System and method providing for user intervention in a diabetes control arrangement

• US 20060276771A1
• Filed: 06/06/2005
• Published: 12/07/2006
• Est. Priority Date: 06/06/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Bousamra, Steven A., Weinert, Stefan, Galley, Paul J., Wagner, Robin, Chittajallu, Siva, Thukral, Ajay
• Application Number:
  US11/145,910
• Publication Number:
  US 20060276771A1
• Time in Patent Office: Days
• US Class Current: 604/503
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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 50/50 for simulation or modelling of medical disorders

Abstract

A system providing for user intervention in a medical control arrangement may comprise a first user intervention mechanism responsive to user selection thereof to produce a first user intervention signal, a second user intervention mechanism responsive to user selection thereof to produce a second user intervention signal, and a processor executing a drug delivery algorithm forming part of the medical control arrangement. The processor may be responsive to the first user intervention signal to include an intervention therapy value in the execution of the drug delivery algorithm, and responsive to the second user intervention signal to exclude the intervention therapy value from the execution of the drug delivery algorithm. The medical control arrangement may be a diabetes control arrangement, the drug delivery algorithm may be an insulin delivery algorithm, and the intervention therapy value may be, for example, an intervention insulin quantity or an intervention carbohydrate quantity.

Claims

1. A system providing for user intervention in a diabetes control arrangement, the system comprising:

means responsive to user selection thereof for producing one of a first and a second user intervention signal, and

a processor executing an insulin delivery algorithm forming part of the diabetes control arrangement, the processor responsive to the first user intervention signal to include one of an intervention insulin quantity and an intervention carbohydrate quantity in the execution of the insulin delivery algorithm, and responsive to the second user intervention signal to exclude the one of the intervention insulin quantity and the intervention carbohydrate quantity from the execution of the insulin delivery algorithm.

2. The system of claim 1 wherein the processor is configured to continue uninterrupted execution of the insulin delivery algorithm regardless of whether the first or second user intervention signal is produced.

3. The system of claim 1 further including means for providing the one of the intervention insulin quantity and the intervention carbohydrate quantity to the processor.

4. The system of claim 1 wherein the processor is responsive to the first user intervention signal to process the intervention insulin quantity by adding the intervention insulin quantity to a current insulin bolus amount.

5. The system of claim 4 wherein the processor is further responsive to the first user intervention signal to command administration of the combination of the intervention insulin quantity and the current insulin bolus amount to the user.

6. The system of claim 4 wherein the current insulin bolus amount is a positive-valued insulin bolus amount.

7. The system of claim 4 wherein the current insulin bolus amount is a zero-valued insulin bolus amount.

8. The system of claim 1 wherein the processor is responsive to the first user intervention signal to process the intervention carbohydrate quantity by modifying a blood glucose target as a function of the intervention carbohydrate quantity.

9. The system of claim 1 further including a database having insulin delivery and intervention carbohydrate information stored therein, and wherein the processor is responsive to either of the first and second user intervention signals to enter the one the intervention insulin quantity and the intervention carbohydrate quantity into the database.

10. The system of claim 1 wherein the processor is operable to wait for a delay time prior to including the one of the intervention insulin quantity and the intervention carbohydrate quantity in the execution of the insulin delivery algorithm.

11. A method of allowing user intervention in a diabetes control arrangement, the method comprising:

executing an insulin delivery algorithm forming part of the diabetes control arrangement,

monitoring first and second user intervention mechanisms,

including one of an intervention insulin quantity and an intervention carbohydrate quantity in the execution of the insulin delivery algorithm in response to user selection of the first user intervention mechanism, and

excluding the one of the intervention insulin quantity and the intervention carbohydrate quantity from the execution of the insulin delivery algorithm in response to user selection of the second user intervention mechanism.

12. The method of claim 11 further including receiving the one of the intervention insulin quantity and the intervention carbohydrate quantity.

13. The method of claim 11 further including entering the one of the intervention insulin quantity and the intervention carbohydrate quantity into a database in response to user selection of either of the first and second user intervention mechanisms.

14. The method of claim 13 further including date and time stamping the one of the intervention insulin quantity and the intervention carbohydrate quantity prior to entry into the database.

15. The method of claim 11 further including waiting for a delay time after the user selection of the first user intervention mechanism and prior to including the one of the intervention insulin quantity and the intervention carbohydrate quantity in the execution of the insulin delivery algorithm.

16. A system providing for user intervention in a medical control arrangement, the system comprising:

a first user intervention mechanism responsive to user selection thereof to produce a first user intervention signal,

a second user intervention mechanism responsive to user selection thereof to produce a second user intervention signal, and

a processor executing a drug delivery algorithm forming part of the medical control arrangement, the processor responsive to the first user intervention signal to include an intervention drug quantity in the execution of the drug delivery algorithm, and responsive to the second user intervention signal to exclude the intervention drug quantity from the execution of the drug delivery algorithm.

17. The system of claim 16 further including means for receiving the intervention drug quantity.

18. The system of claim 16 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm, and the intervention drug quantity is an intervention insulin quantity.

19. The system of claim 18 wherein the processor is responsive to the first user intervention signal to include the intervention insulin quantity in the execution of the insulin delivery algorithm by adding the intervention insulin quantity to a current insulin bolus amount.

20. The system of claim 19 wherein the processor is further responsive to the first user intervention signal to command administration of the combination of the intervention insulin quantity and the current insulin bolus amount to the user.

21. The system of claim 16 further including a database having drug delivery information stored therein,

wherein the processor is responsive to either of the first and second user intervention signals to enter the intervention drug quantity into the database.

22. The system of claim 21 wherein the processor is configured to date and time stamp the intervention drug quantity prior to entry into the database.

23. The system of claim 16 wherein the processor is operable to wait for a delay time prior to including the intervention drug quantity in the execution of the insulin delivery algorithm.

24. The system of claim 16 wherein the processor is configured to continue uninterrupted execution of the drug delivery algorithm regardless of whether the first or second user intervention signal is produced.

25. A method of allowing user intervention in a medical control arrangement, the method comprising:

executing a drug delivery algorithm forming part of the medical control arrangement,

monitoring first and second user intervention mechanisms,

including an intervention drug quantity in the execution of the drug delivery algorithm in response to user selection of the first user intervention mechanism, and

excluding the intervention drug quantity from the execution of the drug delivery algorithm in response to user selection of the second user intervention mechanism.

26. The method of claim 25 further including receiving the intervention drug quantity.

27. The method of claim 25 further including entering the intervention drug quantity into a database in response to user selection of either of the first and second user intervention mechanisms.

28. The method of claim 27 further including date and time stamping the intervention drug quantity prior to entry into the database.

29. The method of claim 25 further including waiting for a delay time after the user selection of the first user intervention mechanism and prior to including the intervention drug quantity in the execution of the drug delivery algorithm.

30. The method of claim 25 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm and the intervention drug quantity is an insulin intervention quantity.

31. A system providing for user intervention in a medical control arrangement, the system comprising:

a first user intervention mechanism responsive to user selection thereof to produce a first user intervention signal,

a second user intervention mechanism responsive to user selection thereof to produce a second user intervention signal, and

a processor executing a drug delivery algorithm forming part of the medical control arrangement, the processor responsive to the first user intervention signal to include an intervention therapy value in the execution of the drug delivery algorithm, and responsive to the second user intervention signal to exclude the intervention therapy value from the execution of the drug delivery algorithm.

32. The system of claim 31 further including means for receiving the intervention therapy value.

33. The system of claim 31 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm, and the intervention therapy value is an intervention insulin quantity.

34. The system of claim 31 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm, and the intervention therapy value is an intervention carbohydrate quantity corresponding to a quantity carbohydrates recently intervention by the user.

35. The system of claim 34 wherein the processor is responsive to the first user intervention signal to include the intervention carbohydrate quantity in the execution of the insulin delivery algorithm by modifying a blood glucose target as a function of the intervention carbohydrate quantity.

36. The system of claim 31 further including a database having therapy value information stored therein,

wherein the processor is responsive to either of the first and second user intervention signals to enter the intervention therapy value into the database.

37. The system of claim 36 wherein the processor is configured to date and time stamp the intervention therapy value prior to entry into the database.

38. The system of claim 31 wherein the processor is operable to wait for a delay time prior to including the intervention therapy value in the execution of the drug delivery algorithm.

39. The system of claim 31 wherein the processor is configured to continue uninterrupted execution of the drug delivery algorithm regardless of whether the first or second user intervention signal is produced.

40. A method of allowing user intervention in a medical control arrangement, the method comprising:

executing a drug delivery algorithm forming part of the medical control arrangement,

monitoring first and second user intervention mechanisms,

including an intervention therapy value in the execution of the drug delivery algorithm in response to user selection of the first user intervention mechanism, and

excluding the intervention therapy value from the execution of the drug delivery algorithm in response to user selection of the second user intervention mechanism.

41. The method of claim 40 further including receiving the intervention therapy value.

42. The method of claim 40 further including entering the intervention therapy value into a database in response to user selection of either of the first and second user intervention mechanisms.

43. The method of claim 42 further including date and time stamping the intervention therapy value prior to entry into the database.

44. The method of claim 40 further including waiting for a delay time after the user selection of the first user intervention mechanism and prior to including the intervention therapy value in the execution of the drug delivery algorithm.

45. The method of claim 40 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm and the intervention therapy value is an insulin intervention quantity.

46. The method of claim 40 wherein the medical control arrangement is a diabetes control arrangement, the drug delivery algorithm is an insulin delivery algorithm and the intervention therapy value is an intervention carbohydrate quantity corresponding to a quantity carbohydrates recently intervention by the user.