Segregating Control Data in Blood Glucose Meters

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Solution Overview

Problem

Existing methods for measuring analyte concentrations in blood, particularly glucose, face challenges due to confounding variables such as hematocrit levels, temperature, and other chemicals, which affect the accuracy of electrochemical measurements, and there is a need to segregate control and calibration data from test data to ensure accurate and reliable results.

Innovation Solution

The use of control and calibration solutions that generate distinct responses, allowing a measuring device to recognize and segregate them from test data, and employing AC and DC signals to measure impedance and correct for interferants, ensuring accurate analyte measurement despite confounding factors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If control and calibration data are stored in the same memory as test data, then device complexity is reduced, but measurement precision deteriorates due to potential co-mingling and inaccurate results

Engineering Contradiction:
Improvedata storage structureVSAvoiddata accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent applies segmentation by dividing the data storage memory into separate segments: a test data storage area and a control/calibration data storage area. This physical separation prevents co-mingling of data types while maintaining overall system simplicity. The meter distinguishes between test results and control/calibration results through this segmented storage architecture, ensuring measurement precision is not compromised.

Inventive Principle:
Principle #1Segmentation

2Productivity

If electrochemical methods are used to measure analyte concentration, then measurement speed is improved, but reliability deteriorates due to confounding variables such as hematocrit, temperature, and other chemicals

Engineering Contradiction:
Improvemeasurement speedVSAvoidmeasurement accuracy
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent implements feedback mechanisms through control solutions and calibration curves. The control solution provides known reference values that feed back into the measurement system to verify accuracy under varying conditions. The calibration curve, derived from control solutions, allows the system to adjust and correct measurements based on observed relationships between electrochemical signals and actual analyte concentrations, compensating for confounding variables like hematocrit and temperature.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent applies parameter changes by adjusting measurement parameters based on detected conditions. The system monitors variables such as hematocrit, temperature, and signal characteristics, and dynamically modifies measurement parameters or applies correction factors. This allows the electrochemical measurement system to maintain reliability across varying physiological conditions while preserving rapid measurement capability.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If control and calibration data are segregated from test data, then measurement precision is improved, but device complexity increases due to separate storage and processing requirements

Engineering Contradiction:
Improvedata accuracyVSAvoiddata management system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges the functionality of control/calibration data management with the existing test data processing architecture. Both control/calibration data and test data are processed through the same microprocessor and display system. The meter automatically identifies control and calibration results and presents them alongside test results, combining multiple functions into a unified system that maintains precision without proportionally increasing complexity.

Inventive Principle:
Principle #5Merging (Combining)

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 enables accurate and rapid measurement of analyte concentrations, including glucose, by correcting for interferants and segregating control/calibration data, thereby improving the reliability and convenience of blood glucose monitoring and extending to other biological fluids for improved medical diagnosis.

Implementation Method 1

electrochemical methods generally involve, alternatively, amperometric or coulometric responses indicative of the concentration of the analyte

Methodology Applied
Scientific EffectElectrochemical response:

Implementation Method 2

employing AC and DC signals to measure impedance and correct for interferants

Methodology Applied
Scientific EffectImpedance measurement: Electrical Resistance

Data Source

PatentEP2344878B1Identification of control and calibration solutions
Publication Date: 2012.08.01 ROCHE DIAGNOSTICS GMBH
  • EP2344878B1 patent drawingFigure 1
  • EP2344878B1 patent drawingFigure 2
  • EP2344878B1 patent drawingFigure 3A~3B

AI summary

Control and calibration solutions are recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data, based on the measured AC admittance of the control and callibration solutions, which is uncharacteristic for biological fluids.