Structured Biomarker Collection Protocol for Diabetes
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Solution Overview
Problem
Existing devices for collecting physiological data, particularly for chronic diseases like diabetes, lack structured protocols for biomarker collection, leading to uninterpreted data and burdens on patients due to overlapping or conflicting requests from clinicians.
Innovation Solution
A system and method for managing the implementation, execution, data collection, and data analysis of a structured collection procedure on a portable, hand-held device, which includes determining compliance with adherence criteria, classifying sampling instances, and performing additional tasks based on adherence events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If unstructured glucose collection is performed, then patient burden is reduced, but data interpretative value is lost
Solution Approach 1:
The collection procedure is segmented into discrete, structured steps with specific timing and context requirements. Each glucose measurement is associated with structured context data (meal timing, medication, activity) that provides interpretative value while maintaining patient-friendly execution through automated device guidance.
Solution Approach 2:
The system provides automated feedback to patients through the portable device, guiding them through structured collection procedures. The device prompts patients for context information and provides real-time feedback on compliance, ensuring data quality without increasing perceived patient burden.
2Adaptability or versatility
If multiple clinician requests for collections are fulfilled, then diagnostic and therapy optimization opportunities increase, but patient burden and conflict increase
Solution Approach 1:
Multiple clinician requests are merged and consolidated into a single unified structured collection procedure. The system integrates requirements from different clinicians into one coordinated protocol, eliminating redundant measurements and conflicting schedules while preserving all diagnostic and therapy optimization opportunities.
Solution Approach 2:
The portable device and collection system are designed with universal functionality to handle multiple types of clinician requests simultaneously. The system can accommodate various diagnostic and therapy optimization needs through a single multi-functional platform that manages diverse collection requirements.
3Device complexity
If manual programming of collection schedules is required, then device complexity is reduced, but time consumption and error potential increase
Solution Approach 1:
The system performs self-service by automatically receiving, processing, and implementing collection schedule instructions from clinicians without manual programming. The portable device autonomously configures collection procedures based on received parameters, eliminating time-consuming manual setup and reducing errors while maintaining simple device operation for patients.
Data Source
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AI summary
Method embodiments for performing a structured collection protocol by utilizing a collection device comprise collecting one or more sampling sets of biomarker data, wherein each sampling set comprises a sufficient plurality of sampling instances recorded over a collection period. The methods further include determining compliance with adherence criteria for the sampling instances, wherein noncompliance with adherence criteria is recorded as an adherence event, classifying sampling instances as primary samples or secondary samples, wherein primary samples, which do not have corresponding recorded adherence events, are sampling instances utilized in the calculations performed by the processor that yield therapy results for a diabetic person, and secondary samples are sampling instances not utilized in the calculations, unless one or more secondary samples are promoted to primary samples, and performing at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event.