Management Method And System For Implementation, Execution, Data Collection, and Data Analysis of A Structured Collection Procedure Which Runs On A Collection Device

• US 20120088989A1
• Filed: 06/21/2011
• Published: 04/12/2012
• Est. Priority Date: 12/21/2009
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bousamra, Steven A., Greenburg, Alan M., Soni, Abhishek S., Weinert, Stefan
• Application Number:
  US13/165,168
• Publication Number:
  US 20120088989A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

In one embodiment, a method of performing a structured collection protocol by utilizing a collection device comprising a processor may include collecting at least one sample using the collection device. The at least one sample can be associated with biomarker data. A classification can be associated with the at least one sample via the processor. The classification can be based upon an intended use of the at least one sample. Compliance with an adherence criteria for the at least one sample can be determined via the processor. When the at least one sample is not compliant with the adherence criteria, an adherence event can be associated with the at least one sample, and the processor can perform at least one additional task that is based upon the classification associated with the at least one sample.

Claims

1. A method of performing a structured collection protocol by utilizing a collection device comprising a processor, wherein the method comprises:

collecting at least one sample using the collection device, wherein the at least one sample is associated with biomarker data;

associating a classification with the at least one sample via the processor, wherein the classification is based upon an intended use of the at least one sample; and

determining compliance with an adherence criteria for the at least one sample via the processor, wherein when the at least one sample is not compliant with the adherence criteria;

an adherence event is associated with the at least one sample; and

the processor performs at least one additional task that is based upon the classification associated with the at least one sample.

2. The method of claim 1, wherein the classification associated with the at least one sample indicates that the at least one sample is a primary sample.

3. The method of claim 1, wherein the at least one additional task comprises replacing the at least one sample with a secondary sample.

4. The method of claim 3, wherein the at least one sample and the secondary sample are associated with a sample instance.

5. The method of claim 3, wherein the secondary sample complies with the adherence criteria.

6. The method of claim 1, wherein the at least one additional task comprises collecting at least one additional sample.

7. The method of claim 1, wherein the at least one additional task comprises collecting at least one additional sample until a maximum number of samples have been collected.

8. The method of claim 1, wherein the at least one additional task comprises restarting a sampling instance.

9. The method of claim 1, wherein the at least one additional task comprises restarting a sampling set.

10. The method of claim 1, wherein the at least one additional task comprises terminating the structured collection protocol.

11. The method of claim 1, wherein the at least one additional task comprises terminating a sampling instance.

12. The method of claim 1, wherein the at least one additional task comprises terminating a sampling set.

13. The method of claim 1, wherein the at least one additional task comprises contacting a healthcare provider.

14. The method of claim 1, wherein the at least one additional task comprises providing a user with a message indicative of the adherence event.

15. The method of claim 1, further comprising initializing a first sampling instance using the collection device, wherein the first sampling instance comprises linking information and the first sampling instance provides for the collection of the at least one sample.

16. The method of claim 15, further comprising initializing a second sampling instance using the collection device, wherein the linking information of the first sampling instance points to the second sampling instance.

17. The method of claim 16, wherein the second sampling instance comprises bidirectional linking information that points to the first sampling instance

18. The method of claim 16, wherein the first sampling instance and the second sampling instance form a portion of a linked list.

19. The method of claim 18, wherein the linked list is a unidirectional linked list.

20. The method of claim 18, wherein the linked list is a circular linked list.

21. A method of performing a structured collection protocol by utilizing a collection device comprising a processor, wherein the method comprises:

initializing a first sampling instance using the collection device, wherein the first sampling instance comprises linking information and the first sampling instance provides for the collection of at least one sample associated with biomarker data;

associating a classification with the at least one sample via the processor, wherein the classification is based upon an intended use of the at least one sample;

determining compliance with an adherence criteria for the at least one sample via the processor, wherein when the at least one sample is not compliant with the adherence criteria an adherence event is associated with the at least one sample;

performing at least one additional task via the processor that is based upon the classification associated with the at least one sample when the adherence event is associated with the at least one sample; and

determining if an exit criteria is met via the processor, wherein when the exit criteria is not met, memory is allocated for a second sampling instance such that the linking information of the first sampling instance points to the second sampling instance.

22. The method of claim 21, wherein the first sampling instance further comprises a relative date and a relative time.

23. The method of claim 21, wherein the first sampling instance further comprises an adherence event response and the at least one additional task is specified by the adherence event response.

24. The method of claim 23, wherein the adherence event response comprises collecting at least one additional sample, restarting the first sampling instance, restarting a sampling set, terminating the structured collection protocol, terminating the first sampling instance, terminating the sampling set, contacting a healthcare provider, or providing a user with a message indicative of the adherence event.

25. The method of claim 21, wherein the first sampling instance further comprises a replacement flag, wherein the replacement flag indicates that the at least one sample of the first sampling instance can be replaced or that the at least one sample of the first sampling instance cannot be replaced.

26. The method of claim 21, wherein the second sampling instance comprises bidirectional linking information that points to the first sampling instance

27. The method of claim 21, wherein the first sampling instance and the second sampling instance form a portion of a linked list.

28. The method of claim 27, wherein the linked list is a unidirectional linked list.

29. The method of claim 27, wherein the linked list is a circular linked list.

30. A collection device configured to guide a diabetic person through a structured collection protocol, comprising:

a meter configured to measure one or more selected biomarkers;

a processor disposed inside the meter and coupled to memory, wherein the memory comprises collection procedures; and

software having instructions that when executed by the processor causes the processor to;

collect at least one sample using the meter, wherein the at least one sample is associated with the one or more selected biomarkers;

associate a classification with the at least one sample via the processor, wherein the classification is based upon an intended use of the at least one sample;

determine compliance with an adherence criteria for the at least one sample;

associate an adherence event with the at least one sample when the at least one sample is not compliant with the adherence criteria; and

perform at least one additional task when the at least one sample is not compliant with the adherence criteria and the classification associated with the at least one sample indicates that the at least one sample is a primary sample, wherein the at least one additional task comprises collecting at least one additional sample, restarting a sampling instance, restarting a sampling set, terminating the structured collection protocol, terminating the sampling instance, terminating the sampling set, contacting a healthcare provider, or providing a user with a message indicative of the adherence event.