Diabetes management methods and systems

• US 20070232876A1
• Filed: 03/31/2006
• Published: 10/04/2007
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Harmon, Kirk, Sharma, Manoj, Otto, Erik, Horwitz, David
• Granted Patent: US 7,824,333 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

The present invention relates to methods and systems for monitoring the effectiveness of diabetes treatment. Methods and systems in accordance with the present invention provide information relating to variability of glucose levels and hypoglycemia and hyperglycemia. Such information is based on time-stamped blood glucose data obtained from a meter or the like and actual measurements of HbA1c levels are not required.

Claims

1. A method of managing blood glucose data, the method comprising the steps of:

providing a plurality of blood glucose data collected over a predetermined period of time;

estimating an idiosyncratic HbA1c level from the plurality of blood glucose data using a first predetermined algorithm having at least one exclusion criteria;

calculating an idiosyncratic variability index of glycemia from the plurality of blood glucose data using a second predetermined algorithm having at least one exclusion criteria; and

comparing the idiosyncratic variability index of glycemia and the idiosyncratic HbA1c level.

2. The method of claim 1, wherein the at least one exclusion criteria for one or both of the first and second algorithms comprises at least one of a history of insufficient testing, a frequency outside of a specified number of tests per day, and a requirement for specified randomness of data on a daily basis.

3. The method of claim 1, comprising reporting the idiosyncratic variability index of glycemia and the idiosyncratic HbA1c level when the at least one exclusion criteria for one or both of the first and second algorithms is not met.

4. The method of claim 3, wherein the reporting step comprises reporting the idiosyncratic variability index of glycemia in relation to the idiosyncratic HbA1c level.

5. The method of claim 4, wherein the reporting step comprises providing the idiosyncratic variability index of glycemia in relation to the idiosyncratic HbA1c level on a weekly basis.

6. The method of claim 4, wherein the reporting step comprises providing the idiosyncratic variability index of glycemia in relation to the idiosyncratic HbA1c level on a monthly basis.

7. The method of claim 3, wherein the reporting step comprises providing the idiosyncratic variability index of glycemia and the idiosyncratic HbA1c level in tabular form.

8. A method of managing blood glucose data, the method comprising the steps of:

providing a plurality of blood glucose data collected over a predetermined period of time;

estimating an idiosyncratic HbA1c level from the plurality of blood glucose data using a first predetermined algorithm having at least one exclusion criteria;

calculating an idiosyncratic variability index of glycemia from the plurality of blood glucose data using a second predetermined algorithm having at least one exclusion criteria;

determining the idiosyncratic variability index of glycemia as a function of the idiosyncratic HbA1c level; and

providing the reported idiosyncratic variability index of glycemia and idiosyncratic HbA1c level while indicating at least one aspect of glycemic control.

9. The method of claim 8, wherein the at least one aspect of glycemic control comprises target, cautionary, and danger regions of glycemic control.

10. The method of claim 8, wherein the at least one exclusion criterion for one or both of the first and second algorithms comprises at least one of a history of testing, a frequency of tests per day, and a randomness of data on a daily basis.

11. The method of claim 8, wherein the determining step comprises determining the idiosyncratic variability index of glycemia as a function of the idiosyncratic HbA1c level on a weekly basis.

12. The method of claim 8, wherein the determining step comprises determining the idiosyncratic variability index of glycemia as a function of the idiosyncratic HbA1c level on a monthly basis.

13. A system for managing blood glucose data, the system comprising:

a processor programmed to;

receive a plurality of blood glucose data collected over a predetermined period of time;

provide an estimation of an idiosyncratic HbA1c level from the plurality of blood glucose data;

provide a calculation of an idiosyncratic variability index of glycemia from the plurality of blood glucose data; and

report the idiosyncratic variability index of glycemia and the idiosyncratic HbA1c level when at least one exclusion criterion is not met.

14. The system of claim 13, wherein the at least one exclusion criterion includes a history of testing, a frequency of tests per day, and a randomness of data on a daily basis.

15. The system of claim 13, wherein the processor is programmed to report the idiosyncratic variability index of glycemia as a function of the idiosyncratic HbA1c level on a weekly basis.

16. The system of claim 13, wherein the processor is programmed to report the idiosyncratic variability index of glycemia as a function of the idiosyncratic HbA1c level on a monthly basis.

17. The system of claim 13, wherein the processor is programmed to report the idiosyncratic variability index of glycemia and the idiosyncratic HbA1c level in tabular form.

18. The system of claim 13, wherein the processor is programmed to estimate the idiosyncratic HbA1c level from a previously measured HbA1c level.

19. The system of claim 13, further comprising a blood glucose measurement device.

20. The system of claim 13, further comprising a memory device.