INSULIN PUMP BASED EXPERT SYSTEM

• US 20080300534A1
• Filed: 05/30/2007
• Published: 12/04/2008
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Blomquist, Michael
• Granted Patent: US 8,221,345 B2
• Time in Patent Office: Days
• 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; and

wherein 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.

2. The apparatus of claim 1, wherein the controller includes a rule module configured to apply a rule to the blood glucose data to determine the question.

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

4. The apparatus of claim 2, wherein the input is configured to receive physiologic data into the device from at least one second device,

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.

5. The apparatus of claim 2, 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.

6. The apparatus of claim 2, 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.

7. The apparatus of claim 2, wherein the controller is configured to present a recommended change to an aspect of a lifestyle of the insulin pump user.

8. The apparatus of claim 2, 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.

9. The apparatus of claim 2, 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.

10. The apparatus of claim 2, including a communication port communicatively coupled to the controller, wherein the communication port is configured to receive the rule into the device from a second separate device.

11. The apparatus of claim 2, wherein the user interface and the input are configured to receive modifications to the rule.

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

13. 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.

14. 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.

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

16. 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.

17. 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.

18. The apparatus of claim 17, 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.

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

20. 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.

21. 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.

22. The apparatus of claim 21, wherein the input includes a communication port configured to receive blood glucose history data from a second separate device, and wherein the controller is configured to present a prompt to download blood glucose history data from the second separate device.

23. 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.

24. The apparatus of claim 23, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data in real time.

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

26. The apparatus of claim 25, wherein the communication port is a wireless communication port configured to receive the blood glucose data from the second separate device wirelessly.

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

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

29. 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.

30. 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.

31. 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 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

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

32. The system of claim 31, wherein the rule development module is configured to develop the rule, wherein the rule is 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.

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

34. The system of claim 31, wherein the first device includes a blood glucose monitor communicatively coupled to the input to provide the blood glucose data.

35. A method comprising:

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

presenting a question related to a blood glucose level of an insulin pump user when determining, from the blood glucose data, that the blood glucose level is different from a target blood glucose level;

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

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

36. The method of claim 35, including applying a rule stored in the device to the blood glucose data to determine the question.

37. The method of claim 36, including applying the rule to the blood glucose data to determine the recommended action.

38. The method of claim 36, including:

receiving physiologic data into the device from a second device;

wherein the applying a rule includes applying the rule to the physiologic data to determine the question; and

wherein the displaying a recommended action includes displaying the recommended action based at least in part on the physiologic data.

39. The method of claim 36, including:

receiving user demographic data into the device;

wherein the applying a rule includes applying the rule to the demographic data to determine the question; and

wherein the presenting a recommended action includes adjusting presentation of the recommended action according to the demographic data.

40. The method of claim 36, including:

receiving user lifestyle data into the device;

wherein the applying a rule includes applying the rule to the lifestyle data to determine the question; and

wherein the presenting a recommended action includes displaying a recommended action based at least in part on the lifestyle data.

41. The method of claim 36, including:

determining a rate of change of a blood glucose level of the user from the blood glucose data; and

applying the rule to the rate of change of a blood glucose level to determine at least one of the question and the recommended action.

42. The method of claim 36, including receiving the rule into the device via a device communication port from a second separate device.

43. The method of claim 36, including receiving the rule into the device via the user interface.

44. The method of claim 36, including:

storing insulin delivery history data of the pump user in the insulin pump device; and

applying 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.

45. The method of claim 35, wherein the presenting a recommended action includes displaying a recommended change to at least one aspect of user lifestyle.

46. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation for troubleshooting at least one of the insulin pump device, an insulin cartridge, an infusion set, infusion set tubing, an insulin basal rate pattern, and the infusion site.

47. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to change at least one of an insulin cartridge, an infusion set, an insulin type, an insulin bolus pattern, and an insulin pump executable program.

48. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to initiate a correction bolus from the insulin pump device when the blood glucose level is at risk of being high.

49. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to initiate a blood glucose measurement.

50. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to perform at least one of a basal rate test, a carbohydrate ratio test, and a correction factor test.

51. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to consume carbohydrates when the blood glucose level is at risk of being low.

52. The method of claim 51, including:

storing a database of food options in association with a known amount of carbohydrates; and

wherein presenting a recommendation to consume carbohydrates includes presenting a food option included in the database.

53. The method of claim 35, wherein the presenting a recommended action includes presenting a recommendation to contact a physician.

54. The method of claim 35, including:

presenting a question after receiving an indication into the device that the recommended action was taken; and

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

55. The method of claim 35, including:

storing blood glucose history data of the user in the insulin pump device; and

applying the rule to the blood glucose history data and the blood glucose data received from the blood glucose monitor to determine the recommended action.

56. The method of claim 55, including presenting a prompt to the pump user to download blood glucose history data from a separate second device to the insulin pump device.

57. The method of claim 35, wherein receiving blood glucose data includes automatically receiving the blood glucose data from a blood glucose monitor included in the insulin pump device.

58. The method of claim 35, wherein receiving blood glucose data includes:

obtaining the blood glucose data using a second device separate from the insulin pump device; and

receiving the blood glucose data into the insulin pump device from the second device through a communication port.

59. The method of claim 58, wherein receiving blood glucose data includes wirelessly receiving the blood glucose data into the insulin pump device from the second device through a wireless communication port.

60. The method of claim 58, wherein receiving blood glucose data includes receiving the blood glucose data into the insulin pump device in real time as the blood glucose data is obtained by the second device.

61. The method of claim 58, wherein receiving blood glucose data includes recurrently displaying a prompt to a user of the insulin pump device to obtain blood glucose data using the second device.

62. The method of claim 35, wherein receiving blood glucose data includes receiving the blood glucose data through a user interface of the insulin pump device configured for manual entry of blood glucose data.

63. The method of claim 35, including activating an audible alarm if it is determined that the blood glucose level of the pump user is different from the target blood glucose level.

64. The method of claim 35, including presenting a recommended action for the user to take that is related to maintaining normoglycemia when determining, from the blood glucose data, that the blood glucose level is near the target blood glucose level.

65. An apparatus comprising:

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

means for presenting a question related to a blood glucose level of an insulin pump user 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 action for the user to take based, at least in part, on the response.