MANAGEMENT METHOD AND SYSTEM FOR IMPLEMENTATION, EXECUTION, DATA COLLECTION, AND DATA ANALYSIS OF A STRUCTURED COLLECTION PROCEDURE WHICH RUNS ON A COLLECTION DEVICE

• US 20100218132A1
• Filed: 12/21/2009
• Published: 08/26/2010
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Weinert, Stefan, Walling, P. Douglas, Rasch-Menges, Juergen, Soni, Abhishek S.
• Granted Patent: US 9,659,037 B2
• Time in Patent Office: Days
• US Class Current: 715/771
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G06F 16/21 Design, administration or maintenance of databases
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

Claims

1. A collection device for performing a structured collection procedure, said device comprising:

memory;

a processor connected to the memory; and

program instructions which when executed by the processor causes the processor to;

initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time,

store in the memory patient data collected in accordance to the schedule of events,

end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and

mark the structure collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

2. A collection device according to claim 1 wherein processor uses a state condition to indicate completion of the structured collection procedure.

3. A collection device according to claim 1 wherein the processor provides a completion flag in the memory to indicate completion of the structured collection procedure.

4. A collection device according to claim 1 wherein at time of initiation of the structure collection procedure, the program instructions cause the processor to create a data structure in memory for the patient data.

5. A collection device according to claim 3 wherein the program instructions further cause the processor to try to resolve exceptions and mark the completion flag as completed if the exceptions are resolved.

6. A collection device according to claim 5 wherein processor tries to resolve the exceptions by the program instructions further causing the processor to scan the patient data and use similar data in the patient data that meets the requirements of the events which caused the exceptions to clear the exceptions.

7. A collection device according to claim 1 wherein the program instructions further cause the processor to performance analysis on the patient data.

8. A collection device according to claim 1 wherein the program instructions further cause the processor to provide prompts and guidance to collect biomarker data according to the schedule of events.

9. A collection device according to claim 8 wherein the program instructions further cause the processor to provide a snooze feature to enable a delay to the collection of the biomarker data when prompted.

10. A collection device according to claim 1 wherein the program instructions further cause the processor to apply adherence criteria to determine whether the patient data was collected within a specific time-window around an event provided in the schedule of events.

11. A collection device according to claim 1 wherein the program instructions further cause the processor to apply adherence criteria to determine whether data collected for each of the events provided in the schedule of events was successful.

12. A collection device according to claim 11 wherein the program instructions further cause the processor to associate in the patient data the data collected successfully with a date-time stamp, the event, any available contextual information, and a unique identifier.

13. A collection device according to claim 11 wherein the program instructions further cause the processor to indicate in the patient data the exception for the event not meeting the adherence criteria.

14. A collection device according to claim 1 wherein the program instructions further cause the processor to end the structured collection procedure when an adverse event occurs.

15. A collection device according to claim 1 wherein the collection device is a blood glucose meter.

16. A system for managing implementation, execution, data collection, and data analysis of a structured collection procedure, said system comprising:

a collection device according to claim 1; and

a computer communicatively coupled to the collection device, wherein the computer provides a graphical user interface which manages the implementation of the structured collection procedure on the collection device.

17. A system according to claim 16, further comprising a server connected to the computer which serves as a central repository for one or more structured collection procedures.

18. A system according to claim 16, wherein the graphical user interface provides information about collection procedures already completed by a patient and associated results, and the collection procedure that the patient is currently performing on the collection device.

19. A system according to claim 16, wherein the graphical user interface provides steps in a workflow for therapy administration for a patient.

20. A system according to claim 19, wherein the steps include disease state, therapy selection, therapy initialization, therapy optimization, and therapy monitoring.

21. A system according to claim 20, wherein the graphical user interface shades the icons to the steps of the workflow already completed.

22. A system according to claim 16, wherein the graphical user interface provides for all available initializing options for initializing a therapy which includes selecting from one or more structured collection procedure available for addressing the therapy.

23. A system according to claim 16, wherein the graphical user interface provides a snapshot of conditions set in the structured collection procedure.

24. A system according to claim 16, wherein the graphical user interface provides a modify protocol icon which when selected permits modification of parameters in the structured collection procedure.

25. A system according to claim 16, wherein the graphical user interface provides an accept icon which when selected causes the computer to send the structured collection procedure to the collection device.

26. A system according to claim 17 wherein communication between the computer and server does not support a full two-way data transfer to protect patient data.

27. A system according to claim 16, wherein analysis of data collected by the collection device can be completed on one or more of the collection device, the computer, and a device reader.

30. A method of performing a structured collection procedure, comprising:

providing a collection device according to claim 1; and

authorizing the structured collection procedure on the collection device.

28. A collection device for performing a structured collection procedure, said device comprising:

memory storing patient data comprising collected biomarker data, a date-time stamp, a completion flag, and other data associated with each instance of the collected biomarker data, said other data comprising contextualized data which characterizes the associated collected biomarker;

a processor connected to the memory; and

program instructions that when executed by the processor causes the processor to;

retrieve automatically from memory a structured collection procedure having parameters defining;

entry criteria which establish conditions needed to be met prior to obtaining biomarker data,

a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request for one or more of information, patient actions, and a collection of at least one type of biomarker data, and

exit criteria which establish the conditions needed to be met prior to exiting the structured collection procedure, and

initiate automatically the schedule of events of the structured collection procedure upon the entry criteria being met at some unknown time,

store in the memory the patient data collected in accordance to the schedule of events,

end automatically the structured collection procedure upon the exit criteria being met at some unknown time, and

indicate the structured collection procedure as completed if no exception occurs during performance of a critical event in the schedule of events to collect the biomarker data, otherwise the processor indicates non-completion of the structured collection procedure.

29. A collection device according to claim 28 wherein if the structure collection procedure is indicated as non-completed, the program instructions further cause the processor to attempt to resolve the exception by attempting to replace any missing biomarker data for the critical event causing the exception.

31. A method of performing a structured collection procedure, comprising:

providing a collection device according to claim 28; and

authorizing the structured collection procedure on the collection device.

32. A method of managing a structured collection procedure comprising:

providing a collection device with the structured collection procedure and a program instructions; and

executing the program instruction on the collection device which cause a processor of the collection device to;

initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time,

store in memory patient data collected in accordance to the schedule of events,

end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and

indicating completion of the structured collection procedure if no exception occur during performance of an event in the schedule of events.