Glycemic risk determination based on variability of glucose

• US 10,019,554 B2
• Filed: 04/28/2016
• Issued: 07/10/2018
• 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 C., Doniger, Kenneth J., Berman, Glenn, Hayter, Gary A., Budiman, Erwin S., Bernstein, Daniel M., Crouther, Nathan
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US15/141,775
• Publication Number:
  US 20160239622A1
• Time in Patent Office: 803 Days
• 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. An apparatus for the display of glycemic information and risk, comprising:

a processor; and

a non-volatile memory in which is stored a plurality of instructions that, when executed, cause the processor to;

determine a plurality of hypoglycemia risk indicators for a subject, wherein each of the plurality of hypoglycemia risk indicators indicates a risk of hypoglycemia at a different time; and

cause presentation of a first display and a second display simultaneously,

wherein the first display comprises a plot of glucose data measurements taken from the subject across a horizontal representation of a plurality of times,

wherein the second display comprises the plurality of hypoglycemia risk indicators, wherein each hypoglycemia risk indicator has a horizontal position within the second display corresponding to the position of that hypoglycemia risk indicator'"'"'s different time in the plurality of times;

wherein the second display comprises a plurality of variability risk indicators, and wherein each variability risk indicator indicates an amount of variability at a different time and has a horizontal position within the second display corresponding to the position of that variability risk indicator'"'"'s different time in the plurality of times.

2. The apparatus of claim 1, wherein the plot of glucose data measurements indicates glucose median values across the horizontal representation of the plurality of times.

3. The apparatus of claim 1, wherein the plurality of instructions, when executed, further cause the processor to determine the risk of hypoglycemia for each hypoglycemia risk indicator based on a corresponding glucose median value and a corresponding variability value.

4. The apparatus of claim 3, wherein the corresponding variability value is the difference of the glucose median value and tenth percentile glucose.

5. The apparatus of claim 1, wherein each variability risk indicator indicates an amount of low range variability.

6. The apparatus of claim 1, wherein each variability risk indicator has a shape with a size that indicates the amount of variability.

7. The apparatus of claim 1, wherein a first one of the plurality of hypoglycemia risk indicators corresponding to a first time is vertically-aligned with a first one of the plurality of variability risk indicators corresponding to the same first time.

8. The apparatus of claim 1, wherein each hypoglycemia risk indicator has a shape with a size that indicates the risk of hypoglycemia.

9. The apparatus of claim 1, wherein the plurality of instructions, when executed, further cause the processor to cause presentation of the first display above the second display.

10. The apparatus of claim 1, wherein the apparatus is a mobile device and further comprises a touch screen, wherein the plurality of instructions, when executed, cause the processor to cause presentation of the first display and the second display simultaneously on the touch screen.

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

determining, with a processor, a plurality of hypoglycemia risk indicators for a subject, wherein each of the plurality of hypoglycemia risk indicators indicates a risk of hypoglycemia at a different time; and

displaying a first display and a second display simultaneously,

wherein the first display comprises a plot of glucose data measurements taken from the subject across a horizontal representation of a plurality of times,

wherein the second display comprises the plurality of hypoglycemia risk indicators, wherein each hypoglycemia risk indicator has a horizontal position within the second display corresponding to the position of that hypoglycemia risk indicator'"'"'s different time in the plurality of times;

wherein the second display comprises a plurality of variability risk indicators, and wherein each variability risk indicator indicates an amount of variability at a different time and has a horizontal position within the second display corresponding to the position of that variability risk indicator'"'"'s different time in the plurality of times.

12. The method of claim 11, wherein the plot of glucose data measurements indicates glucose median values across the horizontal representation of the plurality of times.

13. The method of claim 11, further comprising determining the risk of hypoglycemia for each hypoglycemia risk indicator based on a corresponding glucose median value and a corresponding variability value.

14. The method of claim 13, wherein the corresponding variability value is the difference of the glucose median value and tenth percentile glucose.

15. The method of claim 11, wherein a first one of the plurality of hypoglycemia risk indicators corresponding to a first time is vertically-aligned with a first one of the plurality of variability risk indicators corresponding to the same first time.

16. The method of claim 11, wherein each variability risk indicator indicates an amount of low range variability.

17. The method of claim 11, wherein each variability risk indicator has a shape with a size that indicates the amount of variability and wherein each hypoglycemia risk indicator has a shape with a size that indicates the risk of hypoglycemia.

18. The method of claim 11, further comprising displaying the first display and the second display simultaneously on a touch screen of a mobile device.