IP Library Granted Patent US 12,629,103
Granted Patent B2
US 12,629,103 · App. 17/698,757 · Granted May 19, 2026

System and method to manage diabetes based on hypoglycemic risk

Inventors: Erwin S. Budiman (Fremont, CA); Gary A. Hayter (Oakland, CA); Kenneth J. Doniger (Menlo Park, CA); Timothy C. Dunn (San Francisco, CA); Nathan C. Crouther (San Francisco, CA); Glenn Berman (Alameda, CA); Howard A. Wolpert (Brookline, MA)
Assignee: Abbott Diabetes Care Inc.
A61B5/7275A61B5/14532A61B5/4848A61B5/7282A61B5/742G01N33/66G16H20/10G16H50/30G16Z99/00A61B5/4836A61B5/746G16H15/00
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Quick Facts
Patent No.
US 12,629,103
App. No.
17/698,757
Granted
May 19, 2026
Kind
B2
Abstract

A system and method provides a glucose report for determining glycemic risk based on an ambulatory glucose profile of glucose data over a time period, a glucose control assessment based on median and variability of glucose, and indicators of high glucose variability. Time of day periods are shown at which glucose levels can be seen. A median glucose goal and a low glucose line provide coupled with glucose variability provide a view into effects that raising or lowering the median goal would have. Likelihood of low glucose, median glucose compared to goal, and variability of glucose below median provide probabilities based on glucose data. Patterns can be seen and provide guidance for treatment.

Claims (36)

1 . A method for determining glycemic risk of a patient during pregnancy using a continuous glucose monitor, the method comprising:

continuously collecting glucose measurements of the patient via a sensor of the continuous glucose monitor, wherein the glucose measurements are indicative of an interstitial glucose level;

communicating the glucose measurements collected by the sensor of the continuous glucose monitor to a processor of a computing device, wherein the computing device further comprises an input and a display;

computing a glucose central tendency and a glucose variability for each of a plurality of times of day based on the glucose measurements collected by the sensor of the continuous glucose monitor;

receiving an indication of a pregnant condition of the patient;

adjusting a threshold for determining a hypoglycemia risk level based on the indication;

determining the hypoglycemia risk level based on a comparison of the glucose central tendency and the glucose variability to the threshold on a plot of glucose central tendency over glucose variability for each of the plurality of times of day;

displaying, on the display of the computing device, a visual representation of glucose levels for each of the plurality of times of day and concurrently displaying the hypoglycemia risk level for each of the plurality of times of day, wherein the visual representation is configured to facilitate identification of times of day having an elevated hypoglycemia risk level; and

displaying, on the display of the computing device, treatment recommendation based on the hypoglycemia risk level, wherein the treatment recommendation comprises a medication adjustment or a modification of a self-care behavior.

2 . The method of claim 1 , wherein the visual representation comprises a color corresponding to the hypoglycemia risk level.

3 . The method of claim 1 , wherein the visual representation comprises an indication of the hypoglycemia risk level as one of high, moderate, or low risk.

4 . The method of claim 1 , further comprising displaying on the display of the computing device a plot of the collected glucose measurements over time.

5 . The method of claim 1 , further comprising communicating, by the computing device, the collected glucose measurements to a healthcare provider.

6 . The method of claim 1 , wherein the glucose central tendency and the glucose variability are each based on the glucose measurements collected by the sensor over a period of one or more days.

7 . The method of claim 1 , wherein the plurality of times of day comprise periods corresponding to breakfast, lunch, dinner, and overnight.

8 . The method of claim 1 , wherein the treatment recommendation comprises the modification of the self-care behavior, and wherein the modification of the self-care behavior comprises a modification of eating habits.

9 . The method of claim 1 , wherein the treatment recommendation comprises the medication adjustment, and wherein the medication adjustment comprises an adjustment to a dose of a glucose-lowering medication.

10 . The method of claim 1 , wherein adjusting the threshold comprises increasing the threshold relative to a baseline threshold.

11 . The method of claim 1 , wherein displaying the visual representation of glucose levels for each of the plurality of times of day comprising displaying a graph of a plurality of glucose percentiles for each of the plurality of times of day based on the glucose measurements.

12 . A system for determining glycemic risk of a patient during pregnancy, the system comprising:

a continuous glucose monitor configured to collect glucose measurements of the patient, the continuous glucose monitor comprising a glucose sensor configured to sense an interstitial glucose level; and

a computing device in communication with the continuous glucose monitor, the computing device comprising a display, a processor, and non-volatile memory coupled with the processor, the memory storing a glucose data processing program that, when executed by the processor, causes the processor to:

receive an indication of a pregnant condition of the patient;

adjust a threshold for determining a hypoglycemia risk level based on the indication;

determine a glucose central tendency and a glucose variability for each of a plurality of times of day based on the collected glucose measurements,

determine the hypoglycemia risk level based on a comparison of the determined glucose central tendency and the glucose variability to the threshold on a plot of glucose central tendency over glucose variability for each of the plurality of times of day,

display a visual representation of glucose levels for each of the plurality of times of day and concurrently display the hypoglycemia risk level on the display of the computing device for each of the plurality of times of day, wherein the visual representation is configured to facilitate identification of times of day having an elevated hypoglycemia risk level on the display of the computing device; and

display with the visual representation a treatment recommendation based on the hypoglycemia risk level, wherein the treatment recommendation comprises a medication adjustment or a modification of a self-care behavior.

13 . The system of claim 12 , wherein the computing device comprises a smartphone.

14 . The system of claim 12 , wherein the computing device further comprises an input device.

15 . The system of claim 14 , wherein the input device comprises a touch screen.

16 . The system of claim 12 , wherein the visual representation comprises a color corresponding to the hypoglycemia risk level.

17 . The system of claim 12 , wherein the visual representation comprises an indication of the hypoglycemia risk level as one of high, moderate, or low risk.

18 . The system of claim 12 , wherein the glucose central tendency and the glucose variability are each based on the glucose measurements collected by the glucose sensor over a period of one or more days.

19 . The system of claim 12 , wherein the plurality of times of day comprise periods corresponding to breakfast, lunch, dinner, and overnight.

20 . The system of claim 12 , wherein adjusting the threshold comprises increasing the threshold relative to a baseline threshold.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 31, 2023
From: BUDIMAN, ERWIN S.; HAYTER, GARY A.; DONIGER, KENNETH J.; DUNN, TIMOTHY C.; CROUTHER, NATHAN C.; BERMAN, GLENN H.; WOLPERT, HOWARD A.
To: ABBOTT DIABETES CARE INC.
Reel/Frame 063230/0770 →
Continuity (6)
Continuation 17122970 · Dec 15, 2020
Continuation 16005234 · Jun 11, 2018
Continuation 14214901 · Mar 15, 2014
Provisional Application 61922765 · Dec 31, 2013
Provisional Application 61799139 · Mar 15, 2013
Related Publication 20220287652A1 · Sep 15, 2022
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