Dynamic Insulin Delivery Limit Adjustment Algorithm
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Solution Overview
Problem
Automatic insulin delivery systems often have fixed maximum delivery limits that can either overly constrain or under-constrain insulin delivery for individual diabetic persons, necessitating a method to adjust these limits based on individual criteria for more effective glucose management.
Innovation Solution
The method adjusts the maximum delivery limit of insulin in automatic insulin delivery systems by calculating a factor based on the percentage of cycles limited by the maximum delivery limit, standard deviation of blood glucose levels, percentage of hypoglycemic events, or separate nighttime limits, allowing for dynamic adjustment of the basal rate multiplier to optimize insulin delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed maximum delivery limit is used for safety, then the system prevents overreaction to blood glucose levels, but the system overly constrains or under-constrains insulin delivery for individual diabetic persons
Solution Approach 1:
The maximum delivery limit is transformed from a fixed value to a dynamic parameter that automatically adjusts based on individual patient responses. The system monitors blood glucose excursions and delivery limit violations over time, then modifies the maximum delivery limit accordingly, allowing the system to adapt to each patient's unique needs while maintaining safety constraints
Solution Approach 2:
The system implements feedback loops where the algorithm monitors whether the maximum delivery limit is being violated frequently (indicating it may be too low) or rarely (indicating it may be too high). This feedback information is used to automatically adjust the maximum delivery limit, creating a self-tuning system that balances safety with individualized effectiveness
2Reliability
If the maximum delivery limit is set to prevent overreaction, then the system maintains safety, but the system cannot respond adequately to significant blood glucose excursions
Solution Approach 1:
The system dynamically adjusts the maximum delivery limit based on actual patient needs observed during operation. When significant blood glucose excursions occur that are constrained by the current limit, the system learns from this and increases the limit appropriately, enabling stronger responses when needed while maintaining safety through controlled adaptation
3Ease of operation
If a generalized maximum delivery limit is applied to all users, then the system is simple to operate, but the system does not account for individual variability in insulin response
Solution Approach 1:
The system performs self-adjustment of the maximum delivery limit without requiring manual intervention from the diabetic person or health care professional. The algorithm automatically monitors patient responses, calculates appropriate adjustments based on observed patterns, and modifies the limit autonomously, maintaining ease of operation while achieving individualized precision
Solution Approach 2:
The system changes the maximum delivery limit parameter automatically based on individual patient data. By monitoring variables such as the frequency of limit violations and individual blood glucose response patterns, the system dynamically modifies this parameter to achieve optimal control for each patient without adding operational complexity
Data Source
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AI summary
The disclosed embodiments are directed to methods for adjusting, on a per individual basis, the maximum delivery limit of insulin delivered to a diabetic person via an automatic insulin delivery system, particularly for a diabetic who receives basal or bolus doses of insulin via an automatic insulin delivery system. Various embodiments of the method disclosed herein may be incorporated into a dosing algorithm of an automatic insulin delivery system.