples and any
suitable graphical representation could be used.
Customization
[0060] As discussed above, the analyte sampling devices may be
configured to output a plurality of different prompts. In some
variations, the specific prompts outputted by the analyte
measurement devices may be customized in one or more ways.
Generally, the analyte measurement device is programmed with a
plurality of "prompt types." Each prompt type indicates an instance
during which the analyte measurement device may output a prompt.
For example, an analyte measurement device may be configured with a
first prompt type (e.g., providing a prompt when the device is
powered on or awoken from a low-power sleep state), a second prompt
type (e.g., providing a prompt when a user has performed a given
number of consecutive tests in a given time frame), and a third
prompt type (e.g., providing a prompt when the device has completed
an analyte measurement operation). For each prompt type, the
analyte measurement device may be programmed with one or more
prompts that may be selected for that prompt type. The analyte
measurement device may be figured to select a prompt for each
prompt type, and these selections are collectively referred to as a
prompt set. It may be possible for a user or the device to select
from one of a plurality of possible prompt sets, and the currently
selected prompt set is referred to here as the active prompt set.
The active prompt set may be manually set by a user, or may be
automatically determined by the analyte measurement device, as will
be discussed in more detail below. While typically a single prompt
is selected for each prompt type of a prompt set, in some instances
a plurality of different prompts may be selected for a given prompt
type in a prompt set. In these instances, when the analyte
measurement device determines that conditions for outputting the
prompt type have been met, the device may select one of the
plurality of different prompts in a random or predetermined order.
Additionally, for the purposes of this application, when a specific
prompt of a prompt type is intended to convey a measurement or time
(e.g., a concentration of an analyte in a sample, the duration of
time that has passed between measurements, the number of
consecutive days the device has performed a testing operation, the
current time, etc.), the prompt is considered a single prompt even
though the actual measurement or time conveyed by the prompt may
vary depending between instances that the prompt is output.
[0061] When two or more prompts are used for a given prompt type,
the prompts may vary in any suitable manner. In some variations, a
prompt type may have auditory prompt variations where different
language is used (e.g., "Welcome to POGO.RTM." in a first
variation, "Let's test your glucose!" in a second variation). In
other variations, a prompt type may have visual prompt variations
where different graphics are used (e.g., a sun-rising in a first
variation, a bowl of cereal in a second variation). In some
embodiments, a prompt type may have an auditory prompt, a visual
prompt and a tactile prompt associated with it. In embodiments in
which multiple prompts (e.g., visual, auditory, tactile) are
associated with a prompt type, and the prompt type comprises prompt
variations (e.g., 2 different visual prompts, 2 different auditory
prompts), any combination of the prompts may be used and the
combinations may be selected in any suitable manner (e.g. by the
user, at random, etc.).
[0062] Specifically with respect to auditory prompts, a prompt may
have variations where different voices are used (e.g., a female
voice in a first variation and a male voice in a second variation).
Additionally or alternatively, a prompt may have variations where
different sound effects are associated with a prompt (e.g., when a
prompt gives positive reinforcement for frequent testing, such as
"Way to go! You've tested 4 days in a row," a first variation may
include the sounds of a cheering crowd while a second variation may
include a fanfare of trumpets).
[0063] In some variations, the device may be configured to allow a
user to record one or more auditory prompts. For example, when an
analyte measurement device will be used by a child, it may be
desirable for the device to output auditory prompts that have been
recorded by a parent or caretaker of the child. Providing auditory
prompts with a familiar voice may provide an added level of comfort
to the child as he or she uses the device, which may reduce fear
associated with the device and may encourage the child to test more
frequently. The recorded auditory prompts may be provided to the
analyte measurement device in any suitable manner. In some
variations, the auditory prompts may be recorded by the user on an
external device (e.g., a computer, phone, tablet, recorder, or the
like), and may be transmitted to the analyte measurement device
(e.g., using a physical connection such as a USB connection and/or
a wireless connection such as WiFi or RFID, as discussed in more
detail above). In these variations, the external device may
comprise a program that has a prompt recording mode configured to
facilitate recording of specific auditory prompts, as will be
discussed in more detail below.
[0064] In other variations, the analyte measurement device may be
configured to record one or more auditory prompts. In these
variations, the analyte measurement device may comprise a
microphone or other sound recording device configured to capture a
user's voice. Additionally, the analyte measurement device may be
programmed with a prompt recording mode. When the device is placed
in the prompt recording mode, the device may be configured to guide
the user through recording one or more voice prompts. The prompt
recording mode may be initiated during initial setup of the analyte
measurement device, or may be selectively initiated by a user
(e.g., through a menu command). The analyte measurement device may
be configured to automatically guide the user through recording a
predetermined number of auditory prompts (such as, for example, a
given prompt set), or the user may select which auditory prompts he
or she would like to record. For each auditory prompt that will be
recorded in the prompt recording mode, the analyte measurement
device may be configured to identify what prompt or prompt type
will be recorded (e.g., "Please say a few words of encouragement",
"Please repeat the following when instructed: `Good morning!`"),
instruct the user when to start and/or stop recording (e.g.,
"Please begin recording after the countdown, and press the power
button when you have finished. 3, 2, 1."). When the auditory prompt
has been recorded, the prompt recording mode may be configured to
associate the recorded prompt with one or more prompt types (and in
some instances, one or more prompt sets).
[0065] In some variations where an analyte measurement device may
be used by multiple users, the device may be configured to select a
different active prompt set for different users of the device. For
example, one or more prompt types may include one or more prompts
that are customized to a specific user. For example, when a prompt
type is configured to provide an analyte measurement value, an
active prompt set for a first user may output a first variation of
an auditory prompt (e.g., "John, your blood glucose is 85 mg/mmol")
or a visual prompt (e.g., a cheering man), while an active prompt
set for a second user may output a second variation of an auditory
prompt (e.g., "Sally, your blood glucose is 85 mg/mmol") or a
visual prompt (e.g., a cheering woman). In some variations, prompts
may be tailored to a given user, and may use information about that
user (e.g., by using the user's name, the name of the user's
physician, etc.). Additionally or alternatively, the prompts may be
selected by the user based on his/her preferences (e.g., some users
may prefer a male voice while other users may prefer a female
voice). In some variations, prompts may be tailored to a given user
using information from a user profile setup by the user, as was
discussed above.
[0066] Generally, the analyte measurement device may be configured
to store a user-specific prompt set for a plurality of individual
users. When the device determines that one of the plurality of
individual users is using the device, the device may be configured
to automatically set the user-specific prompt set associated with
that user as the active prompt set. In some variations, the analyte
measurement device may be configured to select or load a specific
prompt set based on information stored in a user's user profile. If
the device is being used by an unrecognized user, the device may be
configured to set a default prompt set as the active prompt set.
Individual users may change their user-specific prompt set (e.g.,
using menu features or changing it in their user profiles), and new
users may be added to the plurality of individual users. The
analyte measurement device may be configured to differentiate
between users in any suitable manner. In some variations, users may
log into or otherwise input an identification code to the analyte
measurement device to access or indicate to the device to access
their user profiles. In some of these variations, a user may be
required to log-in before the device may be used in an analyte
measurement operation. Additionally or alternatively, a user may
insert a USB stick, memory card, or the like into the analyte
measurement device and the device may determine the user's identity
from this component. Additionally or alternatively, a user may
carry a key fob or other external device that may be wirelessly
detected by the analyte measurement device to determine the
user.
Removable or Additional Components
[0067] In some variations, the analyte measurement device may
select an active prompt set (or a default active prompt set) based
on one or more components of the device. In some instances, an
analyte measurement device may be constructed and/or manufactured
such the analyte measurement device may have one of a plurality of
different physical appearances. For example, when the analyte
measurement device comprises an outer housing (such as the meter
housing (118) of the meter (100) discussed above with respect to
FIG. 1B), the outer housing may be altered to change the physical
appearance of the analyte measurement device. For example, the
surface contours and/or the colors of the outer housing may alter
the physical appearance of the analyte measurement device.
Similarly, an outer housing may be configured with one or more
visual patterns (e.g., chevron pattern, polka dots, etc.) and/or
images (e.g., an animal, a race car, or the like).
[0068] Accordingly, in some variations, an analyte measurement
device may be constructed and/or manufactured in one of a plurality
of different configurations, in which each configuration has a
different physical appearance. In some of these variations, each
configuration of the analyte measurement device may have a default
active prompt set associated with that configuration. Accordingly,
systems and kits may include a plurality of analyte measurement
devices having different physical appearances, each having an
appearance-specific default active prompt set. In some instances,
the default active prompt set for a given configuration of the
device may be thematically associated with the physical appearance
of the analyte measurement device. For example, one or more
portions of the housing of one configuration of an analyte
measurement device may include an image of a car, and the
associated auditory prompt set may include car-related sound
effects (e.g., revving engines, squealing tires) and/or speech
(e.g., "Start your engines") and/or the associated visual prompt
set may include car-related visual effects (e.g. driver in car
turning key, rotating tires). Another configuration may include an
image of a cat, and the associated auditory prompt set may include
cat-related sound effects (e.g., purring, meowing) and/or speech
(e.g., "That test was purr-fect") and/or the associated visual
prompt set may include cat-related visual effects (e.g., person
petting cat, cat appearing to speak). The analyte measurement
devices may have any suitable number of different configurations,
each having a graphic appearance and an associated set of
prompts.
[0069] In some variations, a user may replace one or more
components of the analyte measurement device and/or add one or more
additional components to alter the physical appearance of the
device. In some variations, the analyte measurement device may be
configured to change the active prompt set in response to the
replacement or addition of one of these components. In some
instances, a portion of a housing of the analyte measurement device
may be releasably attached to the analyte measurement device such
that the releasable portion may be replaced with another variation
of the releasable portion. In other variations, the housing may be
configured to accept an additional component using snap fit
connectors, sliding connectors, clips, or the like. Systems or kits
may include a single removable housing portion or they may include
a plurality of removable housing portions. In systems or kits that
include a plurality of removable housing portions, the analyte
measurement device may be configured such that one of the plurality
of removable housing portions may be connected to the analyte
measurement device at a time. The plurality of removable housing
portions may have different physical appearances, such as described
above, such that changing the removable housing portion of the
analyte measurement device may change the appearance of the analyte
measurement device. In some variations, changing the removable
housing portion of the device may not significantly change the
physical appearance of the device, but may still change the active
prompt set. In some instances, the removable or additional housing
portion may allow for the delivery of data to the device, for
example, updated software or firmware.
[0070] In some embodiments, the removable portion of the housing
may be a front cover of the housing. For example, in the variation
of the device shown in FIG. 1B, the meter housing (118) may
comprise a removable front cover (132). In other variations, a
front cover may be added to the housing. For example, in the
variation of the analyte measurement device (700) shown in FIG. 7A,
the housing (702) may comprise a first front cover (704) and may be
configured to accept a second front cover (706). The second front
cover (706) may alter the physical appearance of the device, change
the active prompt set and/or deliver data stored within it to the
device. In other embodiments, the removable portion of the housing
may be a component other than the front cover. For example, as
shown in FIGS. 7A and 7B, the removable portion of the housing may
comprise the bottom (708), the port (710), the battery cover (712),
the back cover (714), and the like.
[0071] In some embodiments, the cartridge may be configured to
carry information relating to a prompt set. The cartridge (102) may
comprise an information storage member (134) that carries
information and may communicate with the meter (100) to convey the
stored information. For example, the storage information member
(134) may comprise one or more barcodes, as depicted in FIG. 1C. In
these variations, the meter (100) may comprise one or more barcode
scanners/readers. In variations where the cartridges are
cylindrical or have an otherwise rounded cross-sectional area, the
cartridge may be rotated to facilitate the reading of the barcode.
In other instances, the meter (100) may be configured to move the
cartridge into a position where the barcode may be read.
[0072] The cartridge may comprise any suitable number of barcodes
(e.g., zero, one, two, three, or four or more barcodes). In some
variations, the information storage member (134) may comprise one
or more memory chips or cards, which may convey information to the
meter through, for example, RF transmission, optical communication,
or via direct electrical communication. In other variations, a
separate memory card or chip may be packaged and/or provided with
the cartridge. This memory card or chip may be inserted into a
portion of the meter to convey information to the meter, as is
discussed in more detail below.
[0073] As mentioned above, the analyte measurement device may be
configured to change the active prompt set based on the removable
portion that is currently connected to the analyte measurement
device. In some variations, the analyte measurement device may be
configured to automatically detect which removable portion is
connected to the device and select an active prompt set associated
with that removable portion. In some embodiments, the removable
portion may comprise an identifier that may contain or transmit
information or otherwise communicate with the analyte measurement
device about the removable component connected to it and/or the
prompt set (e.g., auditory, visual, etc.) associated with the
connected removable component. For example, a system may comprise
an analyte measurement device configured to receive a removable
housing portion, and may further comprise a first version of the
removable housing portion and a second version of the removable
housing portion. The first version of the removable housing portion
may have a first prompt set associated therewith, and the second
version of the removable housing portion may have a second prompt
set associated therewith. When the first version of the removable
housing portion is attached to the analyte monitor, the analyte
measurement device may be configured to detect the first version's
identifier and set the first prompt set as the active prompt set. A
user may remove the first version of the removable housing portion
and connect the second version of the removable housing portion to
the analyte measurement device. Upon connection of the second
version of the removable housing portion, the analyte measurement
device may detect the second version's identifier and may set the
second prompt set as the active prompt set. In some variations, the
identifier may be integrally formed with the prompt set.
[0074] Systems and kits may include a single removable housing
portion or a plurality of versions of a given removable housing
portion. Each version of the plurality of versions may have an
associated identifier and prompt set, and the analyte measurement
device may be configured to detect the version of the removable
housing portion and set the associated prompt set as the active
prompt set. In some variations, each version of the removable
housing portion may include a different prompt set. A first prompt
set may be considered different from a second prompt set if at
least one prompt within the prompt set is different or if the
prompt sets comprise different numbers of prompts.
[0075] Additionally or alternatively, as depicted in FIGS. 8A-8B, a
skin (802) (e.g. a silicone case or the like) may be placed over
and connected to a portion of the housing (804) of an analyte
measurement device (800), which may change the physical appearance
of the analyte measurement device (800). In these variations, the
analyte measurement device (800) may be configured to detect the
presence of an identifier in/on the skin (802), and may be
configured to set a prompt set (auditory, visual, etc.) associated
with the skin (802) as the active prompt set. In some instances, a
system or kit may comprise a skin (802) comprising an identifier
that is associated with a prompt set. In other variations, a system
or kit may comprise multiple versions of a skin (802) (e.g., having
different physical appearances or configurations), wherein each
version comprises an identifier with a prompt set associated
therewith. In these variations, the analyte measurement device may
be configured to detect which version of the skin (802) is
connected to the device (800) using the identifier, and may set the
prompt set associated with that identifier as the active prompt
set. For example, a system may include an analyte measurement
device, a first version of a skin having a first prompt set
associated therewith, and a second version of the skin having a
second prompt set associated therewith. The skins may have
different physical appearances, such as discussed above. In these
variations, when the first skin is attached to the analyte
measurement device, the analyte measurement device may be
configured to detect the first skin's identifier and set the first
prompt set as the active prompt set. A user may remove the first
version and connect the second version of the skin to the analyte
measurement device. In these instances, the analyte measurement
device may be configured to detect the second skin's identifier and
may set the second prompt set as the active prompt set. In some
variations, the identifier may be integrally formed with the prompt
set.
[0076] In variations where an analyte measurement device is
configured to receive both a removable portion of a housing and a
skin, the analyte measurement device may be configured to select
the set of auditory prompts based on either the version of the
removable portion or the version of the skin. In some of these
variations, the presence of a skin may override the presence of the
removable portion, such that the analyte measurement device is
configured to set a prompt set associated with the skin as the
active prompt set instead of a prompt set associated with the
removable portion when both the skin and the removable portion are
present. In some instances a user may be able to change the active
prompt set even when a specific version of a skin or removable
housing portion is attached to an analyte measurement device, by
for example, changing a selection in a menu on the device.
[0077] The analyte measurement device may be configured to detect
the identifier of a removable housing portion and/or a skin in any
suitable manner. In some variations, a removable housing
portion/skin may be configured to achieve direct electrical
communication with a control unit of the analyte measurement device
when attached to the analyte measurement device. For example, the
removable housing portion or skin may include an electrical
interface (such as a USB interface) that may physically contact an
electrical interface of the analyte measurement device, and the
analyte measurement device may be able to recognize or determine
the presence and/or identifier of the removable housing
portion/skin based on this electrical connection. Additionally or
alternatively, one or more portions of the removable housing
portion/skin may physically press against one or more buttons of
the analyte measurement device to indicate the presence and/or
identifier of a removable housing portion/skin. Additionally or
alternatively, the removable housing portion/skin may be configured
to wirelessly communicate with the analyte measurement device
(e.g., via WiFi or RFID) such that the analyte measurement device
may be configured to recognize or determine the presence and/or
identifier of a removable housing portion/skin.
[0078] When the analyte measurement device is configured to set an
active prompt set based on a prompt set corresponding to a
removable housing portion's or skin's identifier, the specific
prompts from the prompt set may be retrieved from any suitable
location. In some variations, the analyte measurement device may be
pre-programmed with the necessary prompts included in the various
prompt sets. For example, if a system includes an analyte
measurement device and a plurality of versions of a removable
housing portion, each version having a corresponding prompt set,
the analyte measurement device may be pre-programmed with the
auditory prompts of each of the corresponding prompts. Additionally
or alternatively, the analyte measurement device may be configured
to retrieve one or more prompts from the removable housing
portion/skin. In these variations, the removable housing
portion/skin may be configured to store one or more prompts or
prompt sets (e.g., in a memory such as flash memory or an
integrated circuit), and the analyte measurement device may be
configured to retrieve the prompts or prompt sets from the
removable housing portion/skin. In some of these variations, the
analyte measurement device may be configured to retrieve and use
the prompts from the removable housing portion/skin without
permanently storing the prompts in memory of the analyte
measurement device. In other variations, the analyte measurement
device may be configured to download and store the prompts from the
removable portion/skin. In these variations, the downloaded prompts
may be later selected (e.g., by a user) for use even when the
specific version of the removable housing portion/skin has been
removed from the analyte measurement device, using, for example, a
selection menu. In still other variations, prompts or prompt sets
associated with versions of a removable housing portion/skin may be
downloaded from an external device (e.g., a computer, tablet, phone
in communication with the analyte measurement device, a memory
stick that may be inserted into the analyte measurement device,
etc.) either via direct connection (such as a USB interface) or
wireless connection (e.g., WiFi, RFID). In some variations, the
removable housing portion/skin may contain updated
software/firmware that may be transferred to the device when the
removable housing portion/skin communicates with the device. The
software/firmware updates may be contained on the removable housing
portion/skin in addition to, or instead of, the prompt sets.
[0079] As mentioned above, the analyte measurement device may
comprise a variety of components that enable the transfer of
information from a removable housing portion/skin to the control
unit of the device. FIG. 7C depicts a variation of the analyte
measurement devices described here with the back cover (714)
removed. In this embodiment, the analyte measurement device (700)
may comprise electrical contacts (716) located below the batteries
when the device is in use. The electrical contacts (716) may be
configured to mate or otherwise communicate with corresponding
electrical contacts on a removable housing portion, for example, a
battery cover (712). Alternatively or additionally, the device
(800) may comprise one or more wireless chips (718) that may
communicate with one or more corresponding wireless chips contained
in or on a removable portion of the device. In some embodiments,
the device (800) may also comprise a USB port (720) that may
physically contact a USB plug on the removable portion of the
device. These components may mate with any removable or additional
portion of the housing or with a skin, as described above.
[0080] FIGS. 8A-8D illustrate another variation of the analyte
measurement devices described here. FIGS. 8A and 8B depict front
and perspective views of an analyte measurement device (800) with a
skin (802) partially covering the housing (804). FIGS. 8C-8D depict
a top perspective view of an analyte measurement device (800)
without a skin (802), and with a skin partially covering the
housing (804), respectively. The analyte measurement device (800)
shown here may receive information from the replacement or addition
of a skin (802). The skin (802) may comprise any suitable means for
storing and transferring information. For example, the skin (802)
may comprise a chip (806) that may store information and transfer
it to the control unit of the device (800). In some variations, the
skin may comprise a USB plug (808) that may physically contact a
USB port (810) on the device (800). While the USB port (810) is
depicted on the top of the device (800), it may be placed at any
location that is suitable for connection to a skin (802) or other
removable or additional housing portion. In some variations, the
skin (802) may comprise both a USB plug (808) and a USB port (812)
such that attachment of the skin (802) to the device (800) does not
prevent the device (800) from connecting via USB to another
component.
* * * * *