Diabetes management system and method for controlling blood glucose

• US 5,822,715 A
• Filed: 04/18/1997
• Issued: 10/13/1998
• Est. Priority Date: 01/10/1997
• Status: Expired due to Term

• Current Assignee: Health Hero Network Incorporated (Robert Bosch GmbH)
• Original Assignee: Health Hero Network Incorporated (Robert Bosch GmbH)
• Inventors: Brown, Stephen J., Worthington, David R. L.
• Primary Examiner(s): Teska, Kevin J.
• Assistant Examiner(s): Irshadullah, M.
• Application Number:
  US08/844,245
• Time in Patent Office: 543 Days
• Field of Search: 600/309, 600/300, 600/301, 705/9, 235/375, 435/236, 702/23, 702/19
• US Class Current: 702/19
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/6896 Toys
• 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: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A diabetes management system for predicting a future blood glucose value of a patient and for recommending a corrective action to the patient when the future blood glucose value lies outside of a target range. The system includes a patient-operated apparatus for measuring blood glucose values and for storing data relating to insulin doses administered to the patient. The apparatus predicts the patient'"'"'s future blood glucose value based upon the patient'"'"'s current blood glucose value, the fraction of insulin action remaining from the insulin doses, and the patient'"'"'s insulin sensitivity. The apparatus also determines the corrective action for the patient when the predicted blood glucose value lies outside of a target range. The system also includes a physician computer in communication with the apparatus for receiving the blood glucose values and insulin dose data and for calculating an adjusted insulin sensitivity for use in subsequent predictions.

Claims

1. An apparatus for assisting a patient having diabetes mellitus in controlling blood glucose, said apparatus comprising:

a) an input means for entering a blood glucose value G(t_d) representative of a blood glucose concentration of the patient at time t_d and for entering an insulin dose value representative of an insulin dose administered to the patient prior to time t_d ;

b) a memory means for storing an insulin sensitivity value representative of an insulin sensitivity of the patient and for storing information for determining an insulin action value F_k (t_d) representative of a fraction of insulin action remaining at time t_d from said insulin dose;

c) a processor connected to said input means and said memory means for determining said insulin action value F_k (t_d) and for determining a future blood glucose value G(t_j) representative of an expected blood glucose concentration of the patient at time t_j, wherein said processor determines said future blood glucose value G(t_j) in dependence upon said blood glucose value G(t_d), said insulin dose value, said insulin sensitivity value, and said insulin action value F_k (t_d); and

d) a display means connected to said processor for displaying said future blood glucose value G(t_j), thereby enabling the patient to take timely corrective action to prevent hypoglycemia or hyperglycemia.

2. The apparatus of claim 1, wherein said memory means includes means for storing maximum and minimum values defining a target blood glucose range of the patient, said processor includes means for determining if said future blood glucose value G(t_j) lies outside of said target range and means for determining said corrective action for the patient when said future blood glucose value G(t_j) lies outside of said target range, and said display means includes means for recommending said corrective action to the patient.

3. The apparatus of claim 2, wherein said memory means further includes means for storing a target blood glucose value of the patient, said corrective action comprises an administration of a supplemental insulin dose, and said processor further comprises means for determining said supplemental insulin dose in dependence upon said insulin sensitivity value and a difference between said future blood glucose value G(t_j) and said target blood glucose value.

4. The apparatus of claim 2, wherein said memory means further includes means for storing a target blood glucose value of the patient, said corrective action comprises a consumption of a number of grams of carbohydrates, and said processor further comprises means for determining said number of grams in dependence upon a difference between said future blood glucose value G(t_j) and said target blood glucose value.

5. The apparatus of claim 1, wherein said memory means further includes means for storing a hypoglycemic value indicative of a hypoglycemic threshold of the patient, said processor includes means for determining if said future blood glucose value G(t_j) lies below said hypoglycemic value, and said apparatus further comprises audio means connected to said processor for audibly alerting the patient when said future blood glucose value G(t_j) lies below said hypoglycemic value.

6. The apparatus of claim 1, wherein said input means comprises a blood glucose measuring means for measuring a blood sample of the patient and for producing said blood glucose value G(t_d) from a measurement of said blood sample.

7. The apparatus of claim 1, wherein said insulin dose has an insulin type, said input means includes means for entering said insulin type, and said processor includes means for determining said insulin action value F_k (t_d) in dependence upon said insulin type.

8. The apparatus of claim 7, wherein said insulin type is selected from the group consisting of regular insulin and lispro insulin.

9. The apparatus of claim 1, wherein said processor includes means for determining an insulin action value F_k (t_j) representative of a fraction of insulin action remaining at time t_j from said insulin dose and means for determining said future blood glucose value G(t_j) in further dependence upon said insulin action value F_k (t_j).

10. The apparatus of claim 1, wherein said processor includes means for determining an ultimate time point at which said insulin dose will have no insulin action remaining and means for setting time t_j equal to said ultimate time point.

11. The apparatus of claim 1, wherein said processor includes means for determining a plurality of future blood glucose values representative of a corresponding plurality of expected blood glucose concentrations of the patient, and wherein said display means includes means for displaying said future blood glucose values in graphical form.

12. The apparatus of claim 1, further comprising a communication means connected to said processor for establishing a communication link between said apparatus and a healthcare provider computer and for transmitting and receiving data therebetween.

13. The apparatus of claim 12, wherein said communication means comprises a modem means for establishing said communication link through a communication network.

14. The apparatus of claim 12, wherein said communication means comprises an input/output port for establishing said communication link through a connection cord.

15. A system for assisting a patient having diabetes mellitus in controlling blood glucose, said system comprising:

a) an input means for entering a blood glucose value G(t_d) representative of a blood glucose concentration of the patient at time t_d and for entering an insulin dose value representative of an insulin dose administered to the patient prior to time t_d ;

b) a memory means for storing maximum and minimum values defining a target blood glucose range of the patient, an insulin sensitivity value representative of an insulin sensitivity of the patient, and information for determining an insulin action value F_k (t_d) representative of a fraction of insulin action remaining at time t_d from said insulin dose;

c) a processor connected to said input means and said memory means for determining said insulin action value F_k (t_d), for determining a future blood glucose value G(t_j) representative of an expected blood glucose concentration of the patient at time t_j, and for determining a corrective action for the patient when said future blood glucose value G(t_j) lies outside of said target range, wherein said processor determines said future blood glucose value G(t_j) in dependence upon said blood glucose value G(t_d), said insulin dose value, said insulin sensitivity value, and said insulin action value F_k (t_d); and

d) a display means connected to said processor for recommending said corrective action to the patient.

16. The system of claim 15, wherein said memory means further includes means for storing a target blood glucose value of the patient, said corrective action comprises an administration of a supplemental insulin dose, and said processor further comprises means for determining said supplemental insulin dose in dependence upon said insulin sensitivity value and a difference between said future blood glucose value G(t_j) and said target blood glucose value.

17. The system of claim 15, wherein said memory means further includes means for storing a target blood glucose value of the patient, said corrective action comprises a consumption of a number of grams of carbohydrates, and said processor further comprises means for determining said number of grams in dependence upon a difference between said future blood glucose value G(t_j) and said target blood glucose value.

18. The system of claim 15, wherein said memory means further includes means for storing a hypoglycemic value indicative of a hypoglycemic threshold of the patient, said processor includes means for determining if said future blood glucose value G(t_j) lies below said hypoglycemic value, and said system further comprises audio means connected to said processor for audibly alerting the patient when said future blood glucose value G(t_j) lies below said hypoglycemic value.

19. The system of claim 15, wherein said input means comprises a blood glucose measuring means for measuring a blood sample of the patient and for producing said blood glucose value G(t_d) from a measurement of said blood sample.

20. The system of claim 15, wherein said insulin dose has an insulin type, said input means includes means for entering said insulin type, and said processor includes means for determining said insulin action value F_k (t_d) in dependence upon said insulin type.

21. The system of claim 20, wherein said insulin type is selected from the group consisting of regular insulin and lispro insulin.

22. The system of claim 15, wherein said processor includes means for determining an insulin action value F_k (t_j) representative of a fraction of insulin action remaining at time t_j from said insulin dose and means for determining said future blood glucose value G(t_j) in further dependence upon said insulin action value F_k (t_j).

23. The system of claim 15, wherein said processor includes means for determining an ultimate time point at which said insulin dose will have no insulin action remaining and means for setting time t_j equal to said ultimate time point.

24. The system of claim 15, wherein said processor includes means for determining a plurality of future blood glucose values representative of a corresponding plurality of expected blood glucose concentrations of the patient, and wherein said display means includes means for displaying said future blood glucose values in graphical form.

25. The system of claim 15, wherein said input means includes means for entering a plurality of blood glucose values and a plurality of insulin dose values, and said system further comprises a computing means in communication with said processor for receiving said blood glucose values and said insulin dose values and for calculating from said blood glucose values and said insulin dose values an adjusted insulin sensitivity value.

26. The system of claim 25, wherein said input means, said memory means, said processor, and said display means are included in a patient-operated apparatus, said computing means comprises a healthcare provider computer, and said apparatus includes a communication means connected to said processor for establishing a communication link between said apparatus and said healthcare provider computer.

27. The system of claim 26, wherein said communication means comprises a modem means for establishing said communication link through a communication network.

28. The system of claim 26, wherein said communication means comprises an input/output port for establishing said communication link through a connection cord.

29. A method for assisting a patient having diabetes mellitus in controlling blood glucose, said method comprising the following steps:

a) providing the patient with an apparatus for determining a future blood glucose value G(t_j) representative of an expected blood glucose concentration of the patient at time t_j, wherein said apparatus comprises a memory, an input means for entering a blood glucose value G(t_d) representative of a blood glucose concentration of the patient at time t_d and for entering an insulin dose value representative of an insulin dose administered to the patient prior to time t_d, a display, and a processor connected to said memory, said input means, and said display;

b) storing in said memory an insulin sensitivity value representative of an insulin sensitivity of the patient;

c) storing in said memory information for determining an insulin action value F_k (t_d) representative of a fraction of insulin action remaining at time t_d from said insulin dose;

d) entering in said processor said insulin dose value and said blood glucose value G(t_d);

e) determining in said processor said insulin action value F_k (t_d);

f) determining in said processor said future blood glucose value G(t_j) in dependence upon said blood glucose value G(t_d), said insulin dose value, said insulin sensitivity value, and said insulin action value F_k (t_d); and

g) displaying said future blood glucose value G(t_j) on said display, thereby enabling the patient to take timely corrective action to prevent hypoglycemia or hyperglycemia.

30. The method of claim 29, further comprising the step of determining in said processor an insulin action value F_k (t_j) representative of a fraction of insulin action remaining at time t_j from said insulin dose, and wherein said future blood glucose value G(t_j) is determined in further dependence upon said insulin action value F_k (t_j).

31. The method of claim 29, wherein the step of determining said future blood glucose value G(t_j) is preceded by the steps of determining in said processor an ultimate time point at which said insulin dose will have no insulin action remaining and setting time t_j equal to said ultimate time point.

32. The method of claim 29, further comprising the steps of determining in said processor a plurality of future blood glucose values representative of a corresponding plurality of expected blood glucose concentrations of the patient and displaying said future blood glucose values in graphical form on said display.

33. The method of claim 29, further comprising the steps of storing in said memory maximum and minimum values defining a target blood glucose range of the patient, determining in said processor if said future blood glucose value G(t_j) lies outside of said target range, determining in said processor said corrective action for the patient when said future blood glucose value G(t_j) lies outside of said target range, and recommending said corrective action on said display.

34. The method of claim 33, wherein said corrective action comprises an administration of a supplemental insulin dose, and said method further comprises the steps of storing in said memory a target blood glucose value of the patient and determining in said processor said supplemental insulin dose in dependence upon said insulin sensitivity value and a difference between said future blood glucose value G(t_j) and said target blood glucose value.

35. The method of claim 33, wherein said corrective action comprises a consumption of a number of grams of carbohydrates, and said method further comprises the steps of storing in said memory a target blood glucose value of the patient and determining in said processor said number of grams in dependence upon a difference between said future blood glucose value G(t_j) and said target blood glucose value.

36. The method of claim 29, further comprising the steps of storing in said memory a hypoglycemic value indicative of a hypoglycemic threshold of the patient, determining in said processor if said future blood glucose value G(t_j) lies below said hypoglycemic value, and audibly alerting the patient when said future blood glucose value G(t_j) lies below said hypoglycemic value.

37. The method of claim 29, wherein said input means comprises a blood glucose meter and the step of entering said blood glucose value G(t_d) comprises the steps of measuring a blood sample of the patient with said glucose meter and producing said blood glucose value G(t_d) from a measurement of said blood sample.

38. The method of claim 29, wherein said insulin dose has an insulin type, said method further comprises the step of entering said insulin type in said processor, and said insulin action value F_k (t_d) is determined in dependence upon said insulin type.

39. The method of claim 38, wherein said insulin type is selected from the group consisting of regular insulin and lispro insulin.

40. A method for assisting a patient having diabetes mellitus in controlling blood glucose, said method comprising the following steps:

a) providing the patient with an apparatus for determining a future blood glucose value G(t_j) representative of an expected blood glucose concentration of the patient at time t_j, wherein said apparatus comprises a memory, an input means for entering a blood glucose value G(t_d) representative of a blood glucose concentration of the patient at time t_d and for entering an insulin dose value representative of an insulin dose administered to the patient prior to time t_d, a display, and a processor connected to said memory, said input means, and said display;

b) storing in said memory an insulin sensitivity value representative of an insulin sensitivity of the patient, information for determining an insulin action value F_k (t_d) representative of a fraction of insulin action remaining at time t_d from said insulin dose, and maximum and minimum values defining a target blood glucose range of the patient;

c) entering in said processor said insulin dose value and said blood glucose value G(t_d);

d) determining in said processor said insulin action value F_k (t_d);

e) determining in said processor said future blood glucose value G(t_j) in dependence upon said blood glucose value G(t_d), said insulin dose value, said insulin sensitivity value, and said insulin action value F_k (t_d);

f) determining in said processor if said future blood glucose value G(t_j) lies outside of said target range;

g) determining in said processor a corrective action for the patient when said future blood glucose value G(t_j) lies outside of said target range; and

h) recommending said corrective action to the patient on said display.

41. The method of claim 40, further comprising the step of determining in said processor an insulin action value F_k (t_j) representative of a fraction of insulin action remaining at time t_j from said insulin dose, and wherein said future blood glucose value G(t_j) is determined in further dependence upon said insulin action value F_k (t_j).

42. The method of claim 40, wherein the step of determining said future blood glucose value G(t_j) is preceded by the steps of determining in said processor an ultimate time point at which said insulin dose will have no insulin action remaining and setting time t_j equal to said ultimate time point.

43. The method of claim 40, further comprising the steps of determining in said processor a plurality of future blood glucose values representative of a corresponding plurality of expected blood glucose concentrations of the patient and displaying said future blood glucose values in graphical form on said display.

44. The method of claim 40, wherein said corrective action comprises an administration of a supplemental insulin dose, and said method further comprises the steps of storing in said memory a target blood glucose value of the patient and determining in said processor said supplemental insulin dose in dependence upon said insulin sensitivity value and a difference between said future blood glucose value G(t_j) and said target blood glucose value.

45. The method of claim 40, wherein said corrective action comprises a consumption of a number of grams of carbohydrates, and said method further comprises the steps of storing in said memory a target blood glucose value of the patient and determining in said processor said number of grams in dependence upon a difference between said future blood glucose value G(t_j) and said target blood glucose value.

46. The method of claim 40, further comprising the steps of storing in said memory a hypoglycemic value indicative of a hypoglycemic threshold of the patient, determining in said processor if said future blood glucose value G(t_j) lies below said hypoglycemic value, and audibly alerting the patient when said future blood glucose value G(t_j) lies below said hypoglycemic value.

47. The method of claim 40, wherein said input means comprises a blood glucose meter and the step of entering said blood glucose value G(t_d) comprises the steps of measuring a blood sample of the patient with said glucose meter and producing said blood glucose value G(t_d) from a measurement of said blood sample.

48. The method of claim 40, wherein said insulin dose has an insulin type, said method further comprises the steps of entering said insulin type in said processor, and wherein said insulin action value F_k (t_d) is determined in dependence upon said insulin type.

49. The method of claim 48, wherein said insulin type is selected from the group consisting of regular insulin and lispro insulin.

50. The method of claim 40, further comprising the steps of entering in said processor a plurality of blood glucose values and a plurality of insulin dose values, determining from said blood glucose values and said insulin dose values an adjusted insulin sensitivity value, and storing said adjusted insulin sensitivity value in said memory.