IP Library Granted Patent US 12,121,701
Granted Patent B2
US 12,121,701 · App. 17/582,349 · Granted Oct 22, 2024

Systems and methods for incorporating co-formulations of insulin in an automatic insulin delivery system

Inventors: Joon Bok Lee (Acton, MA); Jason O'Connor (Acton, MA); Yibin Zheng (Hartland, WI); Ashutosh Zade (San Diego, CA)
Assignee: INSULET CORPORATION
A61M5/1723A61B5/14532A61B5/4839A61B5/4866A61B5/7282A61K38/22A61K38/26A61K38/28A61M5/1408A61M5/14248G16H20/17G16H40/67A61M2205/502A61M2205/52A61M2205/8206A61M2230/201
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Quick Facts
Patent No.
US 12,121,701
App. No.
17/582,349
Granted
Oct 22, 2024
Kind
B2
Abstract

Disclosed herein are systems and methods for the delivery of a co-formulation of insulin and a second drug, such as GLP-1, using an automated insulin delivery system. In a first embodiment, a dose of insulin is calculated by a medication delivery algorithm and a reduction factor is applied to account for the effect of second drug on the user's daily insulin requirement. In a second embodiment of the invention, a total amount of the second drug administered to the user during the past 24 hours is used to modify the correction factor and the insulin-to-carbohydrate ratio used by the medication delivery algorithm to cause a reduction in the insulin delivered to the user to account for the effect of the administration of the second drug portion of the co-formulation.

Claims (24)

1. A method comprising:

calculating a quantity of a first drug that has been delivered to a user within a most recent predetermined period of time, wherein the first drug is GLP-1;

calculating a correction factor used in the calculation of a dose of insulin to be delivered to the user;

calculating a modified correction factor based on the calculated correction factor and the calculated quantity of the first drug that has been delivered to the user;

calculating a dose of insulin to be delivered to the user based on the modified correction factor, wherein calculating the dose of insulin comprises:

determining an insulin to carbohydrate (I:C) ratio used in the calculation of the dose of insulin to be delivered to the user,

calculating a modified I:C ratio based on the calculated quantity of GLP-1 that has been delivered to the user, and

calculating the dose of insulin to be delivered to the user based on the modified I:C ratio; and

delivering the calculated dose of insulin to the user;

wherein the calculated dose of insulin delivered to the user is delivered as a co-formulation of the first drug and insulin.

2. The method of claim 1 wherein, when the bolus doses are being delivered to the user, the method further calculates the quantity of GLP-1 that has been delivered to a user, accounting for expected changes in insulin sensitivity of the user due to additional GLP-1 that is delivered.

3. The method of claim 1 wherein calculating a modified correction factor and I:C ratio assumes an average effect of the delivery of the GLP-1 in the co-formulation on the insulin sensitivity of a population of users.

4. A system comprising:

a drug delivery device configured to deliver a co-formulation of insulin and a second drug to a user; and

an algorithm, implemented by software executed by a processor, to determine the timing and quantity of the delivery of the co-formulation of insulin and the second drug to the user, wherein the algorithm:

calculates a quantity of the second drug that has been delivered to a user within a most recent predetermined period of time, wherein the first drug is GLP-1;

calculates a correction factor used in the calculation of a dose of insulin to be delivered to the user;

calculates a modified correction factor based on the calculated correction factor and the calculate quantity of the second drug that has been delivered to the user; and

calculates a dose of insulin to be delivered to the user based on the modified correction factor, wherein calculating the dose of insulin comprises:

determining an insulin to carbohydrate (I:C) ratio used in the calculation of the dose of insulin to be delivered to the user,

calculating a modified I:C ratio based on the calculated quantity of GLP-1 that has been delivered to the user, and

calculating the dose of insulin to be delivered to the user based on the modified I:C ratio; and

wherein the drug delivery device delivers the calculated dose of insulin to the user.

5. The system of claim 4 wherein, when the bolus doses are being delivered to the user, the algorithm further calculates the quantity of the second drug that has been delivered to a user, accounting for expected changes in insulin sensitivity of the user due to additional amount of the second drug that is delivered.

Assignments (2)
SECURITY AGREEMENT SUPPLEMENT Recorded Dec 1, 2022
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 062035/0785 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2022
From: LEE, JOON BOK; O'CONNOR, JASON; ZHENG, YIBIN; ZADE, ASHUTOSH
To: INSULET CORPORATION
Reel/Frame 058827/0484 →
Continuity (2)
Provisional Application 63143437 · Jan 29, 2021
Related Publication 20220241504A1 · Aug 4, 2022