Structured Collection Procedure for Contextual Biomarker Data
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Solution Overview
Problem
Current chronic disease management systems lack structured procedures for biomarker collection, leading to uninterpreted data due to unstructured glucose level measurements, patient burden, and limited guidance from existing devices, which discourages patients from seeking further therapy optimization.
Innovation Solution
A portable, hand-held device that implements a structured collection procedure, including contextualized biomarker data collection and adherence criteria, to optimize therapy management for chronic diseases like diabetes, by generating and executing collection procedures on a blood glucose meter, ensuring data is collected under prescribed conditions and interpreted effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If unstructured glucose level measurements are collected, then data collection is simple and quick, but the data lacks interpretative context and reduces clinical value
Solution Approach 1:
The collection procedure is segmented into discrete steps with specific contextual requirements (fasting state, meal timing, exercise conditions). Each glucose measurement is associated with structured contextual data segments that categorize the measurement conditions, enabling systematic organization and interpretation of otherwise simple patient self-measurements.
Solution Approach 2:
The system performs preliminary assessment of entry criteria before allowing data collection to begin. It evaluates whether the patient meets predefined contextual requirements (fasting duration, recent meal timing, exercise status) before accepting glucose measurements, ensuring that only contextually valid data is collected while maintaining ease of use through automated validation.
2Adaptability or versatility
If multiple collection procedures are requested by different clinicians, then comprehensive diagnostic coverage is achieved, but patient burden increases and compliance decreases
Solution Approach 1:
Multiple collection procedures from different clinicians are merged into a single unified procedure when they share common contextual requirements. The system intelligently combines diagnostic goals and consolidates overlapping measurement requirements, allowing patients to fulfill multiple clinician requests through one integrated data collection effort rather than separate procedures.
Solution Approach 2:
The collection procedure is designed with universal applicability to serve multiple diagnostic purposes simultaneously. A single procedure structure can accommodate various clinical questions (diagnosis, therapy optimization, disease progression monitoring) by configuring different entry and exit criteria, making the system versatile enough to handle diverse clinician requirements without increasing patient burden.
3Device complexity
If manual programming of collection schedules is required, then device functionality is simple, but guidance is limited and patient motivation decreases
Solution Approach 1:
The device provides continuous feedback to patients during the collection process, displaying real-time status of entry criteria fulfillment, collection progress, and adherence to procedural requirements. This automated feedback mechanism guides patients through the procedure, motivates compliance by showing progress toward diagnostic goals, and eliminates the need for complex manual programming while maintaining device accessibility.
Solution Approach 2:
The system performs self-assessment of entry criteria and automated scheduling of collection events without requiring manual patient programming. The device autonomously evaluates whether contextual conditions are met, determines appropriate measurement timing, and guides the patient through the procedure, reducing device complexity while enhancing patient motivation through intelligent automation.
4Productivity
If collection procedures are performed without proper evaluation of suitability, then clinical requests can be quickly fulfilled, but data quality and interpretability suffer
Solution Approach 1:
The system performs preliminary evaluation of entry criteria before initiating data collection, automatically assessing whether the patient's current physiological state and contextual conditions are suitable for the requested procedure. This preliminary check ensures data quality by preventing collection under inappropriate conditions while maintaining productivity through automated assessment that occurs rapidly without manual intervention.
Solution Approach 2:
Manual clinical evaluation of collection suitability is replaced by automated computational assessment of entry criteria. The device uses predefined algorithms to evaluate contextual conditions (fasting status, recent meals, exercise, medication timing) and determine procedural appropriateness, substituting manual judgment with consistent, objective automated decision-making that maintains both speed and data quality.
Data Source
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AI summary
Embodiments related to a system (41) and method (200, 300, 388, 400) managing the implementation, execution, data collection, and data analysis of a structured collection procedure (70) running on a portable, hand-held collection device (24) are disclosed. The collection device (24) performing the structured collection procedure (70) has program (34) instructions that when executed by a processor (102) causes the processor (102) to initiate automatically a schedule of events (222) of the structured collection procedure (70) upon one or more entry criterions (226) being met at some unknown time, store in memory (110) patient data (256, 170, 145) collected in accordance to the schedule of events (222), end automatically the structured collection procedure (70) upon one or more exit criterions (228) being met at some unknown time, and mark/indicate the structured collection procedure (70) as completed if no exception occurred during performance of an event (237) in the schedule of events (222).