Dual Analyte Test Strip for Simultaneous Glucose and Ketone Measurement

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Solution Overview

Problem

Current glucose and ketone monitoring systems for diabetics are cumbersome and time-consuming, requiring separate tests for blood glucose and ketone levels, which can lead to delayed or incomplete analysis, making it difficult for diabetics to manage their condition effectively, especially in critical situations like diabetic ketoacidosis (DKA).

Innovation Solution

A dual test element system that simultaneously measures glucose and ketone levels in a single sample, providing immediate and continuous monitoring, with a meter that displays results and alerts the user to critical levels, allowing for timely intervention and trending analysis to prevent complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If separate tests are performed for blood glucose and ketone levels, then each analyte can be measured with dedicated test elements, but the testing process becomes time-consuming and cumbersome

Engineering Contradiction:
Improveanalyte measurement accuracyVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines multiple test elements (glucose test element and ketone test element) into a single integrated test strip. This allows simultaneous measurement of both glucose and ketone levels in one blood sample, eliminating the need for separate testing procedures and reducing overall testing time while maintaining measurement precision for each analyte

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated test strip is designed to perform multiple functions: it can measure both glucose and ketone levels using a single device and single blood sample. This multi-functional approach allows diabetics to monitor multiple critical parameters simultaneously, making the testing process more efficient without compromising analytical accuracy

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If separate tests are performed for blood glucose and ketone levels, then dedicated analysis can be performed for each analyte, but the overall process becomes complex and burdensome

Engineering Contradiction:
Improveanalyte concentration determinationVSAvoidtesting system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges the glucose test element and ketone test element into a single integrated test strip with multiple reagent zones. Each zone contains specific enzymes and chemicals for detecting its target analyte, allowing simultaneous measurement of multiple parameters in one device without requiring separate testing equipment or procedures

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated test strip serves as a universal testing device that can analyze multiple analytes (glucose and ketones) in a single blood sample. This eliminates the need for multiple separate test strips and devices, reducing system complexity while maintaining the ability to perform dedicated analysis for each analyte type

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If separate urine tests are performed for ketone levels in addition to blood glucose tests, then ketone monitoring is achieved, but the testing routine becomes excessively time-consuming

Engineering Contradiction:
Improveketone level detectionVSAvoidtotal testing duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines ketone detection capability with glucose monitoring in a single integrated test strip. Both measurements are performed simultaneously using one blood sample, eliminating the need for separate urine ketone tests and significantly reducing the total time required for monitoring both parameters

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 system enables diabetics to manage their condition more effectively by providing immediate and continuous monitoring of both glucose and ketone levels, reducing the risk of DKA and other complications through timely intervention and trending analysis.

Implementation Method 1

measures the amount of glucose in the blood sample electrochemically

Methodology Applied
Scientific EffectElectrochemical reaction:

Implementation Method 2

measuring the concentration of hydroxybutyrate, which is the predominate ketone in blood

Methodology Applied
Scientific EffectElectrochemical reaction:

Data Source

PatentEP4152003A1Systems and methods for multiple analyte analysis
Publication Date: 2023.03.22 ROCHE DIABETES CARE GMBH
  • EP4152003A1 patent drawingFigure 1
  • EP4152003A1 patent drawingFigure 2
  • EP4152003A1 patent drawingFigure 3

AI summary

Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.