Insulin Dose Adjustment Algorithm for Glycemic Control

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Solution Overview

Problem

Current methods for adjusting insulin doses in diabetes management often result in under-dosing, leading to suboptimal glycemic control, which can cause short-term discomfort and long-term health issues due to the lack of flexibility and customization in existing titration approaches.

Innovation Solution

A medical device and method that includes storage, data processing, and validation mechanisms to customize insulin dose adjustments based on individual patient needs, using blood glucose data and security validation to stepwise adapt insulin doses, with features like dose setting, carbohydrate calculation, and glycemic event handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If fixed insulin dosing schedules are used, then treatment simplicity is maintained, but glycemic control precision deteriorates

Engineering Contradiction:
Improvetreatment simplicityVSAvoidglycemic control precision
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent implements dynamic dose adjustment through automated titration algorithms that continuously modify insulin dosing based on real-time blood glucose measurements. The system transitions from static fixed schedules to dynamic adaptive dosing, where the dose is automatically adjusted based on measured glycemic values, time since last dose, and patient-specific parameters stored in memory.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback loops where blood glucose measurements are continuously taken, compared against target ranges, and used to automatically adjust subsequent insulin doses. The titration process uses feedback from glycemic events and blood glucose trends to incrementally optimize dosing parameters while maintaining treatment simplicity for the patient.

Inventive Principle:
Principle #23Feedback

2Ease of manufacture

If standardized titration protocols are applied, then ease of implementation is improved, but adaptability to individual patient needs deteriorates

Engineering Contradiction:
Improveease of implementationVSAvoidadaptability to individual patient needs
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent implements local quality by storing and applying patient-specific parameters including individual target blood glucose ranges, personal dosing constraints, historical glycemic data, and specific clinical conditions. Each patient's treatment protocol is customized with locally optimized parameters while using the same overall titration platform, allowing standardized implementation with individualized adaptation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system changes parameters dynamically by adjusting dose amounts, titration step sizes, and target ranges based on individual patient responses. The algorithm modifies dosing parameters incrementally based on measured glycemic outcomes, allowing the same standardized protocol to adapt to each patient's unique metabolic characteristics through parameter optimization.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If manual dose adjustment by healthcare professionals is used, then dosing accuracy can be optimized, but treatment time and complexity increase

Engineering Contradiction:
Improvedosing accuracyVSAvoidtreatment time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent implements self-service through automated self-titration functionality where the system independently performs dose calculations, determines optimal dosing adjustments, and generates treatment recommendations without requiring continuous healthcare professional intervention. The algorithm autonomously analyzes blood glucose data, applies titration rules, and adjusts dosing parameters, freeing healthcare professionals from routine dose calculation tasks while maintaining dosing accuracy.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system replaces manual mechanical dose adjustment processes with automated electronic calculations and algorithmic decision-making. The titration algorithm substitutes human manual computation with automated processing of blood glucose data, eliminating time-consuming manual calculations while maintaining or improving dosing accuracy through consistent application of evidence-based titration rules.

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

Data Source

PatentUS11166650B2Medical device and method for glycemic control
Publication Date: 2021.11.09 SANOFI AVENTIS DEUT GMBH
  • US11166650B2 patent drawing
  • US11166650B2 patent drawing
  • US11166650B2 patent drawing

AI summary

A medical device and method for determining a dose of insulin to be administered for glycemic control is provided, wherein the dose is stepwise adapted. The method includes determining a blood glucose value, receiving glycemic event information in respect to a predetermined glycemic event, wherein the predetermined glycemic event occurred within a predetermined time interval, receiving a previously adapted dose value stored in a storage unit, and setting an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert indicates that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.