IP Library › Granted Patent US 12,569,619
Granted Patent B2
US 12,569,619 · App. 17/027,191 · Granted Mar 10, 2026

Techniques for determining automated insulin delivery dosages

Inventors: Joon Bok Lee (Acton, MA); Yibin Zheng (Hartland, WI); Steven Cardinali (Tewksbury, MA); Jason O'Connor (Acton, MA)
Assignee: INSULET CORPORATION
A61M5/1723A61M5/16804A61B5/14532A61B5/7275A61K38/28A61M2005/14208A61M2205/3327A61M2205/50A61M2205/52A61M2230/201
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Quick Facts
Patent No.
US 12,569,619
App. No.
17/027,191
Granted
Mar 10, 2026
Kind
B2
Abstract

Methods and apparatuses for performing an insulin infusion process are described. For example, an apparatus may include at least one memory and logic coupled to the at least one memory. The logic may operate to determine a basal parameter for a patient based on a type 2 diabetes (T2D) multiple daily injection (MDI) information of the patient, the basal parameter indicating a basal infusion rate, determine an additional insulin (I add ) value based on a mean blood glucose difference (BG diff ) information associated with the patient, determine an insulin volume to infuse into the patient based on the basal parameter and I add , and administer the insulin volume to the patient. Other embodiments are described.

Claims (111)

1 . An apparatus, comprising:

at least one memory; and

logic coupled to the at least one memory, the logic to:

determine a basal parameter for a patient based on a type 2 diabetes (T2D) multiple daily injection (MDI) information of the patient, the basal parameter indicating a basal infusion rate, the MDI information comprising a multiple daily injection therapy specification describing a plurality of manual injections to be administered to the patient on a daily basis,

determine an additional insulin (I add ) value based on a mean blood glucose difference (BG diff ) information associated with the patient, the mean blood glucose difference (BG diff ) information determined based on a difference between a current glycated hemoglobin (A1C current ) level and a target glycated hemoglobin (A1C target ) level for the patient,

wherein the additional insulin (I add ) value is determined according to:

I

add

=

BG

diff

CF

*

x

,

where x is a tunable cycle parameter configured to represent a number of cycles of insulin peak times per an infusion time period and CF is a correction factor

determine an insulin volume to infuse into the patient based on the basal parameter and the additional insulin (I add ) value, and

administer the insulin volume to the patient.

2 . The apparatus of claim 1 , the logic to determine the basal parameter according to:

TDI

=

∑

n

=

1

n

max

⁢

MDI

n

,

⁢

and

basal

⁢

⁢

parameter

=

TDI

t

,

where t is an infusion time period and TDI is a total daily insulin.

3 . The apparatus of claim 1 , wherein the mean blood glucose difference (BG diff ) information is determined based on the equation

A 1 C current −A 1 C target =( BG diff +68.8)/31.5.

4 . The apparatus of claim 1 ,

wherein CF is determined according to:

CF

=

y

z

*

basal

,

where y is an insulin sensitivity factor, z is the infusion time period, and basal is a basal need of the patient in a time period defined by the infusion time period.

5 . The apparatus of claim 1 , the logic to adjust the insulin volume based on at least one safety constraint.

6 . The apparatus of claim 5 , the logic to determine the at least one safety constraint based on an adjustment factor (F S ) determined based on a total daily insulin (TDI) and the additional insulin (I add ) value according to:

F

s

=

1

+

max

⁡

(

0

,

I

add

TDI

)

.

7 . The apparatus of claim 5 , the at least one safety constraint comprising a duration maximum safety constraint indicating a maximum volume of insulin that may be infused into the patient during a duration.

8 . The apparatus of claim 5 , the at least one safety constraint comprising an insulin-on-board (IOB) safety constraint indicating deviations from basal infusion for the patient.

9 . The apparatus of claim 1 , the logic to determine the insulin volume using an automatic insulin delivery (AID) process based on continuous glucose measurement (CGM) information of the patient.

10 . The apparatus of claim 1 , the logic to determine the insulin volume using an automatic insulin delivery (AID) process using manual blood glucose measurement information of the patient.

11 . The apparatus of claim 10 , the logic to determine an adjustment (Δb(i)) in insulin delivery responsive to receiving the manual blood glucose measurement information for the patient, wherein the adjustment (Δb(i)) represents a change in basal insulin of the patient based on the manual blood glucose measurement information for the patient.

12 . A method, comprising:

operatively coupling an automatic insulin delivery (AID) device to a patient;

performing, via a processor of a computing device operatively coupled to the AID device, an insulin infusion method by:

determining a basal parameter for the patient based on a type 2 diabetes (T2D) multiple daily injection (MDI) information of the patient, the basal parameter indicating a basal infusion rate, the MDI information comprising a multiple daily injection therapy specification describing a plurality of manual injections to be administered to the patient on a daily basis,

determining an additional insulin (I add ) value based on a mean blood glucose difference (BG diff ) information associated with the patient, the mean blood glucose difference (BG diff ) information determined based on a difference between a current glycated hemoglobin (A1C current ) level and a target glycated hemoglobin (A1C target ) level for the patient, wherein the additional insulin (I add ) value is determined according to:

I

add

=

BG

diff

CF

*

x

,

where x is a tunable cycle parameter configured to represent a number of cycles of insulin peak times per an infusion time period,

where CF is a correction factor determined according to:

CF

=

y

z

*

basal

,

where y is an insulin sensitivity factor, z is the infusion time period, and basal is a basal need of the patient in a time period defined by the infusion time period, and

determining an insulin volume to infuse into the patient based on the basal parameter and the additional insulin (I add ) value; and

administering the insulin volume to the patient via the AID device.

13 . The method of claim 12 , comprising determining the mean blood glucose difference (BG diff ) information determined based on:

A 1 C current −A 1 C target =( BG diff +68.8)/31.5

where A1C current is the patient's current glycated hemoglobin level and A1C target is the patient's target glycated hemoglobin level.

14 . The method of claim 12 , comprising adjusting the insulin volume based on at least one safety constraint.

15 . The method of claim 14 , the at least one safety constraint comprising a duration maximum safety constraint indicating a maximum volume of insulin that may be infused into the patient during a duration.

16 . The method of claim 14 , the at least one safety constraint comprising an insulin-on-board (IOB) safety constraint indicating deviations from basal infusion for the patient.

17 . The method of claim 12 , comprising determining the insulin volume using an automatic insulin delivery (AID) process based on continuous glucose measurement (CGM) information of the patient.

18 . The method of claim 12 , comprising determining the insulin volume using an automatic insulin delivery (AID) process using manual blood glucose measurement information of the patient.

19 . The method of claim 18 , comprising determining an adjustment (Δb(i)) in insulin delivery responsive to receiving the manual blood glucose measurement information for the patient, wherein the adjustment (Δb(i)) represents a change in basal insulin of the patient based on the manual blood glucose measurement information for the patient.

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 Sep 23, 2020
From: LEE, JOON BOK; ZHENG, YIBIN; CARDINALI, STEVEN; O'CONNOR, JASON
To: INSULET CORPORATION
Reel/Frame 053862/0510 →
Continuity (1)
Related Publication 20220088303A1 · Mar 24, 2022
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