Feedback from Cloud or HCP to Payer or Patient via Meter or Cell Phone

• US 20140088392A1
• Filed: 12/21/2011
• Published: 03/27/2014
• Est. Priority Date: 02/11/2011
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bernstein, Daniel M., Bradrick, Brittany K., Budiman, Erwin S., Cheng, Royce, Davis, Eric, Doniger, Kenneth J., Dunn, Timothy C., Hayter, Gary A., Scott, Steve, Winkler, Todd, Wolpert, Howard, Kyrie, Dominic
• Application Number:
  US13/984,806
• Publication Number:
  US 20140088392A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• 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: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Presented herein are one or more software applications to help a user manager their diabetes. Embodiments and descriptions of the various applications are provided below in conjunction with an analyte measurement device.

Claims

1-19. -19. (canceled)

20. A method, comprising:

displaying a chart having median glucose as a first axis and glucose variability as a second axis; and

displaying an identifier on the chart corresponding to a median glucose value and a glucose variability value for sample data from a first patient, wherein the identifier represents a state of glucose control for the first patient.

21. The method of claim 20, wherein glucose variability is defined by the difference between the median glucose value and a predetermined percentile value of glucose.

22. The method of claim 21, wherein the predetermined percentage value is 10 percent.

23. The method of claim 20, comprising:

displaying a graphical overlay representing a chronic clinical risk on the chart, wherein the graphical overlay derived representing retinopathy risk is based on eAG and median glucose values for a population of patients.

24. The method of claim 23, wherein the chronic clinical risk is retinopathy risk.

25. The method of claim 24, comprising:

displaying a graphical overlay representing an acute risk on the chart, wherein the graphical overlay representing acute risk of hypoglycemia comprises one or more lines of hypoglycemia occurrences per a given time period.

26. The method of claim 25, wherein the acute risk is a risk of hypoglycemia.

27. The method of claim 26, comprising:

directing patient treatment based on the position of the identifier representing the state of glucose control for the first patient with respect to the graphical overlays for retinopathy risk and/or acute risk of hypoglycemia.

28. The method of claim 20, comprising:

displaying a graphical overlay for one or more clinical risks on the chart, wherein the graphical overly of the one or more clinical risks is associated with one or more axis of the chart.

29. The method of claim 20, comprising:

determining lines of constant hypoglycemia rates, wherein the lines of constant hypoglycemia rates are based on a number of occurrences of hypoglycemia per a given time period.

30. The method of claim 29, wherein the lines of constant hypoglycemia rates are determined from a number of occurrences of hypoglycemia per a given time period for a sample population of patients.

31. The method of claim 29, wherein the lines of constant hypoglycemia rates are parallel approximations.

32. The method of claim 29, comprising:

determining a threshold line of constant hypoglycemia rate; and

displaying a hypoglycemia risk zone having a border line on the threshold line of constant hypoglycemia rate.

33. The method of claim 32, comprising:

determining a target A1c level corresponding to a median glucose value; and

displaying a target zone defined by the target A1c level and the border line of the hypoglycemia risk zone.

34. The method of claim 33, comprising:

displaying a buffer zone along the border line and adjacent the target zone; and

defining the remaining area of the chart as a fourth zone.

35. The method of claim 34, comprising:

directing treatment of the first patient based on the position of the identifier representing the state of glucose control for the first patient with respect to the hypoglycemia risk zone, target zone, buffer zone, and/or fourth zone.

36. The method of claim 33, comprising:

directing treatment of the first patient based on the position of the identifier representing the state of glucose control for the first patient with respect to the hypoglycemia risk zone and/or the target zone.

37. The method of claim 20, wherein the identifier representing the state of glucose control for the first patient is calculated from the sample data.

38. The method of claim 20, wherein the identifier representing the state of glucose control for the first patient is calculated from fitting the sample data to a probability distribution.

39. The method of claim 38, wherein the probability distribution is a gamma probability distribution.

40. The method of claim 20, wherein the identifier comprises a bootstrap point cloud.

41. The method of claim 40, comprising:

defining a treatment recommendation point based on a predetermined threshold percentage value, wherein the predetermined threshold percentage value correlates to an acceptable probability threshold of being in a hypoglycemia risk zone on the chart.

42. The method of claim 20, wherein the identifier comprises a boundary line of a bootstrap point cloud.

43. The method of claim 20, wherein the identifier comprises contour plots of a probability distribution function for the state of glucose control for the first patient, wherein the contour plots represent uncertainty levels for the estimate.

44. The method of claim 43, wherein the probability distribution function is based on a first testing schedule over a first time period.

45. The method of claim 44, comprising:

displaying a graphical overlay representing retinopathy risk on the chart, wherein the graphical overlay derived representing retinopathy risk is based on eAG and median glucose values for a population of patients; and

displaying a graphical overlay representing acute risk of hypoglycemia on the chart, wherein the graphical overlay representing acute risk of hypoglycemia comprises one or more lines of hypoglycemia occurrences per a given time period.

46. The method of claim 45, comprising:

directing patient treatment based on a comparison of the contour lines with respect to the graphical overlays for retinopathy risk and/or acute risk of hypoglycemia.

47. The method of claim 45, comprising:

directing patient treatment to a second testing schedule based on a comparison of the contour lines with respect to the graphical overlays for retinopathy risk and/or acute risk of hypoglycemia.

48. The method of claim 44, wherein the first testing schedule is a self-monitored blood glucose (SMBG) testing schedule.

49. The method of claim 43, wherein contour plots are associated with one or more clinical risks.

50. The method of claim 49, wherein the one or more clinical risks comprises retinopathy risk and/or acute risk of hypoglycemia.

51. The method of claim 49, wherein different SMBG testing schedules are collected, and wherein for each schedule, the contour plots are computed a priori from population data.

52. The method of claim 51, wherein the population data is comprised of CGM values or SMBG data taken every 15 minutes or faster.

53. The method of claim 51, wherein the population data is obtained from human studies wearing CGM systems.

54. The method of claim 51, wherein the population data is obtained from in-silico human models representing a wide range of demographics and/or state of diabetes.

55. The method of claim 51, wherein the contour plots from the population data is projected along the gradient of a particular clinical risk.

56. The method of claim 51, wherein adequate and inadequate areas in the glucose control chart are identified for each combination of SMBG testing schedule and clinical risk.

57. The method of claim 56, comprising:

identifying the areas of inadequacy on the chart.

58. The method of claim 49, comprising:

recommending a SMBG testing schedule specific to a latest state of glucose control for the first patient.

59. The method of claim 58, comprising:

identifying adequate and inadequate areas in the chart; and

determining whether initial data under the recommended SMBG testing schedule falls within the adequate or the inadequate area.

60. The method of claim 49, comprising:

identifying adequate and inadequate areas in the chart; and

recommending a SMBG testing schedule to position a next predicted state of glucose control in the adequate area.

61-116. -116. (canceled)