SYSTEMS FOR DIABETES MANAGEMENT AND METHODS

• US 20100331654A1
• Filed: 06/30/2010
• Published: 12/30/2010
• Est. Priority Date: 06/30/2009
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: JERDONEK, Ronald, Stephens, Chris, Raj, Siva, Weseley, Lisa, Longmuir, Alistair, Macrae, Allan
• Application Number:
  US12/826,681
• Publication Number:
  US 20100331654A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Described herein are systems and methods to utilize factual information based on stored blood glucose data to allow greater insight into the management of diabetes of a user.

Claims

1. A diabetes management system comprising:

a blood glucose test strip having an inlet port to receive a blood sample; and

a blood glucose measurement device having a test strip port configured to receive the test strip and a microcontroller coupled to a memory, display screen, and user interface buttons so that upon completion of a current blood glucose measurement with the test strip, the display screen presents a value of the current blood glucose measurement and at least one of two selectable message headers on the display screen comprising a review of blood glucose values stored in the memory over a predetermined time period, or a trend pattern of the stored blood glucose values.

2. The system of claim 1, in which the message indicative of a distribution of stored blood glucose values comprises an identification of a percentage of stored blood glucose values within a first distribution range, a percentage of stored blood glucose values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range.

3. The system of claim 1, in which the message indicative of a distribution of stored blood glucose values comprises a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges.

4. The system of claim 1, in which the message indicative of a distribution of stored blood glucose values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

5. The system of claim 1, in which the message indicative of a distribution of stored blood glucose values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

6. The system of claim 1, in which the message indicative of a trend of the stored values over a second predetermined time period comprises a text indicating one of an increasing trend or decreasing trend in the measured values of the blood glucose.

7. The system of claim 1, in which the message indicative of a trend of the stored values comprises a table having the date, time, and measured blood glucose value at such date and time.

8. The system of claim 1, in which the message comprises a textual message.

9. An analyte test measurement device comprising:

a housing;

a measurement sensor disposed in the housing and configured to receive an analyte test strip; and

a microcontroller coupled to a memory, display screen, user interface buttons and the measurement sensor which are mounted to the housing so that upon completion of a current analyte measurement of a physiological sample with an analyte test strip, the display screen presents the current analyte measurement and at least one of two selectable message headers on the display screen comprising a review of analyte values stored in the memory over a predetermined time period or a trend pattern of the stored analyte values.

10. The device of claim 9, in which the message indicative of a distribution of stored analyte values comprises an identification of a percentage of stored analyte values within a first distribution range, a percentage of stored analyte values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range.

11. The device of claim 9, in which the message indicative of a distribution of stored analyte values comprises a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges.

12. The device of claim 9, in which the message indicative of a distribution of stored analyte values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

13. The device of claim 9, in which the message indicative of a distribution of stored analyte values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

14. The device of claim 9, in which the message indicative of a trend of the stored values over a second predetermined time period comprises a text indicating one of an increasing trend or decreasing trend in the measured values of the analyte.

15. The device of claim 9, in which the message indicative of a trend of the stored values comprises a table having the date, time, and measured analyte value at such date and time.

16. The device of claim 9, in which the identification comprises a message selected from a group consisting essentially of a textual, visual, audio, or combinations thereof.

17. A method of providing analyte information of a user via an analyte meter having a microcontroller coupled to a memory, display, user interface buttons, and an analyte sensor, the method comprising:

measuring with the analyte sensor for at least one analyte present in each of a plurality of physiological samples taken over a first predetermined time period;

storing analyte values representative of the at least one analyte present in each of the plurality of physiological samples;

determining whether a number of the stored analyte values over the first predetermined time period meets a minimum threshold;

presenting, upon completion of a current analyte measurement and achievement of at least the minimum threshold of the number of stored analyte values, at least one of two selectable message headers comprising;

(a) review of the stored analyte values over the predetermined time period;

or

(b) trend pattern of the stored analyte values;

revealing, upon selection of the message header for review of stored analyte values, a message indicative of a distribution of stored analyte values over at least one of a predetermined range, a first threshold or a second threshold higher than the first threshold; and

manifesting, upon selection of the message header for trend pattern, a message indicative of a trend of the stored values over a second predetermined time period.

18. The method of claim 17, in which the measuring comprises depositing a physiological sample on a test strip coupled to the analyte meter and initiating a reaction between the analyte in the sample and an enzyme disposed on the test strip;

and in which the storing comprises indexing the stored analyte value to at least one of a time and date at which the measuring was performed.

19. The method of claim 17, in which the determining comprises defining a range of days within the first predetermined time period and defining the number of measurements as the minimum threshold within the first predetermined time period, in which the range comprises a range selected from a group consisting essentially of three, five, seven, fourteen, thirty, ninety, or one-hundred twenty days.

20. The method of claim 17, in which the message indicative of a distribution of stored analyte values comprises an identification of a percentage of stored analyte values within a first distribution range, a percentage of stored analyte values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range, and the message indicative of a distribution of stored analyte values comprises a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges, and the message indicative of a distribution of stored analyte values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

21. The method of claim 17, in which the message indicative of a distribution of stored analyte values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values.

22. The method of claim 17, in which the message indicative of a trend of the stored values over a second predetermined time period comprises a text indicating one of an increasing trend or decreasing trend in the measured values of the analyte.

23. The method of claim 17, in which the message indicative of a trend of the stored values comprises a table having the date, time, and measured analyte value at such date and time.

24. The method of claim 17, in which the revealing or manifesting comprises displaying the message.

25. A method of providing analyte information of a user via an analyte meter having a microcontroller coupled to a memory, display, user interface buttons, and an analyte sensor, the method comprising:

measuring with the analyte sensor for at least one analyte present in each of a plurality of physiological samples taken over a first predetermined time period;

storing analyte values representative of the at least one analyte present in each of the plurality of physiological samples;

determining whether a number of the stored analyte values over the first predetermined time period meets a minimum threshold;

querying the user, upon completion of a current analyte measurement and achievement of at least the minimum threshold of the number of stored analyte values, to select at least one of two selectable message headers comprising;

(a) review of the stored analyte values over the predetermined time period;

or

(b) trend pattern of the stored analyte values;

annunciating, upon selection of the message header for review of stored analyte values, a message indicative of a distribution of stored analyte values over at least one of a predetermined range, a first threshold or a second threshold higher than the first threshold; and

annunciating, upon selection of the message header for trend pattern, a message indicative of a trend of the stored values over a second predetermined time period.

26. The method of claim 25, in which the audiovisual message indicative of a distribution of stored analyte values comprises identification of a percentage of stored analyte values within a first distribution range, a percentage of stored analyte values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range, and in which the audiovisual message indicative of a distribution of stored analyte values comprises a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges.

27. The method of claim 26, in which the audiovisual message indicative of a distribution of stored analyte values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the audiovisual message indicative of a distribution of stored analyte values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the audiovisual message indicative of a trend of the stored values over a second predetermined time period comprises a text indicating one of an increasing trend or decreasing trend in the measured values of the analyte and in which the audiovisual message indicative of a trend of the stored values having the date with time, and measured analyte value at such date and time.

28. The method of claim 26, in which the identification comprises a message selected from a group consisting essentially of a textual, visual, audio, or combinations thereof.

29. A method of providing analyte information of a user via an analyte meter having a microcontroller coupled to a memory, display, user interface buttons, and an analyte sensor, the method comprising:

measuring with the analyte sensor for at least one analyte present in each of a plurality of physiological samples taken over a first predetermined time period;

reporting to the user at least one result from the measuring;

storing analyte values representative of the at least one analyte present in each of the plurality of physiological samples;

determining whether a number of the stored analyte values over the first predetermined time period meets a minimum threshold;

upon determining that the number meets the minimum threshold, evaluating the stored analyte values against one or more rules prestored in the meter to define a message having some of the stored data as part of the message to the user; and

manifesting the message to the user as the first message delivered to the user before any other messages.

30. A method of providing analyte information of a user via an analyte meter having a microcontroller coupled to a memory, display, user interface buttons, and an analyte sensor, the method comprising:

measuring with the analyte sensor for at least one analyte present in each of a plurality of physiological samples taken over a first predetermined time period;

reporting to the user at least one result from the measuring;

storing analyte values representative of the at least one analyte present in each of the plurality of physiological samples;

determining whether a number of the stored analyte values over the first predetermined time period meets a minimum threshold;

upon determining that the number meets the minimum threshold, evaluating the stored analyte values against one or more rules prestored in the meter to define a message having some of the stored data as part of the message to the user; and

manifesting the message to the user subsequent to the measuring.

31. The method of claim 30, in which the message comprises:

an identification of a percentage of stored analyte values within a first distribution range, a percentage of stored analyte values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range;

a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges.

32. The method of claim 30, in which the message indicative of a distribution of stored analyte values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the message indicative of a distribution of stored analyte values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the message comprises a trend of the stored values over a second predetermined time period comprises a text indicating one of an increasing trend or decreasing trend in the measured values of the analyte, and in which the message indicative of a trend of the stored values comprises a table having the date, time, and measured analyte value at such date and time.

33. A diabetes management system comprising:

a blood glucose test strip having an inlet port to receive a blood sample; and

a blood glucose measurement device having a test strip port configured to receive the test strip and a microcontroller coupled to a memory, display screen, and user interface buttons so that upon completion of a current blood glucose measurement with the test strip, the display screen presents a value of the current blood glucose measurement and at least one of two selectable message headers on the display screen, the message headers comprising a review of blood glucose values stored in the memory over a predetermined time period, or a prompt to tag the current blood glucose measurement.

34. The system of claim 33, in which the message indicative of a distribution of stored blood glucose values comprises an identification of a percentage of stored blood glucose values within a first distribution range, a percentage of stored blood glucose values, if any, lower than a minimum in the first distribution range and a percentage, if any, higher than a maximum in the first distribution range, in which the message indicative of a distribution of stored blood glucose values comprises a first distribution range, a second distribution range with a value smaller than a minimum in the first distribution range, and a third distribution range with a value greater than a maximum in the first distribution range, actual number of measurements having values within respective first, second and third distribution ranges, and a percentage of the measurements within respective first, second and third distribution ranges, in which the message indicative of a distribution of stored blood glucose values above a first predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the message indicative of a distribution of stored blood glucose values below a second predetermined threshold comprises measured values and the dates and times corresponding to the respective measured values, in which the prompt comprises contextual information contemporaneous to the measured value, the information chosen from the group consisting of a fasting condition, a before meal condition, an after meal condition, and a bedtime condition and, in which one of the message headers comprises a query “

HOW AM I DOING?”

35. A method of providing analyte information of a user via a glucose meter having a microcontroller coupled to a memory, display, user interface buttons, and a glucose sensor, the method comprising:

measuring a glucose concentration with the glucose sensor in each of a plurality of physiological samples taken over a first predetermined time period;

automatically identifying, for a particular day, a low trend in glucose values that is detected on a particular day where at least one glucose concentration is below a second predetermined threshold in each of the last three days;

automatically identifying, for a particular day, a high trend in glucose values that is detected on a particular day where at least one glucose concentration is above a first predetermined threshold in each of the last three days at a same time interval; and

reporting to the user a plurality of dates where each date has only one corresponding message, the corresponding messages comprise either the high trend or the low trend, and if on a particular date both the high trend and the low trend are triggered, then only the low trend is reported to the user.

36. The method of claim 35, in which the time interval is about three hours, in which the corresponding messages further comprises either the high trend, the low trend, or that a user selected a report prompt;

and if on a particular date both the high trend and the low trend are not triggered and the user selected the report prompt, then a message is reported to the user indicating that the report was selected.