Automated Insulin Dosing Algorithm for Glycemic Control

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Solution Overview

Problem

Patients with diabetes often experience suboptimal glycemic control due to under-dosing of basal insulin or insulin glargine, leading to fluctuating blood glucose levels and long-term health complications, as current titration methods are inadequate for achieving perfect glycemic control.

Innovation Solution

A medical device that measures blood glucose levels and physical activity, using algorithms to calculate and adjust insulin doses based on user input and sensor data, allowing for personalized titration and improved glycemic control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional titration methods are used to adjust basal insulin dose, then the treatment is simple to implement, but the glycemic control remains suboptimal due to under-dosing

Engineering Contradiction:
Improveglycemic controlVSAvoidtitration method complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements a feedback mechanism where blood glucose measurements are continuously taken and fed into an algorithm that automatically adjusts the basal insulin dose. The system monitors the response to previous dose adjustments and uses this feedback to determine subsequent dosing, creating a closed-loop control system that improves glycemic control while reducing the need for complex manual titration decisions by healthcare professionals

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent enables patients to perform self-titration of basal insulin using an automated algorithm embedded in the dosing device. The system automatically calculates dose adjustments based on blood glucose measurements and pre-programmed algorithms, allowing patients to manage their own titration process without requiring frequent healthcare professional intervention, thus improving glycemic control while maintaining simplicity

Inventive Principle:
Principle #25Self-service

2Reliability

If basal insulin dose is increased to achieve perfect glycemic control, then glycemic control improves, but the risk of hypoglycemia increases

Engineering Contradiction:
Improveglycemic controlVSAvoidhypoglycemia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a cautious titration approach where the algorithm increases basal insulin doses in controlled increments rather than making large jumps. The system applies partial actions (small dose increases) and waits to observe the glycemic response before proceeding, thereby achieving improved glycemic control while minimizing the risk of overshooting and causing hypoglycemia

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent incorporates safety mechanisms that cushion against excessive dose increases. The algorithm includes built-in constraints and safety checks that prevent overly aggressive titration, and the system monitors for signs of hypoglycemia risk, slowing or reversing dose increases when necessary to protect the patient from harmful effects

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Measurement precision

If frequent blood glucose measurements are performed to optimize dosing, then dosing precision improves, but the time and effort required increases

Engineering Contradiction:
Improvedosing precisionVSAvoidtime for measurements
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent implements a periodic measurement schedule where blood glucose is measured at specific intervals (e.g., fasting measurements in the morning, and occasionally evening measurements) rather than requiring continuous monitoring. This periodic approach provides sufficient data for the algorithm to make accurate dose adjustments while minimizing the time and effort burden on the patient

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent replaces complex manual titration calculations and frequent measurements with an automated electronic system that uses embedded algorithms to process measurements and calculate dose adjustments. This substitution reduces the need for frequent measurements by using more efficient measurement strategies and automating the complex calculations that would otherwise require extensive data collection

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

Data Source

PatentEP2685898B1Calculating a medicament dose
Publication Date: 2022.09.07 SANOFI AVENTIS DEUT GMBH
  • EP2685898B1 patent drawingFigure 1
  • EP2685898B1 patent drawingFigure 2
  • EP2685898B1 patent drawingFigure 3

AI summary

A device comprising: means for obtaining a parameter of a sample of body fluid from a user; means for using information provided by one or more sensors to calculate a measure of physical activity of the user; means for calculating a medicament dose using at least in part the measured parameter and the measure of physical activity of the user; and means for indicating the calculated medicament dose to the user.