Glucose Sensor Fault Detection Using Secondary Physiological Signals
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Solution Overview
Problem
Analyte sensors, particularly glucose sensors, suffer from signal response fluctuations leading to false alarms and sensor faults, including nighttime glucose dropouts, which can trigger unnecessary insulin adjustments and reduce accuracy.
Innovation Solution
Utilizing secondary physiological measurements such as lactate levels or heart rate to corroborate glucose readings, employing algorithms to detect suspected glucose dropouts and correct glucose levels, and implementing methods like lag correction or data smoothing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If analyte sensor is used to monitor glucose levels, then health monitoring capability is improved, but false alarms and sensor faults occur due to signal response fluctuations
Solution Approach 1:
The patent introduces a secondary sensing element as an intermediary to detect and identify sensor fault conditions. This secondary element provides additional data that mediates between the primary glucose sensor signal and the final interpretation, allowing the system to distinguish between true glucose changes and sensor faults. The secondary sensing element acts as a mediator that correlates with the primary sensor's performance, enabling fault detection without directly measuring glucose.
Solution Approach 2:
The patent implements feedback mechanisms where the secondary sensing element continuously monitors the sensor's performance and provides feedback about potential faults. This feedback loop allows the system to adjust its interpretation of glucose readings in real-time, compensating for sensor degradation or faults. The feedback from the secondary element triggers alerts or corrections when sensor accuracy is compromised.
2Reliability
If sensor signal response is monitored continuously, then sensor faults can be detected, but device complexity increases
Solution Approach 1:
The patent merges the secondary sensing element with the primary glucose sensor into a single integrated sensor device. This combination allows both sensing functions to coexist in one physical unit, sharing common components such as the substrate, encapsulation, and electronics. The merging reduces overall device complexity compared to using completely separate monitoring systems while still providing comprehensive fault detection capabilities.
Solution Approach 2:
The secondary sensing element is designed with multi-functionality, serving both as a fault detection mechanism and as a potential additional monitoring capability. The same secondary sensing element can detect various types of sensor faults including drift, occlusion, and degradation, making it a universal solution for multiple failure modes rather than requiring separate detection mechanisms for each fault type.
3Measurement precision
If secondary sensing element is added to detect sensor faults, then measurement accuracy is improved, but manufacturing complexity increases
Solution Approach 1:
The patent applies local quality by placing the secondary sensing element only in specific locations where it can most effectively detect sensor faults. Rather than uniformly distributing multiple sensing elements throughout the sensor, the secondary element is strategically positioned to monitor critical aspects of sensor performance. This localized approach reduces manufacturing complexity compared to comprehensive multi-element designs while maintaining effective fault detection.
Solution Approach 2:
The patent utilizes parameter changes in the secondary sensing element's design to simplify manufacturing. By adjusting parameters such as the secondary element's size, position, or sensing properties during manufacturing, the system can optimize fault detection performance without fundamentally changing the manufacturing process. Parameter adjustments allow for flexibility in adapting to different production requirements while maintaining the core functionality of the combined sensing system.
Data Source
AI summary
Various embodiments of systems, devices and methods for improving the accuracy of an analyte sensor and for detecting sensor fault conditions are disclosed. According to some embodiments, these systems, devices, and methods can utilize a first data collected by a glucose sensor and a second data collected by a secondary sensing element. In some embodiments, the secondary sensing element can be one of a lactate sensing element, a ketone sensing element, or a heart rate monitor, among others.