Blood glucose tracking apparatus and methods

• US 20030176183A1
• Filed: 03/29/2002
• Published: 09/18/2003
• Est. Priority Date: 04/02/2001
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bacho, Henrik, Lipman, Kelley, Lortz, Mark, Colman, Fredric C., Drucker, Steven, Liamos, Charles T., Jiang, Feng
• Granted Patent: US 7,041,468 B2
• Time in Patent Office: Days
• US Class Current: 455/414.1
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G01N 33/48778 Containers specially adapted therefor, e.g. for dry storage
• 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: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A measurement module for glucose testing includes a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held computer. Electronics determine the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and the body fluid is placed on a test strip, and communicate the glucose amount to the hand-held computer via the connector portion.

Claims

1. A measurement module for glucose testing comprising:

(a) a glucose testing measurement module housing;

(b) a test strip receptacle formed in the housing;

(c) a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held processing device;

(d) an electrical isolation barrier for substantially electrically isolating the measurement module from the processing device when coupled thereto.

2. The measurement module of claim 1, further comprising:

electronics for determining the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and body fluid is placed on a test strip,

I/O isolation circuitry for communicating the glucose amount to the hand-held processing device via the connector portion; and

power transfer circuitry for transferring power across the isolation barrier.

3. A measurement module for glucose testing comprising:

(a) a test strip receptacle in a glucose measurement module system;

(b) a connector portion formed in the module shaped to permit connection of the module to a hand-held computer by inserting the connector portion of the glucose measurement module into a receptacle defined within the hand-held computer; and

(c) a housing including a connector portion end and a test strip receptacle end which is substantially narrower than the connector portion end for facilitating off-finger/alternate site testing.

4. The module of claim 3, further comprising electronics for determining the amount of glucose present in a glucose-containing sample, when a test strip is positioned in the receptacle and the sample is placed on the test strip, and for communicating the glucose amount to the hand-held computer via the connector portion.

5. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system;

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and glucose-containing sample is applied to the test sensor; and

a measurement module housing including a connector portion end and a test strip receptacle end which is substantially narrower than the connector portion end for facilitating off-finger/alternate site testing.

6. The glucose monitoring apparatus of claim 5, further comprising an electrical isolation barrier disposed between the measurement module and the processing device for substantially electrically isolating the measurement module from the processing device.

7. The apparatus of claim 5, wherein the processing device comprises a hand-held device selected from the group consisting of a device including a PDA, a device including a mobile phone, and a device including a combination PDA/mobile phone.

8. The apparatus of claim 5, wherein data is transferred between the processing device and the measurement module over a opto-isolated serial interface.

9. The apparatus of claim 8, wherein data is converted by a serial-to-parallel converter after transmitting the serial interface from the measurement module to the wireless processing device.

10. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement systems;

a hand-held processing device electrically and mechanically coupled with and separable from the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and a glucose-containing sample is applied to the test sensor; and

an electrical isolation barrier for substantially electrically isolating the measurement module from the processing device when coupled thereto.

11. The glucose monitoring apparatus of claim 10, further comprising power transfer circuitry for transferring power across the isolation barrier.

12. The apparatus of claim 10, wherein the processing device includes a device selected from the group consisting of a device including a PDA, a device including mobile phone and a device including a combination PDA/mobile phone device.

13. The apparatus of claim 10, wherein data is transferred between the processing device and the measurement module over an opto-isolated serial interface.

14. The apparatus of claim 13, wherein data is converted by a serial-to-parallel converter after transmitting the serial interface from the measurement module to the wireless processing device.

15. A glucose monitoring apparatus, comprising:

a measurement module configured to couple with a test sensor; and

a hand-held processing device configured to receive data transmission from the measurement module, the measurement module and processing device forming a detachably integrated hand-held unit for performing and analyzing a glucose measurement after the test sensor is coupled with the measurement module and a glucose-containing sample is applied to the test sensor; and

an electrical isolation barrier for substantially electrically isolating the measurement module from the processing device when coupled thereto,

wherein the monitoring apparatus comprises a single display at the processing device.

16. The apparatus of claim 15, wherein the processing device is electrically and mechanically coupled with and separable from the measurement module to form an integrated hand-held unit.

17. The apparatus of claim 15, wherein the processing device is electrically and mechanically coupled with the measurement module to form an integrated hand-held unit.

18. The glucose monitoring apparatus of claim 15, further comprising power transfer circuitry for transferring power across the isolation barrier.

19. The apparatus of claim 15, wherein the processing device includes a device selected from the group consisting of a device including a PDA, a device including mobile phone and a device including a combination PDA/mobile phone device.

20. A glucose monitoring apparatus, comprising:

a measurement module not having a display for displaying results of glucose measurements, the module including a test strip receptacle in a glucose measurement system;

a hand-held processing device configured to receive data transmission from the measurement module, the measurement module and the processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is coupled with the measurement module and a glucose-containing sample is applied to the test sensor, the processing device comprising a display for displaying said results of said glucose measurements; and

a measurement module housing including a connector portion end and a test strip receptacle end which is substantially narrower than the connector portion end for facilitating off-finger/alternate site testing.

21. The apparatus of claim 20, wherein the processing device is electrically and mechanically coupled with and separable from the measurement module to form an integrated hand-held unit.

22. The apparatus of claim 20, wherein the processing device is electrically and mechanically coupled with the measurement module to form an integrated hand-held unit.

23. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device configured to receive a data transmission from the measurement module, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement, the processing device being configured for automatically receiving said data transmission after the test sensor is coupled with the measurement module and a glucose-containing sample is applied to the test sensor;

an electrical isolation barrier for substantially electrically isolating the measurement module from the processing device when coupled thereto; and

a measurement module housing including a connector portion end and a test strip receptacle end which is substantially narrower than the connector portion end for facilitating off-finger/alternate site testing.

24. The apparatus of claim 23, wherein the processing device is electrically and mechanically coupled with and separable from the measurement module to form an integrated hand-held unit.

25. The apparatus of claim 23, wherein the processing device is electrically and mechanically coupled with the measurement module to form an integrated hand-held unit.

26. The apparatus of claim 23, wherein the monitoring apparatus comprises a single display at the processing device.

27. The apparatus of claim 23, wherein the measurement module is faceless and the processing device comprises a display.

28. A method of performing glucose measurement using a measurement module and a processing device, comprising the steps of:

coupling the processing device electrically and mechanically with the measurement module to form a detachably integrated, hand-held unit for electrochemically performing and analyzing a glucose measurement after a side-filled test sensor is inserted into the measurement module;

coupling the test sensor with the measurement module;

applying a glucose-containing sample to the side-filled test sensor by contacting a side of the test sensor to the sample; and

reading a glucose level from a display on the integrated hand-held unit.

29. A method of performing a glucose measurement using a measurement module and a hand-held processing device, comprising the steps of:

coupling the processing device with the measurement module to receive a data transmission from the measurement module such that the measurement module and the processing device form a detachably integrated, hand-held unit including a single display on the processing device for performing and analyzing a glucose measurement after a test sensor is inserted into the measurement module;

coupling the test sensor with the measurement module;

applying a glucose-containing sample to the test sensor;

coulometrically measuring an analyte level in the sample; and

reading a glucose level from the display on the processing device.

30. A method of performing a glucose measurement using a measurement module and a hand-held processing device, comprising the steps of:

inserting the measurement module into a receptacle defined within the processing device for the processing device to receive a data transmission from the measurement module, such that the measurement module and the processing device form a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after a side-filled test sensor is inserted into the measurement module;

coupling the side-filled test sensor with the measurement module;

applying a glucose-containing sample to the side-filled test sensor by contacting a side of the test sensor with the sample; and

reading a glucose level from a display on the processing device.

31. A method of performing a glucose measurement using a measurement module and a hand-held processing device, comprising the steps of:

coupling the processing device with the measurement module to automatically receive a data transmission from the measurement module after a test sensor is inserted into the measurement module, such that the measurement module and the processing device form a detachably integrated, hand-held unit for performing and analyzing a glucose measurement;

coupling the test sensor with the measurement module;

applying a glucose-containing sample to the test sensor;

coulometrically measuring an analyte level in the sample; and

reading a glucose level from a display.

32. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted and a glucose-containing sample is applied to the test sensor, and

wherein the measurement module is further geometrically configured to enable off-finger/alternate site application of the glucose-containing sample to the test strip.

33. The apparatus of claim 32, wherein a width of the measurement module tapers away from the processing device.

34. The apparatus of claim 33, wherein the measurement module includes a trapezoidal configuration.

35. The apparatus of claim 32, wherein the measurement module includes a processing device coupling end and a test sensor insertion end, the processing device end having at least a width for coupling with the processing device and the test sensor insertion end having a width smaller than the processing device coupling end.

36. The apparatus of claim 32, wherein a shape of the measurement module includes a peak which couples with a test sensor, the peak emanating from a base which couples to a coupling end of the processing device, the peak having a width of less than half of a width of the coupling end of the processing device.

37. The apparatus of claim 32, wherein the processing device comprises a device selected from the group consisting of a device including a PDA, a device including a mobile phone, and a device including a PDA/mobile phone combination.

38. A glucose monitoring apparatus, comprising:

a measurement module comprising an electrochemical side-fill glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted and a glucose-containing sample is applied to the test sensor, and

wherein portions of the measurement module exposed to a user include no sharp corners.

39. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted and a glucose-containing sample is applied to the test sensor, and

wherein portions of the measurement module exposed to a user are rounded in at least two dimensions for providing smooth off-finger/alternate site points of contact with the skin of a user.

40. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted and a glucose-containing sample is applied to the test sensor, and

wherein the measurement module includes a telescoping trapezoidal profile for permitting placement of a test strip inserted within said module at an off-finger/alternate site location of a person being tested.

41. A glucose monitoring apparatus, comprising:

a measurement module comprising a glucose test sensor receptacle in a glucose measurement system; and

a hand-held processing device electrically and mechanically coupled with the measurement module to form an integrated, hand-held unit for performing and analyzing a glucose measurement after a test sensor is inserted and a glucose-containing sample is applied to the test sensor, and

wherein the measurement module comprises an encapsulation port for said test sensor and a PC board including an opto-isolation component, and wherein the measurement module extends less than two inches in length and less than one half inch in thickness beyond dimensions of the processing device.

42. The apparatus of claim 41, wherein said measurement module weighs less than 10 ounces.

43. A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming an detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and a glucose-containing sample is applied to the test sensor, the processing device configured to Synchronize with a PC, the software program including instructions for a processor to perform the steps of:

creating a replica database on the PC of the glucose data stored in a device database on the processing device; and

synchronizing the glucose data to a PC database program, and wherein the synchronizing step includes;

reading the glucose data stored in the device database on the processing device;

matching the data to corresponding data in the replica database;

format converting the data; and

writing the data to the replica database.

44. The software program of claim 43, wherein the matching step includes the steps of:

assigning unique ID numbers in records in the device and replica databases; and

creating mapping tables for mapping the glucose data from the device database to the replica database.

45. The software program of claim 44, wherein the glucose data is stored in the device database in PDB format and the glucose data is written to the replica database in MDB format.

46. A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test strip is inserted and a glucose-containing sample is applied to the test strip, the processing device configured to Synchronize with a PC, the software program including instructions for a processor to perform the steps of:

measuring glucose data from the test strip having the glucose-containing sample applied thereto;

automatically downloading the glucose data from the measurement module to the processing device across an electrical isolation barrier over an opto-isolated serial interface therethrough; and

downloading the glucose data to a personal computer.

47. The software program of claim 46, wherein the step of downloading to a personal computer comprises the steps of:

creating a replica database on the PC of the glucose data stored in a device database on the processing device; and

synchronizing the blood glucose data to a PC database program, and wherein the synchronizing step includes;

reading the glucose data stored in the device database on the processing device;

matching the data to corresponding data in the replica database;

format converting the data; and

writing the data to the replica database.

48. A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and a glucose-containing sample is applied to the test sensor, the hand-held processing device configured to Synchronize with a PC, the method comprising the steps of:

creating a replica database on the PC of the glucose data stored in a device database on the processing device; and

synchronizing the glucose data to a PC database program, and

wherein the synchronizing step includes;

reading the glucose data stored in the device database on the processing device;

matching the data to corresponding data in the replica database;

format converting the data; and

writing the data to the replica database.

49. The method of claim 48, wherein the matching step includes the steps of:

assigning unique ID numbers in records in the device and replica databases; and

creating mapping tables for mapping the blood glucose data from the device database to the replica database.

50. The method of claim 49, wherein the blood glucose data is stored in the device database in PDB format and the glucose data is written to the replica database in MDB format.

51. A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test strip is inserted and a glucose-containing sample is applied to the test strip, the processing device configured to Synchronize with a PC, the method comprising the steps of:

measuring glucose data from the test strip having the glucose-containing sample applied thereto;

automatically downloading the glucose data from the measurement module to the processing device across an electrical isolation barrier over an opto-isolated serial interface therethrough; and

downloading the glucose data to a personal computer.

52. The method of claim 51, wherein the step of downloading to a personal computer comprises the steps of:

creating a replica database on the PC of the glucose data stored in a device database on the processing device; and

synchronizing the glucose data to a PC database program, and wherein the synchronizing step includes;

reading the glucose data stored in the device database on the processing device;

matching the data to corresponding data in the replica database;

format converting the data; and

writing the data to the replica database.

53. A software program for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and a glucose-containing sample is applied to the test sensor, the software program including instructions for a processor to perform the steps of:

measuring glucose data;

providing a sensory output of a glucose level corresponding to the data; and

automatically entering the data into a database accessible by a diabetes management software program, and

wherein the database and program each reside on the hand-held processing device.

54. The software program of claim 53, the software program providing instructions for the processor to perform the further step of receiving manual entries and integrating the manual entries with the automatic entries in the database.

55. The software program of claim 53, the software program providing instructions for the processor to perform the further step of generating a graph from the automatically entered data.

56. The software program of claim 55, wherein the generating step is performed according to previously entered data filtering instructions.

57. A method for analyzing glucose data measured with a glucose monitoring apparatus which includes a measurement module comprising a glucose test sensor receptacle in a glucose measurement system and a hand-held processing device, the measurement module and processing device forming a detachably integrated, hand-held unit for performing and analyzing a glucose measurement after the test sensor is inserted and a glucose-containing sample is applied to the test sensor, the method comprising the steps of:

measuring glucose data;

providing a sensory output of a glucose level corresponding to the data; and

automatically entering the data into a database accessible by a diabetes management software program, and

wherein the database and program each reside on the processing device.

58. The method of claim 57, further comprising the step of receiving manual entries and integrating the manual entries with the automatic entries in the database.

59. The method of claim 57, further comprising the step of generating a graph from the automatically entered data.

60. The method of claim 59, wherein the generating step is performed according to previously entered data filtering instructions.