SYSTEM FOR PERFORMING DIABETES SELF-CARE

• US 20080103377A1
• Filed: 10/24/2007
• Published: 05/01/2008
• Est. Priority Date: 04/26/1994
• Status: Active Grant

• Current Assignee: Stephen Brown
• Original Assignee: Stephen Brown
• Inventors: Brown, Stephen
• Granted Patent: US 7,901,625 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• 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: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• 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: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/90 Blood pressure recorder

Abstract

A system for performing diabetes self-care using at least two devices in communication with one another, comprising (a) a blood glucose monitoring device, including (i) a receptacle for receiving an amount of blood sufficient for the monitoring device to run a blood glucose test sequence, (ii) processing circuitry for controlling a blood glucose test sequence and computing a blood glucose level, (iii) a power source for powering the blood glucose monitoring device, and (b) a portable microprocessor-based device directly coupled with the blood glucose monitoring device for receiving blood glucose test results directly from the blood glucose monitoring device, including (i) a microprocessor that runs according to program instructions stored in a memory for performing analysis of the blood glucose test results, and detecting a need for a change in insulin dosage, (ii) a memory for (A) recording the recorded blood glucose test results, (B) containing programming for establishing a data protocol that allows digital data signal processing, (C) performing analysis of blood glucose, and (D) storing time and date tagged glucose test results and calibration information.

Claims

1. A system for performing diabetes self-care using at least two devices in communication with one another, comprising:

(a) a blood glucose monitoring device, including;

(i) a receptacle for receiving an amount of blood sufficient for the monitoring device to run a blood glucose test sequence;

(ii) processing circuitry for controlling a blood glucose test sequence and computing a blood glucose level,

(iii) a power source for powering the blood glucose monitoring device, and

(b) a portable microprocessor-based device directly coupled with the blood glucose monitoring device for receiving blood glucose test results directly from said blood glucose monitoring device, including;

(i) a microprocessor that runs according to program instructions stored in a memory for performing analysis of the blood glucose test results, and detecting a need for a change in insulin dosage,

(ii) a memory for (A) recording the recorded blood glucose test results, (B) containing programming for establishing a data protocol that allows digital data signal processing, (C) performing analysis of blood glucose, and (D) storing time and date tagged glucose test results and calibration information.

2. The system of claim 1, wherein said receptacle is for receiving a test strip upon which a drop of blood is applied.

3. The system of claim 1, wherein said portable microprocessor-based device includes a palm-top computer.

4. The system of claim 2, wherein the program of instructions include instructions for processing insulin dosage data.

5. The system of claim 2, the program of instructions further including instructions for monitoring whether said test strip is properly inserted into the blood glucose monitoring device.

6. The system of claim 1, wherein the program of instructions further includes instructions for performing a test sequence to confirm that the system is operating properly.

7. The system of claim 1, wherein said program of instructions further includes instructions for running a calibration procedure by reading a code strip inserted into the monitor.

8. A system for performing diabetes self-care using at least two devices in communication with one another, comprising:

(a) a blood glucose monitoring device, including;

(i) a receptacle for receiving an amount of blood sufficient for the monitoring device to run a blood glucose test sequence;

(ii) processing circuitry for controlling a blood glucose test sequence and computing a blood glucose level,

(iii) a power source for powering the blood glucose monitoring device, and

(b) a portable microprocessor-based device directly coupled with the blood glucose monitoring device for receiving blood glucose test results directly from said blood glucose monitoring device, including;

(i) a microprocessor that runs according to program instructions stored in a memory for performing analysis of the blood glucose test results, and monitoring food intake,

(ii) a memory for (A) recording the recorded blood glucose test results, (B) containing programming for establishing a data protocol that allows digital data signal processing, (C) performing analysis of blood glucose, and (D) storing insulin dosage data and calibration information.

9. The system of claim 8, wherein said receptacle is for receiving a test strip upon which a drop of blood is applied.

10. The system of claim 9, wherein the program of instructions includes instructions for monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of the test strip.

11. The system of claim 9, wherein the program of instructions further includes instructions for monitoring whether said test strip is properly inserted into the monitor.

12. The system of claim 8, wherein the program of instructions further includes instructions for performing a test sequence to confirm that the system is operating properly.

13. The system of claim 8, wherein the portable microprocessor-based device comprises an interactive interface, including:

(i) a display screen; and

(ii) a plurality of switches including a pair of spaced-apart push button switches and another pair of switches.

14. The system of claim 8, wherein said food intake is monitored quantitatively in terms of “

Bread Exchange”

units or other suitable terms.

15. The system of claim 14, wherein said food intake is monitored by providing a food intake menu item and using a submenu display, and providing for the selecting of one or more food items using the switches of handheld microprocessor.

16. The system of claim 8, wherein food intake data is stored along with time and date tagged blood glucose test results.

17. The system of claim 8, wherein the program instructions are further for monitoring exercise.

18. A system for performing diabetes self-care using at least two devices in communication with one another, comprising:

(a) a blood glucose monitoring device, including;

(i) a receptacle for receiving an amount of blood sufficient for the monitoring device to run a blood glucose test sequence;

(ii) processing circuitry for controlling a blood glucose test sequence and computing a blood glucose level,

(iii) a power source for powering the blood glucose monitoring device, and

(b) a portable microprocessor-based device directly coupled with the blood glucose monitoring device for receiving blood glucose test results directly from said blood glucose monitoring device, including;

(i) a microprocessor that runs according to program instructions stored in a memory for performing analysis of the blood glucose test results, and indicating trend information of a system user,

(ii) a memory for (A) recording the recorded blood glucose test results, (B) containing programming for establishing a data protocol that allows digital data signal processing, (C) performing analysis of blood glucose, and (D) storing calibration information.

19. The system of claim 18, wherein said receptacle is for receiving a test strip upon which a drop of blood is applied.

20. The system of claim 19, wherein the program of instructions includes instructions for monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of a test strip.

21. The system of claim 19, wherein the program of instructions further includes instructions for monitoring whether said test strip is properly inserted into the monitor.

22. The system of claim 18, wherein the program of instructions further includes instructions for performing a test sequence to confirm that the system is operating properly.

23. The system of claim 18, wherein trend information is displayed in graphic format.

24. The system of claim 18, wherein trend information is displayed in alphanumeric format.

25. The system of claim 18, wherein the system is configured for displaying daily or weekly trend information, or both.

26. A blood glucose monitoring system, comprising:

a. a blood glucose monitor for monitoring a blood glucose level and for producing digitally encoded blood glucose level signals representative of said blood glucose level;

b. a programmable microprocessor-based portable unit;

c. a digital data storage medium, the medium

A. readable by said programmable micro-processor based unit; and

B. tangibly embodying therein a program of instructions executable by said programmable microprocessor-based portable unit, said program of instructions including instructions for signal processing in response to signals generated based upon said digitally encoded blood glucose signals and further for signal processing of insulin dosage data and detecting a need for a change in insulin dosage;

d. a signal interface connectable in signal communication with said programmable microprocessor-based portable unit and said blood glucose monitor for coupling said digitally encoded blood glucose signals supplied by said blood glucose monitor to said programmable microprocessor-based portable unit.

27. The system of claim 26, wherein said microprocessor-based portable unit comprises a palm-top computer.

28. The system of claim 26, the blood glucose monitor for receiving a test strip including a reagent impregnated portion having blood applied thereto.

29. The system of claim 28, the program of instructions including instructions for monitoring whether a sufficient amount of blood has been applied to said reagent impregnated portion of the test strip.

30. The system of claim 29, the program of instructions further including instructions for monitoring whether said test strip is properly inserted into the monitor.

31. The system of claim 28, the program of instructions further including instructions for monitoring whether said test strip is properly inserted into the monitor.

32. The system of claim 28, the program of instructions further including instructions for performing a test sequence to confirm that the system is operating properly.

33. The system of claim 26, at least a component of said signal interface being connectable with a second device, other than said blood glucose monitor, in signal communication with said programmable microprocessor-based portable unit for coupling further signals supplied by said second device to said programmable microprocessor-based portable unit.

34. The system of claim 26, wherein said programmable microprocessor-based portable unit comprises an interactive interface, including:

1) a display for displaying information;

     2) a plurality of switches operable for interactively controlling said programmable microprocessor-based portable unit and for manipulating said information displayed on said display; and

     3) circuit means coupled to said plurality of switches for generating signals in response to said operation of said switches.

35. The system of claim 34, wherein said programmable microprocessor-based portable unit is a palm-top computer.

36. The system of claim 34, the blood glucose monitor for receiving a test strip including a reagent impregnated portion having blood applied thereto.

37. The system of claim 36, the program of instructions including instructions for monitoring whether a sufficient amount of blood has been applied to said reagent impregnated portion of the test strip.

38. The system of claim 37, the program of instructions further including instructions for monitoring whether said test strip is properly inserted into the monitor.

39. The system of claim 36, the program of instructions further including instructions for monitoring whether said test strip is properly inserted into the monitor.

40. The system of claim 36, the program of instructions further including instructions for performing a test sequence to confirm that the system is operating properly.

41. The system of claim 34, at least a component of said signal interface being connectable with a second device, other than said blood glucose monitor, in signal communication with said programmable microprocessor-based portable unit for coupling further signals supplied by said second device to said programmable microprocessor-based portable unit.

42. A system of interconnected devices for performing diabetes self-care, comprising:

(a) a portable blood glucose monitor, including;

(i) a receptacle for receiving an amount of blood sufficient for the monitor to run a blood glucose test sequence;

(ii) processing circuitry for controlling a blood glucose test sequence and computing a blood glucose level,

(iii) a first data port for signal coupling to another electronic device; and

(b) a separately-portable microprocessor-based device for communicating diabetes care data with the portable blood glucose monitor, including;

(A) a second data port for signal coupling with the first data port and receiving blood glucose test results from said blood glucose monitor,

(B) a microprocessor that runs according to program instructions stored in a memory for performing analysis of the blood glucose test results, signal processing of insulin dosage data, and detecting a need for a change in insulin dosage,

(C) a memory for recording the recorded blood glucose test results and insulin dosage information therein, and for containing programming for establishing a data protocol that allows digital data signal processing, and for performing analysis of blood glucose.

43. The system of interconnected devices of claim 42, wherein the program of instructions includes instructions for monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of a test strip.

44. The system of interconnected devices of claim 42, wherein the blood glucose monitor is configured to receive a test strip including a reagent impregnated portion having blood applied thereto.

45. The system of interconnected devices of claim 44, wherein the program of instructions includes instructions for monitoring whether a sufficient amount of blood has been applied to the reagent impregnated portion of the test strip.

46. The system of interconnected devices of claim 44, wherein the program of instructions further includes instructions for monitoring whether the test strip is properly inserted into the monitor.

47. The system of interconnected devices of claim 42, wherein the program of instructions further includes instructions for performing a test sequence to confirm that the system is operating properly.

48. The system of claim 42, further comprising a second device, other than said blood glucose monitor, comprising a third data port, said second data port of said portable microprocessor-based device further for signal coupling with the second data port and receiving a signal from said second device.

49. A system of integrated electronic devices, including one or more processor-readable storage devices having program code embodied thereon for programming one or more processors associated with one or more of the devices to perform a method comprising:

(a) powering a portable blood glucose monitor;

(b) receiving an amount of blood sufficient for the portable blood glucose monitor to run a blood glucose test sequence;

(c) controlling the blood glucose test sequence;

(d) computing a blood glucose level;

(e) transmitting blood glucose test results from said blood glucose monitor directly to a separately portable microprocessor-based device;

(f) performing analysis of the blood glucose test results,

(g) signal processing of insulin dosage data;

(h) detecting a need for a change in insulin dosage; and

(i) recording data and time stamped blood glucose test results, calibration information, and insulin dosage information in a memory of the system; and

(j) establishing a data protocol that allows digital data signal processing and said analysis of blood glucose test results.

50. The system of claim 49, the receiving including (i) inserting a test strip into a receptacle of the blood glucose monitor and (ii) applying a drop of blood to the strip.

51. The system of claim 49, wherein the method further comprises displaying the blood glucose level on a display.

52. The system of claim 49, the controlling comprising monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of a test strip.

53. The system of claim 49, the controlling comprising monitoring whether a test strip is properly inserted into the monitor.

54. The system of claim 49, the controlling comprising performing a test sequence to confirm that the system is operating properly.

55. The system of claim 49, wherein the method further comprises running a calibration procedure by reading a code strip inserted into the monitor.

57. The system of claim 49, the receiving including (i) inserting a test strip into a receptacle of the blood glucose monitor and (ii) applying a drop of blood to the strip.

58. The system of claim 49, wherein the method further comprises displaying the blood glucose level on a display.

59. The system of claim 49, wherein said portable, microprocessor-based electronic device comprises a palm-top computer.

60. The system of claim 49, the receiving comprising receiving a test strip including a reagent impregnated portion having blood applied thereto.

61. The system of claim 49, the controlling comprising monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of a test strip.

62. The system of claim 49, the controlling comprising performing a test sequence to confirm that the system is operating properly.

63. The system of claim 49, wherein the method further comprises monitoring food intake quantitatively in terms of “

Bread Exchange”

units or other suitable terms.

64. The system of claim 49, wherein the method further comprises storing food intake data along with time and date tagged blood glucose test results.

65. The system of claim 49, wherein the method further comprises monitoring exercise.

56. A system of integrated electronic devices, including one or more processor-readable storage devices having program code embodied thereon for programming one or more processors associated with one or more of the devices to perform a method comprising:

(a) powering a portable blood glucose monitor;

(b) receiving an amount of blood sufficient for the portable blood glucose monitor to run a blood glucose test sequence;

(c) controlling the blood glucose test sequence;

(d) computing a blood glucose level;

(e) coupling the blood glucose monitor directly to a separately-portable microprocessor-based device;

(f) transmitting blood glucose test results from said blood glucose monitor directly to said portable microprocessor-based device;

(g) running program instructions stored in a memory of the separately-portable microprocessor-based device for performing analysis of the blood glucose test results, signal processing of insulin dosage data, and detecting a need for a change in insulin dosage; and

(h) recording blood glucose test results and insulin dosage information in a memory of the portable microprocessor-based device, said memory also containing programming for establishing a data protocol that allows digital data signal processing, and for performing said analysis of blood glucose.

66. A system of integrated electronic devices, including one or more processor-readable storage devices having program code embodied thereon for programming one or more processors associated with one or more of the devices to perform a method comprising:

(a) powering a portable blood glucose monitor;

(b) receiving an amount of blood sufficient for the portable blood glucose monitor to run a blood glucose test sequence;

(c) controlling the blood glucose test sequence;

(d) computing a blood glucose level;

(e) transmitting blood glucose test results from said blood glucose monitor directly to a separate, portable microprocessor-based device;

(f) running program instructions stored in a memory of the portable microprocessor-based device for performing analysis of the blood glucose test results, signal processing of insulin dosage data, and detecting a need for a change in insulin dosage;

(g) recording blood glucose test results and insulin dosage information in a memory of the portable microprocessor-based device, said memory also containing programming for establishing a data protocol that allows digital data signal processing, and for performing said analysis of blood glucose; and

(h) indicating trend information of a system user.

67. The system of claim 66, the receiving including (i) inserting a test strip into a receptacle of the blood glucose monitor, and (ii) applying a drop of blood to the strip.

68. The system of claim 66, wherein the method further comprises displaying the blood glucose level on a display.

69. The system of claim 66, the receiving comprising receiving a test strip including a reagent impregnated portion having blood applied thereto.

70. The system of claim 69, the controlling comprising monitoring whether a sufficient amount of blood has been applied to a reagent impregnated portion of a test strip.

71. The system of claim 66, wherein the method further comprises displaying trend information in graphic format.

72. The system of claim 66, wherein the method further comprises displaying trend information in alphanumeric format.

73. The system of claim 66, wherein the method further comprises displaying daily or weekly trend information, or both.