Continuous Glucose Sensor Zero-Signal Subtraction for Interferent Compensation

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Solution Overview

Problem

Current methods for calibrating handheld diabetes managing devices to determine accurate glucose levels from continuous glucose monitors are inefficient and prone to interference from various factors, including interferents in the body fluid, which can affect the accuracy of glucose level estimation.

Innovation Solution

A method and system that process measurement data from a continuous glucose sensor element by subtracting a time-dependent zero-signal level, which represents interferent contributions, to provide accurate glucose level estimation independently of additional blood glucose reference, using a data processing unit in devices like handheld blood glucose management devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional calibration methods using blood glucose reference are used, then calibration can be performed, but the process is time-consuming and requires additional reference measurements

Engineering Contradiction:
Improvecalibration efficiencyVSAvoidcalibration time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The system performs self-calibration by automatically determining the zero-signal level from the sensor signal itself without requiring external blood glucose reference measurements. The processor identifies calibration points where the sensor signal equals zero (indicating no glucose presence) and uses these to automatically establish the zero-signal level, eliminating the need for manual reference calibration.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system performs preliminary characterization of the sensor signal by determining the zero-signal level before actual glucose measurements are taken. This preliminary action involves identifying calibration points and establishing the baseline signal level, which then enables accurate glucose measurements without requiring repeated reference measurements during the measurement process.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If calibration is performed without accounting for interferents, then calibration can be completed, but measurement accuracy is reduced due to interference from substances other than glucose

Engineering Contradiction:
Improveglucose level accuracyVSAvoidinterferent interference
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system converts the harmful effect of interferents into a beneficial calibration opportunity. By identifying calibration points where the sensor signal is zero (which occur when glucose is absent but interferents may be present), the system determines the zero-signal level that accounts for interferent contributions. This transformed approach uses the presence of interferents during zero-glucose conditions to establish an accurate baseline that compensates for their interfering effects.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The zero-signal level acts as an intermediary parameter that mediates between the raw sensor signal and the actual glucose concentration. By first determining this intermediary baseline that accounts for interferent effects, the system can then accurately calculate glucose levels from the corrected sensor signal, effectively separating the glucose measurement from interferent interference.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If multiple calibration references are used to improve accuracy, then measurement precision improves, but device complexity and operational complexity increase

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

Solution Approach 1:

The system extracts the essential calibration information directly from the sensor signal itself by identifying zero-signal points, eliminating the need for external calibration references. This extraction approach isolates the calibration data from the measurement process, allowing the system to perform calibration without adding external reference measurement devices or complex calibration procedures.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS11627894B2Method and a device for determining a body fluid glucose level of a patient, and a computer program product
Publication Date: 2023.04.18 ROCHE DIABETES CARE INC
  • US11627894B2 patent drawing
  • US11627894B2 patent drawing
  • US11627894B2 patent drawing

AI summary

A method for determining a body fluid glucose level of a patient from a continuous signal of a glucose sensor element of a continuous body fluid glucose monitoring device in a data processing unit, comprising receiving measurement data representing a continuous sensor signal provided by a glucose sensor element of a continuous body fluid glucose monitoring device in the data processing unit, receiving calibration data representing a time-dependent zero-signal level of the glucose sensor element in the data processing unit, determining a body fluid glucose level by processing at least the measurement data and the calibration data in the data processing unit, the processing comprising subtraction of the time dependent zero-signal level from the continuous sensor signal, and providing result data indicative of the continuous body fluid glucose level in the processing unit; and a system for determining a body fluid glucose level of a patient.