REGULATING ENTRY INTO A CLOSED-LOOP OPERATING MODE OF AN INSULIN INFUSION SYSTEM

• US 20170281867A1
• Filed: 04/19/2017
• Published: 10/05/2017
• Est. Priority Date: 08/30/2012
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Parikh, Neha J., Roy, Anirban, Keenan, Desmond Barry, Mastrototaro, John J., Grosman, Benyamin
• Granted Patent: US 9,999,728 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An electronic controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop initiation module. The initiation module is operated to obtain a most recent calibration factor for a continuous glucose sensor, the most recent calibration factor representing a first conversion value applicable to convert a first sensor value to a first blood glucose value. The initiation module also obtains a prior calibration factor for the sensor, and calibration timestamp data for the most recent calibration factor and the prior calibration factor. The initiation module regulates entry into a closed-loop operating mode of the insulin infusion device, based on the most recent calibration factor, the prior calibration factor, and the calibration timestamp data.

Claims

1. A method of operating an insulin infusion device to deliver insulin to a body of a user, the method comprising:

obtaining sensor calibration data for a glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identifying at least one of a prior calibration factor and a most recent calibration factor from the sensor calibration data, the most recent calibration factor representing a first conversion value applicable to convert a first value of the sensor variable to a first blood glucose value, the prior calibration factor representing a second conversion value applicable to convert a second value of the sensor variable to a second blood glucose value, and the prior calibration factor corresponding to an earlier time relative to the most recent calibration factor;

permitting entry into a closed-loop operating mode of the insulin infusion device only when the at least one of the prior calibration factor and the most recent calibration factor from the sensor calibration data is greater than or equal to a minimum acceptable calibration factor value and less than or equal to a maximum acceptable calibration factor value; and

operating the insulin infusion device in the closed-loop operating mode to deliver insulin to the body of the user in a manner that is influenced by the most recent calibration factor.

2. The method of claim 1, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode of the insulin infusion device only when CFmin≦

CFR≦

CFmax, wherein CFmin is the minimum acceptable calibration factor value, CFR is the most recent calibration factor, and CFmax is the maximum acceptable calibration factor value.

3. The method of claim 2, wherein permitting entry into the closed-loop operating mode further comprises permitting entry into the closed-loop operating mode only when t−

tRecent≦

tR≦

t;

t is a time when attempting to enter the closed-loop operating mode;

tRecent is a predetermined time period; and

tR is a time when the most recent calibration factor was obtained.

4. The method of claim 2, wherein:

the sensor calibration data comprises a most recent meter blood glucose value and a sensor current value obtained at the time of the most recent meter blood glucose value; and

identifying the most recent calibration factor comprises calculating the most recent calibration factor, using the most recent meter blood glucose value and the sensor current value obtained at the time of the most recent meter blood glucose value.

5. The method of claim 4, wherein:

the most recent calibration factor is calculated in accordance with the expression CFR=meterBG/(Isig−

2);

CFR is the most recent calibration factor;

meterBG is the most recent meter blood glucose value; and

Isig is the sensor current value obtained at the time of the most recent meter blood glucose value.

6. The method of claim 4, further comprising:

receiving a command to enter the closed-loop operating mode; and

in response to receiving the command, generating a request for the most recent meter blood glucose value.

7. The method of claim 1, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode of the insulin infusion device only when CFmin≦

CFP≦

CFmax, wherein CFmin is the minimum acceptable calibration factor value, CFP is the prior calibration factor, and CFmax is the maximum acceptable calibration factor value.

8. The method of claim 7, wherein identifying the at least one of the prior calibration factor and the most recent calibration factor from the sensor calibration data comprises:

selecting a calibration factor that falls between tR−

tDiffmax and tR−

tDiffmin, where tR is a time when the most recent calibration factor was obtained, tDiffmax is a maximum allowable time difference, and tDiffmin is a minimum allowable time difference; and

designating the calibration factor as the prior calibration factor.

9. The method of claim 7, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode only when tR−

tDiffmax≦

tP≦

tR−

tDiffmin, wherein;

tR is a time when the most recent calibration factor was obtained;

tDiffmax is a maximum allowable time difference;

tDiffmin is a minimum allowable time difference; and

tP is a time when the prior calibration factor was obtained.

10. The method of claim 1, wherein:

the sensor calibration data comprises calibration timestamp data for the most recent calibration factor and the prior calibration factor; and

permitting entry into the closed-loop operating mode further comprises regulating entry into the closed-loop operating mode based on the most recent calibration factor, the prior calibration factor, and the calibration timestamp data.

11. A method of operating an insulin infusion device to deliver insulin to a body of a user, the method comprising:

obtaining sensor calibration data for a glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identifying a most recent calibration factor from the sensor calibration data, the most recent calibration factor representing a first conversion value applicable to convert a first value of the sensor variable to a first blood glucose value;

identifying a prior calibration factor from the sensor calibration data, the prior calibration factor representing a second conversion value applicable to convert a second value of the sensor variable to a second blood glucose value, and the prior calibration factor corresponding to an earlier time relative to the most recent calibration factor; and

permitting entry into a closed-loop operating mode of the insulin infusion device only when the prior calibration factor falls within a designated window of time; and

operating the insulin infusion device in the closed-loop operating mode to deliver insulin to the body of the user in a manner that is influenced by the most recent calibration factor.

12. The method of claim 11, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode only when tR−

tDiffmax≦

tP≦

tR−

tDiffmin, wherein;

tR is a time when the most recent calibration factor was obtained;

tDiffmax is a maximum allowable time difference;

tDiffmin is a minimum allowable time difference; and

tP is a time when the prior calibration factor was obtained.

13. The method of claim 12, wherein identifying the prior calibration factor comprises:

selecting a calibration factor that falls between tR−

tDiffmax and tR−

tDiffmin; and

designating the calibration factor as the prior calibration factor.

14. The method of claim 11, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode of the insulin infusion device only when CFmin≦

CFR≦

CFmax, wherein CFmin is a minimum acceptable calibration factor value, CFR is the most recent calibration factor, and CFmax is a maximum acceptable calibration factor value.

15. The method of claim 14, wherein permitting entry into the closed-loop operating mode further comprises permitting entry into the closed-loop operating mode only when t−

tRecent≦

tR≦

t;

t is a time when attempting to enter the closed-loop operating mode;

tRecent is a predetermined time period; and

tR is a time when the most recent calibration factor was obtained.

16. The method of claim 11, wherein permitting entry into the closed-loop operating mode comprises permitting entry into the closed-loop operating mode of the insulin infusion device only when CFmin≦

CFP≦

CFmax, wherein CFmin is a minimum acceptable calibration factor value, CFP is the prior calibration factor, and CFmax is a maximum acceptable calibration factor value.

17. A device comprising:

a processor architecture comprising at least one processor device; and

at least one memory element associated with the processor architecture, the at least one memory element storing processor-executable instructions that, when executed by the processor architecture, cause the processor architecture to;

obtain sensor calibration data for a glucose sensor that generates a sensor variable indicative of blood glucose of a user;

identify at least one of a prior calibration factor and a most recent calibration factor from the sensor calibration data, the most recent calibration factor representing a first conversion value applicable to convert a first value of the sensor variable to a first blood glucose value, the prior calibration factor representing a second conversion value applicable to convert a second value of the sensor variable to a second blood glucose value, and the prior calibration factor corresponding to an earlier time relative to the most recent calibration factor; and

permit entry into a closed-loop operating mode of an insulin infusion device only when the at least one of the prior calibration factor and the most recent calibration factor from the sensor calibration data is greater than or equal to a minimum acceptable calibration factor value and less than or equal to a maximum acceptable calibration factor value, wherein the insulin infusion device operation in the closed-loop operating mode to deliver insulin to a body of the user is influenced by the most recent calibration factor.

18. The device of claim 17, wherein:

CFmin is the minimum acceptable calibration factor value;

CFmax is the maximum acceptable calibration factor value;

CFR is the most recent calibration factor; and

entry into the closed-loop operating mode is permitted only when CFmin≦

CFR≦

CFmax.

19. The device of claim 17, wherein:

CFmin is the minimum acceptable calibration factor value;

CFmax is the maximum acceptable calibration factor value;

CFP is the prior calibration factor; and

entry into the closed-loop operating mode is permitted only when CFmin≦

CFP≦

CFmax.

20. The device of claim 17, wherein:

tR is a time when the most recent calibration factor was obtained;

tDiffmax is a maximum allowable time difference;

tDiffmin is a minimum allowable time difference;

tP is a time when the prior calibration factor was obtained; and

entry into the closed-loop operating mode is permitted only when tR−

tDiffmax≦

tP≦

tR−

tDiffmin.