Method, system, and computer program product for tracking of blood glucose variability in diabetes

• US 9,317,657 B2
• Filed: 11/24/2009
• Issued: 04/19/2016
• Est. Priority Date: 11/26/2008
• Status: Active Grant

• Current Assignee: University of Virginia
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Breton, Marc D., Kovatchev, Boris P.
• Primary Examiner(s): Tsai, Carol S. W.
• Application Number:
  US13/131,467
• Publication Number:
  US 20110264378A1
• Time in Patent Office: 2,338 Days
• Field of Search: 702/19, 702/26, 700/266, 700/17
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An embodiment may be in the field of glycemic analysis and control. More specifically, an embodiment or approach may provide a novel method, system, and computer program for the visual and quantitative tracking of blood glucose variability in diabetes from self-monitoring blood glucose (SMBG) data and/or continuous glucose monitoring (CGM) data. More particularly, an embodiment or aspects thereof may use glucose measurements obtained from self-monitoring data and/or CGM data of an individual or a group of individuals to track and analyze blood glucose variability.

Claims

1. A system for visually tracking blood glucose variability in diabetes in a subject, said system comprising:

an acquisition module acquiring a plurality of blood glucose data of the subject over a predefined period of time;

a processor programmed to

compute blood glucose variability of the subject over said predefined period of time using said blood glucose data; and

plot the computed blood glucose variability on an output display in the form of data points on a graph having a coordinate system representing hypoglycemic risk along one axis of said graph and hyperglycemic risk along another axis of said graph;

wherein the location of a data point in said coordinate system of said graph represents a variable degree of control of blood glucose levels of said subject; and

wherein said tracking provides an area of optimal glucose control in said graph, and provides areas in said graph indicating risk for hyperglycemia and hypoglycemia.

2. The system of claim 1, wherein said graph comprises:

a first axis representing the risk for hypoglycemia; and

a second axis representing the risk for hyperglycemia.

3. The system of claim 1, wherein said graph comprises:

a first axis representing the Low Blood Glucose Index (LBGI); and

a second axis representing the High Blood Glucose Index (HBGI).

4. The system of claim 1, wherein said graph comprises:

a first axis representing the inverse-coded lower percentile; and

a second axis representing the upper percentile.

5. The system claim 1, wherein said graph comprises at least one of:

a first zone representing the optimal control of glucose variability;

a second zone representing moderate deviations into hypoglycemia, but good control of hyperglycemia;

a third zone representing moderate deviations into hyperglycemia, but good control of hypoglycemia;

a fourth zone representing moderate deviations towards both hypoglycemia and hyperglycemia;

a fifth zone representing over-correction of hyperglycemia;

a sixth zone representing over-correction of hypoglycemia;

a seventh zone representing failure to deal with hypoglycemia;

an eighth zone representing failure to deal with hyperglycemia; and

a ninth zone representing an erroneous control.

6. The system of claim 2, wherein said first axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data and the second axis comprises about the 97.5% of a distribution of said blood glucose data.

7. The system of claim 2, wherein said first axis comprises about the 97.5% of a distribution of said blood glucose data and the second axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data.

8. The system of claim 5, wherein said graph comprises:

said first zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 110-200 mg/dl;

said second zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 110-200 mg/dl;

said third zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 200-400 mg/dl;

said fourth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 200-400 mg/dl;

said fifth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 110-200 mg/dl;

said sixth zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about greater than 400 mg/dl;

said seventh zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 200-400 mg/dl;

said eighth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about greater than 400 mg/dl; and

said ninth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about greater than 400 mg/d1.

9. The system of claim 4, wherein said first axis comprises about the inverse-coded 25% and the second axis comprises about the 75% of said blood glucose data.

10. The system of claim 4, wherein said second axis comprises about the inverse-coded 25% and the first axis comprises about the 75% of said blood glucose data.

11. The system of claim 5, wherein:

said first zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 110-180 mg/dl;

said second zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 110-180 mg/dl;

said third zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 180-250 mg/dl;

said fourth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 180-250 mg/dl;

said fifth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 110-180 mg/dl;

said sixth zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about greater than 250 mg/dl;

said seventh zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 180-250 mg/dl;

said eighth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about greater than 250 mg/dl; and

said ninth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about greater than 250 mg/d1.

12. The system of claim 3, wherein said first axis comprises a Low Blood Glucose Index (LBGI) of said blood glucose data.

13. The system of claim 12, wherein said Low Blood Glucose Index (LBGI) is provided by:

14. The system of claim 3, wherein said second axis comprises a High Blood Glucose Index (HBGI) of said blood glucose data.

15. The system of claim 14, wherein said High Blood Glucose Index (HBGI) is provided by:

16. The system of claim 5, wherein:

said first zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about less than 5;

said second zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about less than 5;

said third zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about 5-10;

said fourth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about 5-10;

said fifth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about less than 5;

said sixth zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about greater than 10;

said seventh zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about 5-10;

said eighth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about greater than 10; and

said ninth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about greater than 10.

17. The system of claim 1, wherein said tracking determines extreme glucose events.

18. The system of claim 1, wherein said tracking determines the extent of glycemic fluctuations over a specified time interval.

19. The system of claim 1, wherein said tracking comprises plotting a trajectory of data points from said blood glucose data on a specified time interval.

20. The system of claim 1, wherein said blood glucose data is acquired from continuous glucose monitoring (CGM) or self-monitoring blood glucose (SMBG) or both.

42. The system of claim 18, wherein said specified time interval is approximately two or more days.

43. The system of claim 18, wherein said specified time interval is approximately a daily basis.

44. The system of claim 18, wherein said specified time interval is less than a daily basis.

45. The system of claim 18, wherein said specified time interval is approximately half a day.

46. The system of claim 18, wherein said specified time interval is approximately two or more hours.

47. The system of claim 18, wherein said specified time interval is approximately an hour.

48. The system of claim 18, wherein said specified time interval is less than an hour.

49. The system of claim 18, wherein said specified time interval is approximately fifteen minutes.

21. A computer program product comprising a non-transitory computer useable medium having a computer program logic for enabling at least one processor in a computer system to track blood glucose variability in diabetes in a subject, or in a group of subjects, said computer program logic comprising:

acquiring a plurality of blood glucose data of the subject over a predefined period of time;

computing blood glucose variability of the subject over said predefined period of time using said blood glucose data;

plotting the computed blood glucose variability on an output display in the form of data points on a graph having a coordinate system representing hypoglycemic risk along one axis of said graph and hyperglycemic risk along another axis of said graph;

wherein the location of a data point in said coordinate system of said graph represents a variable degree of control of blood glucose levels of said subject; and

wherein said tracking provides an area of optimal glucose control in said graph, and provides areas in said graph indicating risk for hyperglycemia and hypoglycemia.

22. The computer program product of claim 21, wherein said coordinate system of said graph is transmitted to an interface.

23. The computer program product of claim 21, wherein said coordinate system of said graph comprises:

a first axis representing the risk for hypoglycemia; and

a second axis representing the risk for hyperglycemia.

24. The computer program product of claim 21, wherein said coordinate system of said graph comprises:

a first axis representing the Low Blood Glucose Index (LBGI); and

a second axis representing the High Blood Glucose Index (HBGI).

25. The computer program product of claim 21, wherein said coordinate system of said graph comprises:

a first axis representing the inverse-coded lower percentile; and

a second axis representing the upper percentile.

26. The computer program product of claim 21, wherein said coordinate system of said graph comprises at least one of:

a first zone representing the optimal control of glucose variability;

a second zone representing moderate deviations into hypoglycemia, but good control of hyperglycemia;

a third zone representing moderate deviations into hyperglycemia, but good control of hypoglycemia;

a fourth zone representing moderate deviations towards both hypoglycemia and hyperglycemia;

a fifth zone representing over-correction of hyperglycemia;

a sixth zone representing over-correction of hypoglycemia;

a seventh zone representing failure to deal with hypoglycemia;

an eighth zone representing failure to deal with hyperglycemia; and

a ninth zone representing an erroneous control.

27. The computer program product of claim 23, wherein said first axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data and the second axis comprises about the 97.5% of a distribution of said blood glucose data.

28. The computer program product of claim 23, wherein said first axis comprises about the 97.5% of a distribution of said blood glucose data and the second axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data.

29. The computer program product of claim 23, wherein:

said first zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 110-200 mg/dl;

said second zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 110-200 mg/dl;

said third zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 200-400 mg/dl;

said fourth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 200-400 mg/dl;

said fifth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 110-200 mg/dl;

said sixth zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about greater than 400 mg/dl;

said seventh zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 200-400 mg/dl;

said eighth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about greater than 400 mg/dl; and

said ninth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about greater than 400 mg/d1.

30. The computer program product of claim 25, wherein said first axis comprises about the inverse-coded 25% and the second axis comprises about the 75% of said blood glucose data.

31. The computer program product of claim 25, wherein said second axis comprises about the inverse-coded 25% and the first axis comprises about the 75% of said blood glucose data.

32. The computer program product of claim 25, wherein:

said first zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 110-180 mg/dl;

said second zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 110-180 mg/dl;

said third zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 180-250 mg/dl;

said fourth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 180-250 mg/dl;

said fifth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 110-180 mg/dl;

said sixth zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about greater than 250 mg/dl;

said seventh zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 180-250 mg/dl;

said eighth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about greater than 250 mg/dl; and

said ninth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about greater than 250 mg/d1.

33. The computer program product of claim 24, wherein said first axis comprises a Low Blood Glucose Index (LBGI) of said blood glucose data.

34. The computer program product of claim 33, wherein said Low Blood Glucose Index (LBGI) is provided by:

35. The computer program product of claim 34, wherein said second axis comprises a High Blood Glucose Index (HBGI) of said blood glucose data.

36. The computer program product of claim 25, wherein said High Blood Glucose Index (HBGI) is provided by:

37. The computer program product of claim 26, wherein:

said first zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about less than 5;

said second zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about less than 5;

said third zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about 5-10;

said fourth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about 5-10;

said fifth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about less than 5;

said sixth zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about greater than 10;

said seventh zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about 5-10;

said eighth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about greater than 10; and

said ninth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about greater than 10.

38. The computer program product of claim 21, wherein said tracking determines extreme glucose events.

39. The computer program product of claim 21, wherein said tracking determines the extent of glycemic fluctuations over a specified time interval.

40. The computer program product of claim 21, wherein said tracking comprises plotting a trajectory of data points from said blood glucose data on a specified time interval.

41. The computer program product of claim 21, wherein said blood glucose data is acquired from continuous glucose monitoring (CGM) or self-monitoring blood glucose (SMBG) or both.

50. The computer program product of claim 39, wherein said specified time interval is approximately two or more days.

51. The computer program product of claim 39, wherein said specified time interval is approximately a daily basis.

52. The computer program product of claim 39, wherein said specified time interval is less than a daily basis.

53. The computer program product of claim 39, wherein said specified time interval is approximately half a day.

54. The computer program product of claim 39, wherein said specified time interval is approximately two or more hours.

55. The computer program product of claim 39, wherein said specified time interval is approximately an hour.

56. The computer program product of claim 39, wherein said specified time interval is less than an hour.

57. The computer program product of claim 39, wherein said specified time interval is approximately fifteen minutes.