Dynamic data collection

• US 8,766,803 B2
• Filed: 05/13/2011
• Issued: 07/01/2014
• 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 A., Greenburg, Alan M.
• Primary Examiner(s): MULLEN, THOMAS J
• Application Number:
  US13/107,436
• Publication Number:
  US 20120286953A1
• Time in Patent Office: 1,145 Days
• Field of Search: 340/573.1, 340/539.12, 702/19, 600/300, 600/301, 600/309, 600/316, 600/365
• US Class Current: 340/573.1
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker samples, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via the processor the compliance of the collected biomarker samples with the second criterion.

Claims

1. A method of performing a structured collection protocol on a collection device comprising a processor and a memory component, wherein the method comprises:

providing a plurality of prior biomarker sample data which are stored in the memory component of the collection device, wherein the prior biomarker sample data comprise at least one value based on a measurement of a body fluid, and a plurality of contextualized data components are linked to the prior biomarker sample data, wherein the plurality of contextualized data components comprise documented and interrelated conditions pertaining to each of the plurality of prior biomarker sample data such that the documented and interrelated conditions comprise at least one of a time frame for collection of the prior biomarker sample data, meal intake, exercise or insulin administration;

setting a first criterion, wherein the first criterion classifies the prior biomarker sample data as similar if the prior biomarker sample data shares at least one identical contextualized data component;

determining whether the prior biomarker sample data are similar based on the first criterion;

grouping the prior biomarker sample data that are determined to be similar based on the first criterion;

calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker sample data;

setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or a combination thereof;

collecting one or more biomarker samples which satisfy the first criterion; and

evaluating via the processor the compliance of the collected biomarker samples with the second criterion.

2. The method of claim 1, wherein the first criterion requires biomarker samples to have a plurality of shared identical contextualized data components.

3. The method of claim 1, further comprising recalculating the expected values for future biomarker samples.

4. The method of claim 1, wherein the collected biomarker samples comprise a range from a predicted variance or standard deviation.

5. The method of claim 1, wherein the processor tags similar biomarker samples.

6. The method of claim 1, further comprising triggering an alarm system in the collection device if the second criterion is not fulfilled by one or more collected biomarker samples.

7. The method of claim 1, further comprising displaying an educational tutorial via the collection device if the second criterion is not fulfilled by one or more collected biomarker samples.

8. The method of claim 1, further comprising instructing a diabetic patient to collect a new sampling set if the second criterion is not fulfilled by one or more collected biomarker samples.

9. The method of claim 1, further comprising prompting a diabetic patient via the collection device if the second criterion is not fulfilled by one or more collected biomarker samples.

10. The method of claim 1, wherein the calculation of the second criterion is based on a pattern recognition of the contextualized data and the measured values of the prior biomarker sample data.

11. The method of claim 1, wherein the threshold defines a lower limit, an upper limit, or both.

12. The method of claim 11, wherein biomarker sample values below the lower limit are indicative of a hypoglycemic event.

13. The method of claim 11, wherein biomarker sample values above the upper limit are indicative of a hyperglycemic event.

14. A collection device configured to guide a diabetic patient through a structured collection protocol, comprising:

a meter configured to measure one or more selected ones of the plurality of prior biomarker sample data;

a processor disposed inside the meter and coupled to memory, wherein the memory comprises one or more structured collection protocols; and

software having instructions that when executed by the processor causes the processor to perform the method steps of claim 1.

15. A method of performing a structured collection protocol on a collection device comprising a processor and a memory component, wherein the method comprises:

providing a plurality of prior biomarker sample data which are stored in the memory component of the collection device, wherein the prior biomarker sample data comprise at least one value based on a measurement of a body fluid, and a plurality of contextualized data components are linked to the prior biomarker sample data, wherein the plurality of contextualized data components comprise documented and interrelated conditions pertaining to each of the plurality of prior biomarker sample data such that the documented and interrelated conditions comprise at least one of a time frame for collection of the prior biomarker sample data, meal intake, exercise or insulin administration;

setting a first criterion, wherein the first criterion classifies the prior biomarker sample data as similar if the prior biomarker sample data shares at least one identical contextualized data component;

determining whether the prior biomarker sample data are similar based on the first criterion;

grouping the prior biomarker sample data that are determined to be similar based on the first criterion;

calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker sample data;

setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or a combination thereof;

predicting a number of biomarker samples in a sampling set to be collected within a collection period;

collecting one or more of the biomarker samples of the sampling set, the biomarker samples being compliant with the first criterion;

evaluating via the processor the compliance of the collected biomarker samples with the second criterion; and

determining whether the sampling set needs to be adjusted based on the compliance or lack of compliance of the collected biomarker samples with the second criterion, wherein the adjustment comprises recalculating the number of biomarker samples to be included in a subsequent sampling set, adjusting the frequency of collection of the one or more biomarker samples, adjusting the duration of the collection period, or combinations thereof.

16. The method of claim 15, further comprising recalculating a predicted number of biomarker samples for future collections of sampling sets.

17. The method of claim 15, further comprising increasing the number of biomarker samples if one or more biomarker samples fail to comply with the second criterion.

18. The method of claim 15, further comprising decreasing the number of biomarker samples if the biomarker samples comply with the second criterion.

19. The method of claim 15, wherein the last biomarker sample in the sampling set is eliminated.

20. The method of claim 15, wherein at least one biomarker sample immediately prior to the last biomarker sample in the sampling set is eliminated.

21. The method of claim 15, further comprising increasing the frequency of collection of biomarker samples if one or more biomarker samples fail to comply with the second criterion.

22. The method of claim 15, further comprising decreasing the frequency of collection of biomarker samples if the biomarker samples comply with the second criterion.

23. The method of claim 15, further comprising increasing the duration of the collection period if one or more biomarker samples fail to comply with the second criterion.

24. The method of claim 15, further comprising decreasing the duration of the collection period if the biomarker samples comply with the second criterion.

25. The method of claim 15, wherein the predicted number of biomarker samples includes at least one beginning biomarker sample, at least one end biomarker sample, and at least one intermediate biomarker sample between the beginning biomarker sample and the end biomarker sample.

26. The method of claim 25, wherein the beginning biomarker samples are recorded after an event, wherein an event is an action by a diabetic patient that adjusts the blood glucose or insulin level of the diabetic patient.

27. The method of claim 26, wherein the event is a meal, exercise, insulin administration, or combinations thereof.

28. The method of claim 25, wherein at least one biomarker sample is recorded before an event.

29. The method of claim 25, wherein at least one intermediate biomarker sample is eliminated if at least one evaluated beginning biomarker sample complies with the second criterion.

30. The method of claim 25, wherein a first beginning biomarker sample is collected at a time offset from a set interval between biomarker sample collections within the sampling set.

31. The method of claim 25, further comprising skipping a first beginning biomarker sample.

32. The method of claim 25, further comprising evaluating a second beginning biomarker sample to determine if it is complies with the second criterion, and instructing the user to collect all intermediate biomarker samples if the second beginning biomarker sample fails to comply with the second criterion.

33. The method of claim 25, further comprising decreasing the frequency of collection for biomarker samples collected after the collection of the beginning biomarker samples.

34. The method of claim 33, wherein the frequency of collection is decreased for intermediate samples, and is further decreased for end samples.

35. The method of claim 33, wherein the frequency of collection is decreased for intermediate samples, and is increased for end samples.

36. The method of claim 15, further comprising performing calculations on the sampling set if there are a sufficient number of collected biomarker samples that are compliant with the first and second criteria.

37. The method of claim 15, wherein the threshold defines a lower limit, an upper limit, or both.

38. The method of claim 36, wherein biomarker sample values below the lower limit are indicative of a hypoglycemic event.

39. The method of claim 36, wherein biomarker sample values above the upper limit are indicative of a hyperglycemic event.

40. A collection device configured to guide a diabetic patient through a structured collection protocol, comprising:

a meter configured to measure one or more selected ones of the plurality of prior biomarker sample data;

a processor disposed inside the meter and coupled to memory, wherein the memory comprises one or more structured collection protocols; and

software having instructions that when executed by the processor causes the processor to perform the method steps of claim 15.

41. A method of performing a structured collection protocol on a collection device comprising a processor, wherein the method comprises:

providing a plurality of prior biomarker sample data which are stored in a memory, wherein the prior biomarker sample data comprise at least one value based on a measurement of a body fluid, and whereby the prior biomarker sample data are linked to contextualized data, wherein the contextualized data comprise documented and interrelated conditions pertaining to each of the plurality of prior biomarker sample data such that the documented and interrelated conditions comprise at least one of a time frame for collection of the prior biomarker sample data, meal intake, exercise or insulin administration;

defining biomarker samples as similar based on a predefined first criterion, whereby the first criterion is comprised of the comparison of one or more of the documented and interrelated conditions of the contextualized data of the respective biomarker samples;

tagging similar biomarker samples by the processor;

calculating via the processor an expected value for future similar biomarker samples based on the measured values, whereby the calculation is based on at least a subset of the similar biomarker samples including more than one prior biomarker sample;

setting a second criterion based on the calculated expected value; and

configuring a structured collection protocol by the second criterion.

42. The method of claim 41, wherein the second criterion comprises a threshold, a range, or both.

43. The method of claim 41, wherein an alarm system is triggered if the second criterion is not fulfilled by one or more future biomarker samples.

44. The method of claim 41, wherein a user is prompted if the second criterion is not fulfilled by one or more future biomarker samples.

45. The method of claim 41, wherein the calculation of the expected value for the setting of the second criterion is based on a pattern recognition considering the contextualized data of the prior biomarker sample data and/or the measured values.

46. The method of claim 41, wherein the structured collection protocol comprises a sampling set comprising a predicted number of biomarker samples to be recorded, whereby the number of biomarker samples in the sampling set is recalculated by the processor based on the compliance of future biomarker samples with the second criterion.

47. A collection device configured to guide a diabetic patient through a structured collection protocol, comprising:

a meter configured to measure one or more selected ones of the plurality of prior biomarker sample data;

a processor disposed inside the meter and coupled to memory, wherein the memory comprises one or more structured collection protocols; and

software having instructions that when executed by the processor causes the processor to perform the method steps of claim 41.

48. A device configured to guide a diabetic patient through a structured collection protocol, comprising:

a processor coupled to memory, wherein the memory comprises one or more structured collection protocols; and

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

access a plurality of prior biomarker sample data stored in the memory, wherein the prior biomarker sample data comprise at least one value based on a measurement of a body fluid, and whereby the prior biomarker sample data are linked to contextualized data, wherein the contextualized data comprise documented and interrelated conditions pertaining to each of the plurality of prior biomarker sample data such that the documented and interrelated conditions comprise at least one of a time frame for collection of the prior biomarker sample data, meal intake, exercise or insulin administration;

define biomarker samples as similar based on a predefined or a user-defined first criterion, whereby the first criterion is comprised of a comparison of one or more of the documented and interrelated conditions of the contextualized data of the respective biomarker samples,

tag similar biomarker samples,

calculate via the processor an expected value for future similar biomarker samples based on the measured values, whereby the calculation is based on at least a subset of the similar biomarker samples including more than one prior biomarker sample,

set a second criterion based on the calculated expected value, and

configure the one or more structured collection protocols by the second criterion.

49. The device of claim 48, further comprising a meter configured to measure one or more selected ones of the plurality of prior biomarker sample data.

50. The device of claim 48, wherein the device is a handheld computing device.

51. The device of claim 50, wherein the handheld computing device is a cellular phone.