Regulating entry into a closed-loop operating mode of an insulin infusion system

• US 9,662,445 B2
• Filed: 08/13/2013
• Issued: 05/30/2017
• 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
• Primary Examiner(s): Breene, John
• Assistant Examiner(s): Islam, Mohammad
• Application Number:
  US13/966,114
• Publication Number:
  US 20140066888A1
• Time in Patent Office: 1,386 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. An electronic 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 continuous glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identify 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;

identify 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

permit entry into a closed-loop operating mode of an insulin infusion device for a user based on the most recent calibration factor and the prior calibration factor only when t−

tRecent≦

tR≦

t, wherein;

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

tRecent is a predetermined time period;

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

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.

2. The electronic device of claim 1, wherein:

the electronic device comprises a monitor device for the insulin infusion device; and

the monitor device and the insulin infusion device are physically distinct hardware devices.

3. The electronic device of claim 1, wherein the electronic device comprises the insulin infusion device.

4. The electronic device of claim 1, wherein:

the electronic device comprises a portable wireless device; and

the portable wireless device and the insulin infusion device are physically distinct hardware devices.

5. The electronic device of claim 1, wherein:

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

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

6. The electronic device of claim 1, 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

the most recent calibration factor is calculated 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.

7. The electronic device of claim 6, 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.

8. The electronic device of claim 6, wherein the processor-executable instructions cause the processor architecture to:

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

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

9. The electronic device of claim 1, wherein:

the processor-executable instructions cause the processor architecture to permit the entry to the closed-loop operating mode only when a change between the most recent calibration factor and the prior calibration factor is less than or equal to a threshold value.

10. The electronic device of claim 1, wherein the processor-executable instructions cause the processor architecture to:

identify all intervening calibration factors obtained after the prior calibration factor was obtained and before the most recent calibration factor was obtained; and

permit the entry to the closed-loop operating mode only when each of the intervening calibration factors is greater than or equal to a minimum acceptable calibration factor value, and is less than or equal to a maximum acceptable calibration factor value.

11. The electronic device of claim 1, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when;

CFmin≦

CFR≦

CFmax;

CFmin≦

CFP≦

CFmax;

tR−

tDiffmax≦

tP≦

tR−

tDiffmin; and

a difference between CFR and CFP is less than or equal to a threshold value;

CFR is the most recent calibration factor obtained at tR;

CFP is the prior calibration factor;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value;

tP is a time when CFP was obtained;

tDiffmax is a maximum allowable time difference; and

tDiffmin is a minimum allowable time difference.

12. The electronic device of claim 1, wherein the processor-executable instructions cause the processor architecture to:

determine, based on the most recent calibration factor and the prior calibration factor, that the continuous glucose sensor is accurate for purposes of the closed-loop operating mode; and

initiate the closed-loop operating mode in response to the determining.

13. The electronic device of claim 1, wherein the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when CFmin≦

CFR≦

CFmax, wherein;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value; and

CFR is the most recent calibration factor.

14. An electronic 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 continuous glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identify 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;

identify 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

permit entry into a closed-loop operating mode of an insulin infusion device for a user based on the most recent calibration factor and the prior calibration factor only when CFmin≦

CFR≦

CFmax, wherein;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value;

CFR is the most recent calibration factor; and

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.

15. An electronic 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 continuous glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identify 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;

identify 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

permit entry into a closed-loop operating mode of an insulin infusion device for a user based on the most recent calibration factor and the prior calibration factor only when CFmin≦

CFP≦

CFmax, wherein;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value;

CFP is the prior calibration factor; and

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.

16. An electronic 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 continuous glucose sensor that generates a sensor variable indicative of blood glucose of the user;

identify 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;

identify 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

permit entry into a closed-loop operating mode of an insulin infusion device for a user based on the most recent calibration factor and the prior calibration factor 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;

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

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.

17. A non-transitory computer readable medium containing processor-executable instructions stored therein that, when executed by a processor architecture comprising at least one processor device, cause the processor architecture to:

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

identify 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;

identify 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

permit entry into a closed-loop operating mode of the insulin infusion device, based on the most recent calibration factor and the prior calibration factor only when t−

tRecent≦

tR≦

t, wherein;

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

tRecent is a predetermined time period;

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

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 computer readable medium of claim 17, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when CFmin≦

CFR≦

CFmax;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value; and

CFR is the most recent calibration factor.

19. The computer readable medium of claim 17, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when CFmin≦

CFP≦

CFmax;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value; and

CFP is the prior calibration factor.

20. The computer readable medium of claim 17, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when tR−

tDiffmax≦

tP≦

tR−

tDiffmin;

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.

21. The computer readable medium of claim 17, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when a change between the most recent calibration factor and the prior calibration factor is less than or equal to a threshold value.

22. The computer readable medium of claim 17, wherein the processor-executable instructions cause the processor architecture to:

identify all intervening calibration factors obtained after the prior calibration factor was obtained and before the most recent calibration factor was obtained; and

permit the entry to the closed-loop operating mode only when each of the intervening calibration factors is greater than or equal to a minimum acceptable calibration factor value, and is less than or equal to a maximum acceptable calibration factor value.

23. The computer readable medium of claim 17, wherein:

the processor-executable instructions cause the processor architecture to permit the entry into the closed-loop operating mode only when;

CFmin≦

CFR≦

CFmax;

CFmin≦

CFP≦

CFmax;

tR−

tDiffmax≦

tP≦

tR−

tDiffmin; and

a difference between CFR and CFP is less than or equal to a threshold value;

CFR is the most recent calibration factor obtained at tR;

CFP is the prior calibration factor;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value;

tP is a time when CFP was obtained;

tDiffmax is a maximum allowable time difference; and

tDiffmin is a minimum allowable time difference.

24. The computer readable medium of claim 17, wherein the processor-executable instructions cause the processor architecture to:

determine, based on the most recent calibration factor and the prior calibration factor, that the continuous glucose sensor is accurate for purposes of the closed-loop operating mode; and

initiate the closed-loop operating mode in response to the determining.

25. An electronic controller for an insulin infusion device, the electronic controller 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, provide a closed-loop initiation module configured to;

obtain a most recent calibration factor for a continuous glucose sensor that generates a sensor variable indicative of blood glucose of a user, 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;

obtain a prior calibration factor for the continuous glucose sensor, 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;

obtain calibration timestamp data for the most recent calibration factor and the prior calibration factor; and

permit 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 only when t−

tRecent≦

tR≦

t, wherein;

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

tRecent is a predetermined time period;

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

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.

26. The electronic controller of claim 25, wherein:

the electronic controller is implemented in a monitor device for the insulin infusion device; and

the monitor device and the insulin infusion device are physically distinct hardware devices.

27. The electronic controller of claim 25, wherein the electronic controller is implemented in the insulin infusion device.

28. The electronic controller of claim 25, wherein:

the electronic controller is implemented in a portable wireless device; and

the portable wireless device and the insulin infusion device are physically distinct hardware devices.

29. The electronic controller of claim 25, wherein the closed-loop initiation module permits the entry into the closed-loop operating mode only when CFmin≦

CFR≦

CFmax, wherein;

CFmin is a minimum acceptable calibration factor value;

CFmax is a maximum acceptable calibration factor value; and

CFR is the most recent calibration factor.