Adaptive Basal Insulin Titration via Continuous Glucose Monitoring

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Solution Overview

Problem

Current insulin titration methods for diabetes patients are inadequate due to reliance on discrete blood glucose measurements, which can be inaccurate and missed, leading to excessive insulin dosing and poor glycemic control, especially with the dawn phenomenon affecting morning glucose levels.

Innovation Solution

A system that uses continuous glucose monitor data to autonomously detect a titration glucose level, filtering out inadequate quality data and accounting for the influence of short-acting insulin, to adjust long-acting insulin dosages dynamically, ensuring accurate basal insulin titration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If discrete blood glucose measurements (SMBG) are used for insulin titration, then the measurement process is simple, but the measurement precision and reliability are poor due to missed measurements and inaccurate readings

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

Solution Approach 1:

The patent replaces the mechanical finger-stick measurement system with an electrochemical continuous glucose monitoring system that uses a sensor to detect glucose levels continuously, eliminating the need for repeated manual blood sampling and providing more reliable data for insulin titration

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

Solution Approach 2:

The patent implements continuous glucose monitoring instead of discrete measurements, maintaining constant surveillance of glucose levels to capture the true baseline value and avoid missed measurements, thereby improving measurement precision and reliability

Inventive Principle:
Principle #20Continuity of useful action

2Reliability

If fasting blood glucose measurements are used for basal insulin titration, then the titration process is straightforward, but the reliability is poor due to the dawn phenomenon causing elevated morning glucose levels

Engineering Contradiction:
Improvetitration reliabilityVSAvoiddata processing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary analysis of glucose data to identify the true baseline level before using it for titration decisions, detecting patterns such as the dawn phenomenon in advance and selecting appropriate measurement timepoints that reflect the actual basal glucose level rather than transient elevations

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent incorporates feedback mechanisms that continuously monitor glucose levels and adjust the identified baseline value based on observed patterns, ensuring that the titration is based on reliable baseline data that accounts for physiological variations like the dawn phenomenon

Inventive Principle:
Principle #23Feedback

3Measurement precision

If continuous glucose monitoring data is used to identify titration glucose levels, then the measurement precision improves, but the device complexity and data processing requirements increase

Engineering Contradiction:
Improvetitration glucose level detection precisionVSAvoiddata analysis system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the continuous glucose data into distinct periods (fasting, postprandial, bedtime) and applies different analysis methods to each segment, identifying the titration glucose level specifically from the fasting segment to improve precision while managing data complexity through structured organization

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements dynamic algorithms that adaptively identify the titration glucose level based on the actual glucose profile and pattern recognition, allowing the system to automatically adjust to individual patient patterns and physiological variations rather than using fixed thresholds

Inventive Principle:
Principle #15Dynamics

4Productivity

If manual blood glucose monitoring is used, then the system is simple to operate, but the productivity and glycemic control effectiveness are reduced due to adherence barriers and missed measurements

Engineering Contradiction:
Improveglycemic control efficiencyVSAvoidmonitoring operation ease
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent implements a system that automatically performs glucose measurements and data analysis without requiring active patient participation in each measurement event, with the CGM sensor continuously monitoring glucose levels and the algorithm automatically identifying titration-relevant values, thereby improving productivity while maintaining ease of operation through minimal user intervention

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3639268B1Basal titration with adaptive target glucose level
Publication Date: 2024.10.09 NOVO NORDISK AS
  • EP3639268B1 patent drawingFigure 1
  • EP3639268B1 patent drawingFigure 2A
  • EP3639268B1 patent drawingFigure 2B~2C

AI summary

Systems and methods are provided for adjusting long acting insulin medicament dosages for a subject. A plurality of timestamped glucose measurements of the subject is obtained. A titration glucose level (246) is computed as a measure of central tendency (244, 268, 274) of a titration subset of small glucose measurements (240, 269, 273) identified within the timestamped glucose measurements, wherein the measure of central tendency represents a measure of small glucose measurements for the primary time window. A long acting insulin medicament dosage (216) is adjusted or maintained based upon the obtained titration glucose level (246).