System and methods for analyzing blood glucose data and quantifying the success or failure of insulin therapy

• US 10,102,344 B2
• Filed: 03/14/2013
• Issued: 10/16/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Rees, Christen A, Wagner, Robin, Wegmann, Nathan
• Primary Examiner(s): Vanni, G Steven
• Application Number:
  US13/803,770
• Publication Number:
  US 20140278124A1
• Time in Patent Office: 2,042 Days
• Field of Search: None
• 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 computerized method of determining and reporting effectiveness of a blood glucose treatment therapy of multiple daily injections administered to a patient with diabetes which quantifies effectiveness as a success or failure of the administered blood glucose treatment therapy to reach glycemic goals based on blood glucose data collected from the patient via a biosensor, comprising:

transmitting to a computing device via a wired and/or wireless connection blood glucose data collected from the patient via the biosensor;

averaging blood glucose level readings from the biosensor in the blood glucose data per day over a first period and thereby determining a first average testing frequency;

calculating a low blood glucose index (LBGI) with the computing device by;

using a logarithmic formula which transforms each collected blood glucose level from the blood glucose data to a symmetric scale which addresses scale skewing that diminishes significance of hypoglycemia indicated in the blood glucose data;

assigning a risk value to each transformed blood glucose level using a rule; and

averaging the assigned risk values and thereby determining the LBGI;

calculating a mean blood glucose level from the blood glucose data with the computing device;

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

determining with the computing device a failure of effectiveness of an administered blood glucose treatment therapy of the multiple daily injections administered to the patient with diabetes based upon;

determining with the computing device that the first average testing frequency exceeds a first testing frequency limit which governs sufficiency of the blood glucose data collected from the patient for use in quantifying the failure or success of the effectiveness of the administered blood glucose treatment therapy, and

determining with the computing device that one or more of the following conditions have been met;

(i) the calculated LB GI exceeds a value for hypoglycemic risk,

(ii) the calculated mean blood glucose level exceeds a limit for glycemic control, and

(iii) the calculated standard deviation exceeds a limit for glycemic variability; and

reporting by the computing device via an input/output (I/O) device a recommendation to change from a blood glucose treatment therapy of the multiple daily injections to a continuous subcutaneous insulin infusion (CSII) therapy upon the failure of the effectiveness of the administered blood glucose treatment therapy from determining by the computing device that the first average testing frequency exceeds the first testing frequency limit and the one or more of the conditions (i)-(iii) were met.

2. The method according to claim 1, further comprising reporting an inadequate testing frequency with the computing device when the first average testing frequency is below the first testing frequency limit.

3. The method according to claim 1, 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.

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

5. The method according to claim 3, wherein the second period is shorter than the first period.

6. The method according to claim 3, wherein the second period is about 15 days.

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

8. The method according to claim 1, wherein the first period is 30 days.

9. The method according to claim 1, wherein the first testing frequency limit is 4 glucose tests per day.

10. The method according to claim 1, wherein said logarithmic formula used to generate the transformed blood glucose level (Transformed BG) is as follows:

Transformed BG=1.509×

{[log (BG)]^1.084−

5.381}

where;

BG=Blood Glucose Reading (mg/dL); and

wherein said rule assigning the risk values is 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;

11. The method according to claim 10, 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.

12. The method according to claim 11, wherein said reporting includes providing a warning that the risk of hypoglycemia is elevated when the LBGI is moderate or high.

13. The method according to claim 1, wherein said reporting includes providing a warning that glycemic control is suboptimal when the mean blood glucose level exceeds the limit for glycemic control.

14. The method according to claim 13, wherein the limit for glycemic control is 154 mg/dL.

15. The method according to claim 1, wherein the limit for glycemic variability is the mean blood glucose level and said method further comprises:

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

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

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

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

reporting by the computing device that glycemic variability is good in response to said determining that three times the standard deviation is greater than the mean blood glucose level.

17. The method according to claim 1, 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

reporting by the computer device 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.

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

reporting by the computing device that therapy goals have been achieved upon none of the conditions (i)-(iii) being met.

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

20. The method according to claim 19, further comprising:

collecting the blood glucose data with the glucose meter.

21. The method according to claim 20, wherein the glucose meter includes a continuous glucose monitoring meter or a self-monitoring blood glucose meter.

22. 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 reporting that the recommendation to change from the blood glucose treatment therapy of the multiple daily injections to a continuous subcutaneous insulin infusion (CSII) therapy.

23. The method according to claim 1, wherein the biosensor includes a discrete test strip and/or continuous monitoring probe.

24. The method according to claim 1, wherein the transmitting to the computing device via the wired and/or wireless connection of the blood glucose data collected from the patient via the biosensor is from a self-monitoring blood glucose meter, a continuous glucose monitoring meter, and/or the insulin pump.

25. The method of claim 1, wherein the I/O device is one or more of a touch screen, a display, a speaker, and a printer.

26. A system for determining and reporting effectiveness of a blood glucose treatment therapy of the multiple daily injections administered to a patient with diabetes which quantifies effectiveness as a success or failure of the administered blood glucose treatment therapy to reach glycemic goals based on blood glucose data collected from the patient via a biosensor, comprising:

a computing device comprising a non-transitory machine-readable storage medium comprising instructions that when executed by a processor of the computing device cause the computing device to;

receive, via a wired and/or wireless connection, blood glucose data collected from the patient via a biosensor;

average blood glucose level readings from the biosensor in the blood glucose data per day over a first period and which determines a first average testing frequency;

calculate a low blood glucose index (LBGI) by;

using a logarithmic formula which transforms each collected blood glucose level from the blood glucose data to a symmetric scale and which thereby addresses scale skewing that diminishes significance of hypoglycemia indicated in the blood glucose data;

assigning a risk value to each transformed blood glucose level via a rule; and

averaging the assigned risk values which determines the LBGI;

calculate a mean blood glucose level from the blood glucose data;

calculate a standard deviation of the blood glucose data;

determine a failure of effectiveness of an administered blood glucose treatment therapy of the multiple daily injections administered to the patient with diabetes based upon;

a determination that the first average testing frequency exceeds a first testing frequency limit which governs sufficiency of the blood glucose data collected from the patient for use in quantifying the failure or success of the effectiveness of the administered blood glucose treatment therapy and

a determination that one or more of the following conditions have been met;

(i) the calculated LBGI exceeds a value for hypoglycemic risk,

(ii) the calculated mean blood glucose level exceeds a limit for glycemic control, and

(iii) the calculated standard deviation exceeds a limit for glycemic variability; and

report via an input/output (I/O) device a recommendation to change from the blood glucose treatment therapy of the multiple daily injections to a continuous subcutaneous insulin infusion (CSII) therapy upon the failure of the effectiveness of the administered blood glucose treatment therapy from the determination that the first average testing frequency exceeds the first testing frequency limit and the one or more of the conditions (i)-(iii) were met.

27. The system according to claim 26, further comprising a glucose meter.

28. The system according to claim 26, wherein the biosensor includes a discrete test strip and/or continuous monitoring probe.

29. The system according to claim 26, wherein the computing device is communicatively coupled via the wired and/or wireless connection to a self-monitoring blood glucose meter, a continuous glucose monitoring meter, and/or the insulin pump which provide the blood glucose data collected from the patient via the biosensor.

30. The system according to claim 26, wherein said instructions further cause the computing device to report via the I/O device an inadequate testing frequency upon the first average testing frequency being below the first testing frequency limit.

31. The system according to claim 26, wherein said instructions further cause the computing device to:

calculate a second average testing frequency for the blood glucose data over a second period when the first average testing frequency is below the first testing frequency limit; and

determine whether the second average testing frequency is below a second testing frequency limit.

32. The system according to claim 31, wherein said instructions further cause the computing device to report via the I/O device an inadequate testing frequency with the computing device when the second average testing frequency is below the second testing frequency limit.

33. The system according to claim 31, wherein the second period is shorter than the first period.

34. The system according to claim 26, wherein said logarithmic based formula used to generate the transformed blood glucose level (Transformed BG) is as follows:

Transformed BG=1.509×

{[log (BG)]^1.084−

5.381}

where;

BG=Blood Glucose Reading (mg/dL), and

wherein said rule to assign the risk values is 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 the LBGI is determined based on the following formula;

35. The system according to claim 34, 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.

36. The system according to claim 35, wherein said instructions further cause the computing device to provide via the I/O device:

a warning that the risk of hypoglycemia is elevated when the LBGI is moderate or high, and

a warning that glycemic control is suboptimal when the mean blood glucose level exceeds the limit for glycemic control.

37. The system according to claim 26, wherein the limit for glycemic variability is the mean blood glucose level, and said instructions further cause the computing device to:

determine whether two times the standard deviation is greater than the mean blood glucose level, and

provide via the I/O device a warning that glycemic variability is suboptimal in response to a determination that two times the standard deviation is greater than the mean blood glucose level.

38. The system according to claim 26, wherein said instructions further cause the computing device to:

determine whether three times the standard deviation is greater than the mean blood glucose level and

provide via the I/O device a report that glycemic variability is good in response to a determination that three times the standard deviation is greater than the mean blood glucose level.

39. The system according to claim 26, wherein said instructions further cause the computing device to:

determine whether three times the standard deviation is less than or equal to the mean blood glucose level and

provide via the I/O device a report that glycemic variability is excellent in response to a determination that three times the standard deviation is less than or equal to the mean blood glucose level.

40. The system according to claim 26, wherein said instructions further cause the computing device to:

provide via the I/O device a report therapy goals have been achieved upon none of the conditions (i)-(iii) being met.

41. The system according to claim 26, wherein said instructions further cause the computing device to:

provide to a third party payer via the I/O device a report recommending a change in the treatment therapy in response to reporting the recommendation to change from the blood glucose treatment therapy of the multiple daily injections to a continuous subcutaneous insulin infusion (CSII) therapy.

42. The system according to claim 26, wherein the I/O device is one or more of a touch screen, a display, a speaker, and a printer.