CARBOHYDRATE RATIO TESTING USING FREQUENT BLOOD GLUCOSE INPUT

• US 20080206799A1
• Filed: 02/27/2007
• Published: 08/28/2008
• Est. Priority Date: 02/27/2007
• Status: Abandoned Application

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Blomquist, Michael
• Application Number:
  US11/679,712
• Publication Number:
  US 20080206799A1
• Time in Patent Office: Days
• US Class Current: 435/14
• 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 5/142 Pressure infusion, e.g. using pumps
• 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

Abstract

An apparatus comprising a user interface configured to generate an electrical signal to begin a carbohydrate ratio test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration (including a time duration after delivery of an initial carbohydrate insulin bolus), and a controller in electrical communication with the input and the user interface. The controller includes a carbohydrate ratio module configured to establish a blood glucose baseline from a measure of an initial blood glucose level of the patient, and determine a carbohydrate ratio according to a difference between a blood glucose level of the patient at the end of the specified time duration and the blood glucose baseline. Other systems and methods are disclosed.

Claims

1. An apparatus comprising:

a user interface configured to generate an electrical signal to begin a carbohydrate ratio test when prompted by a user;

an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration after delivery of an initial carbohydrate insulin bolus; and

a controller in electrical communication with the input and the user interface, the controller including a carbohydrate ratio module configured to;

establish a blood glucose baseline from a measure of an initial blood glucose level of the patient; and

determine a carbohydrate ratio according to a difference between a blood glucose level of the patient at the end of the specified time duration and the blood glucose baseline.

2. The apparatus of claim 1, wherein the carbohydrate ratio module is further configured to:

determine an amount of correction insulin to reduce the blood glucose of the patient to the blood glucose baseline if the blood glucose of the patient is above the blood glucose baseline at the end of the specified time duration; and

determine the carbohydrate ratio by adding the correction insulin amount to the initial carbohydrate insulin amount.

3. The apparatus of claim 1, wherein the carbohydrate ratio module is further configured to:

determine an amount of insulin that was over-delivered to the patient if the blood glucose of the patient is below the blood glucose baseline at the end of the specified time duration; and

determine the carbohydrate ratio by subtracting the over-delivered insulin amount from the initial carbohydrate insulin bolus amount.

4. The apparatus of claim 1, wherein the carbohydrate ratio module is configured to determine a carbohydrate ratio according to a difference between a blood glucose level of the patient at the end of the specified time duration and the blood glucose baseline and a rate of change of the blood glucose level of the patient.

5. The apparatus of claim 1, further including an insulin calculation module configured to calculate the initial carbohydrate insulin bolus based on an initial carbohydrate ratio and an amount of carbohydrates ingested by the patient.

6. The apparatus of claim 5, further including:

a display in electrical communication with the controller; and

a memory configured to store a database of meal options in association with a known amount of carbohydrates,

wherein the controller is configured to display a meal option from the database to the user, and

wherein the user interface is further configured to receive a meal selection from the user to indicate the amount of carbohydrates.

7. The apparatus of claim 6, wherein the memory is further configured to store the database of meal options in association with a known amount of nutrient content.

8. The apparatus of claim 7, further including:

a pump mechanism, operatively coupled to the controller, configured to deliver the initial carbohydrate insulin bolus to the patient according to a specified bolus delivery profile;

wherein the carbohydrate ratio module is configured to determine that a blood glucose level of the patient decreased below a specified blood glucose threshold substantially near the beginning of the specified time duration; and

wherein the controller is configured to alter the bolus delivery profile according to the blood glucose data and the nutrient content of meal option selection received from the user.

9. The apparatus of claim 6, wherein the controller is configured to display at least one user instruction for the carbohydrate ratio test.

10. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

a blood glucose monitor communicatively coupled to the input.

11. The apparatus of claim 10, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data.

12. The apparatus of claim 10, further including:

a display in electrical communication with the controller, and

wherein the controller is configured to prompt the user, via the display, to begin a blood glucose measurement using the blood glucose monitor.

13. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

wherein the user interface and the input are configured to receive the sampled blood glucose data entered manually by the user.

14. The apparatus of claim 13, further including:

a display in electrical communication with the controller, wherein the controller is configured to display at least one user instruction for the carbohydrate ratio test, including periodically prompting the user to enter a blood glucose value.

15. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller;

wherein the insulin calculation module is further configured to determine an amount of active insulin in the patient, and

wherein the controller is configured to cancel the carbohydrate ratio test if the active insulin amount is above a specified threshold amount.

16. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

wherein the controller is configured to prevent delivery of a correction insulin bolus during the carbohydrate ratio test.

17. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller; and

wherein the controller is configured to cancel the carbohydrate ratio test if a delivery of a correction insulin bolus is detected during the carbohydrate ratio test.

18. The apparatus of claim 5, further including:

a pump mechanism configured to deliver the initial carbohydrate insulin bolus to the patient, wherein the pump mechanism is operatively coupled to the controller;

wherein the carbohydrate ratio module is configured to determine that a blood glucose level of the patient decreased below the blood glucose baseline substantially near the beginning of the specified time duration, and

wherein the controller is configured to;

produce an indication recommending a second carbohydrate ratio test; and

deliver a carbohydrate insulin bolus, including an extended insulin bolus, during the second carbohydrate ratio test; and

wherein the carbohydrate ratio module is further configured to determine the carbohydrate ratio according to a difference between the blood glucose baseline and a blood glucose level of the patient at the end of a specified time duration of the second carbohydrate ratio test.

19. The apparatus of claim 1, wherein the controller is configured to cancel the carbohydrate ratio test if a blood glucose level of the patient is outside of a specified range of blood glucose levels.

20. The apparatus of claim 1, wherein the controller is configured to cancel the carbohydrate ratio test if the rate of change of blood glucose of the patient is outside of a specified range of blood glucose level rates of change.

21. The apparatus of claim 1, further including:

a timer circuit; and

a display, wherein the timer circuit and the display are operatively coupled to the controller, and wherein the controller is configured to display at least one user instruction for executing the carbohydrate ratio test at one or more specified times during a day.

22. The apparatus of claim 21, wherein the controller is configured to display the user instruction during a substantially same time on multiple days.

23. The apparatus of claim 1, further including a display in electrical communication with the controller, and wherein the controller is configured to display the carbohydrate ratio.

24. The apparatus of claim 1, wherein the input is a first input and the apparatus further includes:

a blood glucose sensor circuit operatively coupled to the first input, the blood glucose sensor circuit configured to produce a blood glucose signal representative of a blood glucose level of the patient and provide the sampled blood glucose data to the first input;

a second input in electrical communication with the controller, wherein the controller is configured to receive information related to insulin delivery via the second input; and

wherein the carbohydrate ratio module is configured to determine the carbohydrate ratio using the insulin delivery information and the sampled blood glucose data.

25. The apparatus of claim 24, wherein the information related to insulin delivery includes:

an amount of insulin in a carbohydrate insulin bolus;

a carbohydrate ratio; and

an amount of active insulin, if any, in the patient.

26. The apparatus of claim 24, further including a communication port coupled to the second input, the communication port to receive the information related to insulin delivery.

27. The apparatus of claim 26, wherein the controller is configured to communicate the carbohydrate ratio through the communication port.

28. The apparatus of claim 24, wherein the user interface and the second input are configured to receive the information related to insulin delivery entered manually by the user.

29. The apparatus of claim 1, wherein the input includes a communication port configured to receive the sampled blood glucose information together with at least one time-stamp and to receive information related to insulin delivery, including an amount of insulin in the carbohydrate insulin bolus and a time the carbohydrate insulin bolus was delivered, and

wherein the carbohydrate ratio module is configured to determine the carbohydrate ratio using the information related to insulin delivery and the time-stamped sampled blood glucose data.

30. The apparatus of claim 29, wherein the information related to insulin delivery includes:

an amount of insulin in the carbohydrate insulin bolus;

a time the carbohydrate insulin bolus was delivered;

a carbohydrate ratio; and

an amount of active insulin, if any, in the patient.

31. The apparatus of claim 29, wherein the controller is configured to communicate the carbohydrate ratio through the communication port.

32. A method comprising:

receiving a user prompt in a blood glucose (BG) management device to start a carbohydrate ratio test;

receiving sampled blood glucose data of a patient obtained during a specified time duration, including a time duration after delivery of an initial carbohydrate insulin bolus;

establishing a blood glucose baseline from at least one measure of a blood glucose level of the patient; and

determining a carbohydrate ratio, using the BG management device, according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration.

33. The method of claim 32, further including:

determining an amount of correction insulin to reduce the blood glucose of the patient to the blood glucose baseline if the blood glucose of the patient is above the blood glucose baseline at the end of the specified time duration; and

determining the carbohydrate ratio by adding the correction insulin amount and the initial carbohydrate insulin bolus amount.

34. The method of claim 32, further including:

determining an amount of insulin that was over-delivered to the patient if the blood glucose of the patient is below the blood glucose baseline at the end of the specified time duration; and

determining the carbohydrate ratio by subtracting the over-delivered insulin amount from the initial carbohydrate insulin bolus amount.

35. The method of claim 32, wherein determining the carbohydrate ratio includes determining the carbohydrate ratio using a rate of change of the blood glucose level of the patient.

36. The method of claim 32, further including:

displaying at least one meal option from a database in the BG management device before delivery of the carbohydrate insulin bolus, the meal option associated in the database with a known amount of carbohydrates;

receiving a meal option selection in the BG management device; and

calculating an amount of the initial carbohydrate insulin bolus based on an initial carbohydrate ratio value and an amount of carbohydrates in the meal option selection.

37. The method of claim 36, wherein displaying at least one meal option includes presenting a user with at least one meal option associated in the database with a known amount of nutrient content.

38. The method of claim 37, including:

determining, using the blood glucose data, that a blood glucose level of the patient decreased below a specified blood glucose level after delivery of the initial carbohydrate insulin bolus, the carbohydrate insulin bolus delivered according to a bolus delivery profile; and

altering the bolus delivery profile using the blood glucose data and a meal selection received from a user.

39. The method of claim 32, further including:

receiving an electrical signal via a user interface of the BG management device to start a determination of the carbohydrate ratio; and

displaying at least one instruction to a user for the determination using the BG management device.

40. The method of claim 32, including delivering the initial insulin correction bolus using the BG management device.

41. The method of claim 40, further including:

determining an amount of active insulin in the patient prior to delivering the initial carbohydrate insulin bolus; and

canceling the carbohydrate ratio test if an amount of active insulin is above a specified threshold active insulin amount.

42. The method of claim 40, further including preventing the BG management device from delivering a correction bolus of insulin during the carbohydrate ratio test.

43. The method of claim 40, further including canceling the carbohydrate ratio test if a correction bolus of insulin is delivered during the carbohydrate ratio test.

44. The method of claim 40, further including:

determining that a blood glucose level of the patient decreases below the blood glucose baseline substantially near the beginning of the specified time duration using the BG management device;

indicating that a second determination of the carbohydrate ratio is recommended; and

delivering a carbohydrate insulin bolus that includes an extended insulin bolus during the second determination of the carbohydrate ratio.

45. The method of claim 40, wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device, and wherein the method includes automatically running the carbohydrate ratio test using the BG management device after the user prompt is received.

46. The method of claim 40, wherein receiving sampled blood glucose data includes:

obtaining the sampled blood glucose data using a device separate from the BG management device; and

receiving the sampled blood glucose data into the BG management device from the separate device through a communication port.

47. The method of claim 46, wherein receiving sampled blood glucose data includes wirelessly receiving the sampled blood glucose data into the BG management device from the separate device through a wireless communication port.

48. The method of claim 47, wherein receiving sampled blood glucose data includes periodically prompting a user through a user interface of the BG management device to obtain blood glucose data using the separate device.

49. The method of claim 40, wherein receiving sampled blood glucose data includes receiving the sampled blood glucose data through a user interface of the BG management device configured for manual entry of blood glucose data.

50. The method of claim 49, wherein receiving sampled blood glucose data includes prompting a user to manually enter a blood glucose value during the carbohydrate ratio test.

51. The method of claim 32, including delivering the initial carbohydrate insulin bolus using a second device;

wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device; and

wherein the method further includes receiving information related to insulin delivery into the BG management device.

52. The method of claim 51, wherein the information related to insulin delivery includes:

an amount of insulin in the initial carbohydrate insulin bolus;

a carbohydrate ratio; and

an amount of active insulin, if any, in the patient.

53. The method of claim 51, wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery from the second device through a communication port.

54. The method of claim 53, further including communicating the carbohydrate ratio to the second device using the communication port.

55. The method of claim 51, wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery manually through a user interface on the BG management device.

56. The method of claim 51, further including displaying the carbohydrate ratio using the BG management device.

57. The method of claim 32, further including:

delivering the initial carbohydrate insulin bolus using a second device;

providing information related to the initial carbohydrate insulin bolus to the BG management device using the second device,

wherein receiving sampled blood glucose data includes receiving time-stamped sampled blood glucose data into the BG management device, and

wherein determining the carbohydrate ratio includes determining the carbohydrate ratio using the time-stamped sampled blood glucose data and the information related to the initial carbohydrate insulin bolus.

58. The method of claim 57, wherein the information related to insulin delivery includes:

an amount of insulin in the initial carbohydrate insulin bolus;

a bolus delivery time;

a carbohydrate ratio; and

an amount of active insulin, if any, in the patient.

59. An apparatus comprising:

means for receiving a user prompt in a blood glucose (BG) management device to start a carbohydrate ratio test;

means for receiving sampled blood glucose data of a patient obtained during a specified time duration, including a time duration after delivery of an initial carbohydrate insulin bolus;

means for establishing a blood glucose baseline from a measure of an initial blood glucose level of the patient; and

means for determining a carbohydrate ratio, using the BG management device, according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration.