Dynamic Insulin Delivery Rate Constraint for Closed-Loop Systems

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Solution Overview

Problem

Current insulin delivery systems face challenges in setting effective dynamic constraints for insulin dosing, particularly when considering temporary basal rates, extended boluses, and combination boluses, which can lead to aggressive or ineffective control, resulting in over-insulinization or ineffective glycemic management.

Innovation Solution

A method for determining a dynamic maximum insulin delivery rate using a controller that takes into account basal delivery rates, temporary delivery rates, and extended boluses, employing a model predictive control algorithm or PID control to adjust insulin delivery safely and effectively, ensuring glycemic control without adverse effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a constant maximum insulin delivery rate constraint is used in MPC control, then the system is simple to implement, but it fails to account for temporary basal rates and extended boluses, leading to aggressive control and over-insulinization

Engineering Contradiction:
Improvesafety of insulin deliveryVSAvoidcomplexity of constraint calculation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements dynamic maximum insulin delivery rate constraints that automatically adjust based on the current insulin delivery profile. The controller calculates the maximum rate as a function of the basal rate, temporary basal rate, and extended bolus parameters, allowing the constraint to adapt in real-time to changing delivery conditions without requiring complex manual configuration

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system continuously monitors the current insulin delivery profile (basal rate, temporary basal rate, extended bolus status) and uses this feedback to dynamically adjust the maximum insulin delivery rate constraint. This closed-loop approach ensures the constraint remains appropriate for the current operational state, preventing both over-insulinization and ineffective control

Inventive Principle:
Principle #23Feedback

2Productivity

If the maximum insulin delivery rate is set high to handle extended boluses, then extended bolus delivery is effective, but aggressive control and hypoglycemia may occur during temporary basal rates

Engineering Contradiction:
Improveeffectiveness of extended bolus deliveryVSAvoidrisk of hypoglycemia
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The maximum insulin delivery rate is dynamically adjusted based on the type of insulin delivery active at each moment. When an extended bolus is detected, the maximum rate increases to accommodate the higher delivery需求. When only temporary basal rate is active, the maximum rate decreases to prevent aggressive control and hypoglycemia, thus adapting the constraint to the current operational mode

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

Different maximum insulin delivery rate constraints are applied locally to different operational states. The system identifies the current state (extended bolus, temporary basal rate, or basal rate only) and applies the appropriate constraint level, ensuring each operational mode has an optimized safety boundary tailored to its specific risk profile

Inventive Principle:
Principle #3Local quality

3Reliability

If dynamic constraints accounting for temporary basal rates and extended boluses are implemented, then safe and effective insulin delivery is achieved, but the calculation and control complexity increases

Engineering Contradiction:
Improvesafety and effectiveness of insulin deliveryVSAvoidcomplexity of dynamic constraint calculation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system implements dynamic constraints through real-time monitoring of insulin delivery profile parameters (basal rate, temporary basal rate, extended bolus status) and automatic adjustment of the maximum insulin delivery rate constraint accordingly. This allows the system to adapt to changing conditions without requiring complex manual configuration or intervention

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The controller automatically calculates and adjusts the maximum insulin delivery rate constraint based on the current operational state, eliminating the need for manual constraint configuration by healthcare providers. The system self-adjusts the safety boundaries based on the detected insulin delivery profile, reducing burden on users while maintaining safety

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS11497851B2Maintaining maximum dosing limits for closed loop insulin management systems
Publication Date: 2022.11.15 LIFESCAN ENTERPRISES LLC
  • US11497851B2 patent drawing
  • US11497851B2 patent drawing
  • US11497851B2 patent drawing

AI summary

A system and a method for management of diabetes are provided. The system includes an infusion pump, glucose sensor, and controller that is programmed to control insulin delivery based upon at least one stored variable. The controller calculates a maximum insulin delivery rate based on the default basal insulin delivery rate, temporary basal insulin delivery rate, extended bolus rate, or a combination thereof.