IP Library Granted Patent US 11,957,876
Granted Patent B2
US 11,957,876 · App. 17/212,984 · Granted Apr 16, 2024

Glucose control system with automated backup therapy protocol generation

Inventors: Edward B. Raskin (Irvine, CA); David Chi-Wai Lim (Irvine, CA); Michael J. Rosinko (Anaheim, CA); Firas H. El-Khatib (Allston, MA); Edward R. Damiano (Acton, MA)
Assignee: BETA BIONICS, INC.
A61M5/1723A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 11,957,876
App. No.
17/212,984
Granted
Apr 16, 2024
Kind
B2
Abstract

An automated blood glucose control system is configured to generate a backup therapy protocol comprising insulin therapy instructions derived from autonomously determined doses of insulin. The system generates a dose control signal using a control algorithm configured to autonomously determine doses of insulin to be infused into a subject for the purpose of controlling blood glucose of the subject based at least in part on a glucose level signal received from a glucose sensor. The system can track insulin therapy administered to the subject over a tracking period, including storing an indication of the autonomously determined doses of insulin delivered to the subject as basal insulin, as correction boluses of insulin, or as mealtime boluses of insulin. The system can generate a backup injection therapy protocol or a backup pump therapy protocol with insulin therapy instructions based at least in part on the insulin therapy administered to the subject over the tracking period.

Claims (56)

1. An automated glucose level control system configured to generate a backup therapy protocol comprising insulin therapy dosing recommendations derived from autonomously determined doses of insulin, the automated glucose level control system comprising:

a medicament delivery interface configured to operatively connect to a medicament pump for infusing medicament into a subject;

a memory configured to store specific computer-executable instructions; and

a hardware processor in communication with the memory and configured to execute the specific computer-executable instructions to at least:

track insulin therapy administered to the subject over a tracking period by the automated glucose level control system, wherein tracking the insulin therapy comprises storing an indication of autonomously determined doses of insulin delivered to the subject as correction boluses of insulin or as basal doses of insulin;

generate the backup therapy protocol comprising at least one of a plurality of backup therapy dosing recommendations, wherein the plurality of backup therapy dosing recommendations comprises:

a correction dosing recommendation comprising a correction factor based on at least some of the correction boluses of insulin administered during the tracking period; and

a basal dosing recommendation comprising a basal rate based on at least some of the basal doses of insulin administered during the tracking period; and

output the backup therapy protocol as determined by the automated glucose level control system for the purpose of being used when the automated glucose level control system is not providing therapy to the subject.

2. The automated glucose level control system of claim 1 , wherein the backup therapy protocol comprises one or more of a backup injection therapy protocol or a backup pump therapy protocol, wherein the backup injection therapy protocol comprises one or more insulin dosing recommendations useable by a user to manually inject insulin, and wherein the backup pump therapy protocol comprises one or more insulin dosing recommendations useable to configure one or more glucose level control systems to infuse medicament into the subject.

3. The automated glucose level control system of claim 1 , wherein the basal rate comprises an hourly basal rate or a daily basal rate.

4. The automated glucose level control system of claim 1 , wherein the basal dosing recommendation comprises a plurality of basal rates, at least one basal rate of the plurality of basal rates corresponding to a different portion of a day than at least one other basal rate of the plurality of basal rates.

5. The automated glucose level control system of claim 4 , wherein the at least one basal rate of the plurality of basal rates comprises an hourly basal rate.

6. The automated glucose level control system of claim 1 , wherein tracking the insulin therapy further comprises storing an indication of autonomously determined doses of insulin delivered to the subject as a mealtime bolus of insulin.

7. The automated glucose level control system of claim 1 , wherein the plurality of backup therapy dosing recommendations further comprises a meal dosing recommendation comprising an indication of a mealtime bolus size of insulin corresponding to an average mealtime bolus provided as a mealtime bolus to the subject during the tracking period.

8. The automated glucose level control system of claim 7 , wherein the meal dosing recommendation is one of a plurality of meal dosing recommendations included in the plurality of backup therapy dosing recommendations, at least one meal dosing recommendation of the plurality of meal dosing recommendations associated with a different meal occurring during a day than at least one other meal dosing recommendation of the plurality of meal dosing recommendations.

9. The automated glucose level control system of claim 7 , wherein the meal dosing recommendation is one of a plurality of meal dosing recommendations included in the plurality of backup therapy dosing recommendations, at least one meal dosing recommendation of the plurality of meal dosing recommendations associated with a different size meal than at least one other meal dosing recommendation of the plurality of meal dosing recommendations.

10. The automated glucose level control system of claim 7 , wherein the average mealtime bolus is calculated as a moving average determined over a particular time period window during the tracking period.

11. The automated glucose level control system of claim 1 , wherein the basal rate is based on: a moving average determined over a particular time period and/or a particular number of doses during the tracking period.

12. The automated glucose level control system of claim 1 , wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least track counter-regulatory agent therapy administered to the subject over the tracking period, wherein tracking the counter-regulatory agent therapy comprises storing an indication of autonomously determined doses of counter-regulatory agent delivered to the subject responsive to a glucose level signal.

13. The automated glucose level control system of claim 12 , wherein the plurality of backup therapy dosing recommendations further comprises a counter-regulatory agent dosing recommendation comprising an indication of total counter-regulatory agent and/or daily counter-regulatory agent provided to the subject over the tracking period.

14. The automated glucose level control system of claim 1 , wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least output the backup therapy protocol on a display.

15. The automated glucose level control system of claim 1 , wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least:

establish a communication channel with an external computing system that is separate from the automated glucose level control system; and

transmit the backup therapy protocol to the external computing system.

16. The automated glucose level control system of claim 1 , wherein the correction factor corresponds to a change in glucose level at least partially attributable to a unit of insulin provided in a correction bolus to the subject.

17. The automated glucose level control system of claim 1 , wherein the correction factor is an average change in glucose level at least partially attributable to a unit of insulin.

18. The automated glucose level control system of claim 1 , wherein the basal rate is an average of the at least some of the basal doses of insulin administered during one or more days or sub-periods of a day during the tracking period.

19. The automated glucose level control system of claim 18 , wherein the average is a moving average calculated based on a particular set of basal doses of insulin administered during the tracking period.

20. The automated glucose level control system of claim 1 , wherein the basal dosing recommendation comprises a recommendation of a dose of long-acting insulin.

21. The automated glucose level control system of claim 20 , wherein the recommendation of the dose of long-acting insulin is based on an aggregation of at least some of the basal doses of insulin.

22. A computer-implemented method of generating a backup therapy protocol comprising insulin therapy dosing recommendations derived from autonomously determined doses of insulin determined by an automated glucose level control system, the computer-implemented method comprising:

by a hardware processor of the automated glucose level control system,

tracking insulin therapy administered to a subject over a tracking period by the automated glucose level control system, wherein tracking the insulin therapy comprises storing an indication of autonomously determined doses of insulin delivered to the subject as correction boluses of insulin or as basal doses of insulin;

generating the backup therapy protocol comprising at least one of a plurality of backup therapy dosing recommendations, wherein the plurality of backup therapy dosing recommendations comprises:

a correction dosing recommendation comprising a correction factor based on at least some of the correction boluses of insulin administered during the tracking period; and

a basal dosing recommendation comprising a basal rate based on at least some of the basal doses of insulin administered during the tracking period; and

outputting the backup therapy protocol as determined by the automated glucose level control system for the purpose of being used when the automated glucose level control system is not providing therapy to the subject.

23. The computer-implemented method of claim 22 , wherein the backup therapy protocol comprises one or more of:

a backup injection therapy protocol comprising one or more insulin dosing recommendations useable by a user to manually inject insulin; or

a backup pump therapy protocol comprising one or more insulin dosing recommendations useable to configure one or more glucose level control systems to infuse medicament into the subject.

24. The computer-implemented method of claim 22 , wherein the basal rate comprises one or more of a daily basal rate or an hourly basal rate.

25. The computer-implemented method of claim 22 , wherein the basal dosing recommendation comprises a plurality of basal rates, at least one of the plurality of basal rates corresponding to a different portion of a day than at least one other basal rate of the plurality of basal rates.

26. The computer-implemented method of claim 22 , wherein tracking the insulin therapy further comprises storing an indication of autonomously determined doses of insulin delivered to the subject as a mealtime bolus of insulin; and wherein the plurality of backup therapy dosing recommendations further comprises a meal dosing recommendation comprising an indication of a mealtime bolus size of insulin corresponding to an average mealtime bolus provided as a mealtime bolus to the subject during the tracking period.

27. The computer-implemented method of claim 26 , wherein the meal dosing recommendation is one of a plurality of meal dosing recommendations included in the plurality of backup therapy dosing recommendations, and wherein:

at least one meal dosing recommendation of the plurality of meal dosing recommendations is associated with a different meal occurring during a day than at least one other meal dosing recommendation of the plurality of meal dosing recommendations; and/or

at least one meal dosing recommendation of the plurality of meal dosing recommendations is associated with a different size meal than at least one other meal dosing recommendation of the plurality of meal dosing recommendations.

28. The computer-implemented method of claim 22 , further comprising tracking counter-regulatory agent therapy administered to the subject over the tracking period, wherein tracking the counter-regulatory agent therapy comprises storing an indication of autonomously determined doses of counter-regulatory agent delivered to the subject responsive to a glucose level signal, and wherein the plurality of backup therapy dosing recommendations further comprises a counter-regulatory agent dosing recommendation comprising an indication of total counter-regulatory agent and/or daily counter-regulatory agent provided to the subject over the tracking period.

29. The computer-implemented method of claim 22 , wherein outputting the backup therapy protocol further comprises:

outputting the backup therapy protocol on a display; or

establishing a communication channel with an external computing system that is separate from the automated glucose level control system, and transmitting the backup therapy protocol to the external computing system.

30. The computer-implemented method of claim 22 , wherein the correction factor corresponds to a change in glucose level at least partially attributable to a unit of insulin provided in a correction bolus to the subject.

31. The computer-implemented method of claim 22 , wherein the correction factor is an average change in glucose level at least partially attributable to a unit of insulin.

32. The computer-implemented method of claim 22 , wherein the basal rate is an average of the at least some of the basal doses of insulin administered during one or more days or sub-periods of a day during the tracking period.

33. The computer-implemented method of claim 32 , wherein the average is a moving average calculated based on a particular set of basal doses of insulin administered during the tracking period.

34. The computer-implemented method of claim 22 , wherein the basal dosing recommendation comprises a recommendation of a dose of long-acting insulin, and wherein the dose of long-acting insulin is based on an aggregation of at least some of the basal doses of insulin.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2024
From: EL-KHATIB, FIRAS H.
To: BETA BIONICS, INC.
Reel/Frame 068594/0244 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 13, 2024
From: LIM, DAVID CHI-WAI
To: BETA BIONICS, INC.
Reel/Frame 068578/0329 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2024
From: RASKIN, EDWARD B.; LIM, DAVID CHI-WAI; ROSINKO, MICHAEL J.; EL-KHATIB, FIRAS H.; DAMIANO, EDWARD R.
To: BETA BIONICS, INC.
Reel/Frame 068570/0957 →
Continuity (20)
Continuation In Part 17061990 · Oct 2, 2020
Continuation In Part PCTUS2020042269 · Jul 16, 2020
Continuation In Part PCTUS2020042195 · Jul 15, 2020
Continuation In Part PCTUS2020042198 · Jul 15, 2020
Provisional Application 62874928 · Jul 16, 2019
Provisional Application 62874934 · Jul 16, 2019
Provisional Application 62874950 · Jul 16, 2019
Provisional Application 62874954 · Jul 16, 2019
Provisional Application 62874959 · Jul 16, 2019
Provisional Application 62874964 · Jul 16, 2019
Provisional Application 62874968 · Jul 16, 2019
Provisional Application 62874972 · Jul 16, 2019
Provisional Application 62874975 · Jul 16, 2019
Provisional Application 62874977 · Jul 16, 2019
Provisional Application 62910970 · Oct 4, 2019
Provisional Application 62911017 · Oct 4, 2019
Provisional Application 62911143 · Oct 4, 2019
Provisional Application 62987842 · Mar 10, 2020
Provisional Application 63037472 · Jun 10, 2020
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