Multi-variant Competitive Binding Sensor for Wide-range Glucose Detection
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Solution Overview
Problem
Current non-invasive glucose monitoring devices for diabetes management are limited by their ability to accurately measure glucose concentrations over a wide range, particularly at very low levels, which is crucial for preventing hypoglycemia and managing diabetes effectively.
Innovation Solution
A sensor system utilizing multiple variants of competitive binding assays with overlapping or adjoining ranges of sensitivity, each optimized for specific glucose concentration ranges, allows for accurate measurement of glucose levels from 0 to 35 mM, using energy transfer mechanisms like FRET to provide a continuous and reversible optical signal for monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a single competitive binding assay is used for glucose monitoring, then the device is simple and easy to operate, but it cannot accurately measure glucose concentrations over a wide range (0-35 mM)
Solution Approach 1:
The sensor is divided into multiple independent assay compartments, each containing a different variant of the competitive binding assay optimized for specific glucose concentration ranges. This segmentation allows each compartment to accurately measure within its optimal range while collectively covering the full 0-35 mM range, resolving the contradiction between measurement precision and device complexity.
Solution Approach 2:
The patent transitions from a single-dimension measurement approach to a multi-dimensional approach by incorporating multiple assay variants with different sensitivity profiles. Each variant operates in its own optimal range, and the results are integrated to provide comprehensive coverage across the entire glucose concentration spectrum, enabling accurate measurement from 0-35 mM.
2Reliability
If blood glucose testing is performed frequently (4+ times per day) to improve diabetes control, then glucose management improves, but patient burden and discomfort increase
Solution Approach 1:
The patent replaces the mechanical blood withdrawal system (lancet-based finger pricks) with a subcutaneous sensor system that continuously or frequently monitors glucose in interstitial fluid. This substitution eliminates the painful and inconvenient blood sampling process while maintaining reliable glucose control, allowing frequent measurements without increasing patient burden.
Solution Approach 2:
The sensor system performs self-monitoring of glucose levels in interstitial fluid without requiring active patient participation in blood sampling. The device autonomously collects and analyzes interstitial fluid glucose, providing reliable measurements that reflect blood glucose levels without requiring the patient to perform painful finger pricks.
3Ease of operation
If non-invasive subcutaneous glucose monitoring is implemented, then patient comfort improves, but measurement accuracy at very low glucose concentrations deteriorates
Solution Approach 1:
Different regions or compartments of the sensor are assigned different qualities - specifically, different assay variants with different sensitivity characteristics. Compartments containing assays with higher sensitivity are positioned or weighted to provide accurate measurements at very low glucose concentrations, while other compartments handle higher concentration ranges, ensuring overall accuracy across the full spectrum.
Solution Approach 2:
The patent varies key parameters of the competitive binding assays across different compartments, including the affinity constants (Kd) of the binding agents and the concentrations of analyte analogues. This parameter variation allows each assay variant to be optimized for specific concentration ranges, with higher sensitivity assays detecting very low glucose levels accurately while maintaining patient comfort through non-invasive subcutaneous monitoring.
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 more sensitive and accurate glucose monitoring across the clinically relevant range, reducing false alarms and improving long-term glucose control, thereby aiding in the prevention of diabetes-related complications.
Implementation Method 1
Energy transfer occurs between the donors and the acceptors when they are brought together, which produces a detectable lifetime change (reduction) of the fluorescence of the energy donor moiety
Implementation Method 2
the other part of the donor-acceptor pair (bound to a ligand carrier) and any analyte present compete for binding sites on the receptor carrier
Data Source
AI summary
A sensor for sensing analyte concentration comprises at least two different variants of an appropriate competitive binding assay, the sensor being capable of sensing accurately a required range of analyte concentrations by means of the variants of the assay each being capable of sensing accurately a part only of the required range of analyte concentrations and the variants of the assay being chosen to sense overlapping or adjoining ranges of concentration covering the whole of the required range.