Insulin pump based expert system

• US 8,221,345 B2
• Filed: 05/30/2007
• Issued: 07/17/2012
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Blomquist, Michael
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/755,480
• Publication Number:
  US 20080300534A1
• Time in Patent Office: 1,875 Days
• Field of Search: 604/66, 604/131, 604/151, 600/309, 600/345, 600/347, 600/365, 705/3
• US Class Current: 604/66
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• 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 5/7275 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: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An apparatus comprising a pump configured to deliver insulin, an input configured to receive blood glucose data, a user interface, and a controller communicatively coupled to the pump, the input, and the user interface. The controller includes a blood glucose data module to compare the blood glucose data to a target blood glucose level for an insulin pump user. The controller is configured to present a question related to the blood glucose level via the user interface when the blood glucose level is different than the target blood glucose level, receive a response to the question via the user interface, and present a recommended user action based at least in part on the response. Other devices, systems, and methods are disclosed.

Claims

1. An apparatus comprising:

a pump configured to deliver insulin;

an input configured to receive blood glucose data;

a user interface; and

a controller communicatively coupled to the pump, the input, and the user interface, wherein the controller includes;

a blood glucose data module configured to compare the blood glucose data to a target blood glucose level for an insulin pump user;

a rule module configured to apply a rule to the blood glucose data to determine a question related to the blood glucose level and to receive modifications to the rule via the user interface; and

wherein the controller is configured to;

present the question via the user interface when the blood glucose level is different than the target blood glucose level;

receive a response to the question via the user interface; and

present a recommended corrective user action based at least in part on the response.

2. The apparatus of claim 1, wherein the rule module is configured to apply the rule to the response to determine the recommended action.

3. The apparatus of claim 1, wherein the input is configured to receive physiologic data into the apparatus from at least one second apparatus,

wherein the rule module is configured to apply the rule to the physiologic data to determine the question, and

wherein the controller is configured to determine the recommended action based at least in part on the physiologic data.

4. The apparatus of claim 1, including:

a memory, communicatively coupled to the controller, to store demographic data of the insulin pump user,

wherein the rule module is configured to apply the rule to the demographic data to determine the question, and

wherein the controller is configured to adjust presentation of the recommended action based on the demographic data.

5. The apparatus of claim 1, including:

a memory, communicatively coupled to the controller, to store lifestyle data of the insulin pump user,

wherein the rule module is configured to apply the rule to the lifestyle data to determine the question, and

wherein the controller is configured to determine the recommended action based at least in part on the lifestyle data.

6. The apparatus of claim 1, wherein the controller is configured to present a recommended change to an aspect of a lifestyle of the insulin pump user.

7. The apparatus of claim 1, wherein the controller is configured to determine a rate of change of a blood glucose level of the insulin pump user from the blood glucose data, and

wherein the rule module is configured to apply the rule to the rate of change of a blood glucose level to determine at least one of the question and the recommended action.

8. The apparatus of claim 1, including:

a memory, communicatively coupled to the controller, to store insulin delivery history data of the insulin pump user, and

wherein the rule module is configured to apply the rule to the blood glucose data and the insulin delivery history data to determine at least one of the question and the recommended action.

9. The apparatus of claim 1, including a communication port communicatively coupled to the controller, wherein the communication port is configured to receive the rule into the apparatus from a second separate apparatus.

10. The apparatus of claim 1, wherein the recommended action includes troubleshooting at least one of the pump, an insulin cartridge, an infusion set, infusion set tubing, and the infusion site.

11. The apparatus of claim 1, wherein the recommended action includes changing at least one of an insulin cartridge, an infusion set, an insulin type, an insulin bolus pattern, an insulin basal rate pattern, and an insulin pump executable program.

12. The apparatus of claim 1, wherein the recommended action includes a recommendation to initiate a correction bolus when the blood glucose module determines the blood glucose level is at risk of being high.

13. The apparatus of claim 1, wherein the recommended action includes a recommendation to initiate at least one blood glucose measurement.

14. The apparatus of claim 1, wherein the recommended action includes a recommendation to perform at least one of a basal rate test, a carbohydrate ratio test, and a correction factor test.

15. The apparatus of claim 1, wherein the recommended action includes a recommendation to consume carbohydrates if the blood glucose level is at risk of being low.

16. The apparatus of claim 15, including:

a memory, communicatively coupled to the controller, to store a database of food options in association with a known amount of carbohydrates, and

wherein the controller is configured to present a food option included in the database.

17. The apparatus of claim 1, wherein the recommended action includes contacting a physician.

18. The apparatus of claim 1, wherein the controller is configured to:

present a question after receiving an indication via the user interface that a recommended action was taken; and

present a further recommended action for the user to take based, at least in part, on a response to the question presented after receiving the indication.

19. The apparatus of claim 1, including:

a memory, communicatively coupled to the controller, to store blood glucose history data of the pump user, and

wherein the rule module is configured to apply the rule to the blood glucose history data and the blood glucose data received by the input.

20. The apparatus of claim 19, wherein the input includes a communication port configured to receive blood glucose history data from a second separate apparatus, and wherein the controller is configured to present a prompt to download blood glucose history data from the second separate apparatus.

21. The apparatus of claim 1, including a blood glucose monitor communicatively coupled to the input, wherein the input is configured to receive the blood glucose data from the blood glucose monitor.

22. The apparatus of claim 21, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data in real time.

23. The apparatus of claim 1, wherein the input includes a communication port configured to receive the blood glucose data from a second separate apparatus.

24. The apparatus of claim 23, wherein the communication port is a wireless communication port configured to receive the blood glucose data from the second separate apparatus wirelessly.

25. The apparatus of claim 23, wherein the controller is configured to recurrently prompt the user to obtain blood glucose data using the separate apparatus.

26. The apparatus of claim 1, wherein the user interface and the input are configured to receive the blood glucose data.

27. The apparatus of claim 1, including an alarm circuit coupled to the controller, wherein the controller is configured activating an audible alarm if it is determined that the blood glucose level of the subject different from a target blood glucose level.

28. The apparatus of claim 1, wherein the blood glucose data module is configured to determine, from the blood glucose data, whether a blood glucose level of the subject is at the target blood glucose level, and wherein the controller is configured for displaying a recommended user action when the blood glucose level is near the target blood glucose level, wherein the recommended action is related to maintaining normoglycemia.

29. A system comprising:

a first device including;

a pump configured to deliver insulin;

an input including a communication port configured to receive blood glucose data;

a user interface; and

a controller communicatively coupled to the pump, the input, and the user interface, wherein the controller includes;

a blood glucose data module configured to compare the blood glucose data to a target blood glucose level for an insulin pump user; and

a rule module configured to;

receive a rule via the input;

determine a question related to the blood glucose level via the user interface when the blood glucose level is different than the target blood glucose level; and

determine a recommended corrective action for the user to take by applying the rule to the blood glucose data and a response to the question received via the user interface,

wherein the controller is configured to present the question and the recommended action; and

a second device comprising;

a user interface;

a processor, communicatively coupled to the user interface, including a rule development module configured for developing the rule via the user interface and configured to provide an environment for a caregiver to modify a logical rule; and

a communication port, communicatively coupled to the processor, configured to communicate the rule to the first device.

30. The system of claim 29, wherein the rule development module is configured to develop a rule to be applied to the blood glucose data and at least one of physiologic data, demographic data, patient lifestyle data, insulin delivery history data, and blood glucose history data to determine the recommended action.

31. The system of claim 29, wherein the input of the first device includes a communication port configured to receive the blood glucose data from a third device.

32. The system of claim 29, wherein the first device includes a blood glucose monitor communicatively coupled to the input to provide the blood glucose data.

33. An apparatus comprising:

means for receiving blood glucose data into a device that includes an insulin pump;

means for applying a rule to the blood glucose data to determine a question related to a blood glucose level of an insulin pump user;

means for modifying the rule;

means for presenting the question when determining, from the blood glucose data, that the blood glucose level is different from a target blood glucose level;

means for receiving a response to the question into the insulin pump device; and

means for presenting a recommended corrective action for the user to take based, at least in part, on the response.