Dual Electrode Continuous Glucose Sensor Calibration

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Solution Overview

Problem

Conventional continuous glucose sensors require frequent recalibration due to sensitivity changes over time, caused by metabolic changes, tissue maturation, and interfering species, necessitating multiple daily or weekly blood glucose measurements for accurate calibration.

Innovation Solution

The implementation of electrode systems and signal processing techniques that measure glucose-related and non-glucose-related signals to calculate a glucose-to-oxygen ratio, allowing for reduced reference glucose values and improved calibration stability, enabling fewer calibration events and increased accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional continuous glucose sensors are used, then glucose monitoring is provided, but sensitivity changes over time require frequent recalibration

Engineering Contradiction:
Improveglucose measurement accuracyVSAvoidtime for recalibration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent introduces an intermediary substance (glucose oxidase enzyme) that mediates the measurement process. The enzyme is immobilized on the electrode surface and catalyzes the oxidation of glucose, producing a measurable signal. This enzymatic mediation stabilizes the measurement process and reduces sensitivity drift over time, eliminating the need for frequent recalibration while maintaining measurement accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The sensor system performs self-calibration through the use of internal reference mechanisms and stable enzymatic reactions. The glucose oxidase enzyme provides a consistent, reproducible response that serves as an internal reference, allowing the system to self-correct for drift without requiring external calibration interventions, thereby reducing the time loss associated with recalibration.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If frequent recalibration is performed to maintain accuracy, then measurement precision is improved, but device complexity and user burden increase

Engineering Contradiction:
Improveglucose measurement accuracyVSAvoidcalibration system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The sensor incorporates self-calibrating features through the use of stable enzymatic reactions and internal reference mechanisms. The glucose oxidase enzyme provides a consistent response that serves as an internal standard, enabling the system to automatically compensate for drift without requiring complex external calibration procedures or multiple reference measurements, thereby reducing both device complexity and user burden.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent employs parameter changes in the enzymatic reaction conditions and electrode design to stabilize the sensor response over time. By optimizing the enzyme immobilization methodology and reaction parameters, the system achieves long-term stability that reduces the frequency and complexity of recalibration requirements, simplifying the overall system while maintaining accuracy.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If multiple blood glucose measurements are taken for calibration, then calibration accuracy is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvecalibration accuracyVSAvoidcalibration convenience
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The sensor system performs self-calibration using internal reference mechanisms and stable enzymatic responses, eliminating the need for users to perform multiple manual blood glucose measurements for calibration. The glucose oxidase enzyme provides a consistent internal standard that automatically compensates for drift, making the sensor self-sufficient and greatly improving ease of operation while maintaining calibration accuracy.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The glucose oxidase enzyme serves as an intermediary that provides a stable, reproducible signal that can be used for automatic calibration. This enzymatic mediator creates a consistent reference response that the system can use for self-calibration, eliminating the need for multiple user-performed reference measurements and thereby improving convenience while maintaining accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If sensor sensitivity is increased to improve detection, then measurement precision improves, but sensitivity to interfering species increases

Engineering Contradiction:
Improveglucose detection sensitivityVSAvoidinterference from other species
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by immobilizing glucose oxidase enzyme specifically on the electrode surface where glucose detection occurs. This localized enzymatic activity provides high sensitivity to glucose while the enzyme's specificity inherently rejects other species. The enzyme is confined to the immediate vicinity of the electrode, creating a localized sensing zone with high glucose selectivity and sensitivity while minimizing interference from other substances in the sample.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent employs parameter changes in the enzymatic reaction conditions, including optimizing pH, temperature, and enzyme concentration, to enhance glucose sensitivity while maintaining selectivity. By carefully controlling these parameters, the system achieves high detection sensitivity for glucose while the enzymatic mechanism inherently provides selectivity against interfering species, resolving the contradiction between sensitivity and interference resistance.

Inventive Principle:
Principle #35Parameter changes

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 simplifies and enhances calibration, providing patients with more convenient and accurate glucose monitoring, reducing the frequency of calibration and improving the reliability of glucose sensor data.

Implementation Method 1

a first working electrode configured to generate a first signal associated with glucose and non-glucose related electroactive compounds

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 2

a second working electrode configured to generate a second signal associated with noise of the glucose sensor comprising signal contribution due to non-glucose related electroactive compounds

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 3

The sensor further comprises a membrane system configured to cover a substantial portion of the first working electrode and the second working electrode

Methodology Applied
Scientific EffectSelective permeability: Semipermeable Membrane

Data Source

PatentUS11633133B2Dual electrode system for a continuous analyte sensor
Publication Date: 2023.04.25 DEXCOM INC
  • US11633133B2 patent drawing
  • US11633133B2 patent drawing
  • US11633133B2 patent drawing

AI summary

Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure additional analyte or non-analyte related signal. Such measurements may provide a background and/or sensitivity measurement(s) for use in processing sensor data and may be used to trigger events such as digital filtering of data or suspending display of data.