IP Library Granted Patent US 11,376,362
Granted Patent B2
US 11,376,362 · App. 16/213,799 · Granted Jul 5, 2022

Systems for determining insulin on board and recommending insulin therapy and related methods

Inventor: Bryan Mazlish (Palo Alto, CA)
Assignee: Bigfoot Biomedical, Inc.
A61M5/1723A61M5/14244G16H20/17G16H40/63G16H40/67G16H50/20G16Z99/00A61B5/14532A61B5/4839A61M2005/14208A61M2005/1726A61M2205/18A61M2205/3553A61M2205/3561A61M2205/3584A61M2205/3592A61M2209/01A61M2230/201
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Quick Facts
Patent No.
US 11,376,362
App. No.
16/213,799
Granted
Jul 5, 2022
Kind
B2
Abstract

A system is provided with an insulin delivery device configured to deliver insulin to a user of the system and a computer-based control unit associated with the insulin delivery device. The computer-based control unit includes a user interface and a computer-based processor. The computer-based processor is configured to calculate a relative insulin on board value for a specific time by calculating a first value that represents a reference insulin on board value at the specific time, calculating a second value that represents an automated insulin on board value at the specific time, and subtracting one of the first and second values from the other. The automated insulin on board value represents at least one insulin delivery automatically specified by the computer-based control unit. Methods of use are also disclosed.

Claims (36)

1. A computer-implemented insulin delivery assistance system, comprising:

a control unit:

a non-transitory computer-readable storage medium storing instructions thereon that, when executed by the control unit, cause the computer-implemented insulin delivery assistance system to:

receive blood glucose levels of a patient and insulin delivery information, wherein the insulin delivery information comprises information about automated or semi-automated insulin delivery to the patient over time;

determine an estimated insulin-on-board (JOB) responsive to the insulin delivery information; and

obtain a relative IOB that represents a difference between a reference IOB and the estimated JOB, the reference IOB representing an amount of insulin required to maintain blood glucose stasis of the patient; and

a bolus calculator configured to determine a suggested bolus dose of insulin for a correction bolus or for a meal bolus, wherein the bolus calculator is configured to determine the suggested bolus dose of insulin by performing operations comprising:

determining that a change to basal insulin delivery to the patient might affect future blood glucose levels based, at least in part, on the relative JOB; and

determining if the suggested bolus dose of insulin is necessary based on modeling data.

2. The system of claim 1 , wherein the bolus calculator is configured to provide the suggested bolus dose of insulin to the patient responsive to determining that the suggested bolus dose of insulin is necessary.

3. The system of claim 1 , wherein the bolus calculator is configured to discard the suggested bolus dose of insulin responsive to determining that the suggested bolus dose of insulin is not necessary.

4. The system of claim 1 , wherein the bolus calculator is configured to:

obtain a first set of projected blood glucose levels based, at least in part, on an anticipated meal intake; and

obtain a second set of projected blood glucose levels responsive to the determining that the change to basal insulin delivery might affect future blood glucose levels.

5. The system of claim 4 , wherein the bolus calculator is configured to determine a meal bolus dose based, at least in part, on a difference between the second set of projected blood glucose levels and a target blood glucose level.

6. The system of claim 1 , wherein the bolus calculator is configured to determine a correction dose of insulin responsive to determining that a received blood glucose level is outside a target range for blood glucose levels.

7. The system of claim 1 , wherein the change to basal insulin delivery is an increase to basal insulin delivery or a decrease to basal insulin delivery.

8. The system of claim 1 , wherein the bolus calculator is configured to determine that the suggested bolus dose of insulin is necessary to keep blood glucose levels of a patient within a target range for blood glucose levels responsive to determining that delivery of the suggested bolus dose of insulin will compensate for received blood glucose levels outside the target range for blood glucose levels to be within the target range for blood glucose levels.

9. The system of claim 1 , wherein the bolus calculator is configured to determine that the suggested bolus dose of insulin is necessary to keep blood glucose levels of a patient within a target range for blood glucose levels responsive to determining that delivery of the suggested bolus dose of insulin will compensate for projected increased blood glucose levels due to anticipated meal intake to be within the target range for blood glucose levels.

10. A computer-implemented method for assisting with insulin delivery, comprising:

receiving sensor blood glucose data of a patient and insulin delivery data, wherein the insulin delivery data comprises data corresponding to automated or semi-automated insulin delivery to the patient over time;

determining an estimated insulin-on-board (JOB) responsive to the insulin delivery data and the sensor blood glucose data;

obtaining a relative IOB responsive to a difference between a reference IOB and the estimated JOB, the reference IOB representing an amount of insulin required to maintain blood glucose stasis of the patient;

determining a suggested bolus dose of insulin for a correction bolus or for a meal bolus;

determining that a change to basal insulin delivery to the patient might affect future blood glucose levels based, at least in part, on the relative JOB; and

determining if the bolus dose of insulin is necessary.

11. The method of claim 10 , further comprising providing the suggested bolus dose of insulin to the patient responsive to determining that the suggested bolus dose of insulin is necessary.

12. The method of claim 10 , further comprising discarding the suggested bolus dose of insulin responsive to determining that the suggested bolus dose of insulin is not necessary.

13. The method of claim 10 , further comprising:

obtaining a first projected blood glucose levels based, at least in part, on an anticipated meal intake; and

obtaining a second projected blood glucose levels responsive to the determining that the change to basal insulin delivery might affect future blood glucose levels.

14. The method of claim 13 , further comprising determining a meal bolus dose based, at least in part, on a difference between the second projected blood glucose level and a target blood glucose level.

15. The method of claim 10 , further comprising determining a correction dose of insulin responsive to detecting that an estimated blood glucose level is outside a target range for blood glucose levels.

16. The method of claim 10 , wherein the determining that a change to basal insulin delivery might affect future blood glucose levels comprises: detecting an increase to basal insulin delivery responsive to the relative JOB; or detecting a decrease to basal insulin delivery responsive to the relative JOB.

17. The method of claim 10 , wherein the determining whether the suggested bolus dose of insulin is necessary comprises determining that the suggested bolus dose of insulin is necessary to keep blood glucose levels of a patient within a target range for blood glucose levels responsive to determining that delivery of the suggested bolus dose of insulin will compensate for received blood glucose levels outside the target range for blood glucose levels to be within the target range for blood glucose levels.

18. The method of claim 10 , wherein the determining whether the suggested bolus dose of insulin is necessary comprises determining that the suggested bolus dose of insulin is necessary to keep blood glucose levels of a patient within a target range for blood glucose levels responsive to determining that delivery of the suggested bolus dose of insulin will compensate for projected increased blood glucose levels due to anticipated meal intake to be within the target range for blood glucose levels.

Assignments (15)
SECURITY INTEREST Recorded Jan 10, 2025
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 069870/0519 →
SECURITY INTEREST Recorded Jan 10, 2025
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 069870/0456 →
SECURITY INTEREST Recorded Sep 30, 2024
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 069074/0001 →
SECURITY INTEREST Recorded Sep 30, 2024
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 069073/0912 →
SECURITY INTEREST Recorded Sep 24, 2024
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 069030/0104 →
SECURITY INTEREST Recorded Sep 24, 2024
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 069030/0296 →
SECURITY INTEREST Recorded Sep 23, 2024
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 069019/0142 →
SECURITY INTEREST Recorded Sep 23, 2024
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 069019/0188 →
SECURITY INTEREST Recorded Sep 12, 2024
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 068948/0172 →
SECURITY INTEREST Recorded Sep 12, 2024
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 068948/0324 →
SECURITY AGREEMENT SUPPLEMENT Recorded Sep 7, 2023
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 064840/0181 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2023
From: BIGFOOT BIOMEDICAL, INC.
To: INSULET CORPORATION
Reel/Frame 062900/0001 →
RELEASE OF SECURITY INTEREST Recorded Feb 17, 2023
From: MADRYN FUND ADMINISTRATION, LLC
To: BIGFOOT BIOMEDICAL, INC.
Reel/Frame 062793/0316 →
SECURITY INTEREST Recorded Feb 10, 2023
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 062702/0145 →
SECURITY INTEREST Recorded Mar 12, 2021
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 055583/0044 →