Adaptive Basal Insulin Titration for Hypoglycemia Risk Reduction

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Solution Overview

Problem

Current insulin titration systems rely on fixed targets set by healthcare practitioners, which do not account for changes in physiological parameters or adherence, leading to potential overdosing and hypoglycemic events due to forgotten injections or inaccurate glucose measurements.

Innovation Solution

A titrator with a variable target fasting blood glucose level, adjusted based on glucose and insulin data, including total glucose level variability, fasting glucose variance, minimum glucose values, insulin sensitivity, and adherence to the insulin regimen, to autonomously adjust long-acting insulin dosages.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a fixed target fasting blood glucose level is used for insulin titration, then the titration process is simple and easy to implement, but it leads to hypoglycemic events when patients miss injections or have inaccurate glucose measurements

Engineering Contradiction:
Improvesimplicity of titration processVSAvoidrisk of hypoglycemic events
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements dynamic target glucose levels that automatically adjust based on adherence metrics and glucose variability. Instead of a fixed target, the system calculates adaptive targets that rise when adherence is poor or variability is high, and fall when adherence is good and variability is low. This dynamic adjustment prevents hypoglycemia while maintaining simplicity for the user.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback loops that continuously monitor adherence data and glucose measurements, then adjust the target glucose level accordingly. The feedback mechanism uses adherence thresholds and variability metrics to automatically modify treatment targets, creating a closed-loop control system that responds to patient behavior and physiological responses.

Inventive Principle:
Principle #23Feedback

2Reliability

If the target glucose level is adjusted dynamically based on multiple parameters, then the reliability and safety of insulin titration is improved, but the device complexity and computational requirements increase

Engineering Contradiction:
Improvesafety of insulin titrationVSAvoidcomplexity of titration system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the parameters used for titration from a single fixed target to multiple dynamic parameters including adherence metrics, glucose variability measures, and adaptive target levels. The system monitors adherence thresholds and variability thresholds, then adjusts the target glucose parameter accordingly. This approach maintains safety while using computationally manageable parameter changes.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system segments the titration process into distinct phases: an initial phase with higher targets for patients with poor adherence or high variability, and a subsequent phase with lower targets for patients with good adherence and low variability. This segmentation allows complex adaptive logic to be implemented through manageable阶段性 protocols.

Inventive Principle:
Principle #1Segmentation

3Adaptability or versatility

If traditional fixed target titration is used, then treatment adherence monitoring is not required, but adherence to the insulin regimen directly impacts glucose control and safety

Engineering Contradiction:
Improveresponsiveness to adherence changesVSAvoidneed for adherence monitoring system
Core Design Contradiction:
Adaptability or versatilityVSExtent of automation

Solution Approach 1:

The system implements self-service adherence monitoring where the titration algorithm automatically detects and responds to adherence patterns. The system monitors whether patients are taking their insulin as prescribed and automatically adjusts targets based on this information, eliminating the need for manual adherence assessment by healthcare providers.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system incorporates feedback loops that continuously monitor adherence data and glucose measurements, then adjust the target glucose level accordingly. The feedback mechanism uses adherence thresholds and variability metrics to automatically modify treatment targets, creating a closed-loop control system that responds to patient behavior and physiological responses.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3481274B1Basal titration with adaptive target glucose level
Publication Date: 2023.01.25 NOVO NORDISK AS
  • EP3481274B1 patent drawingFigure 1
  • EP3481274B1 patent drawingFigure 2
  • EP3481274B1 patent drawingFigure 3

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 and insulin injection data is obtained. A first glycaemic risk measures is determined, where the first risk glycaemic risk measure is i) glucose level variability across the glucose measurements, (ii) a variability in fasting glucose levels calculated from the glucose measurements, (iii) a minimum observed glucose measurement in the plurality of glucose measurements (iv) rate of change in ISF, or (v) adherence values. A fasting blood glucose target function is computed based upon at least the first glycaemic risk measure thereby obtaining an updated target fasting blood glucose level that is between a minimum and maximum target fasting blood glucose level. The long acting insulin medicament dosage is adjusted based upon the updated target fasting blood glucose level.