CGM Sensor Probing Potential Modulation for Calibration
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Solution Overview
Problem
Continuous glucose monitoring (CGM) sensors deployed in non-whole blood environments face challenges such as long break-in times, reliance on factory calibration, and changes in sensitivity due to environmental factors, leading to errors in analyte sensing.
Innovation Solution
The implementation of probing potential modulation sequences applied to CGM sensors, which involve periodic changes in voltage potential to assess sensor conditions and calibrate in-situ, allowing for continuous glucose monitoring with reduced need for factory calibration and improved sensitivity stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If factory calibration is used for CGM sensors, then manufacturing process is simplified, but sensor sensitivity changes due to environmental factors cause measurement errors
Solution Approach 1:
The system performs preliminary probing measurements at multiple voltage potentials before final glucose calculation. By pre-assessing sensor sensitivity at different potentials (including the target potential and additional potentials above/below it), the system prepares calibration data in advance to compensate for sensitivity changes, resolving the contradiction between simplified manufacturing and measurement accuracy.
Solution Approach 2:
The system changes the voltage potential parameter during probing, measuring sensor response at multiple different potentials rather than a single fixed potential. This allows the system to detect and compensate for sensitivity changes caused by environmental factors like temperature and hematocrit, maintaining measurement precision while keeping the manufacturing process simple through software-based calibration.
2Ease of operation
If constant voltage potential is applied to CGM sensor, then sensor operation is simplified, but sensor sensitivity changes over time and with environmental conditions
Solution Approach 1:
The system implements periodic probing at multiple voltage potentials during sensor operation. Instead of relying on a single constant voltage measurement, the system periodically applies probing sequences at different potentials (above, at, and below the target potential) to assess sensitivity changes over time and with environmental conditions, maintaining reliability while keeping operation simple through automated periodic assessments.
Solution Approach 2:
The system uses feedback from probing measurements at multiple potentials to dynamically adjust glucose calculations. By continuously monitoring sensor response at different voltage levels and using these measurements to correct for sensitivity drift, the system maintains reliable measurements without complicating the basic constant voltage operation mode.
3Measurement precision
If probing potential modulation sequence is applied to assess sensor conditions, then calibration accuracy is improved, but measurement time and complexity increase
Solution Approach 1:
The system applies probing at multiple voltage potentials (excessive action beyond the single target potential) to obtain comprehensive sensitivity data. By measuring at the target potential plus additional potentials above and below it, the system gains redundant information that improves calibration accuracy and allows for robust error correction, accepting increased measurement time as a trade-off for significantly improved precision.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach shortens the warm-up time, corrects for sensor sensitivity changes, and enhances accuracy by providing self-sufficient calibration indices, thereby improving the reliability of continuous glucose monitoring.
Implementation Method 1
measuring primary current signals resulting from the constant voltage potential and storing measured primary current signals in the memory; applying a probing potential modulation sequence to the sensor, measuring probing potential modulation current signals resulting from the probing potential modulation sequence
Data Source
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Figure 5A~5B
AI summary
Apparatus and methods are operative to probe the condition of a sensor either initially, at any point thereafter or continuously during a continuous sensor operation for measuring an analyte in a bodily fluid (such as performed by, e.g., a continuous glucose monitoring (CGM) sensor). Results of the probe may include calibration indices determined from electrical signals obtained during the probe. The calibration indices may indicate whether in-situ adjustment of the sensor-s calibration should be performed either initially and/or at random check points. Probing potential modulation parameters also may be used during analyte calculations to reduce the effects of lot-to-lot sensitivity variations, sensitivity drift during monitoring, temperature, interferents, and/or the like. Other aspects are disclosed.