Fluid infusion system that automatically determines and delivers a correction bolus

• US 10,894,126 B2
• Filed: 02/13/2019
• Issued: 01/19/2021
• Est. Priority Date: 09/28/2018
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Lintereur, Louis J., Roy, Anirban, Grosman, Benyamin, Weydt, Patrick E., Parikh, Neha J., Wu, Di, Dianaty, Ali
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US16/275,290
• Publication Number:
  US 20200101222A1
• Time in Patent Office: 706 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A method of controlling an insulin infusion device involves controlling the device to operate in an automatic basal insulin delivery mode, obtaining a blood glucose measurement for the user, and initiating a correction bolus procedure when: the measurement exceeds a correction bolus threshold value; and a maximum basal insulin infusion rate is reached during the automatic basal insulin delivery mode. The correction bolus procedure calculates an initial correction bolus amount, and scales the initial amount to obtain a final correction bolus amount, such that a predicted future blood glucose level resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level. The final amount is delivered to the user during operation in the automatic basal insulin delivery mode.

Claims

1. A method of controlling operation of an insulin infusion device comprising a fluid reservoir for insulin to be delivered from the insulin infusion device to a body of a user, and further comprising at least one processor device to perform the method, comprising:

controlling the insulin infusion device to operate in an automatic basal insulin delivery mode;

obtaining a blood glucose measurement that indicates a current blood glucose level of the user;

initiating a correction bolus procedure when;

(1) the blood glucose measurement exceeds a correction bolus threshold value; and

(2) a maximum allowable basal insulin infusion rate (Umax) has been reached during operation in the automatic basal insulin delivery mode, the correction bolus procedure comprising;

calculating an initial correction bolus amount for the user;

scaling the initial correction bolus amount to obtain a final correction bolus amount for the user, such that a predicted future blood glucose level of the user resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level; and

delivering the final correction bolus amount to the body of the user during operation in the automatic basal insulin delivery mode.

2. The method of claim 1, wherein:

the final correction bolus amount is less than the initial correction bolus amount; and

the scaling step maximizes the final correction bolus amount without causing the predicted future blood glucose level to fall below the low blood glucose threshold level.

3. The method of claim 1, wherein the scaling step reduces the initial correction bolus amount in a stepwise manner to obtain the final correction bolus amount.

4. The method of claim 1, wherein the scaling step multiplies the initial correction bolus amount by a scaling factor between 0.0 and 1.0, inclusive, to obtain the final correction bolus amount.

5. The method of claim 1, wherein the blood glucose measurement is obtained from a blood glucose meter.

6. The method of claim 1, wherein the blood glucose measurement is obtained from a continuous glucose sensor coupled to the body of the user.

7. The method of claim 1, wherein:

delivering the final correction bolus amount is performed only when the final correction bolus amount exceeds a bolus delivery threshold amount; and

the method further comprises the step of delivering basal insulin at a rate of Umax when the final correction bolus amount does not exceed the bolus delivery threshold amount.

8. The method of claim 7, wherein the bolus delivery threshold amount is defined as a percentage of Umax.

9. The method of claim 1, further comprising the steps of:

detecting, based on the blood glucose measurement and at least one historical blood glucose measurement, a blood glucose trend that is indicative of meal consumption by the user; and

in response to the detecting, reducing a default value of the low blood glucose threshold level to obtain a reduced value of the low blood glucose threshold value, wherein the scaling step compares predicted future blood glucose levels of the user against the reduced value of the low blood glucose threshold value.

10. An insulin infusion device comprising:

a fluid reservoir for insulin to be delivered from the insulin infusion device to a user;

at least one processor device; and

at least one memory element associated with the at least one processor device, the at least one memory element storing processor-executable instructions configurable to be executed by the at least one processor device to perform a method of controlling delivery of insulin from the insulin reservoir to the user, the method comprising;

controlling the insulin infusion device to operate in an automatic basal insulin delivery mode;

obtaining a blood glucose measurement that indicates a current blood glucose level of the user; and

initiating a correction bolus procedure when;

(1) the blood glucose measurement exceeds a correction bolus threshold value; and

(2) a maximum allowable basal insulin infusion rate (Umax) has been reached during operation in the automatic basal insulin delivery mode, the correction bolus procedure comprising;

calculating an initial correction bolus amount for the user;

scaling the initial correction bolus amount to obtain a final correction bolus amount for the user, such that a predicted future blood glucose level of the user resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level; and

delivering the final correction bolus amount to the body of the user during operation in the automatic basal insulin delivery mode.

11. The insulin infusion device of claim 10, wherein:

the final correction bolus amount is less than the initial correction bolus amount; and

the scaling step maximizes the final correction bolus amount without causing the predicted future blood glucose level to fall below the low blood glucose threshold level.

12. The insulin infusion device of claim 10, wherein the scaling step reduces the initial correction bolus amount in a stepwise manner to obtain the final correction bolus amount.

13. The insulin infusion device of claim 10, wherein the scaling step multiplies the initial correction bolus amount by a scaling factor between 0.0 and 1.0, inclusive, to obtain the final correction bolus amount.

14. The insulin infusion device of claim 10, wherein:

delivering the final correction bolus amount is performed only when the final correction bolus amount exceeds a bolus delivery threshold amount; and

the method further comprises the step of delivering basal insulin at a rate of Umax when the final correction bolus amount does not exceed the bolus delivery threshold amount.

15. The insulin infusion device of claim 14, wherein the bolus delivery threshold amount is defined as a percentage of Umax.

16. The insulin infusion device of claim 10, wherein the method further comprises the steps of:

detecting, based on the blood glucose measurement and at least one historical blood glucose measurement, a blood glucose trend that is indicative of meal consumption by the user; and

in response to the detecting, reducing a default value of the low blood glucose threshold level to obtain a reduced value of the low blood glucose threshold value, wherein the scaling step compares predicted future blood glucose levels of the user against the reduced value of the low blood glucose threshold value.

17. A tangible and non-transitory electronic storage medium having processor-executable instructions configurable to be executed by at least one processor device to perform a method of controlling delivery of insulin from a fluid reservoir of an insulin infusion device to a user, the method comprising:

controlling the insulin infusion device to operate in an automatic basal insulin delivery mode;

obtaining a blood glucose measurement that indicates a current blood glucose level of the user; and

initiating a correction bolus procedure when;

(1) the blood glucose measurement exceeds a correction bolus threshold value; and

(2) a maximum allowable basal insulin infusion rate (Umax) has been reached during operation in the automatic basal insulin delivery mode, the correction bolus procedure comprising;

calculating an initial correction bolus amount for the user;

scaling the initial correction bolus amount to obtain a final correction bolus amount for the user, such that a predicted future blood glucose level of the user resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level; and

delivering the final correction bolus amount to the body of the user during operation in the automatic basal insulin delivery mode.

18. The storage medium of claim 17, wherein:

the final correction bolus amount is less than the initial correction bolus amount; and

the scaling step maximizes the final correction bolus amount without causing the predicted future blood glucose level to fall below the low blood glucose threshold level.

19. The storage medium of claim 17, wherein:

delivering the final correction bolus amount is performed only when the final correction bolus amount exceeds a bolus delivery threshold amount; and

the method further comprises the step of delivering basal insulin at a rate of Umax when the final correction bolus amount does not exceed the bolus delivery threshold amount.

20. The storage medium of claim 17, wherein the method further comprises the steps of:

detecting, based on the blood glucose measurement and at least one historical blood glucose measurement, a blood glucose trend that is indicative of meal consumption by the user; and

in response to the detecting, reducing a default value of the low blood glucose threshold level to obtain a reduced value of the low blood glucose threshold value, wherein the scaling step compares predicted future blood glucose levels of the user against the reduced value of the low blood glucose threshold value.