Continuous Analyte Monitoring for Real-Time Kidney Disease Staging
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Solution Overview
Problem
Existing techniques for diagnosing and staging kidney disease, such as albumin-to-creatinine ratio (ACR) tests and glomerular filtration rate (GFR) tests, are imprecise and lack sensitivity and specificity, leading to delayed diagnosis and ineffective monitoring of kidney function, which can result in irreversible health decline and even death.
Innovation Solution
A continuous analyte monitoring system that measures analytes like glucose and 1,5-AG in real-time, providing real-time therapy management guidance through a therapy management system that includes a sensor electronics module, display device, and machine learning models to monitor and stage kidney disease.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional ACR and GFR tests are used for kidney disease diagnosis, then the diagnostic process is simple and cost-effective, but the measurement precision and sensitivity are insufficient leading to delayed diagnosis
Solution Approach 1:
The patent segments the monitoring system into multiple independent components: continuous analyte sensor for real-time detection, sensor electronics module for signal processing, display device for information presentation, and therapy management system for clinical decision support. This segmentation enables high measurement precision through specialized sensors while managing overall system complexity through modular architecture.
Solution Approach 2:
The patent introduces an intermediary continuous analyte monitoring system that bridges the gap between simple traditional tests and complex gold standard measurements. The system uses analytes like glucose and 1,5-AG as intermediaries to indirectly assess kidney function with high precision, avoiding the need for direct complex measurements while achieving superior diagnostic accuracy.
2Reliability
If continuous analyte monitoring system is implemented, then real-time monitoring precision is improved, but the device complexity and cost increase
Solution Approach 1:
The continuous analyte monitoring system is designed with multi-functionality to justify its complexity: it simultaneously provides real-time analyte concentration measurements, calculates kidney function metrics (GFR, reabsorption threshold), stages kidney disease progression, and generates therapy management guidance. This universality consolidates multiple functions into a single integrated system, improving reliability while managing complexity through functional integration.
Solution Approach 2:
The system implements continuous feedback loops where real-time analyte measurements are immediately processed to update kidney function assessments and disease staging. The therapy management system receives ongoing feedback from the monitoring components, enabling dynamic adjustment of treatment guidance. This feedback mechanism enhances monitoring reliability by ensuring continuous validation and updating of diagnostic information.
3Speed
If traditional periodic testing is used, then the system is easier to operate and maintain, but the response time for disease progression detection is delayed
Solution Approach 1:
The patent implements continuous monitoring of analyte concentrations in the patient's bloodstream, eliminating the periodic interruptions inherent in traditional testing. The sensor continuously measures glucose and 1,5-AG levels, providing an unbroken data stream that immediately reflects changes in kidney function. This continuity enables rapid detection of disease progression while the automated processing and display systems maintain ease of operation by handling the continuous data flow without requiring constant user intervention.
Data Source
AI summary
Certain aspects of the present disclosure provide a monitoring system comprising a continuous analyte sensor configured to penetrate a skin of a patient and generate a sensor current indicative of analyte levels of the patient, and a sensor electronics module coupled to the continuous analyte sensor. The sensor electronics module comprises an analog to digital converter configured to receive the sensor current and convert the sensor current generated by the continuous analyte sensor into digital signals, a processor configured to convert the digital signals to a set of analyte measurements indicative of the analyte levels of the patient, and a Bluetooth antenna configured to transmit the set of analyte measurements wirelessly to a wireless communications device using Bluetooth or BLE communications protocols.