Title of Invention

ANALYTE TESTING DEVICE

Abstract A testing device for testing an analyte in a sample of bodily fluid, comprising: memory storing data, said data being analyte data related to analyte measurements carried out by the testing device and lifestyle data, and the analyte data includes a pointer to a bodily location from which an analyte sample was taken by an individual using the testing device, wherein the testing device utilizes a plurality of data pointers, each of said data pointers indicating a separate bodily location; initiation means for initiating immediate entry of data related to a specific category of lifestyle data, navigation means for entry and navigation of said data; and transfer means for transferring said data to said memory.
Full Text ANALYTE TESTING DEVICE
FIELD OF THE INVENTION
The present invention relates to a testing device for testing analytes in samples of bodily
fluid and storing and analysing lifestyle data, which may not be analyte related. A
preferred use of the testing device is for testing the glucose level in the blood of
individuals, including people with diabetes. Lifestyle data may, for example, comprise data
related to the food consumption, exercise level, medication intake or other health related
data of an individual. An example of a use for such a testing device is by physicians, who
routinely need to make an assessment of an individual's lifestyle.
BACKGROUND OF THE INVENTION
Glucose monitoring is a fact of everyday life for diabetic individuals. The accuracy of
such monitoring can significantly affect the health and ultimately the quality of life of the
person with diabetes. Generally, a diabetic patient measures blood glucose levels several
times a day to monitor and control blood sugar levels. Failure to test blood glucose levels
accurately and on a regular basis can result in serious diabetes-related complications,
including cardiovascular disease, kidney disease, nerve damage and blindness. There are a
number of electronic devices currently available which enable an individual to test the
glucose level in a small sample of blood. One such glucose meter is the OneTouch®
Profile ™ glucose meter, a product which is manufactured by Lifescan.
In addition to glucose monitoring, diabetic individuals often have to maintain tight control
over their lifestyle, so that they are not adversely affected by, for example, irregular food
consumption or exercise. In addition, a physician dealing with a particular diabetic
individual requires detailed information on the lifestyle of the individual to provide
effective treatment or modification of treatment for controlling diabetes. Currently, one of
the ways of monitoring the lifestyle of an individual with diabetes has been for the
individual to keep a paper logbook of their lifestyle. Another way is for an individual to
simply rely on remembering facts about their lifestyle and then relay these details to their
physician on each visit.
The aforementioned methods of recording lifestyle information are inherently difficult,
time consuming and possibly inaccurate. Paper logbooks are not necessarily always
carried by an individual and may not be accurately completed when required. Such paper
logbooks are small and it is therefore difficult to enter detailed information requiring
detailed descriptors of lifestyle events. Furthermore, an individual may often forget key
facts about their lifestyle when questioned by a physician who has to manually review and
interpret information from a hand-written notebook. There is no analysis provided by the
paper logbook to distil or separate the component information. Also, there are no graphical
reductions or summary of the information. Entry of data into a secondary data storage
system, such as a database or other electronic system, requires a laborious transcription of
information, including lifestyle data, into this secondary data storage. Difficulty of data
recordation encourages retrospective entry of pertinent information that results in
inaccurate and incomplete records.
Moreover, a diabetic individual often has to keep a plurality of devices on their person for
diagnosis and treatment, for example both glucose level monitoring equipment and
medication. Hence, having to carry paper records of their lifestyle is an added unwanted
burden and entry of data therein is very time consuming.
There currently exist a number of portable electronic devices that can measure glucose
levels in an individual and store the levels for recalling or uploading to another computer
for analysis. On such device is the Accu-Check™ Complete™ System from Roche
Diagnostics, which provides limited functionality for storing lifestyle data. However, the
Accu-Check™ Complete™ System only permits a limited selection of lifestyle variables to
be stored in a meter. Also, there are only three navigation buttons on the meter, which
makes it difficult to input lifestyle data. There is a no intelligent feedback from values
previously entered into the meter and the user interface is unintuitive for an infrequent user
of the meter.
Therefore, what is required is an electronic device for logging and analysing lifestyle data,
which does not increase the number of devices an individual has to keep on their person
and is also more intuitive and easier to use than other devices, thereby encouraging an
individual to record information related to their lifestyle. Lifestyle data should be taken to
mean any quantifiable information which might affect or represent an individual's physical
condition. Examples of lifestyle data are food consumption, physical exertion (e.g.
exercise), medication intake and health checks performed on the individual.
SUMMARY OF THE INVENTION
In view of the foregoing and in accordance one aspect of the present invention, there is
provided a testing device for testing an analyte in a sample of bodily fluid, comprising:
memory for storing data, said data being analyte data related to analyte
measurements carried out by the meter and lifestyle data;
initiation means for initiating entry of data related to a specific category of lifestyle
data;
navigation means for entry and navigation of said data; and
transfer means for transferring said data to said memory.
Such a testing device provides simple and effective recordal of both analyte and lifestyle
related data in a single, compact device. Input of lifestyle data can be initiated simply
through use of the initiation means, without having to first perform an analyte
measurement. Of course, it will be appreciated that the testing device could be used to
measure only analyte levels, such as glucose levels for diagnosis and treatment of diabetes,
without the added lifestyle functionality impinging on the usability of the testing device.
Conversely, the testing device could also be used for diagnosis and treatment of diseases
other than diabetes, either independently or in combination with diabetes tracking.
Preferably, the testing device comprises a display screen, wherein the transfer means is a
processor, the processor being adapted to access the data stored in the memory and display
said data on the display screen. The display screen may be a Liquid Crystal Display
(LCD) screen able to render graphical objects in black and white, grayscale or colour.
Improved chemiluminescence and/or a backlight provide visual enhancements over prior-
art testing devices. Thus, use of the testing device is improved for individuals with
impaired vision, which is particularly prevalent amongst people with diabetes.
Preferably, the processor is further adapted to perform an analysis on the data and display
results of said analysis on the display screen.
Preferably, said analysis includes determining whether data lies outside a predetermined
range. Such analysis allows simple self-diagnosis by an individual of their condition using
the testing device, thereby increasing the individual's awareness of their condition and
encouraging changes in their lifestyle, where required. Additional information may be
immediately added following determination that data lies outside a predetermined range.
This ensures that lifestyle information is entered in a timely and therefore accurate way.
In one embodiment of the present invention, said analysis comprises averaging data stored
in the memory over a predetermined time period.
Preferably, said navigation means is adapted to select data for analysis or for display on the
display screen.
Preferably, the analyte data includes a pointer to a bodily location from which an analyte
sample was taken by an individual using the testing device. Thus, the accuracy and
interpretation of measurements performed by the testing device can be improved. A user
of the testing device or health care professional can more easily and accurately interpret the
information provided in the data analysis performed by the testing device. Additionally, if
a control solution is used as the analyte to be tested, the analyte data resulting from the
testing of the control solution is flagged and such data is not used in any analysis of results
performed by the testing device.
Preferably, said lifestyle data is stored in the memory as lifestyle records, each lifestyle
record comprising:
a date and time-stamp;
a pointer to a lifestyle event; and
a lifestyle value.
Preferably, said analyte data is stored in the memory as analyte records, each analyte
record comprising:
a date and time-stamp; and
an analyte value;
Preferably, each analyte record further comprises:
a pointer to a bodily location from which an analyte sample was taken by an
individual using the testing device;
a pointer to a lifestyle event; and
a lifestyle value.
The time-stamp may be a multi-bit binary representation of the time and date for each
record. The pointer to a lifestyle event may be a multi-bit binary value which corresponds
to each specific type of quantifiable lifestyle data.
Preferably, said initiation means is a plurality of function-specific buttons, each function-
specific button corresponding to a specific category of lifestyle data. Thus, entry of
lifestyle data relating to a specific category of lifestyle data is quick and easy.
Tn view of the foregoing and in accordance a second aspect of the present invention, there
is provided a testing device for testing an analyte in a sample of bodily fluid, comprising:
memory for storing data;
navigation means for entry and navigation of said data;
transfer means for transferring said data to said memory; and
user interface generation means for generating a user interface on a display screen,
wherein:
said data is analyte data related to analyte measurements carried out by the meter
and lifestyle data;
said lifestyle data is arranged into one or more categories of lifestyle data;
said user interface has sub-category options for each category of lifestyle data;
said navigation means is adapted to select said sub-category options;
said user interface generation means is responsive to selection of a given sub-
category option, such that value options for each of said sub-category options are displayed
in the user interface;
said navigation means is adapted to select said value options;
said user interface generation means is responsive to selection of a value option,
such that values for the selected value options are displayed in the user interface;
said navigation means is adapted to select said values; and
said transfer means is responsive to selection of said values for transferring one or
more selected values into said memory.
A standard data entry approach for all types of lifestyle data is thus achieved, making the
user interface easy to use and entry and manipulation of lifestyle data simple for an
individual not familiar with such testing devices or for someone who is only uses the
testing device occasionally. This way, use of the testing device for entry of lifestyle data is
also encouraged.
Preferably, the transfer means further transfers into said memory with said one or more
selected values:
a time-stamp; and
a pointer to the selected value option.
Preferably, the user interface generation means is responsive to said navigation means,
such that selectable categories of said data are displayed in the user interface, said
navigation means being adapted to select said selectable options, the user interface
generation means being responsive to selection of one of said selectable categories to
display on the display screen data from the memory corresponding to a selected category
of said data.
Preferably, the testing device further comprises analysis means for performing an analysis
on said data, wherein analysis options for each selectable category are displayed in the user
interface, said navigation means being adapted to select said analysis options, the analysis
means being responsive to selection of one of said analysis options to analyse said data
stored in the memory, the user interface generation means being responsive to said analysis
means to display results of said analysis on the display screen. The results of said analysis
may be displayed graphically on the display screen, for example, as graphs of different
types of stored data against time.
Preferably, said analysis comprises averaging said data stored in said memory over a
predetermined time period, said predetermined time period being determined by selection
of one of said analysis options.
Preferably, the testing device further comprises one or more function-specific buttons,
wherein:
each function-specific button corresponds to an associated category of lifestyle
data; and
the user interface generation means is responsive to operation of one of the
function-specific buttons to immediately display said sub-category options for the
associated category of lifestyle data in the user interface. Thus, entry of lifestyle data
relating to a specific category of lifestyle data is quick and simple.
Preferably, said categories of lifestyle data comprise:
a food category relating to food intake of an individual;
a medication category relating to medication use of an individual;
a health category relating to health check-ups, health test results and/or health
condition of an individual; and
an exercise category relating to exercise levels of an individual.
In accordance with a third aspect of the present invention, there is provided a testing device
for testing an analyte in a sample of bodily fluid, comprising:
memory for storing data, said data being analyte data related to analyte
measurements carried out by the testing device and lifestyle data;
navigation means for entry and navigation of said data;
transfer means for transferring said data to said memory; and
prompt means for prompting a user of the testing device to enter lifestyle data
associated with an analyte measurement following a carrying out of said analyte
measurement, if said analyte measurement lies outside a pre-defined range.
Preferably, there is further provided a display screen and the prompt means is adapted to
display messages on the display screen, said messages prompting a user of the testing
device to enter lifestyle data associated with said analyte measurement.
Preferably, said transfer means is a processor and said processor is adapted to perform an
analysis on selected lifestyle data and/or analyte data and display results of said analysis on
the display.
In accordance with a fourth aspect of the present invention, there is provided a testing
device for testing an analyte in a sample of bodily fluid, comprising:
memory for storing analyte data; and
navigation means,
wherein:
said sample of bodily fluid is usually obtained from a specific bodily location on an
individual; and
said navigation means is adapted to flag analyte data stored in the memory if said
sample of bodily fluid is obtained from an alternate bodily location other than said specific
bodily location following a carrying out of an analyte measurement.
Preferably, said navigation means is further adapted to indicate to the memory said
alternate bodily location, such that a pointer to said alternate location is stored with
associated analyte data in the memory.
In one embodiment of the present invention, there is further provided a display screen, and
said navigation means comprises a cursor button and an OK button, such that operation of
the cursor button adapts the display screen to display one or more alternate bodily location
options corresponding to one or more alternate bodily locations and operation of the OK
button sends said alternate bodily location to the memory.
In accordance with a fifth aspect of the present invention, there is provided a testing device
for testing an analyte in a sample of bodily fluid, comprising:
memory adapted for storing data, said data being analyte data and lifestyle data;
a display screen;
a processor adapted to access said data and display said data on the display screen;
and
navigation means adapted to be operated to select said data to be accessed by the
processor.
Preferably, the processor is further adapted to perform an analysis on selected data and
display results of said analysis on the display screen.
Preferably, the navigation means is one or more navigation buttons.
Preferably, the navigation buttons consist of a cursor button, an OK button and a back
button.
In one embodiment of the present invention, there is provided communication means
adapted to transfer data between said memory and an external device. Thus, diagnosis and
treatment of an individual using the testing device is improved. In fact, the use of a
personal computer allows diagnosis and prescription of treatment from a remote location,
since data stored in the testing device may be transferred from the testing device and
transmitted, optionally via the Internet, to a physician anywhere in the world.
Preferably, the testing device is a glucose meter and one of the analytes being tested is
glucose. Thus, diagnosis and treatment of diabetes in an individual using the testing device
is improved.
In accordance with a sixth aspect of the present invention, there is provided a method of
storing lifestyle data related to the lifestyle of an individual in a testing device for testing
an analyte in a sample of bodily fluid, comprising the steps of:
indicating a specific category of lifestyle data to the testing device;
indicating a sub-category of lifestyle data to the testing device;
inputting a value into the testing device; and
storing the value in memory in the testing device.
In accordance with a seventh aspect of the present invention, there is provided a method of
manipulating lifestyle data related to the lifestyle of an individual and analyte data stored
in a testing device for testing an analyte in a sample of bodily fluid, said method
comprising the steps of:
indicating a category of data to the testing device;
analysing data from said category of data, thereby generating analytical results; and
displaying said analytical results on a display screen on the testing device.
Preferably, the method further comprises the step of indicating a time period for analysis of
said data before analysing said data, the step of analysing data comprising averaging data
from said category of data over said time period.
In accordance with an eighth aspect of the present invention, there is provided a method of
storing analyte data in a testing device for testing an analyte in a sample of bodily fluid,
said method comprising the steps of:
obtaining a sample of bodily fluid from a bodily location, said sample of bodily
fluid normally being obtained from a specific bodily location on an individual;
measuring an analyte level in the sample of bodily fluid;
storing said analyte level in memory in the testing device; and
flagging said analyte level in the memory if said sample of bodily fluid was
obtained from an alternate bodily location other than said specific bodily location.
Preferably, the step of flagging said analyte level in the memory comprises storing a
pointer to said alternate bodily location with said analyte level in the memory.
The present invention provides a testing device for sampling and performing an analysis on
a sample of bodily fluid, such as blood, and storing the results of said analysis, including
means for inputting and storing inputted lifestyle data.
The present invention facilitates the monitoring of an individual's lifestyle by integrating
into a single device the steps involved in sampling and analysing blood and recording other
information about an individual's everyday life into a simple process employing a single
device.
BRIEF DESCRIPTION OF DRAWINGS
A specific embodiment is now described by way of example only and with reference to the
accompanying drawings, in which:
Fig. 1 is a three-dimensional representation of the testing device according to one
embodiment of the present invention;
Fig. 2a is a block diagram of the principal internal components of the testing device of Fig.
l;
Fig 2b shows a layer structure of functional components of the testing device of Fig. 1.
Fig. 3 is a generic representation of a user interface displayed on a display screen of the
testing device of Fig. 1;
Fig. 4 is a representation of a generalised lifestyle data entry sequence employed by the
testing device of Fig. 1;
Figs. 5a to 5d show specific data entry sequences for entry of food, medication, health and
exercise related lifestyle data according to the generalised lifestyle data entry sequence of
Fig. 4;
Fig. 6a shows an information menu displayed in a user interface of the testing device of
Fig. 1 for displaying data stored in the testing device;
Fig. 6b shows a sample logbook screen displayed in the user interface of the testing device
of Fig. 1 for displaying data stored in the testing device;
Fig. 7 shows a testing sequence for measuring glucose levels with the testing device of Fig.
1 through use of a test-strip inserted into the testing device; and
Fig. 8 shows a generalised sequence for entering health, exercise and food comments
following measurement of a glucose level.
DETAILED DESCRIPTION OF DRAWINGS
The present invention will be described below relative to an illustrative embodiment.
Those skilled in the art will appreciate that the present invention may be implemented in a
number of different applications and embodiments and is not specifically limited in its
application to the particular embodiment depicted herein. In particular, the present
invention will be discussed below in connection with sampling blood, although those of
ordinary skill will recognise that the device could be modified to be used with other types
of fluids or analytes besides glucose.
Referring to Fig. 1, there is shown a testing device (100) for testing glucose levels in the
blood of an individual. The testing device (100) externally includes initiation means (102)
for initiating entry of data related to a specific category of lifestyle data, specifically
function-specific buttons (108, 110, 112, 114), and navigation means (104) for entry and
navigation of data, specifically navigation buttons (118, 120, 122). Lifestyle data is any
information which is related to the everyday lifestyle of an individual. In the embodiment
shown in Fig. 1, lifestyle data is divided into four categories, namely food, medication,
health and exercise categories, which relate respectively to food intake, medication use, the
occurrence of health check-ups and general health condition and exercise levels of an
individual. Further included on the testing device is a liquid crystal display screen (106) for
displaying measured glucose levels and facilitating entry of lifestyle related information
into the testing device (100).
Each category of lifestyle data has an associated function-specific button, operation of
which immediately initiates a sequence for entry of data corresponding to the category of
lifestyle to which the operated function-specific button relates. The categories to which
each of the function-specific buttons (102) relate are shown on the surface of the function-
specific buttons (102) by a graphical representation. The food category is represented on a
food function-specific button (108) by a conventional "knife and fork" icon. There are
similar suitable representations on a medication function-specific button (110), health
function-specific button (112) and an exercise function-specific button (114). In an
alternative embodiment, the function-specific buttons may have tactile icons on their
surfaces, such tactile icons facilitating operation of the testing device by partially sighted
or blind individuals. Operation of one of the function-specific buttons (102) when the
testing device (100) is switched off, immediately switches the testing device on and
initiates a sequence for entry of data.
The function-specific buttons (102) ensure that a user of the testing device (100) does not
need to navigate through a complex and unfamiliar menu system to enter lifestyle data.
Instead, to immediately enter an applicable data entry sequence, a user merely needs to
press one of the function-specific buttons (102). The required function specific-button is
easily determinable from the graphical icon on the button's surface. An information button
(116) is another function-specific button, but it does not relate to a specific category of
lifestyle data. Instead, pressing the information button (116) immediately allows a user to
view and analyse data stored in the testing device (100). Such data may be any data stored
in the testing device (100), for example previously measured glucose levels or entered
lifestyle information.
The navigation buttons (104) comprise an OK button (118), a back button (120) and a
cursor button (122) and facilitate entry and analysis of data stored in the testing device by
enabling a user to navigate through a user interface (250) displayed on the display screen
(106). The cursor button is bi-directional and has an upwards operative section (122a) and
a downwards operative section (122b).
The testing device (100) is switched on by pressing any one of the function-specific
buttons (102) or the back button (120). In addition, the testing device (100) is
automatically switched on when a test-strip is inserted into test-strip port (124) for
measurement of a glucose level in a sample of blood placed on the test-strip. The testing
device (100) can be switched off by holding down the back button (120) for a pre-defined
period of time. The display screen of the testing device (106) includes a backlight, which
can be switched on or off by holding down the OK button (118) for a pre-defined period of
time.
Additionally, there is a communication port (126) on one side of the testing device (100)
which accepts a connector attached to a connecting lead, thereby allowing the testing
device (100) to be linked to an external device such as a personal computer. The personal
computer, running appropriate software, allows entry and modification of set-up
information (e.g. the current time and date and language), as well as being able to perform
other analysis and display functions performed by the testing device (100). In addition, the
personal computer may be able to perform advanced analysis functions or transmit
transferred data to another personal computer, optionally via the Internet, for improved
diagnosis and treatment at a remote location. This way, improved treatment and diagnosis
of diabetes by a medical practitioner is facilitated by being able to link the testing device
(100) with the personal computer.
Referring to Fig. 2a, the internal layout of the testing device (100) is shown. Internally, the
testing device comprises a processor (200), which, in the testing device of Fig. 1, is a 32-
bit RISC microcontroller. The processor is bi-directionally connected via I/O ports (214)
to memory (202), which, in the testing device of Fig. 1, is an EEPROM. Also connected to
the processor (200) via I/O ports (214) are the communication port (126), the navigation
buttons (104), the function-specific buttons (102) and a display screen driver (236). The
communication port (126) is serially connected to the processor (200), thereby enabling
transfer of data between the memory (202) and an external device, such as a personal
computer. The navigation buttons (104) and the function-specific buttons (102) are
directly connected to the processor (200). The processor (200) controls the display screen
(106) via the display screen driver (236).
An Application Specific Integrated Circuit (ASIC) (204) implements electronic circuitry
required to facilitate measurement of a glucose level from a sample of blood on a test-strip
inserted into the test-strip port (124). For the purpose of internal crosschecking, analogue
voltages can be supplied to the ASIC (204) and measured from the ASIC (204) by the
processor (200) through an internal A/D converter (216).
The processor (200) further comprises internally: a processor core (208), a ROM (210)
containing computer code, RAM (212) and a clock (218), which provide control circuitry
for components, which are connected externally to the processor (200) to the I/O ports
(214) and the A/D converter (216).
Referring to Fig. 2b, a layer structure of the functional aspects of the testing device (100) is
shown. User interface generation means (252) generates a user interface (250) on the
display screen (106) of the testing device (100). The navigation means (104) (specifically
the navigation buttons (104) in the described embodiment) and the initiation means (102)
(specifically the function-specific buttons (102) in the described embodiment) allow a user
to interact with the user interface (250). Transfer means (258), on instruction from the user
interface generation means (252), transfers data stored in the memory (202) back to the
user interface generation means (252) for display in the user interface (250). Analysis
means (254), under instruction from the user interface generation means (252), performs an
analysis on data stored in the memory (202) and returns results of the analysis to the user
interface generation means (252) for display in the user interface (250). When measured
glucose levels are outside a pre-defined range, prompt means (256) instructs the user
interface generation means (252) to display a message prompting a user of the testing
device (100) to enter lifestyle data following measurement of a glucose level from a
sample of blood on a test strip inserted into the testing device (100).
Fig. 3 shows a generic user interface (250) generated by the user interface generation
means (252) and displayed on the display screen (106). Selectable objects (304) are
displayed in the user interface (250). The user interface generation means (252) adapts the
user interface (250) on operation of the navigation means (104), which in the presently
described embodiment, are the navigation buttons (104).
The selectable objects (304) are highlighted by operating the cursor button (122). The user
interface generation means (252) adapts the user interface (250) such that the selectable
objects (304) are highlighted in turn. In the embodiment shown, the selectable objects
(304) are highlighted by a highlight bar (306), which inverts the contents of a rectangular
area surrounding a highlighted selectable object (308). A title (314) and a graphical icon
(316) related to the most recently operated function-specific button (102) are displayed in
the user interface (250). Both the title (314) and the graphical icon (316) correspond to the
current screen being displayed in the user interface (250). Operation of the cursor button
(122) on its upwards or downwards operative section (122a, 122b) will move the highlight
bar (306) up or down through the selectable objects (304) respectively. However, it will be
readily appreciated that a selectable object (308) could also be considered as highlighted
by being the only selectable object (308) displayed in the user interface (250) at a given
time. In such a case, operation of the cursor button (122) on its upwards or downwards
operative section (122a, 122b) would cause the user interface generation means (252) to
adapt the user interface (250) so that the current highlighted selectable object (308)
becomes hidden and either the previous or next selectable object (312, 310) is displayed.
The highlighted selectable object (308) is selected by activating the OK button (118).
In general navigation of the user interface (250) described herein, operation of the back
button (120), unless otherwise specified, generally causes the user interface generation
means (252) to return the user interface (250) to a previous state of the user interface (250),
prior to the previous operation of the OK button (118), thereby ensuring data stored in the
memory (202) remains unchanged from its state prior to operation of the OK button (118).
Referring to Fig. 4, activation of one of the function-specific buttons (102) relating to a
specific category of lifestyle data starts a lifestyle data entry sequence (400) for the specific
category of lifestyle data. A generalised lifestyle data entry sequence (400) is described
below with reference to Fig. 4.
For each category of lifestyle data, the user interface generation means (252) generates a
user interface (250) to query whether the current lifestyle data being input is for the present
time and date or for another time and date. Two selectable objects (304), namely time
options (402) are displayed in the user interface (250). Option A (402a) shows the current
time and date and option B (402b) displays the message "Other time". Throughout the
lifestyle data entry sequence (400), a title (314) and a graphical icon (316), both
corresponding to the category of lifestyle data selected by operation of one of the function
specific buttons (102), are shown in the user interface (250). Thus, a user of the testing
device (100) can immediately recognise whereabouts in the user interface (250) they are.
Hence, ease of use and navigation of the user interface (250), especially in combination
with operation of the back button (120), is improved.
If option A (402a) is selected, the current date and time is used as time and date
information for storing with lifestyle data entered in the current lifestyle data entry
sequence (400).
If option B (402b) is selected, the user interface generation means (252) starts a date and
time selection sequence to set the time and date information for storing with lifestyle data
entered in the current lifestyle data entry sequence (400). The date and time selection
sequence comprises: the user interface generation means (252) displaying selectable dates
on the display screen (106), selection of a date, the user interface generation means (252)
then displaying selectable times of day on the display screen (106) and selection of a time
of day for entry of lifestyle data.
Following selection of the date and time information, the user interface generation means
(252) modifies the user interface (250) to display selectable objects (304) which are
selectable sub-category options (404) for each category of lifestyle data. The user interface
generation means (252) is responsive to selection of one of the selectable sub-category
options (404), such that a further set of selectable objects, specifically selectable value
options (406), which are appropriate for a selected sub-category option (404a), are
displayed in the user interface (250). It will be appreciated that the selectable value
options (406) can be displayed alongside the selectable sub-category options (404) or in a
separate screen in the user interface (250) entirely.
On selection of a highlighted selectable value option (410), selectable values (408), which
may be numerical or descriptive, can be viewed and selected as described above. The
selectable values (408) are shown either alongside the selectable value options (406), as
shown in Fig. 3, or in a separate screen in the user interface (250). Operation of the back
button (120) allows a user to highlight other selectable value options (406), without a
selectable value being selected for the current selected sub-category option (404a). Once
all desired selectable value options have been selected (i.e. an entire list of selectable value
options has been scrolled through or had values entered), the transfer means (258), which
is responsive to the user interface generation means (252), recognising that the OK button
(118) has been operated, transfers one or more values (408) for the given sub-category of
lifestyle data directly into the memory (202) of the testing device (100). Optionally, there
may be a dedicated "Save" selectable value option (412), selection of which immediately
transfers one or more values (408) for the given sub-category of lifestyle data directly into
the memory (202) of the testing device (100). If one or more values, which are descriptive,
have been entered, then a numerical value acting as a pointer to the descriptive value is
transferred into the memory (202).
One of the sub-category options (404), value options (410) and/or values (408) may
labelled "-------", selection of which skips entry of data for the selected lifestyle category,
sub-category option or value option respectively by inserting a null value into the memory
(202). Thus, there is a common approach for entry and editing of data in different lifestyle
categories, which all have different sub-categories and support different types of data.
Hence, it is easy to learn how to use the testing device (100) for manipulation and viewing
of different types of data.
Referring to Fig. 5a, the generalised lifestyle data entry sequence (400) is now described in
detail specifically in relation to entry of lifestyle data in the food category. Upon operation
of the food function-specific button (108), the time options (402), as described above, are
displayed in the user interface (250). Having selected the time and date, food sub-category
options (514), specifically labelled "Breakfast", "Lunch", "Dinner", "Snack" and "Alcohol"
are displayed in the user interface (250) for selection. One of the food sub-category
options is labelled "-------", selection of which skips entry of data and displays a logbook
(560) in the user interface (250) (see below). On initial display of the food sub-category
options (514), a default food sub-category option (515) is highlighted, the default food sub-
category option (515) being determined by comparing pre-defined meal times with the
current time. Thus, the user interface (250) provides for intelligent interaction between a
given user and the testing device (100)
Selection of one of the food sub-category options (514), corresponding to "Breakfast",
"Lunch", "Dinner" and "Snack" displays selectable food value options (516) in the user
interface (250) labelled "Carbs", "Fats", "Calories" and "Proteins", relating to
carbohydrate, fat, calorific energy and protein intake. Each of the selectable food value
options (516) can be highlighted in turn by operation of the cursor button (122) and
selected by operation of the OK button (118). Food values (518) can be entered for one or
more of the selectable food value options (516) (as described above). Any food values
(518) that are selected and entered are stored in the memory (202) following entry of the
last of the food values (518) (i.e. the food value relating to protein intake).
Selection of the "Alcohol" food sub-category option (517) immediately transfers a pointer
corresponding to a unit of alcohol consumption into the memory (202), without displaying
selectable value options (516) in the user interface (250).
Following entry of lifestyle data for the food category, the logbook (560) (see below) is
displayed in the user interface (250).
Referring to Fig. 5b, the generalised lifestyle data entry sequence (400) is now described in
detail specifically in relation to entry of lifestyle data in the medication category. Upon
operation of the medication function-specific button (110), the time options (402), as
described above, are displayed in the user interface (250). Having entered the time and
date information, medication sub-category options (524), nominally labelled "Pill A", "Pill
B", "Insulin A", "Insulin B", "Pump Bolus" and "Pump Daily Total" are displayed in the
user interface (250) for selection. One of the medication sub-category options (524) is
labelled "Exit Meds Entry", selection of which skips the entry of data and displays the
logbook (560) in the user interface (250) (see below). Some of the aforementioned
medication sub-category options (524) are customisable through a set-up sequence
(described below) and need not necessarily relate to medication which is specifically for
treatment of diabetes.
Selection of one of the medication sub-category options (524) displays one or more
selectable medication value options (526) in the user interface (250). Each of the selectable
medication value options (526) can be selected by operation of the OK button (118) so that
medication values (528) can be highlighted and selected for one or more of the selectable
medication value options (526) corresponding to one of the selected medication sub-
category options (524). Entered medication values (528) are stored in the memory (202)
with a pointer to the selected medication sub-category and the time and date information.
Previously selected medication values (528) are used as default medication values, in that a
previously entered medication value for a given selectable medication value option and a
given time of day (as specified in a set-up sequence of the testing device (see below))
becomes the medication value which is initially highlighted upon selection of a given
selectable medication value option (526). Thus, the user interface (250) provides for
intelligent interaction between a given user and the testing device (100). Additionally, use
of the cursor key (122) is minimised. Accordingly, the general usability of the testing
device (100) is improved.
Referring to Fig. 5c, the generalised lifestyle data entry sequence (400) is now described in
detail specifically in relation to entry of lifestyle data in the health category. Upon
operation of the health function-specific button (112), the time options (402), as described
above, are displayed in the user interface (250). Having selected the time and date
information, health sub-category options (534), specifically labelled "Health Notes" and
"Health Checks" are displayed in the user interface (250) for selection.
Selection of the "Health Notes" health sub-category option (534a), displays in the user
interface (250) additional selectable health values (538) labelled "Stress", "Feel Hypo",
"Illness", "Menses", "Vacation" and "Other". Selection of one of the selectable health
values (538) immediately transfers a corresponding comment with the time and date
information into the memory (202). Following entry of lifestyle data for the "Health
Notes" health sub-category option (534a), the logbook (560) (see below) is displayed in the
user interface (250).
Selection of the "Health Checks" health sub-category option (534b), displays in the user
interface (250) selectable health value options (536) labelled "Ketones", "HbAlc",
"Microalbumin", "Cholesterol", "Blood pressure", "Eye Exam", "Foot Exam", "Weight /
Height" and "Dr. Visit".
Selection of one of the selectable health value options (536) labelled "Ketones", "HbAlc",
"Microalbumin", "Cholesterol", "Blood pressure" or "Weight / Height" displays one or
more selectable health values (538), thereby permitting entry of one or more appropriate
numerical values, which might be measured analyte levels, blood pressure, weight or
height. Other possible analyte levels could also be measured, such as High Density
Lipoprotein (HDL), Low Density Lipoprotein (LDL) or triglyceride levels, for which there
would be appropriate selectable health value options (536). Any entered health values
(538) are stored in the memory (202) with the time and date information and a pointer to a
corresponding health value option.
Previously selected health values (538) are used as default health values, in that a
previously entered health value for a given selectable health value option becomes the
health value (538) which is initially highlighted upon selection of a given selectable health
value option (536). Thus, the user interface (250) provides for intelligent interaction
between a user and the testing device (100). Additionally, use of the cursor key (122) is
minimised. Accordingly, the general usability of the testing device (100) is improved.
Selection of one of the selectable health value options (536) labelled "Eye Exam", "Foot
Exam" or "Dr. Visit" causes a confirmation message (539) to be displayed in the user
interface (250), requesting confirmation that a marker for one of these aforementioned
selectable health value options (536) should be input into the memory (202). Further
operation of the OK button (118) immediately stores in the memory (202) a marker for the
selected health value option with the time and date information.
Following entry of lifestyle data for the health category labelled "Health Checks", the
aforementioned health value options (536) for the "Health Checks" health sub-category
(534b) are again displayed in the user interface (250). This way, further health-checkup
related information can be immediately entered, if required.
Referring to Fig. 5d, the generalised lifestyle data entry sequence (400) is now described in
more detail specifically in relation to entry of lifestyle data in the exercise category. Upon
operation of the exercise function-specific button (114), the time options (402), as
described above, are displayed in the user interface (250). Having selected the time and
date, selectable exercise value options (546), specifically labelled "Exercise" and
"Duration" are displayed in the user interface (250) for selection (there are no exercise sub-
category options for entry of lifestyle data in the exercise category).
For the "Exercise" selectable exercise value option (546a), selectable exercise type values
(548a) corresponding to an intensity of exercise can be selected, specifically "Mild",
"Moderate" and "Hard". Additionally there is a selectable exercise value labelled as "------
", selection of which skips the entry of data and displays a logbook (560) in the user
interface (250) (see below). Following selection of one of the selectable exercise duration
values (548a), the "Duration" selectable exercise value option (546b) is highlighted and
selectable exercise duration values (548b) corresponding to a duration of exercise can be
entered. Similarly, there is a numerical value labelled "------", selection of which skips the
entry of data and displays a logbook (560) in the user interface (250) (see below).
Following selection of one of the selectable exercise duration values (548b) by operation
of the OK button (118), the values for the exercise intensity and duration are transferred to
the memory (202).
Following entry of lifestyle data for the exercise category, the logbook (560) (see below) is
displayed in the user interface (250).
Referring to Fig. 6a, the user interface (250) displays menu options (600) upon operation
of the information button (116). The information button (116) is referred to as a
"FastFacts" button and the menu options (600) are collectively referred to as a "FastFacts
Menu".
In the embodiment shown in Fig. 6a, the menu options (600) are entitled: "Logbook",
"Glucose by Meals", "Glucose Analysis", "Insulin Intake", "Hypo Info", "Food
Averages", "Health Checks" and "Help".
Selection of the "Logbook" menu option (601) causes a logbook (see below) to be
displayed in the user interface (250).
Selection of the "Glucose by Meals" menu option (602) allows measured glucose levels to
be displayed for each day prior to the current day. The analysis means (254) averages
measured glucose levels stored in the memory (202) and displays on the display screen
(106) for each day in one of the following four time-period categories: (a) before and after
breakfast; (b) before and after lunch; (c) before and after dinner; and (d) night. The time-
periods for the aforementioned categories are pre-defined through a set-up sequence of the
testing device (see below).
Selection of the "Glucose Analysis" menu option (604) causes further menu options to be
displayed relating to the analysis of measured glucose levels. Measured glucose levels
stored in the memory (202) can be displayed graphically (i.e. points plotted on a graph of
date against measured glucose level) or in tabular form. The analysis means (254) receives
measured glucose levels from the memory (202) and passes analytical results to the user
interface generation means (252) for displaying or plotting graphically on the display
screen (106). Measured glucose levels for each day can be displayed or the time of day can
be selected (i.e. before breakfast, after breakfast, before lunch, after lunch, before dinner,
after dinner or night) such that only measured glucose levels for these particular time
periods of day are plotted on the display screen (106). In addition, values for averages of
all glucose levels stored in the memory (202) can be calculated over a number of different
time periods (e.g. 7, 14, 30, 60 and 90 days) and all displayed together on the display
screen (106).
A user can easily navigate back for re-selection of the time period by operation of the back
button (120). A longer or shorter time period can then be highlighted by operation of the
cursor button (122) and selected by operation of the OK button (118) to view different
results. Repetition of this procedure can help identify treatment trends or the impact of
changes in treatment or lifestyle and its impact on measured glucose levels over time.
In a similar manner, values for averages of all glucose levels stored in the memory (202)
can be calculated for each time period of a day (as mentioned above) and displayed on the
display screen (106). Moreover, values for averages of all glucose levels stored in the
memory (202) can be calculated over a number of different time periods and displayed for
three exercise periods, specifically "before exercise", "during exercise" and "after
exercise". Another analysis method allows range information to be displayed on the
display screen. Such range information shows the proportions of averaged measured
glucose levels which are above, within or below pre-defined ranges. Such ranges are
determined in a testing device set-up sequence (see below). The range information is
viewed as a percentage either before or after one of four pre-defined meal time-period
categories (i.e. breakfast, lunch, dinner or night).
Selection of the "Insulin Intake" menu option (606) causes further menu options to be
displayed relating to the intake of insulin, data for which has been entered through prior
operation of the medication function-specific button (110). In particular, the intake of
different amounts of different types of insulin specified in a set-up sequence of the testing
device (see below) can be viewed as average amounts over a given time period or as total
amounts on each day prior to the current day. Analysis means (254) processes the stored
insulin data. In addition, the total and average intake of insulin can be viewed on the
display screen (106). Specifying the type of insulin may include specifying whether the
insulin is given through a syringe or pump, or taken as a pill or inhaled.
Selection of the "Hypo Info" menu option (608) allows incidents of the diabetic "hypo"
condition to be viewed. The "hypo" condition is pre-defined in the testing device set-up
sequence (as described below) as a configurable glucose level below which a diabetic
individual is considered as being "hypo". The incidents of the diabetic "hypo" condition
are viewed as the number of incidents which have occurred in a chosen time period for
each of the following times of day: before breakfast, after breakfast, before lunch, after
lunch, before dinner, after dinner and night.
Selection of the "Food Averages" menu option (610), allows averages for previously
entered data stored in the memory (202) relating to food consumption of an individual to
be displayed on the display screen (106). The analysis means (254) processes stored food
related data according to options selected in the user interface (250) through operation of
the navigation buttons (104). Carbohydrate and fat levels, calorific content and protein
intake for each predefined time-period: "Breakfast", "Lunch", "Dinner" and "Snack" can
be averaged by the analysis means (254) over selected time-periods and displayed on the
display screen (106).
Selection of the "Health Checks" menu option (612) allows averages for entered data
stored in the memory (202) relating to health checkups of an individual to be displayed on
the display screen (106). Displayed in the user interface (250) are the selectable health
value options (536) relating to health checkups of an individual, along with the date of the
last checkup and a value measured at the last checkup.
Selection of the "Help" menu option (614) (not shown in Fig. 6a), causes contact
information for help in using the testing device (100) to be displayed on the display screen
(106). For example such contact information may read "Contact LifeScan Customer
Service or visit the Website at www.LifeScan.com".
Referring to Fig. 6b, a logbook (560) is displayed in the user interface (250) following
selection of the "Logbook" menu option (601). Date and time records (650) stored in the
memory (202) are displayed in the user interface (250) with associated data records (652),
such as stored glucose levels and/or lifestyle data. Glucose levels are displayed with
associated glucose comments (654) (see below). Operation of the navigation buttons (104)
allows each data record (652) to be scrolled though in date and time order, with each
record for a particular date and time being highlighted in turn, before the next time and
date and corresponding records are displayed in the user interface (250). Each data record
(652) can be highlighted in turn by the navigation buttons (104) and selected by operation
of the OK button (118). Selection of a glucose data record (656) allows a glucose
comment (see below) to be entered for the selected glucose data record. Selection of a
lifestyle data record (658) displays two options, labelled "Edit" and "Delete", selection of
which allows the selected lifestyle data record to be edited or deleted easily with few
operations of the navigation buttons (104). The sequence for editing of lifestyle data is
similar to the generalised lifestyle data entry sequence (400) described above, except that
previously entered values for the lifestyle data record being edited are pre-selected by the
user from the logbook (560).
Operation of one of the function-specific buttons (102) corresponding to a particular
category of lifestyle data, whilst viewing the logbook (560), allows immediate entry of
lifestyle data using the time and date currently being shown in the user interface (250).
Referring to Fig. 7, a testing sequence (700) for measuring a glucose level (708) of an
individual is shown. A test-strip is inserted into the test-strip port (124), which
immediately turns on the testing device (100). A default code (702) relating to calibration
parameters used with the testing device for a particular type of test-strip is displayed in the
display screen (106). The code (702) can be changed by operation of the cursor button
(122) and selected by operation of the OK button (118). If a particular type of test-strip
has previously been used with the testing device (100) on a pre-defined number of
occasions, then the corresponding code (702) of the test-strip is stored in the memory (202)
and used as a default code (702), which is initially displayed in the display screen (106) of
the testing device (100) following insertion of a test-strip into the test-strip port (124).
Unless the code (702) is changed, as described above, then after a pre-defined time period,
then default code (702) is automatically selected without a user having to operate the OK
key (102). However, following selection of the code (702), operation of the back button
(120) allows a user to reselect the code (702).
Following selection of the code (702), one of a plurality of messages (706) is displayed on
the display screen (106), requesting a blood sample to be applied to the test-strip. At this
stage, operation of the cursor button (122) cycles through three messages (706) on the
display screen (106), specifically "Apply Blood", "Alternate Site" and "Control Solution".
This way, the testing device (100) can recognise for each individual measured glucose
level (708) that a control solution is being applied to the test-strip or that blood is being
taken from an alternate site on an individual. Normally, blood samples would be taken
from the same bodily location on an individual. However, sometimes another location, an
"alternate site", might be used, for example if the one bodily location becomes sensitive or
inconvenient. For example, an alternate site might refer to an upper arm location if a lower
arm location is normally used. If an alternate site for sampling of blood is used, it is
important that this is recognised, particularly when analysis of the measured glucose levels
is being performed at a later stage. Such information could be used in any future general
investigation, using a number of people, into any differences in analyte levels in blood
samples extracted from different locations on the body.
When an appropriate message is displayed on the display screen (106), a solution, blood or
otherwise, can be applied to the test-strip. Measurement of a glucose level in the solution
takes place following application of the solution to the test-strip. The measured glucose
level (708) is displayed in the display screen (106) and stored in the memory (202)
together with the date and time of day and whether the blood sample was taken from an
alternate site on an individual. If the measured glucose level (708) lies outside a pre-
defined target range, then the prompt means (256) instructs the user interface generation
means (252) to display a message (709) in the user interface (250) prompting a user of the
testing device (100) to press the OK button (118), so that lifestyle data in the form of
glucose comments (see below) which are associated with the measured glucose level (708)
can be entered. Two pre-defined target ranges can be specified for each meal time,
specifically for a period before and after each meal time. Thus, by pressing one of the
navigation buttons (104), in this case the OK button (118), lifestyle data can be entered
immediately. This way, when the measured glucose level (708) is outside a pre-defined
target range (as specified in the testing device set-up sequence (see below)) a user is
automatically prompted to enter a glucose comment. Thus, improved diagnosis on out-of-
range glucose levels can made by a physician at a later stage.
If the measured glucose level (708) additionally lies below a pre-defined glucose "Hypo"
level, then a further message is displayed on the display screen (106) querying whether a
user of the testing device (100) should consider having a snack.
Referring to Fig. 8, operation of the OK button (118), following measurement of a glucose
level, immediately starts a glucose comment insertion sequence (800). Glucose comments
(654) are descriptive comments which fall into one of a number of glucose comment sub-
categories (802), specifically a food comment sub-category, a health comment sub-
category and an exercise comment sub-category. The glucose comments (654) are stored
in the memory with an associated measured glucose level (708) and are displayed in the
logbook (560). Thus, the status of an individual's food intake, health or exercise level can
be immediately entered at the time of measurement of a glucose level. Additionally, the
glucose comment insertion sequence (800) can be initiated from the logbook (560) by
operation of the OK button (118) when a glucose data record (656) is highlighted in the
user interface (250).
Each of the glucose comment sub-categories (802) can be highlighted in turn by operation
of the cursor button (122) and selected by operation of the OK button (118). For each of
the glucose comment sub-categories (802), there are a number of different glucose
comments (654) which can be highlighted by operation of the cursor button (122) and
selected by operation of the OK button (118). For each of the glucose comment sub-
categories (802), one of the glucose comments (654) can be selected, except for the health
comment sub-category (802b), for which, following insertion of one health glucose
comment, causes the user interface (250) to be adapted such that an additional health
glucose comment can be inserted. This way, up to six health glucose comments can be
selected and stored with the measured glucose level (708) in the memory (202).
For the food glucose comment sub-category (802a), the following food glucose comments
(654a) can be selected and stored in the memory (202): "Bef Brkft", "Aft Brkft", "Bef
Lunch", "Aft Lunch", "Bef Dinner", "Aft Dinner" and "Night", corresponding to before
breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner and night.
For the health glucose comment sub-category (802b), the following health glucose
comments (654b) can be selected and stored in the memory (202): "Stress", "Feel Hypo",
"Illness", "Menses", "Vacation" and "Other", having self-explanatory meanings. For the
exercise glucose comment sub-category (802c), the following exercise glucose comments
(654c) can be selected and stored in the memory (202): "Before", "During" and "After",
having self-explanatory meanings.
Also displayed in the user interface (250) with the glucose comment sub-categories is a
"Save" option (802d), which can be highlighted by operation of the cursor button (122).
Selection of the "Save" option (802d) causes the transfer means (258) to transfer the
measured glucose level (708), with any glucose comments (654) which have been entered,
into the memory (202) with time and date information.
The testing device (100) has a set-up sequence which is initiated when the testing device
(100) is used for the first time or when the OK button (118) and the back button (120) are
operated together. The set-up sequence allows customisation of the operation of the testing
device (100) through the user interface (250). Customisable settings are stored in the
memory (202) for use in data entry, display or analysis. In particular, the following are
examples of customisable settings: the language used in the user interface (250), the
current time and date, the number of doses and types of insulin taken by an individual
using the testing device (100), whether an insulin pump is used by a user using the testing
device (100) and the number and type of different pills taken by an individual using the
testing device. Additionally, the times of day for different meal periods (i.e. before
breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner and night)
can be set. Glucose level ranges which are displayed as horizontal lines on any graphs
displayed by the testing device (100) in the display screen (106) can be specified for
"before" and "after" meal periods. Furthermore, a "Hypo" level can be set, which specifies
a glucose level used to compare against measured glucose levels and generate a warning if
a measured glucose level (708) is below this "Hypo" level.
The prompt means (256) can also immediately generate non-customisable warnings on the
display screen (106) for high measured glucose levels (above 600 mg/dL) and low
measured glucose levels (below 20 mg/dL).
In conclusion, the testing device of the present invention significantly reduces the obstacles
associated with maintaining an accurate record of an individual's lifestyle. The present
invention promotes frequent monitoring for diabetic individuals by providing a simple,
efficient way of recording, not only blood glucose levels, but also other information which
is likely to affect an individual's prognosis. By logging glucose and lifestyle information in
the manner described herein, the testing device provides and effective medication recordal
system. For instance, in the United States the device meets the requirements of the
National Committee for Quality Assurance's (NCQA) Health Plan Employer Data and
Information Set (HEDIS®). HEDIS® provides standardised performance measures for
providing individuals with information needed to reliably compare the performance of
managed health care plans.
It will of course be understood that the present invention has been described purely by way
of example only and that modifications of detail can be made within the scope of the
invention.
WE CLAIM:
1. A testing device for testing an analyte in a sample of bodily fluid,
comprising:
memory storing data, said data being analyte data related to analyte
measurements carried out by the testing device and lifestyle data, and the
analyte data includes a pointer to a bodily location from which an analyte
sample was taken by an individual using the testing device, wherein the
testing device utilizes a plurality of data pointers, each of said, data
pointers indicating a separate bodily location;
initiation means for initiating immediate entry of data related to a specific
category of lifestyle data,
navigation means for entry and navigation of said data; and
transfer means for transferring said data to said memory.
2. The testing device as claimed in claim 1, further comprising a display
screen, wherein the transfer means is a processor, the processor being
adapted to access the data stored in the memory and display said data on
the display said data on the display screen.
3. The testing device as claimed in claim 2, wherein the processor is further
adapted to perform an analysis on the data and display results of said
analysis on the display screen.
4. The testing device as claimed in claim 3, wherein said analysis includes
determining whether data lies outside a predetermined range, such that if
said data lies outside that predetermined range, the analysis means
displays a prompt on the display screen requesting input of one or more
comments from a user of the testing device.
5. The testing device as claimed in claim 3, wherein said analysis comprises
averaging data stored in the memory over a predetermined time period.
6. The testing device as claimed in claim 3, wherein said navigation means is
adapted to select data for analysis or for display on the display screen.
7. The testing device as claimed in claim 1, wherein said lifestyle data is
stored in the memory as lifestyle records, each lifestyle record comprising:
a date and time-stamp;
a pointer to a lifestyle event; and
a lifestyle value.
8. The testing device as claimed in claim 1, wherein said analyte data is
stored in the memory as analyte records, each analyte record comprising:
a data and time-stamp; and
an analyte value.
9. The testing device as claimed in claim 1, wherein each analyte record
further comprises:
a pointer to a bodily location from which an analyte sample was taken by
an individual using the testing device;
a pointer to a lifestyle event; and
a lifestyle value.
10. The testing device as claimed in claim 1, wherein said initiation means is a
plurality of function-specific buttons, each function-specific button
corresponding to a specific category of lifestyle data.
11. The testing device as claimed in claim 1, further comprising
communication means adapted to transfer data between said memory and
an external device.
12.The testing device as claimed in claim 1, wherein the testing device is a
glucose meter and one of the analytes being tested is glucose.
13.The testing device for testing an analyte in a sample of bodily fluid,
comprising:
memory for storing analyte data; and
navigation means,
wherein:
said sample of bodily fluid is usually obtained from a specific bodily
location on an individual; and
said navigation means is adapted to flag analyte data stored in the
memory if said sample of bodily fluid is obtained from an alternate bodily
location other than said specific bodily location following a carrying out of
an analyte measurement.
14. The testing device as claimed in claim 13, wherein said navigation means
is further adapted to indicate to the memory said alternate bodily location,
such that a pointer to said alternate location is stored with associated
analyte data in the memory.
15. The testing device as claimed in claim 14, further comprising a display
screen, wherein said navigation means comprises a cursor button and an
OK button, such that operation of the cursor button adapts the display
screen to display one or more alternate bodily location options
corresponding to one or more alternate bodily locations and operation of
the OK button send said alternate bodily location to the memory.
A testing device for testing an analyte in a sample of bodily fluid, comprising:
memory storing data, said data being analyte data related to analyte
measurements carried out by the testing device and lifestyle data, and the
analyte data includes a pointer to a bodily location from which an analyte sample
was taken by an individual using the testing device, wherein the testing device
utilizes a plurality of data pointers, each of said data pointers indicating a
separate bodily location;
initiation means for initiating immediate entry of data related to a specific
category of lifestyle data,
navigation means for entry and navigation of said data; and
transfer means for transferring said data to said memory.

Documents:

319-KOL-2003-FORM-27.pdf

319-kol-2003-granted-abstract.pdf

319-kol-2003-granted-claims.pdf

319-kol-2003-granted-correspondence.pdf

319-kol-2003-granted-description (complete).pdf

319-kol-2003-granted-drawings.pdf

319-kol-2003-granted-examination report.pdf

319-kol-2003-granted-form 1.pdf

319-kol-2003-granted-form 18.pdf

319-kol-2003-granted-form 2.pdf

319-kol-2003-granted-form 26.pdf

319-kol-2003-granted-form 3.pdf

319-kol-2003-granted-form 5.pdf

319-kol-2003-granted-reply to examination report.pdf

319-kol-2003-granted-specification.pdf

319-kol-2003-granted-translated copy of priority document.pdf


Patent Number 223860
Indian Patent Application Number 319/KOL/2003
PG Journal Number 39/2008
Publication Date 26-Sep-2008
Grant Date 23-Sep-2008
Date of Filing 05-Jun-2003
Name of Patentee DIABETES DIAGNOSTICS, INC.
Applicant Address 200 PROSPECT WALTHAM, MASSACHUSETTS
Inventors:
# Inventor's Name Inventor's Address
1 CUMMINGS ELIZABETH ANNE 3595 SOUTH BASCOM NO. 30 CAMBELL, CA 95008
2 MCEVOY MARY ELLEN 1925 ARBOR AVENUE, BELMONT CA 94002
3 BERGER LARS HELMUT PFARRERHOEHE 25 93180 DEUERLING
4 KRAFT ULRICH MOZARTSTRASSE 7 61440 OBERURSEL
5 TEUCHER RAINER RUDOLF AUGUST BEBEL STR 37 64347 FRIESHEIM
6 DAVIS JOHN CHRISTOPHER 1435 MARLBOROUGH AVENUE LOS ALTOS, CA 94024
PCT International Classification Number A61B 5/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 0212920.3 2002-06-05 U.K.