Optical Glucose Sensor Calibration via Modified Michaelis-Menten
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Solution Overview
Problem
Calibration of analyte sensors, particularly glucose sensors, is challenging due to sensor-to-sensor variation, environmental differences, and methodological discrepancies, leading to potential errors in analyte concentration measurements, which can result in adverse medical responses if not accurately calibrated.
Innovation Solution
The use of a modified Michaelis-Menten equation with determined parameters and a correction factor, applied through one-point in vivo or in vitro calibration, to estimate analyte concentration from optical intensity signals, specifically for glucose sensors employing a fluorophore and analyte binding moiety, ensuring accurate glycemic control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional calibration methods are used for analyte sensors, then sensor-to-sensor variation and environmental differences can be accounted for, but the calibration process becomes difficult, time-consuming, and prone to errors
Solution Approach 1:
The patent transforms the calibration problem from solving complex nonlinear equations to a simple linear calculation by changing the mathematical model parameters. The modified Michaelis-Menten equation with predetermined parameters reduces calibration to determining only two parameters (a and b), dramatically simplifying the process while maintaining accuracy across sensor-to-sensor variations and environmental differences
Solution Approach 2:
The patent performs preliminary determination of Michaelis-Menten parameters (Km and Vmax) during sensor manufacturing or pre-use preparation. This preliminary action eliminates the need to determine these complex parameters during actual calibration, reducing the calibration process to simple linear parameter determination and significantly cutting calibration time
2Measurement precision
If calibration is performed after sensor placement in the bloodstream, then the sensor can be calibrated to the patient's specific conditions, but the process becomes uncomfortable and intrusive requiring multiple blood draws
Solution Approach 1:
The patent uses a one-point calibration approach instead of traditional multi-point calibration. By determining calibration parameters from a single blood glucose measurement, the patent maintains patient-specific accuracy while dramatically reducing the number of blood draws required, thus minimizing patient discomfort and intrusion
Solution Approach 2:
The patent extracts the complex nonlinear calibration calculations from the patient-side calibration process and relocates them to the manufacturing or pre-preparation phase. This extraction leaves only simple linear parameter determination for the patient, eliminating the need for multiple blood draws and complex calculations during patient use
3Adaptability or versatility
If the sensor output is non-linear when compared to analyte concentration, then the sensor can capture the full dynamic range, but additional complexity and uncertainty are involved requiring greater attention and time for calibration
Solution Approach 1:
The patent changes the mathematical parameters of the sensor response model by using a modified Michaelis-Menten equation with predetermined Km and Vmax values. This parameter transformation converts the complex nonlinear calibration problem into a simple linear determination of two parameters, maintaining full dynamic range capability while eliminating calibration complexity
Solution Approach 2:
The patent introduces the modified Michaelis-Menten equation with predetermined parameters as an intermediary mathematical model between the sensor's nonlinear optical response and the linear analyte concentration measurement. This intermediary transformation simplifies the calibration process while preserving the sensor's ability to capture the full dynamic range
4Adaptability or versatility
If different analytical methodologies are used to measure the same sample, then various measurement techniques can be applied, but different analyte concentrations are reported due to methodological discrepancies
Solution Approach 1:
The patent creates a universal calibration approach using the modified Michaelis-Menten equation that can be applied across different sensor types and measurement methodologies. By predetermining the Michaelis-Menten parameters and using a standardized linear calibration process, the patent ensures consistent and agreed-upon analyte concentration measurements regardless of the specific analytical technique used
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 method provides a reliable and efficient calibration process for analyte sensors, reducing errors and ensuring accurate glucose concentration measurements, thereby improving patient safety and treatment efficacy.
Implementation Method 1
an optical glucose sensor comprising a fluorophore operably coupled to a glucose binding moiety
Data Source
AI summary
Disclosed are embodiments that relate to algorithms and methods for calibrating an analyte sensor, and more particularly, to algorithms for calibrating an optical glucose sensor comprising an equilibrium fluorescent chemical indicator system. In particular, a method of detecting an analyte concentration is disclosed where a modified Michaelis-Menten equation comprising Michaelis-Menten parameters is used to characterize the signal generated by the analyte sensor.