Insulin Dosage Optimization System with Safety Factor

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Solution Overview

Problem

Current insulin dosage titration regimens for patients with type 2 diabetes are time-consuming and prone to errors, especially when patients self-titrate, which can lead to incorrect adjustments and potential hypoglycemia due to aggressive titration algorithms.

Innovation Solution

A system comprising a BG meter, memory, and processor that calculates a correction value to adjust insulin dosages based on blood glucose data, incorporating a safety factor to reduce the aggressiveness of titration recommendations and ensuring compliance with the regimen, which can be integrated into a drug delivery device or used as a standalone cap device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If aggressive titration algorithms are used for self-titration, then dosage optimization speed is improved, but safety deteriorates due to increased risk of hypoglycemia

Engineering Contradiction:
Improvedosage optimization speedVSAvoidsafety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system applies preliminary anti-action by implementing a safety factor that counteracts aggressive titration recommendations before they can cause harm. The safety factor reduces the aggressiveness of titration algorithms proactively, preventing hypoglycemia rather than reacting to it after occurrence.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The safety factor acts as an intermediary between the aggressive titration algorithm and the actual dosage adjustment. It mediates the relationship by modifying the algorithm's output to ensure safety while maintaining optimization effectiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If complex algorithms are implemented to account for patient characteristics, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improvedosage recommendation accuracyVSAvoidalgorithm complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system applies partial action by implementing a safety factor that partially modifies titration recommendations rather than completely redesigning the algorithm. This approach achieves improved accuracy through a targeted intervention rather than comprehensive complexity.

Inventive Principle:
Principle #16Partial or excessive action

3Reliability

If safety factors are incorporated to reduce aggressiveness, then reliability is improved, but productivity decreases due to more conservative adjustments

Engineering Contradiction:
ImprovesafetyVSAvoidtitration speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system changes parameters by introducing a safety factor that modifies the aggressiveness parameter of titration algorithms. This parameter change allows the system to maintain reliability while preserving acceptable productivity through controlled adjustment of the safety factor level.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2798546B1Adaptive system for optimizing a drug dosage regimen over time
Publication Date: 2020.12.23 NOVO NORDISK AS
  • EP2798546B1 patent drawingFigure 1~2
  • EP2798546B1 patent drawingFigure 3~4
  • EP2798546B1 patent drawingFigure 5

AI summary

A system for optimizing a patient's basal insulin dosage regimen over time, adapted to determine from blood glucose values whether and by how much to vary a patient's present recommended amount of the insulin-containing drug in order to maintain the patient's future blood glucose level measurements within a predefined range, and wherein a given blood glucose value is disregarded if no patient-actuated operation being indicative of the administration of a dose of an insulin containing drug has been detected in a pre-defined amount of time prior to the determination of the given blood glucose value.