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

Patent metadata

Field	Value
Publication number	US-12102454-B2
Application number	US-202217742088-A
Country	US
Kind code	B2
Filing date	May 11, 2022
Priority date	Dec 31, 2012
Publication date	Oct 1, 2024
Grant date	Oct 1, 2024

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.

First claim

What is claimed is:

1. A system for managing diabetes during pregnancy, the system comprising:
a continuous glucose monitor comprising a sensor configured to be positioned in interstitial tissue of a patient, such that the continuous glucose monitor is configured to monitor glucose levels of the patient; and
a display device in wireless communication with the continuous glucose monitor to receive the monitored glucose levels, wherein the display device comprises:
an input device,
a display,
a non-volatile, non-transitory memory storing a glucose data processing program, and
a processor coupled with the non-volatile, non-transitory memory, and configured to execute the glucose data processing program to cause the processor to:
adjust a threshold for determining a glycemic risk level from a first setting to a second setting that is different than the first setting based on a pregnant condition of the patient, wherein the threshold comprises a fraction of a period of time in which glucose levels are below a predetermined low glucose level, wherein the first setting comprises a first fraction of the period of time in which glucose levels are below the predetermined low glucose level and the second setting comprises a second fraction of the period of time in which glucose levels are below the predetermined low glucose level, and wherein the second fraction is greater than the first fraction,
determine a glucose metric for one or more periods of time based on the received monitored glucose levels,
determine the glycemic risk level for the one or more periods of time based on a comparison of the determined glucose metric to the threshold, and
determine a treatment recommendation based at least in part on the glycemic risk level, wherein the treatment recommendation comprises a modification to self-care behavior.

2. The system of claim 1 , wherein the second setting is more tolerant of hypoglycemia than the first setting.

3. The system of claim 1 , wherein the glycemic risk level comprises a hypoglycemia risk level.

4. The system of claim 1 , wherein the processor is further configured to receive a selection from the input device of the display device to adjust the threshold.

5. The system of claim 1 , wherein the threshold is selected from a predetermined list of settings.

6. The system of claim 5 , wherein the predetermined list of settings comprises small, medium, or large.

7. The system of claim 1 , wherein the processor is further caused to display a graph of the glucose levels and a visual indication of the glycemic risk level for the one or more periods of time on the display.

8. A method for managing diabetes during pregnancy, the method comprising:
monitoring glucose levels by a continuous glucose monitor comprising a sensor configured to be positioned in interstitial tissue of a patient;
wirelessly communicating the monitored glucose levels from the continuous glucose monitor to a display device;
adjusting a threshold for determining a glycemic risk level from a first setting to a second setting that is different than the first setting based on a pregnant condition of the patient, wherein the threshold comprises a fraction of a period of time in which glucose levels are below a predetermined low glucose level, wherein the first setting comprises a first fraction of the period of time in which glucose levels are below the predetermined low glucose level and the second setting comprises a second fraction of the period of time in which glucose levels are below the predetermined low glucose level, and wherein the second fraction is greater than the first fraction;
determining, by a processor of the display device, a glucose metric for one or more periods of time based on the glucose levels;
determining, by the processor of the display device, the glycemic risk level for the one or more periods of time based on a comparison of the glucose metric to the threshold; and
determining a treatment recommendation based at least in part on the comparison of the glucose metric to the glucose metric threshold, wherein the treatment recommendation comprises a modification to self-care behavior.

9. The method of claim 8 , wherein the second setting is more tolerant of hypoglycemia than the first setting.

10. The method of claim 8 , wherein the glycemic risk level comprises a hypoglycemia risk level.

11. The method of claim 8 , wherein the glycemic risk level comprises one of high, moderate or low risk.

12. The method of claim 8 , further comprising displaying a graph of the glucose levels and a visual indication of the glycemic risk level for the one or more periods of time on a display of the display device.

13. A system for managing diabetes during pregnancy, the system comprising:
a continuous glucose monitor comprising a sensor configured to be positioned in interstitial tissue of a patient, such that the continuous glucose monitor is configured to monitor glucose levels of the patient; and
a display device in wireless communication with the continuous glucose monitor to receive the monitored glucose levels, wherein the display device comprises:
an input device,
a display,
a non-volatile, non-transitory memory storing a glucose data processing program, and
a processor coupled with the non-volatile, non-transitory memory, and configured to execute the glucose data processing program to cause the processor to:
adjust a threshold for determining a glycemic risk level from a first setting to a second setting that is different than the first setting based on a pregnant condition of the patient, wherein the threshold comprises a fraction of a period of time in which glucose levels are below a predetermined low glucose level, wherein the first setting comprises a first fraction of the period of time in which glucose levels are below the predetermined low glucose level and the second setting comprises a second fraction of the period of time in which glucose levels are below the predetermined low glucose level, and wherein the second fraction is greater than the first fraction,
determine a glucose metric for one or more periods of time based on the received monitored glucose levels,
determine the glycemic risk level for the one or more periods of time based on a comparison of the determined glucose metric to the threshold, and
determine a treatment recommendation based at least in part on the glycemic risk level, wherein the treatment recommendation comprises an adjustment to a medication dose.

14. A method for managing diabetes during pregnancy, the method comprising:
monitoring glucose levels by a continuous glucose monitor comprising a sensor configured to be positioned in interstitial tissue of a patient;
wirelessly communicating the monitored glucose levels from the continuous glucose monitor to a display device;
adjusting a threshold for determining a glycemic risk level from a first setting to a second setting that is different than the first setting based on a pregnant condition of the patient, wherein the threshold comprises a fraction of a period of time in which glucose levels are below a predetermined low glucose level, wherein the first setting comprises a first fraction of the period of time in which glucose levels are below the predetermined low glucose level and the second setting comprises a second fraction of the period of time in which glucose levels are below the predetermined low glucose level, and wherein the second fraction is greater than the first fraction;
determining, by a processor of the display device, a glucose metric for one or more periods of time based on the glucose levels;
determining, by t

Assignees

• Abbott Diabetes Care Inc

Inventors

• Dunn Timothy C
• Doniger Kenneth J
• Berman Glenn
• Hayter Gary A
• Budiman Erwin S
• Bernstein Daniel M
• Crouther Nathan

Classifications

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title

• A61B5/743

  Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/7275 Primary

  Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor · CPC title