Analyte testing method and device for calculating basal insulin therapy

• US 8,688,386 B2
• Filed: 06/30/2010
• Issued: 04/01/2014
• Est. Priority Date: 06/30/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Price, David, Sieh, Zara, Shadforth, Ian, Montgomery, Brenda, Bergman, Eric David
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US12/826,670
• Publication Number:
  US 20100332142A1
• Time in Patent Office: 1,371 Days
• Field of Search: None
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• 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

Abstract

Described herein are various methods to ensure safety and the compliance of therapeutic diabetes protocols. The method can be achieved by performing safeguards against hypoglycemia of the user prior to any change in basal insulin dosage based on the plurality of data.

Claims

1. A method for management of diabetes for basal insulin dosing of a user with an insulin delivery device and a handheld diabetes data management unit having an analyte test sensor, a processor coupled to a memory and display screen, the method comprising:

measuring a plurality of blood glucose concentration values of the user with the analyte test sensor over a plurality of time periods;

collecting data representative of a plurality of fasting blood glucose concentration values with the handheld diabetes data management unit;

ascertaining from the collected data whether the user has conducted a minimum number of fasting blood glucose concentration measurements within at least one of four prescribed time periods;

determining whether the collected data indicate one of a first low blood glucose concentration pattern and a second low blood glucose concentration pattern lower than the first low blood glucose concentration pattern;

evaluating whether basal insulin adjustment in the handheld diabetes data management unit is appropriate in the event that glucose concentration value results for two consecutive days are below a first low value for a first pattern;

evaluating whether basal insulin adjustment in the handheld diabetes data management unit is appropriate in the event that glucose concentration value results for four consecutive days are each between about a low threshold and about a first low value for a second pattern;

upon determination of at least one of the first and second low blood glucose concentration patterns of the user, displaying safety notifications on the display screen of the handheld diabetes data management unit; and

prohibiting basal insulin adjustment in one of the insulin delivery device and handheld diabetes data management unit whenever either one of the first or second low blood glucose concentration pattern is determined.

2. The method of claim 1, in which consecutive days include a first day having a first glucose measurement and a second day having a second glucose measurement, where the two glucose measurements are apart by at least more than a first time interval.

3. The method of claim 2, in which the first time interval is greater than about two hours.

4. The method of claim 2, in which the determining comprises recommending insulin dosage that is decreased by a first decrement where a prior last glucose concentration value is less than a first low threshold.

5. The method of claim 2, in which the determining comprises recommending no changes to a current insulin dose stored in the memory of the handheld diabetes data management unit in the event that all three prior consecutive fasting blood glucose concentration values are not higher than a high threshold;

and recommending, in the event that all three prior consecutive fasting blood glucose concentration values are greater than an upper threshold, an increase in insulin by a first increment, otherwise recommending an increase in insulin by a second increment.

6. The method of claim 2, in which the evaluating comprises determining whether there are at least three fasting blood glucose measurements stored in the handheld diabetes data management unit and if true, recommending no changes to current insulin dose otherwise displaying last three blood glucose concentration values with a lowest of the three values highlighted.

7. The method of claim 6, in which the determining comprises deciding whether the lowest value is less than a predetermined low threshold and if true then displaying a new insulin dose having a value less than a current insulin dose stored in the memory of the handheld diabetes data management unit by a decreased value.

8. The method of claim 7, in which the decreased value comprises about 4 units.

9. The method of claim 6, in which the determining comprises deciding whether the lowest value is greater than a predetermined high threshold and less than a predetermined upper threshold and if true displaying a new insulin dose having an increased value greater than a current insulin dose stored in the memory of the handheld diabetes data management unit.

10. The method of claim 9, in which the increased value comprises about 2 units.

11. The method of claim 6 in which the determining comprises deciding whether the lowest value is greater than a predetermined upper threshold value and if true, displaying a new insulin dose having an increased value greater than a current insulin dose stored in the memory of the handheld diabetes data management unit.

12. The method of claim 11, in which the increased value comprises about 4 units.

13. The method of claim 1, in which the glucose concentration value results comprise fasting glucose value results.

14. The method of claim 1, in which the ascertaining comprises determining whether the fasting blood glucose concentration values of the user are within predetermined target for a predetermined period of time.

15. The method of claim 14, in which the predetermined period comprises approximately three consecutive days.

16. The method of claim 1, in which the ascertaining comprises determining whether the user has missed at least two fasting blood glucose tests in the first time period.

17. The method of claim 16, in which the determining comprises notifying the user, in the event that the user:

(a) has missed at least two fasting blood glucose tests during the first time period, (b) is not compliant with testing, or (c) is to continue with prescribed insulin dosage; and

recommending that the user contacts a health care provider.

18. The method of claim 1, in which the ascertaining comprises determining whether the user has missed a one day prior fasting glucose test.

19. The method of claim 1, further comprising

flagging a recent glucose concentration value as a fasting measurement;

displaying a recommended insulin dosage that is increased by a first increment where the last three glucose concentration value are all greater than a high threshold but less than an upper threshold;

displaying a recommended insulin dosage that is increased by a second increment where the last three glucose concentration value are all greater than an upper threshold;

deactivating the basal adjustment algorithm where the user misses two or more fasting glucose measurements over a four day period;

providing a warning message where the user misses a fasting glucose measurement yesterday;

or

deactivating the basal adjustment algorithm where four consecutive fasting glucose concentration values are less than 50 mg/dL.

20. A method to safeguard basal insulin dose changes with an insulin delivery device and a handheld diabetes data management unit having a test sensor, a processor coupled to a memory and display, the method comprising:

collecting data representative of a plurality of fasting blood glucose concentration values as measured by the test sensor of the handheld diabetes data management unit;

performing safeguards against hypoglycemia of the user prior to any change in basal insulin dosage based on the plurality of data, wherein the safeguards comprise;

prohibiting basal insulin adjustment in one of the insulin delivery device and handheld diabetes data management unit ascertaining from the collected data whether the user has conducted a minimum number fasting blood glucose measurements within at least one of two prescribed time periods;

determining whether the collected data indicates one of a first low blood glucose concentration pattern and a second low blood glucose concentration pattern; and

upon determination of at least one of the first and second low blood glucose concentration patterns of the user, displaying respective safety notifications on the display screen of the handheld diabetes data management unit; and

upon completion of the safeguards, recommending one of no change in the current basal insulin dose, an increase or decrease in the current basal insulin dose as a function of at least three consecutive fasting glucose concentration values from the plurality of fasting blood glucose concentration values.

21. The method of claim 20, in which the determining comprises recommending insulin dosage that is decreased by a first decrement where a prior last glucose concentration value is less than a first low threshold;

recommending no changes to a current insulin dose stored in the memory of the handheld diabetes data management unit in the event that all three prior consecutive fasting blood glucose concentration values are not higher than a high threshold; and

in the event that all three prior consecutive fasting blood glucose concentration values are greater than a upper threshold, recommending an increase in insulin by a first increment otherwise recommending an increase in insulin by a second increment.

22. The method of claim 20, in which the recommending comprises

determining whether there are at least three fasting blood glucose measurements stored in the handheld diabetes data management unit and if true, recommending no changes to current insulin dose otherwise displaying last three blood glucose concentration values with a lowest of the three values highlighted;

and

deciding whether the lowest value is less than a predetermined low threshold and if true then displaying a new insulin dose having a value less than a current insulin dose stored in the memory of the handheld diabetes data management unit by a decreased value.

23. The method of claim 22, in which the decreased value comprises about 4 units.

24. The method of claim 20, in which the recommending comprises deciding whether the lowest value is greater than a predetermined low threshold and less than a predetermined upper threshold and if true displaying a new insulin dose having an increased value greater than a current insulin dose stored in the memory of the handheld diabetes data management unit.

25. The method of claim 24, in which the increased value comprises about 2 units.

26. The method of claim 20, in which the recommending comprises deciding whether the lowest value is greater than a predetermined upper threshold value and if true, displaying a new insulin dose having an increased value greater than a current insulin dose stored in the memory of the handheld diabetes data management unit.

27. The method of claim 26, in which the increased value comprises about 4 units.