Analyte Sensor Calibration System for Continuous Glucose Monitoring
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Solution Overview
Problem
Conventional methods for monitoring blood glucose levels in diabetic patients are inadequate, as they provide only intermittent and inaccurate data, leading to delayed detection of hyper- or hypo-glycemic conditions, which can be dangerous.
Innovation Solution
A system and method for continuously and accurately calibrating an analyte sensor, converting sensor data into calibrated data, and evaluating the calibration for clinical acceptability, enabling real-time and retrospective glucose monitoring to prevent dangerous glycemic events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If conventional self-monitoring blood glucose (SMBG) methods are used, then the measurement process is simple and requires minimal equipment, but the monitoring frequency is limited to 2-4 times per day resulting in delayed detection of glycemic conditions
Solution Approach 1:
The patent replaces the mechanical finger-pricking SMBG method with an implantable continuous glucose sensor that uses electrochemical detection. The sensor continuously monitors glucose levels in interstitial fluid through enzymatic reactions and electrical signal detection, eliminating the need for repeated blood sampling and enabling real-time glycemic monitoring without mechanical intrusion.
Solution Approach 2:
The patent implements continuous glucose monitoring by maintaining a permanently implanted sensor that operates 24/7, providing uninterrupted glucose level data. This continuous action allows real-time detection of hyper- and hypo-glycemic events, enabling patients and healthcare providers to respond immediately rather than waiting for the next scheduled SMBG measurement.
2Reliability
If continuous analyte sensor data is collected, then real-time glucose monitoring is achieved, but data accuracy and reliability are compromised without proper calibration and evaluation processes
Solution Approach 1:
The patent implements a feedback mechanism where sensor data is continuously compared against reference glucose measurements. The system evaluates the correlation between sensor readings and reference values, automatically adjusting calibration parameters to maintain accuracy. This feedback loop ensures data reliability while managing processing complexity through automated algorithms.
Solution Approach 2:
The patent performs preliminary calibration and evaluation of sensor data before clinical use. The system pre-processes sensor readings by comparing them with reference measurements, establishing calibration curves and evaluating data quality metrics in advance. This preliminary action ensures that only accurate and reliable data is presented to patients and healthcare providers.
Data Source
AI summary
Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.