Glycemic risk determination based on variability of glucose levels

• US 9,351,670 B2
• Filed: 12/31/2012
• Issued: 05/31/2016
• Est. Priority Date: 12/31/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Dunn, Timothy, Doniger, Kenneth J., Berman, Glenn, Hayter, Gary A., Budiman, Erwin S., Bernstein, Daniel, Crouther, Nathan
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US13/732,184
• Publication Number:
  US 20140187887A1
• Time in Patent Office: 1,247 Days
• US Class Current: 1/1
• 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: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• 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
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for determining glycemic risks based on an analysis of glucose data includes visualization of hypoglycemia, variability, and hyperglycemia with a control grid, increasing the accuracy of glucose estimates using a combination of CGM and HbA1c, calculating glycemic risk by applying a probability distribution, and tailoring SMBG test schedules based on CGM use/wear.

Claims

1. A system for displaying glycemic information and risk, the system comprising:

a non-volatile memory in which is stored a glucose data processing program configured to program a processor to analyze received glucose data of a person and from the analysis, produce a display;

a display device; and

a processor, coupled with the nonvolatile memory and the display device, the processor being configured to access the memory to load and run in the processor the glucose data processing program to analyze glucose data, wherein the processor is programmed to;

analyze the received glucose data to determine a plurality of glucose medians, low range variability of glucose, and hypoglycemia risk; and

cause the display device to visually present a first display and a second display at the same time,

wherein the first display comprises a graph having a vertical axis representing glucose levels, a horizontal axis representing a plurality of times of the day, and a plot of the glucose median of received glucose data across the plurality of times of the day, and

wherein the second display comprises a plurality of hypoglycemia risk indicators and a plurality of variability risk indicators,

wherein each hypoglycemia risk indicator indicates an amount of risk that hypoglycemia will occur in a different segment of time within the plurality of times of the day and each hypoglycemia risk indicator has a horizontal position within the second display that corresponds to the position of that different segment of time within the plurality of times of the day, and

wherein each variability risk indicator indicates an amount of low range glucose variability in a different segment of time within the plurality of times of the day and each variability risk indicator has a horizontal position within the second display that corresponds to the position of that different segment of time within the plurality of times of the day.

2. The system of claim 1, wherein the glucose data processing program further programs the processor to control the display device to visually present, at a different time from the first and second displays, a control grid on which is shown a hypoglycemia risk curve, a glucose variability curve, and risk reduction distances for hypoglycemia and glucose variability.

3. The system of claim 2, wherein the glucose data processing program further programs the processor to control the display device to visually present on the control grid a treatment recommendation point.

4. The system of claim 2, wherein the glucose data processing program further programs the processor to control the display device to visually present on the control grid an uncertainty boundary.

5. The system of claim 2, wherein the glucose data processing program further programs the processor to control the display device to visually present on the control grid a hyperglycemia curve and a risk reduction distance for hyperglycemia.

6. The system of claim 1, wherein the system further comprises a touch screen associated with the display device,

wherein the glucose data processing program further programs the processor to visually present changes in one or more of the plurality of hypoglycemia risk indicators resulting from input from the touch screen representing alteration in the glucose median and/or a glucose variability.

7. The system of claim 1, wherein the glucose data processing program further programs the processor to:

analyze received HbA1c data with the glucose data;

determine an estimate of average glucose; and

control the display device to visually present the estimate of average glucose.

8. The system of claim 1, wherein the glucose data processing program further programs the processor to subject the glucose data to an analysis of probability distribution in determining glycemic risk.

9. The system of claim 1, wherein the glucose data processing program further programs the processor to control the display device to visually present how a self-monitoring blood glucose (SHBG) test schedule may be tailored to obtain further desired glucose data.

10. The system of claim 1, wherein the glucose data processing program further programs the processor to cause the display device to visually present the first display on an upper portion of a display screen and the second display on a lower portion of the display screen.

11. The system of claim 1, wherein each hypoglycemia risk indicator has a shape with a size that indicates the amount of risk that hypoglycemia will occur and wherein each variability risk indicator has a shape with a size that indicates the amount of risk of low range glucose variability.

12. The system of claim 1, wherein a first one of the plurality of hypoglycemia risk indicators indicates the amount of risk that hypoglycemia will occur in a first segment of time within the plurality of times of the day and is vertically-aligned with a first one of the plurality of variability risk indicators that indicates the amount of low range glucose variability in the same first segment of time.

13. A method for displaying glycemic information and risk, the method comprising:

receiving glucose data;

analyzing, with a processor, the received glucose data to determine a glucose median, low range variability of glucose, and hypoglycemia risk;

displaying a first display comprising a graph having a vertical axis representing glucose levels, a horizontal axis representing a plurality of times of the day, and a plot of the glucose median of received glucose data across the plurality of times of the day; and

displaying a second display at the same time as the first display, wherein the second display comprises a plurality of hypoglycemia risk indicators and a plurality of variability risk indicators,

wherein each hypoglycemia risk indicator indicates an amount of risk that hypoglycemia will occur in a different segment of time within the plurality of times of the day and each hypoglycemia risk indicator has a horizontal position within the second display that corresponds to the position of that different segment of time within the plurality of times of the day, and

wherein each variability risk indicator indicates an amount of low range glucose variability in a different segment of time within the plurality of times of the day and each variability risk indicator has a horizontal position within the second display that corresponds to the position of that different segment of time within the plurality of times of the day.

14. The method of claim 13, further comprising:

displaying, at a different time from the first and second displays, a third display comprising a control grid with a hypoglycemia risk curve, a glucose variability curve, and risk reduction distances for hypoglycemia and glucose variability.

15. The method of claim 14, further comprising:

displaying on the control grid a treatment recommendation point.

16. The method of claim 14, further comprising:

displaying on the control grid an uncertainty boundary.

17. The method of claim 14, further comprising:

displaying on the control grid a hyperglycemia curve and a risk reduction distance for hyperglycemia.

18. The method of claim 13, further comprising:

receiving input from a touch screen and displaying changes in hypoglycemia risk resulting from the input from the touch screen representing alteration in the glucose median and/or a glucose variability.

19. The method of claim 13, further comprising:

receiving HbA1c data;

analyzing, with the processor, the HbA1c data with the glucose data;

determining, with the processor, an estimate of average glucose; and

displaying the estimate of average glucose.

20. The method of claim 13, further comprising:

performing an analysis of probability distribution on the glucose data to determine glycemic risk.

21. The method of claim 13, further comprising:

displaying how a self-monitoring blood glucose (SHBG) test schedule may be tailored to obtain further desired glucose data.

22. The method of claim 13, further comprising displaying the first display on an upper portion of a display screen and displaying the second display on a lower portion of the display screen.

23. The method of claim 13, wherein each hypoglycemia risk indicator has a shape with a size that indicates the amount of risk that hypoglycemia will occur and wherein each variability risk indicator has a shape with a size that indicates the amount of risk of low range glucose variability.

24. The method of claim 13, wherein a first one of the plurality of hypoglycemia risk indicators indicates the amount of risk that hypoglycemia will occur in a first segment of time within the plurality of times of the day and is vertically-aligned with a first one of the plurality of variability risk indicators that indicates the amount of low range glucose variability in the same first segment of time.