ANALYTE TESTING METHOD AND SYSTEM

• US 20100332445A1
• Filed: 06/29/2010
• Published: 12/30/2010
• Est. Priority Date: 06/30/2009
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Srinivasan, Aparna, Matian, Greg, RAY, Pinaki
• Application Number:
  US12/826,659
• Publication Number:
  US 20100332445A1
• Time in Patent Office: Days
• US Class Current: 706/54
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system and method of detecting a flagged glucose concentration pattern with the use of medians having a common type of flag collected over discrete time periods so that whenever significant differences between the medians arise, the user or a caretaker of a diabetic user is notified.

Claims

1. A diabetes management system comprising:

a plurality of glucose test strips, each test strip configured to receive a physiological sample;

a test strip port connector configured to receive the plurality of test strips; and

a diabetes data management device comprising;

a housing;

a microprocessor coupled to a memory, display, and power supply disposed proximate the housing, the microprocessor coupled to the test strip sensor to provide data representative of a first group and second group of blood glucose values of the user over respective first and second time periods so that respective first and second medians of the first and second group are evaluated by the microprocessor to determine whether one of the first and second medians is significantly different enough to inform the user of the same on the display of the device.

2. The diabetes management system of claim 1, in which the first and second medians are calculated by the microprocessor with glucose values including a common type of flag.

3. The diabetes management system of claim 2, in which the common type of flag comprises at least one of a fasting flag or a bedtime flag.

4. The diabetes management system of claim 1, in which the diabetes data management device comprises a blood glucose meter.

5. The diabetes management system of claim 1, in which the diabetes data management device comprises a combination of a blood glucose meter and mobile phone electronically coupled to each other and in which the blood glucose meter includes the test strip port and a microprocessor to provide blood glucose data to a microprocessor of the mobile phone.

6. A method of detecting a fasting glucose concentration pattern with an analyte testing device having a microprocessor coupled to a memory, the method comprising:

obtaining from the memory of the analyte testing device a first group and second group of glucose measurements over a first time period and a second time period, respectively;

determining whether the fasting glucose concentrations of the first group are significantly different than the fasting glucose concentrations of the second group;

calculating a first median and a second median of the fasting glucose measurements over a first time period and a second time period, respectively;

displaying a message indicating that the second group has a significantly higher fasting glucose concentration than the first group where the second median is greater than the first median, and the first group and second group are significantly different; and

displaying a message indicating that the second group has a significantly lower fasting glucose concentration than the first group where the second median is less than the first median, and the first group and second group are significantly different.

12. The method of claim 6, in which the first group and the second group each have greater than ten fasting glucose concentrations.

7. A method of detecting a fasting glucose concentration pattern for a day of the week with an analyte testing device having a microprocessor coupled to a memory, the method comprising:

obtaining from the memory a number of glucose measurements over a plurality of weeks, via the analyte testing device;

determining whether the fasting glucose concentrations acquired on at least one day of the week is significantly different than the other days; and

displaying a message indicating that a particular day of the week has a significantly lower or significantly higher fasting glucose concentration than the other days of the week.

8. The method according to claim 7, in which the significant difference includes a statistical difference.

9. The method according to claim 7, in which the determining comprises calculating a chi-squared value using a chi-squared test.

10. The method of claim 9, in which the calculating of the chi-squared value comprises the following equation:

11. The method of claim 9, in which the calculating comprises a determination that at least one of the time periods i is statistically different when the calculated chi-squared value is greater than a reference chi-squared value.

13. The method of claim 10, in which F_i,pre comprises a value based on the following equation,

14. The method of claim 10, in which F′

_i,pre comprises a value based on the following equation,

15. A method of detecting a bedtime glucose concentration pattern with an analyte testing device having a microprocessor coupled to a memory, the method comprising:

obtaining from the memory of the analyte testing device a first group and second group of glucose measurements over a first time period and a second time period, respectively;

determining whether the bedtime glucose concentrations of the first group are significantly different than the bedtime glucose concentrations of the second group;

calculating a first median and a second median of the bedtime glucose measurements over a first time period and a second time period, respectively;

displaying a message indicating that the second group has a significantly higher bedtime glucose concentration than the first group where the second median is greater than the first median, and the first group and second group are significantly different; and

displaying a message indicating that the second group has a significantly lower bedtime glucose concentration than the first group where the second median is less than the first median, and the first group and second group are significantly different.

21. The method of claim 15, in which the first group and the second group each have greater than ten bedtime glucose concentrations.

16. A method of detecting a bedtime glucose concentration pattern for a day of the week with an analyte testing device having a microprocessor coupled to a memory, the method comprising:

obtaining from the memory a number of glucose measurements over a plurality of weeks, via the analyte testing device;

determining whether the bedtime glucose concentrations acquired on at least one day of the week is significantly different than the other days; and

displaying a message indicating that a particular day of the week has a significantly lower or significantly higher bedtime glucose concentration than the other days of the week.

17. The method according to claim 16, in which the significant difference includes a statistical difference.

18. The method according to claim 16, in which the determining comprises calculating a chi-squared value using a chi-squared test.

19. The method of claim 18, in which the calculating of the chi-squared value comprises the following equation:

20. The method of claim 18, in which the calculating comprises a determination that at least one of the time periods i is statistically different when the calculated chi-squared value is greater than a reference chi-squared value.

22. The method of claim 19, in which B_i,pre comprises a value based on the following equation,

23. The method of claim 19, in which B′

_i,pre comprises a value based on the following equation,