Optical Glycemic Assessment Using Analyte Panel Predictive Models

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Solution Overview

Problem

Current methods for assessing glycemic regulation and atherosclerotic cardiovascular disease (ASCVD) are inadequate, particularly in early detection and management, as they rely on invasive and time-consuming tests like the insulin suppression test and oral glucose tolerance test, which are uncomfortable and resource-intensive, and do not provide timely or accurate indicators for individualized treatment.

Innovation Solution

A method involving the measurement of a panel of analytes, including clinical data, personal data, metabolites, protein constituents, genomic DNA, transcript expression, lipids, and human microbiota, used in computational predictive models to determine steady-state plasma glucose and glucose tolerance levels, allowing for personalized treatment approaches based on Bayesian or ridge regression models.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standard glycemia assessment methods (FPG, HbA1c, OGTT, insulin suppression test) are used, then glycemic regulation can be evaluated, but the process is invasive, time-consuming, and resource-intensive

Engineering Contradiction:
Improveglycemic regulation assessment accuracyVSAvoidassessment time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces invasive mechanical blood sampling and laboratory testing with non-invasive optical sensing technology. The system uses optical sensors to measure glycemic parameters and other analytes through the skin or other body surfaces, eliminating the need for traditional needle sticks and blood collection procedures while maintaining measurement accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates a digital copy of the physiological state through optical measurements. Instead of directly measuring blood glucose through invasive means, the system optically detects correlates of glycemic status and processes this information through algorithms to infer metabolic parameters, creating a virtual representation of physiological state without physical intrusion.

Inventive Principle:
Principle #26Copying

2Measurement precision

If standard glycemia assessment methods are used, then glycemic regulation can be evaluated, but the process is uncomfortable for patients

Engineering Contradiction:
Improveglycemic regulation assessment accuracyVSAvoidpatient comfort
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces uncomfortable mechanical needle sticks and blood draws with gentle optical sensing. The optical sensors detect glycemic information through light transmission or reflection through the skin, causing no pain, bleeding, or tissue damage, thereby dramatically improving patient comfort while maintaining diagnostic accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system enables continuous self-monitoring without requiring patient intervention in the form of blood sampling. The optical sensing device can be worn continuously and automatically captures glycemic data, allowing patients to monitor their own metabolic state without the discomfort and inconvenience of repeated invasive testing.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If invasive blood sampling and laboratory testing are used, then accurate glycemic data can be obtained, but resource consumption increases

Engineering Contradiction:
Improveglycemic data accuracyVSAvoidresource consumption
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent replaces resource-intensive laboratory infrastructure and blood processing systems with portable optical sensing technology. The system uses minimal hardware components including light sources, detectors, and signal processing electronics, eliminating the need for centralized labs, reagents, and complex sample processing while maintaining data accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs disposable optical sensors and single-use measurement elements that can be discarded after use, eliminating the need for expensive reusable laboratory equipment, reagent bottles, and complex disposal protocols. The low-cost disposable sensors reduce both capital expenditure and operational costs while providing continuous accurate measurement.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Reliability

If traditional assessment methods are used, then current glycemic status can be determined, but early detection of progression to diabetes and ASCVD is not enabled

Engineering Contradiction:
Improvecurrent glycemic status determinationVSAvoidearly detection capability
Core Design Contradiction:
ReliabilityVSForce

Solution Approach 1:

The patent performs preliminary optical measurements of multiple analytes including glucose, lipids, and inflammatory markers to detect early signs of metabolic dysfunction before clinical diagnosis is required. By continuously monitoring and analyzing trends in these markers, the system can identify individuals at risk for developing diabetes or cardiovascular disease and enable early intervention before symptoms appear.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent transitions from single-point-in-time glycemic measurement to multi-dimensional continuous monitoring. The system simultaneously measures multiple analytes (glucose, lipids, proteins, metabolites) and tracks their temporal trends, adding the dimension of time and biological context to the assessment. This multi-dimensional approach enables detection of subtle changes and patterns that indicate early disease progression.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Data Source

PatentUS11929171B2Methods for evaluation and treatment of glycemic dysregulation and atherosclerotic cardiovascular disease and applications thereof
Publication Date: 2024.03.12 THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIV
  • US11929171B2 patent drawing
  • US11929171B2 patent drawing
  • US11929171B2 patent drawing

AI summary

Methods to compute glycemia tests and applications thereof are described. Additional methods to compute risk of atherosclerotic cardiovascular disease and applications thereof are described. Generally, systems utilize analyte measurements to determine a glycemic status or cardiovascular disease risk, which can be used as a basis to treat individuals.