Insulin Delivery Controller TDD Tracking Phases
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Solution Overview
Problem
Conventional subcutaneous insulin replacement therapy for diabetes is imperfect due to day-to-day and moment-to-moment variability, requiring frequent monitoring and insulin delivery adjustments, which can be burdensome for patients.
Innovation Solution
A closed-loop system that uses a controller to calculate filtered total daily doses of insulin based on initial and steady-state tracking phases, with rate limits and system gains, to automatically adjust insulin delivery in response to continuous glucose monitoring data, minimizing patient interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional insulin replacement therapy with repeated monitoring and manual adjustment is used, then patient autonomy and simplicity are maintained, but glucose control precision and reliability deteriorate due to day-to-day and moment-to-moment variability
Solution Approach 1:
The closed-loop system automatically monitors glucose levels and adjusts insulin delivery without requiring patient intervention. The controller continuously receives glucose data from the CGM, calculates appropriate insulin doses using control algorithms, and commands the infusion pump to deliver the calculated doses, enabling the system to self-regulate glucose control
Solution Approach 2:
The system implements continuous feedback by monitoring glucose levels via CGM and using this information to dynamically adjust insulin delivery. The controller receives real-time glucose data, processes it through control algorithms, and modifies insulin dosing accordingly, creating a closed-loop feedback mechanism that improves glucose control precision
2Ease of operation
If conventional therapy with repeated finger sticks and vigilant monitoring is used, then device simplicity is maintained, but patient burden and ease of operation worsen
Solution Approach 1:
The system performs automatic glucose monitoring and insulin dosing adjustments without requiring patient actions such as finger sticks or manual calculations. The CGM continuously measures glucose levels, and the controller automatically determines and executes insulin dosing decisions, freeing the patient from burdensome manual tasks
Solution Approach 2:
The system replaces manual mechanical processes (finger sticks, manual insulin injection) with automated electronic systems. The CGM eliminates the need for physical finger pricks, and the electronic controller replaces manual insulin dose calculations and injections with automated pump delivery
3Reliability
If manual insulin delivery control is used, then system simplicity is maintained, but glucose control reliability and productivity deteriorate
Solution Approach 1:
The closed-loop system continuously monitors glucose levels and dynamically adjusts insulin delivery based on real-time feedback. The controller receives glucose data from the CGM, processes it through control algorithms that account for variability, and automatically modifies insulin dosing to maintain target glucose ranges, improving reliability
Solution Approach 2:
The system dynamically adapts to changing glucose conditions by continuously adjusting insulin delivery rates. The control algorithms process real-time glucose data and modify dosing parameters on-the-fly, enabling the system to respond to moment-to-moment and day-to-day variability in glucose metabolism
Data Source
AI summary
A system includes a controller that is in communication with a medication delivery device and that includes control logic. The control logic is operative to calculate a first filtered total daily dose (TDD) during an initial tracking phase based, at least in part, on a first set of insulin delivery doses and subject to a first set of rate limits. The control logic is also operative to calculate a second filtered TDD during a steady state tracking phase based, at least in part, on a second set of insulin delivery doses and subject to a second set of rate limits.