SYSTEM, TOOLS, DEVICES AND A PROGRAM FOR DIABETES CARE

• US 20080242963A1
• Filed: 03/07/2008
• Published: 10/02/2008
• Est. Priority Date: 09/09/2005
• Status: Active Grant

• Current Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Original Assignee: Disetronic Licensing Ag (Roche Holding AG)
• Inventors: Essenpreis, Matthias, Schoemaker, Michael, Brandt, Derek, Koschinsky, Theodor, La Bastide, Sebastiaan, Heckermann, Sascha
• Granted Patent: US 7,766,831 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method for diabetes care, the method (which also may be referred to as, involve or incorporate at least one of a tool, device or program) allowing for the characterization of the relevance of errors of parameters affecting glucose concentration on a postprandial glucose concentration outcome for a person with diabetes mellitusm, wherein the method involves at least one of sensing, determining, calculating, predicting, describing and communicating the effects of potential errors of parameters affecting glucose concentration on postprandial glucose concentration values within a clinically relevant glucose range.

Claims

1. A system for determining postprandial glucose concentration, said system taking into account:

a preprandial glucose concentration measurement by self-monitoring of glucose;

an effect of carbohydrate-portion on maximum glucose increase;

an estimate of carbohydrate amount in a meal;

an effect of prandial insulin on maximum glucose decrease; and

an insulin dosage;

wherein

a margin of error for the self-monitored preprandial glucose is taken into account and postprandial glucose values are calculated based on a therapeutic action scheme.

2. The system according to claim 1, further comprising taking into account an error associated with at least one of:

the effect of carbohydrate-portion on maximum glucose concentration increase;

the estimate of carbohydrate amount in a meal;

the effect of prandial insulin on maximum glucose concentration decrease; and

the insulin dosage.

3. The system according to claim 2, wherein postprandial glucose concentration is determined for different ranges of preprandial glucose concentration values according to the therapeutic scheme.

4. The system according to claim 3, wherein a result is displayed as postprandial blood glucose over preprandial blood glucose.

5. The system according to claim 4, wherein it is determined whether a critical point is reached by exceeding a lower limit for glucose concentration or by exceeding an upper limit for glucose concentration.

6. The system according to claim 5, wherein the therapeutic scheme includes a carbohydrate self-adjustment in relation to preprandial glucose concentration according to the relation:

BG (mg/dl) <

40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P (n) X+2 X+1 X X−

1 X−

2 X−

3 X−

4 X−

5

wherein X equals the number of carbohydrate portions (X=1, 2, 3, 4 or

     5) for the blood glucose-range of 61-120 mg/dl.

7. The system according to claim 5, wherein the therapeutic scheme includes a pre-prandial insulin dose self-adjustment according to the relation:

BG (mg/dl) <

61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

Ins.-Dose (U) 0 −

1Y Y +1Y +2Y +3Y +4Y +5Y

wherein Y equals e.g. 1 unit insulin per 1 CARB-P for the blood glucose range of 81-120 mg/dl.

8. The system according to claim 1, wherein the trend of a continuous blood glucose monitoring is considered as follows:

9. A method of therapy, diagnosis or education involving postprandial glucose concentration, said method comprising the step of taking into account at least one of:

a preprandial glucose measurement by self-monitoring of glucose concentration;

an effect of carbohydrate-portion on maximum glucose increase;

an estimate of carbohydrate amount in a meal;

an effect of prandial insulin on maximum glucose decrease; and

an insulin dosage, wherein

a margin of error for self-monitored preprandial glucose is taken into account and postprandial glucose values are calculated based on a therapeutic action scheme.

10. The method according to claim 9, further comprising the step of taking into account an error associated with at least one of:

the effect of carbohydrate-portion on maximum glucose increase;

the estimate of carbohydrate amount in a meal;

the effect of prandial insulin on maximum glucose decrease; and

the insulin dosage.

11. The method according to claim 9, wherein postprandial blood glucose is determined for different ranges of preprandial glucose concentration values according to the therapeutic scheme.

12. The method according to claim 9, wherein a result is communicated as postprandial glucose over preprandial glucose.

13. The method according to claim 9, wherein it is determined whether a critical point is reached by exceeding a lower limit for glucose concentration or by exceeding an upper limit for glucose concentration.

14. The method according to claim 9, wherein the therapeutic scheme includes a carbohydrate self-adjustment in relation to preprandial glucose concentration according to the relation:

Glucose (mg/dl) <

40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P (n) X+2 X+1 X X−

1 X−

2 X−

3 X−

4 X−

5

wherein X equals the number of carbohydrate portions (X=1, 2, 3, 4 or

     5) for the glucose-range of 61-120 mg/dl.

15. The method according to claim 9, wherein the therapeutic scheme includes a pre-prandial insulin dose self-adjustment according to the relation:

BG (mg/dl) <

61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

Ins.-Dose (U) 0 −

1Y Y +1Y +2Y +3Y +4Y +5Y

wherein Y equals e.g. 1 unit insulin per 1 CARB-P for the blood glucose range of 81-120 mg/dl.

16. The method according to claim 9, wherein the trend of a continuous glucose monitoring is considered as follows:

17. The method according to claim 9, said method carried out or performed by or in conjunction with one of an a blood glucose meter, an insulin pump or a continuous glucose monitor.

18. The method according to claim 17, and an error grid for the evaluation of measurement errors associated with said blood glucose meter.

27. The computer program according to claim 17 and a data carrier containing the computer program.

49. The method according to claim 9, adapted for glucose measurement or glucose monitoring in any tissue compartment, tissues, body fluid or interstitial fluid.

19. A computer program for determining postprandial glucose concentration, the program taking into account at least one of:

a preprandial glucose measurement by self-monitoring of glucose;

an effect of carbohydrate-portion on maximum glucose increase;

an estimate of carbohydrate amount in a meal

an the effect of prandial insulin on maximum glucose decrease; and

an insulin dosage, wherein

a margin of error for self-monitored preprandial glucose is taken into account and postprandial glucose values are calculated based on a therapeutic action scheme.

20. The computer program according to claim 19, further comprising taking into account an error associated with at least one of:

the effect of carbohydrate-portion on maximum glucose increase;

the estimate of carbohydrate amount in a meal;

the effect of prandial insulin on maximum blood glucose decrease; and

the insulin dosage.

21. The computer program according to claim 19, wherein postprandial glucose concentration is determined for different ranges of preprandial blood glucose values according to the therapeutic scheme.

22. The computer program according to claim 21, wherein a result is displayed as postprandial glucose concentration over preprandial glucose concentration.

23. The computer program according to claim 19, wherein it is determined whether a critical point is reached by exceeding a lower limit for glucose or by exceeding an upper limit for glucose concentration.

24. The computer program according to claim 23, wherein the therapeutic scheme includes a carbohydrate self-adjustment in relation to preprandial glucose concentration according to the relation:

Glucose (mg/dl) <

40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P (n) X+2 X+1 X X−

1 X−

2 X−

3 X−

4 X−

5

wherein X equals the number of carbohydrate portions (X=1, 2, 3, 4 or

     5) for the glucose-range of 61-120 mg/dl.

25. The computer program according to claim 19, wherein the therapeutic scheme includes a pre-prandial insulin dose self-adjustment according to the relation:

Glucose (mg/dl) <

61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

Ins.-Dose (U) 0 −

1Y Y +1Y +2Y +3Y +4Y +5Y

wherein Y equals e.g. 1 unit insulin per 1 CARB-P for the glucose concentration range of 81-120 mg/dl.

26. The computer program according to claim 19, wherein the trend of a continuous blood glucose monitoring is considered as follows:

28. A device for determining postprandial glucose concentration taking into account at least one of:

a preprandial glucose measurement by self-monitoring of glucose;

an effect of carbohydrate-portion on maximum glucose concentration increase;

an estimate of carbohydrate amount in a meal;

an the effect of prandial insulin on maximum glucose concentration decrease; and

an insulin dosage, wherein

a margin of error for self-monitored preprandial glucose is taken into account and postprandial glucose values are calculated based on a therapeutic action scheme.

29. The device according to claim 28, wherein an error associated with at least one of the effect of carbohydrate-portion on maximum glucose concentration increase, the estimate of carbohydrate amount in meal, the effect of prandial insulin on maximum glucose concentration decrease, and the insulin dosage is taken into account.

30. The device according to claim 29, wherein postprandial glucose concentration is determined for different ranges of preprandial glucose values according to the therapeutic scheme.

31. The device according to claim 30, wherein the result is displayed as postprandial glucose concentration over preprandial glucose concentration.

32. The device according to claim 28, wherein it is determined whether a critical point is reached by exceeding a lower limit for glucose concentration or by exceeding an upper limit for glucose concentration.

33. The device according to claim 28, wherein the therapeutic scheme includes a carbohydrate self-adjustment in relation to preprandial glucose concentration according to the relation:

Glucose (mg/dl) <

40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P (n) X+2 X+1 X X−

1 X−

2 X−

3 X−

4 X−

5

wherein X equals the number of carbohydrate portions (X=1, 2, 3, 4 or

     5) for the glucose-range of 61-120 mg/dl.

34. The device according to claim 28, wherein the therapeutic scheme includes a pre-prandial insulin dose self-adjustment according to the relation:

Glucose (mg/dl) <

61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

Ins.-Dose (U) 0 −

1Y Y +1Y +2Y +3Y +4Y +5Y

wherein Y equals e.g. 1 unit insulin per 1 CARB-P for the glucose range of 81-120 mg/dl.

35. The device according to claim 28, wherein the trend of a continuous glucose monitoring is considered as follows:

36. The device according to claim 28, wherein the device is one of a blood glucose meter, an insulin pump or a continuous glucose monitor.

37. The device according to claim 36, wherein the device is a blood glucose meter and the meter has an associated error grid for the evaluation of measurement errors of the meter.

38. A device wherein, on the basis of at least one result of the analysis of glucose, at least one of a result, advice or information is provided by the device or a peripheral device, and wherein the result, advice or information is provided depending on a measurement error.

39. The device of claim 38, wherein the device is portable and is provided for measuring the glucose value of a patient.

40. The device according to claim 38, wherein the device is adapted to display a result, advice or information in a first measurement range or several first measurement ranges despite the measurement error, and is adapted to inhibit the display of a result, advice or information in a second measurement range or in several measurement ranges depending on the measurement error.

41. The device according to claim 38, further comprising an operably coupled display in one of wired or wireless connection with the device.

42. The device according to claim 41, further comprising at least one movement sensor wherein the display may be activated or inhibited dependent on a signal from the movement sensor.

43. The device according to claim 38, said device adapted to take into account at least one of:

a preprandial glucose concentration measurement by self-monitoring of glucose;

an effect of carbohydrate-portion on maximum glucose increase;

an estimate of carbohydrate amount in a meal;

an effect of prandial insulin on maximum glucose decrease; and

an insulin dosage;

wherein

a margin of error for the self-monitored preprandial glucose is taken into account and postprandial glucose values are calculated based on a therapeutic action scheme.

44. The device according to claim 43, further comprising taking into account an error associated with at least one of:

the effect of carbohydrate-portion on maximum glucose concentration increase;

the estimate of carbohydrate amount in a meal;

the effect of prandial insulin on maximum glucose concentration decrease, and

the insulin dosage.

45. The device according to claim 44, wherein postprandial glucose concentration is determined for different ranges of preprandial glucose concentration values according to the therapeutic scheme.

46. The device according to claim 45, wherein a result is displayed as postprandial blood glucose over preprandial blood glucose.

47. The device according to claim 46, wherein the device is one of a blood glucose meter, a continuous glucose monitor or an insulin pump.

48. The device according to claim 43, adapted for glucose measurement or glucose monitoring in blood or any tissue compartment, tissues, body fluid or interstitial fluid.