Systems and methods for handling unacceptable values in structured collection protocols

• US 8,755,938 B2
• Filed: 05/13/2011
• Issued: 06/17/2014
• Est. Priority Date: 05/13/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bousamra, Steven, Duke, David L., Galley, Paul J., Greenburg, Alan M., Weinert, Stefan
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US13/107,467
• Publication Number:
  US 20120289803A1
• Time in Patent Office: 1,131 Days
• Field of Search: 700/266, 700/17, 700/18, 700/83, 702/19, 702/22, 702/31, 702/32, 600/365
• US Class Current: 700/266
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Claims

1. A method of performing by a patient managing a chronic disease a structured collection protocol on a collection device comprising a processor, wherein the method comprises:

receiving on the collection device a selection of a selected structured collection protocol from a plurality of structured collection protocols, wherein each of the structured collection protocols specify sequential collection events over a collection period in which to collect samples of biomarker data which is useful to address a particular situation or problem the patient is having with management of the chronic disease;

automatically determining, via the processor, an acceptable range of values for a future collected sample from an evaluation of at least one sampling set of biomarker data having a plurality of collected samples recorded over a previous collection period in compliance with adherence criteria for the selected structure collection protocol and read by the processor from a memory, wherein the adherence criteria establishes at least one procedural steps leading up to taking of a sample according to the selected structure collection protocol in order for the future collected sample to be useful in an evaluation addressing the situation or problem of the selected structure collection protocol;

querying the patient via a display unit operatively coupled to the processer of the collection device regarding compliance with the adherence criteria of the selected structure collection protocol;

receiving on the collection device a result from the querying;

starting on the collection device a new collection period and instructing on the display unit for the patient to collect at least one sample for a new sampling set of biomarker data that the processor stores in the memory;

comparing, via the processor, the collected sample to the acceptable range if the result from the querying indicates compliance with the adherence criteria;

informing, via the display unit, the patient if the collected sample is an unacceptable value which falls outside of the acceptable range;

performing, via the processor, at least one additional task after detecting the unacceptable value;

storing, via the processor, in the memory the collected sample as part of the new sampling set of biomarker data;

indicating, via the processor, in the memory the collected sample as being acceptable if falling within the acceptable range; and

if the at least one additional task is not to terminate the structure collection protocol, checking, via the processor, to see if the new collection period has ended otherwise continuing with a next sample to be collected at an event specified in the selected structured collection protocol, wherein the new collection period ends upon a predetermined number of sampling values in the new sampling set being indicated in the memory as acceptable such that a new acceptable range of values for another future collected sample in another future collection period is determinable from evaluating at least the new sampling set of the biomarker data.

2. The method of claim 1 wherein the additional task comprises querying the patient on the display unit to input into the collection device an explanation for the detection of the unacceptable value.

3. The method of claim 1 wherein the additional task comprises collecting via the collection device at least one additional sample from the patient.

4. The method of claim 3 wherein the additional task further comprises replacing the unacceptable value with the at least one additional sample in the new sampling set.

5. The method of claim 4 wherein the replacement of the unacceptable value is performed automatically via the processor.

6. The method of claim 1 wherein the additional task comprises storing in the memory the collected sample with the unacceptable value such that the processor ignores the unacceptable value as being part of the predetermined number of sampling values in the new sampling set as being indicated in the memory as acceptable.

7. The method of claim 1 wherein the additional task comprises restarting the new collection period of the new sampling set.

8. The method of claim 1 wherein the additional task comprises terminating the structured collection protocol.

9. The method of claim 1 wherein the additional task comprises contacting a healthcare provider.

10. The method of claim 1 wherein the additional task comprises computing a therapeutic result utilizing any other samples previously collected and indicated in the memory as acceptable.