System and Methods for Analyzing Blood Glucose Data and Quantifying the Success or Failure of Insulin Therapy

• US 20140278124A1
• Filed: 03/14/2013
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wagner, Robin, Rees, Christen A, Wegmann, Nathan
• Granted Patent: US 10,102,344 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and technique are enclosed for determining the effectiveness of a blood glucose therapy treatment. Examples of this technique include analyzing sufficiency of blood glucose data collected from a patient with a computing device, analyzing hypoglycemic risk based on the blood glucose data with the computing device, analyzing glycemic control for the blood glucose data with the computing device, analyzing glycemic variability of the blood glucose data with the computing device, and outputting results from said analyzing the sufficiency, said analyzing the hypoglycemic risk, said analyzing the glycemic control, and said analyzing the glycemic variability with the computing device.

Claims

1. A method of determining effectiveness of a blood glucose treatment therapy, comprising:

analyzing sufficiency of blood glucose data collected from a patient with a computing device;

analyzing hypoglycemic risk based on the blood glucose data with the computing device;

analyzing glycemic control for the blood glucose data with the computing device;

analyzing glycemic variability of the blood glucose data with the computing device; and

outputting results from said analyzing the sufficiency, said analyzing the hypoglycemic risk, said analyzing the glycemic control, and said analyzing the glycemic variability with the computing device.

2. The method according to claim 1, wherein said outputting the results includes providing a recommendation to change from a multiple daily injection (MDI) therapy to a continuous subcutaneous insulin infusion (CSII) therapy when the blood glucose data fails any one of said analyzing acts.

3. The method according to claim 1, wherein the analyzing the sufficiency includes

calculating a first average testing frequency for the blood glucose data over a first period with the computing device, and

determining with the computing device whether the first average testing frequency is below a first testing frequency limit.

4. The method according to claim 3, further comprising reporting an inadequate testing frequency with the computing device when the first average testing frequency is below the first testing frequency limit.

5. The method according to claim 3, further comprising:

calculating a second average testing frequency for the blood glucose data over a second period with the computing device when the first average testing frequency is below the first testing frequency limit, and

determining with the computing device whether the second average testing frequency is below a second testing frequency limit.

6. The method according to claim 5, further comprising reporting an inadequate testing frequency with the computing device when the second average testing frequency is below the second testing frequency limit.

7. The method according to claim 5, wherein the second period is shorter than the first period.

8. The method according to claim 5, wherein the second period is about 15 days.

9. The method according to claim 5, wherein the second testing frequency limit is 4 glucose tests per day.

10. The method according to claim 3, wherein the first period is 30 days.

11. The method according to claim 3, wherein the first testing frequency limit is 4 glucose tests per day.

12. The method according to claim 1, wherein said analyzing the hypoglycemic risk includes evaluating the low blood glucose index (LBGI).

13. The method according to claim 12, wherein said outputting the results includes reporting that the risk of hypoglycemia is elevated when the LBGI is moderate or high.

14. The method according to claim 12, wherein said evaluating the LBGI includes:

transforming the blood glucose data to a symmetric scale;

assigning one or more risk values based on said transforming; and

determining the LBGI based on an average of the risk values.

15. The method according to claim 14, further comprising:

wherein said transforming the blood glucose data includes generating a transformed blood glucose level (Transformed BG) using the following formula;

Transformed BG=1.509×

{[log(BG)]^1.084−

5.381}

where;

BG=Blood Glucose Reading (mg/dL);

wherein said assigning the risk values are assigned as follows;

If Transformed BG<

0, then

Risk(BG)=10×

(Transformed BG)²

otherwise

Risk(BG)=0

where;

Risk (BG)=risk value for a blood glucose reading; and

wherein said determining the LBGI is based on the following formula;

16. The method according to claim 12, wherein the hypoglycemic risk is:

minimal when LBGI≦

1.1;

low when 1.1<

LBGI≦

2.5;

moderate when 2.5<

LBGI≦

5.0; and

high when LBGI>

5.0.

17. The method according to claim 1, wherein said analyzing glycemic control includes evaluating a mean blood glucose level.

18. The method according to claim 17, wherein said outputting the results includes reporting that glycemic control is suboptimal when the mean blood glucose level exceeds a limit.

19. The method according to claim 18, wherein the limit is 154 mg/dL.

20. The method according to claim 1, wherein said analyzing glycemic variability includes:

calculating a standard deviation of the blood glucose data with the computing device; and

evaluating the standard deviation with respect to a limit with the computing device.

21. The method according to claim 20, further comprising:

determining with the computing device whether two times the standard deviation is greater than mean blood glucose level; and

wherein said outputting the results includes reporting that glycemic variability is suboptimal in response to said determining that two times the standard deviation is greater than the mean blood glucose level.

22. The method according to claim 21, further comprising:

determining with the computing device whether three times the standard deviation is greater than the mean blood glucose level; and

wherein said outputting the results includes reporting that glycemic variability is good in response to said determining that three times the standard deviation is greater than the mean blood glucose level.

23. The method according to claim 21, further comprising:

determining with the computing device whether three times the standard deviation is less than or equal to the mean blood glucose level; and

wherein said outputting the results includes reporting that glycemic variability is excellent in response to said determining that three times the standard deviation is less than or equal to the mean blood glucose level.

24. The method according to claim 1, wherein said outputting the results includes reporting therapy goals have been achieved when said analyzing the sufficiency, said analyzing the hypoglycemic risk, said analyzing the glycemic control, and said analyzing the glycemic variability with the computing device provide acceptable results.

25. The method according to claim 1, wherein the computing device includes a glucose meter.

26. The method according to claim 25, further comprising:

collecting the blood glucose data with the glucose meter.

27. The method according to claim 26, wherein the glucose meter includes a continuous glucose meter.

28. The method according to claim 1, further comprising:

providing to a third party payer a report recommending a change in the treatment therapy in response to said outputting results.

29. A system for determining effectiveness of a blood glucose treatment therapy, comprising:

a computing device comprising a non-transitory machine-readable storage medium comprising instructions that when performed by the computing device result in operations comprising;

analyzing sufficiency of blood glucose data collected from a patient.

analyzing hypoglycemic risk based on the blood glucose data.

analyzing glycemic control for the blood glucose data.

analyzing glycemic variability of the blood glucose data. and

generating a report that provides the results from said analyzing the sufficiency, said analyzing the hypoglycemic risk, said analyzing the glycemic control, and said analyzing the glycemic variability.

30. The system according to claim 29, further comprising a glucose meter.

31. A system according to claim 29, wherein the computing device includes an input/output device.