CGM-Based Basal Insulin Titration System

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Solution Overview

Problem

Current basal insulin titration methods for Type 2 Diabetes rely on manual finger-stick blood glucose measurements, which are cumbersome and prone to errors, leading to potential hypoglycemia risks due to reliance on single samples and lack of continuous glucose monitoring, hindering the determination of optimal insulin dosages.

Innovation Solution

A device and method utilizing continuous glucose monitoring (CGM) data to generate historical estimated glucose values, daily blood glucose state parameters, and effective insulin doses, coupled with models to adjust basal insulin doses automatically, minimizing hypoglycemia risks and improving insulin titration accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual finger-stick blood glucose measurements are used for insulin titration, then the process is simple and does not require complex devices, but the measurement precision and reliability are insufficient due to reliance on single samples and patient compliance

Engineering Contradiction:
Improveblood glucose measurement accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces manual finger-stick blood glucose measurement (mechanical/chemical system) with continuous glucose monitoring using CGM sensors (electronic/biochemical system). The CGM system continuously measures interstitial glucose levels and transmits data wirelessly, eliminating the need for repeated finger pricks and providing more accurate, reliable glucose profiles for insulin titration decisions.

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

2Reliability

If continuous glucose monitoring is implemented for automated insulin titration, then the reliability and safety are improved by reducing hypoglycemia risks, but the device complexity and cost increase

Engineering Contradiction:
Improveinsulin titration safetyVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements a closed-loop feedback system where CGM continuously monitors glucose levels and transmits data to a processor that analyzes the glucose profile, insulin sensitivity, and hypoglycemia risk. The system automatically adjusts basal insulin dosage recommendations based on this feedback, creating a dynamic titration process that adapts to the patient's real-time glucose metabolism, thereby improving safety and reliability.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables automated insulin titration by having the algorithm independently analyze CGM data, calculate insulin sensitivity factors, predict hypoglycemia risk, and generate dosage recommendations without requiring manual intervention or interpretation by healthcare providers or patients, reducing human error and improving consistency.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If multiple blood glucose samples are collected to improve titration accuracy, then the measurement precision improves, but the ease of operation decreases due to increased burden on patients

Engineering Contradiction:
Improveglucose profile accuracyVSAvoidpatient compliance
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent implements continuous glucose monitoring that operates 24/7 without interruption, continuously measuring interstitial glucose levels and transmitting data throughout the day and night. This eliminates the need for patients to perform discrete finger-stick measurements at specific times, as the CGM system continuously captures the complete glucose profile, including fasting, postprandial, and sleep periods, thereby maintaining high measurement precision while significantly improving ease of operation and patient compliance.

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentUS20240058532A1System and method for titrating basal insulin doses
Publication Date: 2024.02.22 DEXCOM INC
  • US20240058532A1 patent drawing
  • US20240058532A1 patent drawing
  • US20240058532A1 patent drawing

AI summary

A continuous glucose monitor (CGM)-driven basal insulin titration system and method for patients with Type 2 Diabetes can be adapted to the needs and concerns of subjects just starting on basal insulin therapy. The method uses as inputs historical CGM data, basal insulin dose information, reports of hypoglycemia, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop. The method can generate a new recommendation on a regular basis (e.g., each day) until it determines an adequate, consistent dose size.