Continuous Analyte Sensor Self-Calibration for Sensitivity Drift
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Solution Overview
Problem
Existing glucose sensors, both implantable and transdermal, face challenges in accurately and continuously measuring blood glucose levels over extended periods, leading to potential dangerous hypoglycemic or hyperglycemic events due to infrequent and inaccurate measurements.
Innovation Solution
A method for calibrating sensor data from continuous analyte sensors involves iteratively determining sensitivity values over time using a priori information, without requiring reference blood glucose data, to achieve high accuracy over several days.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional self-monitoring blood glucose (SMBG) methods are used, then measurement simplicity is maintained, but measurement frequency is insufficient (2-4 times per day) and real-time monitoring capability is lost
Solution Approach 1:
The sensor system performs automatic self-calibration using factory-calibrated sensitivity profiles and a priori information without requiring user intervention or reference blood glucose measurements. The system autonomously determines sensitivity values over time and adjusts calibration parameters, enabling continuous monitoring without increasing user burden while maintaining high measurement frequency
Solution Approach 2:
Sensitivity profiles and calibration parameters are predetermined during manufacturing through factory calibration. This preliminary action stores a priori information about sensor behavior over time, allowing the system to automatically compensate for sensitivity drift without requiring user calibration during operation, thus enabling continuous monitoring without increasing operational complexity
2Duration of action of stationary object
If implantable glucose sensors are used for continuous measurement, then measurement continuity is improved, but sensor accuracy deteriorates over time due to sensitivity drift and complications
Solution Approach 1:
The system continuously monitors sensor sensitivity over time using factory-calibrated sensitivity profiles and automatically adjusts calibration parameters based on elapsed time and a priori information. This feedback mechanism compensates for sensitivity drift that occurs during continuous operation, maintaining measurement accuracy throughout extended sensor sessions without requiring reference measurements
Solution Approach 2:
The system dynamically changes calibration parameters (sensitivity values) based on elapsed time and predetermined sensitivity profiles. By adjusting these parameters according to known sensor behavior patterns established during manufacturing, the system compensates for temporal drift and maintains accuracy throughout the extended operational duration
3Ease of operation
If transdermal sensors are used for continuous glucose monitoring, then non-invasive measurement is achieved, but measurement accuracy deteriorates over extended periods
Solution Approach 1:
Comprehensive sensitivity profiles and calibration parameters are predetermined during manufacturing through factory calibration. This preliminary action stores detailed a priori information about sensor behavior under various conditions, allowing the system to automatically compensate for drift during continuous operation without requiring user calibration, thus maintaining accuracy while preserving ease of application
Solution Approach 2:
The sensor system autonomously performs calibration adjustments using factory-stored sensitivity profiles and a priori information without requiring user intervention or reference measurements. This self-service capability maintains measurement accuracy throughout extended use while preserving the ease of non-invasive application
4Measurement precision
If factory calibration with predetermined sensitivity profiles is implemented, then calibration accuracy is improved, but device complexity increases
Solution Approach 1:
Comprehensive sensitivity profiles and calibration parameters are predetermined during manufacturing through factory calibration. This preliminary action transfers calibration complexity from the use phase to the manufacturing phase, allowing simple automated application during operation while achieving high accuracy. The system stores a priori information about sensor behavior that automatically compensates for drift without requiring complex user-side calibration mechanisms
Data Source
AI summary
Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.


