Personalized Insulin Delivery Control with CR and ISF Lockouts

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Solution Overview

Problem

Current insulin delivery systems for diabetes management impose a significant cognitive burden on patients and caregivers, requiring frequent and individualized dosing determinations, and there is a lack of a reliable and safe automated solution for glycemic control.

Innovation Solution

A system and method that personalizes insulin delivery by determining relationships between basal rate (BR), carbohydrate-to-insulin ratio (CR), and insulin sensitivity factor (ISF), comparing these to general probability distributions, and providing user interfaces for recommended adjustments, with features like lockout mechanisms to prevent excessive insulin delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual insulin dosing is used, then flexibility in dosing decisions is maintained, but cognitive burden on patients and caregivers increases significantly

Engineering Contradiction:
Improveease of insulin dosingVSAvoidcognitive burden
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The system enables self-service by automatically calculating and adjusting insulin dosing parameters (CR and ISF) based on continuous glucose monitoring data, eliminating the need for manual dosing decisions by patients and caregivers while maintaining personalized therapy

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system implements continuous feedback loops where glucose monitoring data automatically triggers parameter adjustments and dosing recommendations, creating a closed-loop system that adapts to changing physiological conditions without requiring cognitive processing by the user

Inventive Principle:
Principle #23Feedback

2Reliability

If frequent dosing adjustments are made to improve glycemic control, then glycemic control improves, but safety risks increase due to potential for excessive insulin delivery

Engineering Contradiction:
Improveglycemic controlVSAvoidrisk of excessive insulin delivery
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system implements beforehand cushioning through lockout mechanisms that prevent excessive insulin delivery by limiting the frequency and magnitude of dosing adjustments, and by requiring confirmation for certain parameter changes, thereby cushioning against potential harmful errors before they occur

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

Solution Approach 2:

Continuous glucose monitoring provides real-time feedback that automatically triggers parameter adjustments only when clinically indicated, ensuring that dosing changes are responsive to actual physiological needs rather than arbitrary modifications, thereby improving reliability while maintaining safety

Inventive Principle:
Principle #23Feedback

3Extent of automation

If automated insulin delivery is implemented, then cognitive burden is reduced, but system complexity and regulatory approval challenges increase

Engineering Contradiction:
Improveautomation of insulin deliveryVSAvoidsystem complexity
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The system applies segmentation by dividing the automated delivery function into separate adjustable parameters (CR and ISF) that can be independently optimized and adjusted, allowing the complex automated system to be managed through simple, discrete parameter modifications rather than monolithic control

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS20250256027A1System and method for adjusting insulin delivery
Publication Date: 2025.08.14 INSULET CORP
  • US20250256027A1 patent drawing
  • US20250256027A1 patent drawing
  • US20250256027A1 patent drawing

AI summary

The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include receiving and/or determining one or more user specific dosage parameters.