IP Library Granted Patent US 11,911,595
Granted Patent B2
US 11,911,595 · App. 17/323,529 · Granted Feb 27, 2024

Systems and methods for automated insulin delivery response to meal announcements

Inventors: Thomas R. Ulrich (Oceanside, CA); Virginia S. Lu (San Diego, CA)
Assignee: TANDEM DIABETES CARE, INC.
A61M5/1723A61M5/142A61M2005/14208A61M2205/3553A61M2205/502A61M2230/201
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Quick Facts
Patent No.
US 11,911,595
App. No.
17/323,529
Granted
Feb 27, 2024
Kind
B2
Abstract

Disclosed herein are apparatuses and methods that account for meal announcements in closed loop insulin delivery systems. Rather than simply increasing an insulin delivery rate in response to the meal announcement, the closed loop algorithm can be modified to increase the insulin on board tolerance during eating periods. This approach utilizes the stability of the cascaded loop in the closed loop algorithm to prevent the oscillations in glucose levels that can occur by simply increasing the basal rate.

Claims (33)

1. A system for closed loop diabetes therapy, comprising:

a pump mechanism configured to facilitate delivery of insulin to a user;

a communications device adapted to receive glucose levels from a continuous glucose monitor;

at least one processor functionally linked to the pump mechanism and the communications device, the at least one processor configured to:

calculate and deliver insulin doses to the user based on a closed loop insulin delivery algorithm, the closed loop insulin delivery algorithm including an outer glucose loop that compares glucose levels from the continuous glucose monitor to a glucose target to determine an insulin on board target for the user and an inner insulin on board loop that compares an estimated insulin on board for the user to the insulin on board target to determine an insulin on board error used to calculate insulin doses configured to maintain the insulin on board of the user at the insulin on board target and the glucose levels of the user at the glucose level target;

receive an indication that the user will be eating a meal;

activate a pre-meal scale for the closed loop insulin delivery algorithm in response to the indication that the user will be eating the meal, the pre-meal scale modifying the inner insulin on board loop of the closed loop delivery algorithm that calculates insulin doses to maintain the insulin on board of the user at the insulin on board target; and

calculate and deliver insulin doses to the user based on glucose levels from the continuous glucose monitor using the pre-meal scale of the closed loop insulin delivery algorithm following the indication that the user will be eating the meal.

2. The system of claim 1 , where the pre-meal scale modifies the inner glucose loop of the closed loop delivery algorithm by modifying the insulin on board target of the inner glucose loop.

3. The system of claim 2 , wherein the insulin on board target is modified by applying a temporary constant to the insulin on board target to increase the insulin on board target.

4. The system of claim 3 , wherein the temporary constant increases the insulin on board target by a predetermined percentage.

5. The system of claim 1 , wherein the pre-meal scale is activated for a predetermined period of time following the indication that the user will be eating the meal.

6. The system of claim 1 , wherein the indication that the user is eating the meal is received through a user interface communicatively linked with the processor.

7. The system of claim 1 , where the pre-meal scale modifies the inner glucose loop of the closed loop delivery algorithm by introducing a temporary basal rate into the inner glucose loop.

8. The system of claim 7 , wherein the temporary basal rate is introduced as a constant that increases a stored basal rate used in calculating the estimated insulin on board for the user.

9. The system of claim 1 , wherein the pump mechanism and the at least one processor are part of an ambulatory infusion pump.

10. The system of claim 1 , wherein the at least one processor is part of a remote control device for remotely controlling an ambulatory infusion pump including the pump mechanism.

11. A method of closed loop diabetes therapy, comprising:

receiving glucose levels of a user from a continuous glucose monitor;

calculating insulin doses to the user based on a closed loop insulin delivery algorithm, the closed loop insulin delivery algorithm including an outer glucose loop that compares glucose levels from the continuous glucose monitor to a glucose target to determine an insulin on board target for the user and an inner insulin on board loop that compares an estimated insulin on board for the user to the insulin on board target to determine an insulin on board error used to calculate insulin doses configured to maintain the insulin on board of the user at the insulin on board target and the glucose levels of the user at the glucose level target;

delivering the calculated insulin doses to the user with a pump mechanism;

receiving an indication that the user will be eating a meal;

activating a pre-meal scale for the closed loop insulin delivery algorithm in response to the indication that the user will be eating the meal, the pre-meal scale modifying the inner insulin on board loop of the closed loop delivery algorithm that calculates insulin doses to maintain the insulin on board of the user at the insulin on board target; and

calculating and delivering insulin doses to the user based on glucose levels from the continuous glucose monitor using the pre-meal scale of the closed loop insulin delivery algorithm following the indication that the user will be eating the meal.

12. The method of claim 11 , where the pre-meal scale modifies the inner glucose loop of the closed loop delivery algorithm by modifying the insulin on board target of the inner glucose loop.

13. The method of claim 12 , wherein the insulin on board target is modified by applying a temporary constant to the insulin on board target to increase the insulin on board target.

14. The method of claim 13 , wherein the temporary constant increases the insulin on board target by a predetermined percentage.

15. The method of claim 11 , wherein the pre-meal scale is activated for a predetermined period of time following the indication that the user will be eating the meal.

16. The method of claim 11 , wherein the indication that the user is eating the meal is received through a user interface communicatively linked with the processor.

17. The method of claim 11 , where the pre-meal scale modifies the inner glucose loop of the closed loop delivery algorithm by introducing a temporary basal rate into the inner glucose loop.

18. The method of claim 17 , wherein the temporary basal rate is introduced as a constant that increases a stored basal rate used in calculating the estimated insulin on board for the user.

19. The method of claim 11 , wherein the pump mechanism is part of an ambulatory infusion pump that calculates the insulin doses.

20. The method of claim 11 , wherein the insulin doses are calculated by a processor of a remote control device for remotely controlling an ambulatory infusion pump including the pump mechanism.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Mar 24, 2024
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: TANDEM DIABETES CARE, INC.
Reel/Frame 066880/0918 →
SECURITY INTEREST Recorded May 25, 2022
From: TANDEM DIABETES CARE, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 060179/0100 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 31, 2022
From: ULRICH, THOMAS R.; LU, VIRGINIA S.
To: TANDEM DIABETES CARE, INC.
Reel/Frame 059460/0183 →