Collection device with selective display of test results, method and computer program product thereof

• US 8,849,458 B2
• Filed: 06/18/2010
• Issued: 09/30/2014
• Est. Priority Date: 12/23/2008
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Weinert, Stefan, Essenpreis, Matthias, Surridge, Nigel, Laan, Remmert
• Primary Examiner(s): LEVKOVICH, NATALIA A
• Application Number:
  US12/818,875
• Publication Number:
  US 20110152656A1
• Time in Patent Office: 1,565 Days
• Field of Search: 702/19, 700/266
• US Class Current: 700/266
• 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: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

Claims

1. A portable, handheld collection device for the management of diabetes comprising:

a display;

a user interface;

a measurement engine to measure a biomarker value;

a non-transitory memory containing a data file and a structured collection procedure, the structured collection procedure having parameters defining;

a schedule of collection events having one or more collection events which provide a request for a measurement of the biomarker value under defined conditions which are related to the biomarker value as contextual information associated with the biomarker value, and

a view flag associated with each of the one or more collection events, the view flag having a viewable value and a non-viewable value;

a processor connected to the display, the user interface, the measurement engine, and the memory; and

a power supply for powering the device;

wherein the processor is programmed to;

read the structured collection procedure from the memory,

permit an authorized user to select at least one criterion under which a data record of the data file for the structured collection procedure is designated as viewable,

run the structured collection procedure,

send automatically the request of each of the one or more collection events according to the structured collection procedure,

store automatically biomarker value(s) measured by the measurement engine or information entered via the user interface in an associated data record of the data file in the memory in response to sent request,

store and link automatically contextual information associated with each biomarker value or the information entered in the associated data record of the data file to form contextualized biomarker data,

designate automatically the associated data record in the memory containing the contextualized biomarker data as viewable if the view flag associated with the sent request in the structured collection procedure has the viewable value or the at least one criterion is met and as not viewable if the view flag has the non-viewable value or the at least one criterion is not met, and

provide to the display only biomarker values associated to data records containing the contextualized biomarker data if the data records are designated in the memory as viewable.

2. The portable collection device according to claim 1, wherein the structured collection procedure further comprises entry criterion defining one or more conditions which when satisfied start the schedule of collection events, and exit criterion defining one or more conditions which when satisfied end the structured collection procedure, and wherein the software having instructions that when executed by the processor further causes the processor to run automatically the structured collection procedure when the entry criterion is satisfied, and end automatically the structured collection procedure when the exit criterion is satisfied.

3. The portable collection device according to claim 1, wherein the at least one viewable criterion is at least one of a threshold value for the biomarker value, value(s) above and/or below a range, or values that fall within a range.

4. The portable collection device according to claim 1, wherein the at least one viewable criterion is selected from the contextualized data of the biomarker value.

5. The portable collection device according to claim 1, wherein the portable collection device is a blood glucose meter or a continuous glucose monitor.

6. The portable collection device according to claim 1, wherein the portable collection device further comprises a communications module, wherein the structured collection procedure is programmed externally and the processor receives the structured collection procedure from an external device via the communications module.

7. The portable collection device according to claim 6, wherein the structured collection procedure is received via I/R communications between the processor and the external device.

8. The portable collection device according to claim 6, wherein the structured collection procedure is received via network based communications between the processor and the external device.

9. The portable collection device according to claim 8, wherein the network based communications is one of wireless and wired communications.

10. The portable collection device according to claim 1, wherein the portable collection device further comprises an interface connector, and wherein the processor receives the structured collection procedure via a removable storage device connected to the interface connector, the removable storage device containing the structured collection procedure.

11. The portable collection device according to claim 1, wherein the processor downloads the structured collection procedure from an external device.

12. The portable collection device according to claim 1, wherein the structured collection procedure has parameters defining that the schedule of collection events spans multiple days.

13. The portable collection device according to claim 1, wherein the portable collection device contains in memory various structured collection procedures each defining a different structured collection procedure, and wherein one of the various structured collection procedures is selected through the user interface for execution by the processor.

14. The portable collection device according to claim 1, wherein the device contains in memory various structured collection procedures each defining a different structured collection procedure, and wherein one of the various structured collection procedures is selected remotely by an authorized device for execution by the processor.

15. The portable collection device according to claim 1, wherein the processor provides to the display any biomarker value measured by the measurement engine not in response to a sent request.

16. The portable collection device according to claim 1, wherein any biomarker value measured by the measurement engine which indicates a hypoglycemic or hyperglycemic condition is viewable on the display.

17. The portable collection device according to claim 1, wherein the user interface and the display are provided together as a touchscreen.

18. The portable collection device according to claim 1, wherein the user interface comprises user-operated buttons.

19. The portable collection device according to claim 1, wherein the processor implements the structured collection procedure when invoked through input received from the user interface.

20. The portable collection device according to claim 1, wherein the device further comprises a communication device, and the processor implements the structured collection procedure when invoked by input received from the communication device from a remote device having authorization to invoke the structured collection procedure.

21. The portable collection device according to claim 1, wherein the collection event further comprises a request for an indication of meal size, a request for an indication of energy level, a request for an indication of completion of prescribed exercise, and combinations thereof.

22. The portable collection device according to claim 1, wherein a timing indicates at least one of a specific date, a specific time of day, or an amount of time after a previous collection event.

23. The portable collection device according to claim 1, wherein the collection events are at least one of before breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner, before bed, before exercising, after exercising, before receiving a drug, after receiving a drug, or combinations thereof.

24. The portable collection device according to claim 1, wherein the processor designates the contextualized biomarker data in the associated data record as viewable if the view flag provided in the structured collection procedure for the collection event has the viewable value by writing a flag to a field in the associated data record and as not viewable if the view flag has the non-viewable value by not writing the flag to the field in the associated data record.

25. The portable collection device according to claim 1, wherein the data file is downloaded to a remote computer having analysis software in which to view and analyze all data records contained in the data file.

26. The portable collection device according to claim 1, wherein the structured collection procedure further has a parameter defining one or more adherence criteria, and the view flag of the structured collection procedure further has a conditionally viewable value, and wherein the software has instructions that when executed by the processor causes the processor to use the one or more adherence criteria as a logical switch to decide whether the associated data record in the memory is viewable when the view flag associated with the sent request in the structured collection procedure has the conditionally viewable value.

27. The portable collection device according to claim 24, wherein the processor automatically designates the contextualized biomarker data in the associated data record in the memory as viewable when the view flag associated with the sent request in the structured collection procedure has the conditionally viewable value and the one or more adherence criteria is satisfied by the biomarker value measured by the measurement engine or the information entered via the user interface in response to the sent request.

28. The portable collection device according to claim 24, wherein the processor automatically designates the contextualized biomarker data in the associated data record in the memory as viewable when the view flag associated with the sent request in the structured collection procedure has the conditionally viewable value and the one or more adherence criteria is not satisfied by the biomarker value measured by the measurement engine or the information entered via the user interface in response to the sent request.

29. The portable collection device according to claim 24, wherein the structured collection procedure further has a parameter defining one or more options, and wherein the software has instructions that when executed by the processor further causes the processor to send a message when the one or more adherence criteria is satisfied by the biomarker value measured by the measurement engine or the information entered via the user interface in response to the sent request.

30. The portable collection device according to claim 24, wherein the structured collection procedure further has a parameter defining one or more options, and wherein the software has instructions that when executed by the processor further causes the processor to send a message when the one or more adherence criteria is not satisfied by the biomarker value measured by the measurement engine or the information entered via the user interface in response to the sent request.

31. The portable collection device according to claim 1, wherein the software has further instructions that when executed by the processor causes the processor to permit an authorized user to select which of the one or more collection events is assigned the viewable value or the non-viewable value of the view flag.