IP Library › Granted Patent US 12,370,307
Granted Patent B2
US 12,370,307 · App. 17/166,072 · Granted Jul 29, 2025

Use of fuzzy logic in predicting user behavior affecting blood glucose concentration in a closed loop control system of an automated insulin delivery device

Inventors: Joon Bok Lee (Acton, MA); Ashutosh Zade (San Diego, CA); Jason O'Connor (Acton, MA); Yibin Zheng (Hartland, WI); Steven Cardinali (Tewksbury, MA)
Assignee: INSULET CORPORATION
A61M5/1723G16H10/60G16H20/17G16H20/30G16H50/20A61M2205/505A61M2205/52
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Quick Facts
Patent No.
US 12,370,307
App. No.
17/166,072
Granted
Jul 29, 2025
Kind
B2
Abstract

In an automated insulin delivery device, fuzzy logic may be applied to the responding to the possibility of a user taking additional action that may affect the blood glucose concentration. Fuzzy sets may be defined for empirically derived different likelihoods of the user taking such additional action based on correlated factors. A membership function may be provided for each fuzzy set. The membership function may provide a probability of membership in the set based on a parameter. Each fuzzy set may have a response that is reflective of the likelihood of additional user action associated with the fuzzy set. The responses by the AID device to each of these cases may reflect the probability of each such case occurring as evidenced by empirical data.

Claims (47)

1. A method performed by a processor for controlling an automated insulin delivery device, comprising:

analyzing blood glucose history, insulin bolus history and/or meal event flags for a user of the automated insulin delivery device to identify when the user has ingested meals and to categorize sizes of the ingested meals;

analyzing the blood glucose history, insulin delivery history and/or user-entered information for the user to identify when the user has exercised and categorizing an intensity of the identified user exercise;

determining likelihood categories for additional user action affecting blood glucose based on when the meals are ingested, the categorized sizes of the meals ingested, when the user exercises and the categorized intensity of exercise of the user, each likelihood category representing a range of probabilities that the user will take additional action;

creating a fuzzy set for each of the categories, wherein each fuzzy set is associated with a quantitative response to be taken by the automated insulin delivery device according to the respective categories of determined likelihoods that the user will take additional action affecting blood glucose;

for a given time of day, determining a set membership probability for each of the fuzzy sets for the user;

weighting the quantitative responses of each of the fuzzy sets by the determined membership probabilities for the respective fuzzy sets for the given time of day;

summing the weighted quantitative responses of the fuzzy sets to determine the cumulative response to apply for the given time of day; and

applying the cumulative response in the automated insulin delivery device.

2. The method of claim 1 , wherein the identifying of when the user has ingested meals and the categorizing of the sizes of ingested meals comprises analyzing blood glucose excursions in the blood glucose history.

3. The method of claim 1 , wherein the identifying of when the user has ingested meals and the categorizing of the sizes of ingested meals comprises determining when a user delivers insulin boluses and dosages of the insulin boluses.

4. The method of claim 3 , wherein the dosages of the insulin boluses are analyzed to categorize the sizes of the meals.

5. The method of claim 1 , wherein the identifying of when the user has ingested meals comprises determining times of meal event flags.

6. The method of claim 1 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises identifying when the user has activated a mode that decreases or halts automated delivery of insulin by the insulin delivery device and determining the intensity of the user exercise based on a duration that the mode remains activated.

7. The method of claim 1 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises analyzing the blood glucose history for an excursion to identify when the user exercised and analyzing a magnitude and/or duration of the excursion to identify the intensity of the user exercise.

8. The method of claim 1 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises analyzing insulin delivery history to identify when insulin delivery decreased at least a threshold amount and identifying a duration and/or magnitude of the decrease of the insulin delivery decrease to identify the intensity of the user exercise.

9. The method of claim 1 , wherein the additional action affecting blood glucose is one or more of the user delivering an excessive insulin bolus, the user delivering an insufficient insulin bolus, the user overestimating meal carbohydrate content, the user underestimating meal carbohydrate content, the user signaling exercise but not exercising and the user signaling a need for a correction bolus but had not ingested a meal.

10. The method of claim 1 , wherein the cumulative response is delivery of a specified amount of insulin to the user via the automated insulin delivery device or halting delivery of insulin to the user via the automated insulin delivery device.

11. A non-transitory computer-readable storage medium storing instructions that cause a processor to:

analyze blood glucose history, insulin bolus history and/or meal event flags for a user of the automated insulin delivery device to identify when the user has ingested meals and to categorize sizes of the ingested meals;

analyze the blood glucose history, insulin delivery history and/or user-entered information for the user to identify when the user has exercised and categorizing an intensity of the identified user exercise;

determine likelihood categories for additional user action affecting blood glucose based on when the meals are ingested, the categorized sizes of the meals ingested, when the user exercises and the categorized intensity of exercise of the user, each likelihood category representing a range of probabilities that the user will take additional action;

create a fuzzy set for each of the categories, wherein each fuzzy set is associated with a quantitative response to be taken by the automated insulin delivery device according to the respective categories of determined likelihoods that the user will take additional action affecting blood glucose;

for a given time of day, determine a set membership probability for each of the fuzzy sets for the user;

weight the quantitative responses of each of the fuzzy sets by the determined membership probabilities for the respective fuzzy sets for the given time of day;

sum the weighted quantitative responses of the fuzzy sets to determine the cumulative response to apply for the given time of day; and

apply the cumulative response in the automated insulin delivery device.

12. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying of when the user has ingested meals and the categorizing of the sizes of ingested meals comprises analyzing blood glucose excursions in the blood glucose history.

13. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying of when the user has ingested meals and the categorizing of the sizes of ingested meals comprises determining when a user delivers insulin boluses and dosages of the insulin boluses.

14. The non-transitory computer-readable storage medium of claim 13 , wherein the dosages of the insulin boluses are analyzed to categorize the sizes of the meals.

15. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying of when the user has ingested meals comprises determining times of meal event flags.

16. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises identifying when the user has activated a mode that decreases or halts automated delivery of insulin by the insulin delivery device and determining the intensity of the user exercise based on a duration that the mode remains activated.

17. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises analyzing the blood glucose history for an excursion to identify when the user exercised and analyzing a magnitude and/or duration of the excursion to identify the intensity of the user exercise.

18. The non-transitory computer-readable storage medium of claim 11 , wherein the identifying when the user has exercised and categorizing an intensity of the identified user exercise comprises analyzing insulin delivery history to identify when insulin delivery decreased at least a threshold amount and identifying a duration and/or magnitude of the decrease of the insulin delivery decrease to identify the intensity of the user exercise.

19. The non-transitory computer-readable storage medium of claim 11 , wherein the additional action affecting blood glucose is one or more of the user delivering an excessive insulin bolus, the user delivering an insufficient insulin bolus, the user overestimating meal carbohydrate content, the user underestimating meal carbohydrate content, the user signaling exercise but not exercising and the user signaling a need for a correction bolus but had not ingested a meal.

20. The non-transitory computer-readable storage medium of claim 11 , wherein the cumulative response is one of delivery of a specified amount of insulin to the user via the automated insulin delivery device or halting delivery of insulin to the user via the automated insulin delivery device.

21. An electronic device comprising:

a storage medium for storing blood glucose history for a user, insulin delivery history for a user and a control software for controlling automated insulin delivery to the user; and

a processor for executing the control software for:

analyzing blood glucose history, insulin bolus history and/or meal event flags for a user of the automated insulin delivery device to identify when the user has ingested meals and to categorize sizes of the ingested meals;

analyzing the blood glucose history, insulin delivery history and/or user-entered information for the user to identify when the user has exercised and categorizing an intensity of the identified user exercise;

determining likelihood categories for additional user action affecting blood glucose based on when the meals are ingested, the categorized sizes of the meals ingested, when the user exercises and the categorized intensity of exercise of the user, each likelihood category representing a range of probabilities that the user will take additional action affecting blood glucose;

creating a fuzzy set for each of the likelihood categories wherein each fuzzy set is associated with a quantitative response to be taken by the automated insulin delivery device according to the respective categories of determined likelihoods that the user will take additional action affecting blood glucose;

for a given time of day, determining a set membership probability for each of the fuzzy sets for the user;

weighting the quantitative responses of each of the fuzzy sets by the determined membership probabilities for the respective fuzzy sets for the given time of day;

summing the weighted quantitative responses of the fuzzy sets to determine the cumulative response to apply for the given time of day; and

applying the cumulative response in the automated insulin delivery device.

Assignments (2)
SECURITY AGREEMENT SUPPLEMENT FOR INTELLECTUAL PROPERTY Recorded Nov 16, 2022
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 061951/0977 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2021
From: LEE, JOON BOK; ZADE, ASHUTOSH; O'CONNOR, JASON; ZHENG, YIBIN; CARDINALI, STEVEN
To: INSULET CORPORATION
Reel/Frame 055130/0401 →
Continuity (2)
Provisional Application 62969393 · Feb 3, 2020
Related Publication 20210236730A1 · Aug 5, 2021
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