Analysis of glucose median, variability, and hypoglycemia risk for therapy guidance

• US 10,383,580 B2
• Filed: 12/31/2013
• Issued: 08/20/2019
• 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): Riggs, II, Larry D
• Application Number:
  US14/145,554
• Publication Number:
  US 20140188400A1
• Time in Patent Office: 2,058 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 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 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

A system and method to provide guidance for diabetes therapy includes determining glycemic risks based on an analysis of glucose data. The analysis includes visualization of a glucose median, the variability of glucose in a patient, and the risk of hypoglycemia. An Advanced Daily Patterns report includes a visualization of an ambulatory glucose profile and a glucose control measure. The glucose control measure provides a highly visible and understandable display of the glucose condition of a patient visually expressed in the categories of low glucose, median glucose, and glucose variability.

Claims

1. A system for determining glycemic risk for a user based on analysis of glucose data, the system comprising:

a non-volatile memory in which is stored a program;

a communication input at which measured glucose data is received;

a display; and

a processor coupled with the nonvolatile memory, the input, and the display, the processor being configured to access the memory to load and run in the processor the program, wherein the program, when run by the processor, causes the processor to;

reference a plurality of hypoglycemia risk zones that are customizable with one or more predetermined glycemic settings adjustable by the user;

determine an assessment of a risk of hypoglycemia and an assessment of glycemic variability for each of a plurality of different daily time segments, wherein a combination of a glucose central tendency value and a glucose variability value associated with each different daily time segment corresponds to one of the plurality of hypoglycemia risk zones, and wherein the assessment of the risk of hypoglycemia for each of the plurality of different daily time segments is determined by assessment of which of the plurality of hypoglycemia risk zones each combination of glucose central tendency value and glucose variability value corresponds to;

cause the display of a plot of glucose central tendency and glucose variability for the plurality of daily time segments; and

cause the display of a table at the same time as the plot, the table comprising a column for each of the plurality of different daily time segments, each column including both the assessment of the risk of hypoglycemia and the assessment of glycemic variability for the daily time segment, and wherein each column of the table is visually aligned with the corresponding daily time segment of the plot.

2. The system of claim 1, wherein the program, when run by the processor, further causes the processor to cause the display of both the assessment of the risk of hypoglycemia and the assessment of glycemic variability for the plurality of different times of the day visually expressed in terms of at least one of three categories of low, moderate, and high.

3. The system of claim 1, wherein the display is a touch screen display, and wherein the program, when run by the processor further causes the processor to cause the display to visually present changes in hypoglycemia risk resulting from received input from the touch screen showing alteration in glucose central tendency or glucose variability.

14. The system of claim 1, wherein the glucose central tendency value is a glucose median value.

15. The system of claim 1, wherein the glucose variability value is an asymmetric measure of variability of data less than the glucose central tendency value.

16. The system of claim 1, wherein the glucose variability value is a difference between a glucose median value and a relatively lower glucose percentile metric.

17. The system of claim 1, wherein the plurality of hypoglycemia risk zones are defined, at least in part, by a hypoglycemia risk curve stored in the non-volatile memory and defined by a plurality of glucose central tendency values and a plurality of glucose variability values.

18. The system of claim 1, wherein the program, when run by the processor, causes the processor to:

determine, for each of the plurality of different daily time segments, an assessment of glucose central tendency by comparison of the glucose central tendency value to a goal value; and

cause the display of the assessment of glucose central tendency in the table for the plurality of different daily time segments.

19. The system of claim 18, wherein the assessment of glucose central tendency is visually expressed, for each of the plurality of different daily time segments, in terms of at least one of three categories of low, moderate, and high.

20. The system of claim 1, wherein the plurality of different daily time segments in the plot are aligned with the columns corresponding to those plurality of different daily time segments.

21. The system of claim 17, wherein the hypoglycemia risk curve is customizable by adjustment of one of a plurality of predetermined glycemic settings by input received from the user.

4. A method for determining glycemic risk for a user based on analysis of glucose data, the method being performed by a processor executing a program, the method comprising:

referencing a plurality of hypoglycemia risk zones that are customizable with one or more predetermined glycemic settings adjustable by the user;

determining an assessment of a risk of hypoglycemia and an assessment of glycemic variability for each of a plurality of different daily time segments, wherein a combination of a glucose central tendency value and a glucose variability value associated with each different daily time segment corresponds to one of the plurality of hypoglycemia risk zones, and wherein the assessment of the risk of hypoglycemia for each of the plurality of different daily time segments is determined by assessing which of the plurality of hypoglycemia risk zones each combination of glucose central tendency value and glucose variability value corresponds to;

causing display of a plot of glucose central tendency and glucose variability for the plurality of different daily time segments; and

causing display of a table at the same time as the plot, the table comprising a column for each of the different daily time segments, each column including both the assessment of the risk of hypoglycemia and the assessment of glycemic variability for the daily time segment, and wherein each column of the table is visually aligned with the corresponding daily time segment of the plot.

5. The method of claim 4, further comprising:

causing display of both the assessment of the risk of hypoglycemia and the assessment of glycemic variability for the plurality of different daily time segments visually expressed in terms of at least one of three categories of low, moderate, and high.

6. The method of claim 4, wherein the display is a touch screen display, the method further comprising:

controlling the touch screen display to visually present changes in hypoglycemia risk resulting from received input from the touch screen display showing alteration in glucose central tendency or glucose variability.

7. The method of claim 4, wherein the glucose central tendency value is a glucose median value.

8. The method of claim 4, wherein the glucose variability value is an asymmetric measure of variability of data less than the glucose central tendency value.

9. The method of claim 4, wherein the glucose variability value is a difference between a glucose median value and a relatively lower glucose percentile metric.

10. The method of claim 4, wherein the plurality of hypoglycemia risk zones are defined, at least in part, by a hypoglycemia risk curve defined by a plurality of glucose central tendency values and a plurality of glucose variability values.

11. The method of claim 4, further comprising:

determining, for each of the plurality of different times of the day, an assessment of glucose central tendency by comparison of the glucose central tendency value to a goal value; and

controlling the display to visually present the assessment of glucose central tendency for the plurality of different times of the day.

12. The method of claim 11, wherein the assessment of glucose central tendency is visually expressed, for each of the plurality of different times of the day, in terms of three categories of low, moderate, and high.

13. The method of claim 4, wherein the plurality of different daily time segments in the plot are aligned with the columns corresponding to those plurality of different daily time segments.

22. The method of claim 10, wherein the hypoglycemia risk curve is customizable by adjustment of one of a plurality of predetermined glycemic settings by input received from the user.