User-Specific Cost Functions for Closed-Loop Artificial Pancreas Dosing

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Solution Overview

Problem

Conventional closed loop insulin delivery systems fail to account for individual differences in daily insulin needs, leading to inadequate insulin dosages that can result in hypoglycemia or hyperglycemia for users with high or low insulin requirements.

Innovation Solution

A closed loop artificial pancreas system uses a customized cost function that adjusts penalties for glucose and insulin excursions based on a user's unique insulin needs, incorporating parameters such as insulin sensitivity, insulin to carbohydrate ratio, and basal insulin level to optimize insulin delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual bolus insulin delivery is used, then the patient can receive insulin correction, but the patient may receive improper amounts of insulin leading to hypoglycemia risk

Engineering Contradiction:
Improveinsulin dosage accuracyVSAvoidhypoglycemia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The closed loop control system continuously monitors glucose levels and uses this feedback to automatically adjust and deliver appropriate insulin bolus amounts, eliminating the manual estimation errors that cause improper dosing and hypoglycemia risk

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables self-service by automatically calculating and delivering the correct insulin dosage based on real-time glucose monitoring, removing the need for manual patient intervention and reducing dosing errors

Inventive Principle:
Principle #25Self-service

2Extent of automation

If closed loop control system delivers insulin at fixed intervals, then insulin delivery is automated, but the system may deliver smaller insulin doses more frequently which can still result in inadequate dosing for users with high or low insulin requirements

Engineering Contradiction:
Improveinsulin delivery automationVSAvoidinsulin dosage adequacy
Core Design Contradiction:
Extent of automationVSReliability

Solution Approach 1:

The system dynamically changes the insulin delivery parameters (dosage amount, frequency, and timing) based on individual user characteristics including insulin sensitivity, insulin to carbohydrate ratio, and basal insulin level, allowing customization for users with varying insulin requirements

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The closed loop control system dynamically adjusts insulin delivery parameters in real-time based on continuous glucose monitoring and user-specific parameters, transitioning from fixed-interval dosing to adaptive dosing that responds to changing physiological needs

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS12427251B2User parameter dependent cost function for personalized reduction of hypoglycemia and/or hyperglycemia in a closed loop artificial pancreas system
Publication Date: 2025.09.30 INSULET CORP
  • US12427251B2 patent drawing
  • US12427251B2 patent drawing
  • US12427251B2 patent drawing

AI summary

Exemplary embodiments described herein relate to a closed loop artificial pancreas system. The artificial pancreas system seeks to automatically and continuously control the blood glucose level of a user by emulating the endocrine functionality of a healthy pancreas. The artificial pancreas system uses a closed loop control system with a cost function. The penalty function helps to bound the infusion rate of insulin to attempt to avoid hypoglycemia and hyperglycemia. However, unlike conventional systems that use a generic or baseline parameter for a user's insulin needs in a cost function, the exemplary embodiments may use a customized parameter in the cost function that reflects the individualized insulin needs of the user. The use of the customized parameter causes the cost function to result in insulin dosages over time better suited to the individualized insulin needs of the user. This helps to better avoid hypoglycemia and hyperglycemia.