Automated Insulin Delivery With Shelf-Life Risk Lockout
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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 manual adjustments and recalibration, and there is a lack of reliable, safe, and simple automatic control systems to maintain glycemic control.
Innovation Solution
A system and method that includes an insulin delivery device with a control unit capable of determining a shelf-life risk score for undelivered insulin, locking out automated modifications to the baseline basal insulin rate if the score exceeds a threshold, and utilizing continuous glucose monitoring to adjust insulin delivery based on personalized therapeutic parameters such as basal rate, carbohydrate-to-insulin ratio, and insulin sensitivity factor.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If automated control systems are implemented to reduce cognitive burden, then ease of operation is improved, but reliability may worsen due to potential errors in automated decision-making
Solution Approach 1:
The patent introduces a hybrid system where an automated control unit serves as an intermediary between the patient and the insulin delivery device. This intermediary provides automated recommendations and adjustments while allowing patient override, thus reducing cognitive burden while maintaining reliability through human-in-the-loop verification.
Solution Approach 2:
The system implements continuous feedback loops where glucose monitor data is fed back to the control unit, which then adjusts insulin delivery recommendations. This closed-loop feedback mechanism enables automated control to adapt to changing physiological conditions while maintaining safety through continuous monitoring and adjustment.
2Reliability
If continuous glucose monitoring with automated adjustment is implemented, then glycemic control is improved, but device complexity increases
Solution Approach 1:
The control unit is designed as a multi-functional device that integrates glucose data analysis, insulin dosage calculation, automated adjustment algorithms, and user interface functions. By consolidating these functions into a single universal controller, the system achieves improved glycemic control without proportionally increasing overall system complexity.
Solution Approach 2:
The patent merges the glucose monitoring system, insulin delivery device, and control unit into an integrated hybrid closed-loop system. This consolidation allows the components to work together seamlessly, improving glycemic control while reducing the complexity that would arise from separate standalone systems.
3Manufacturing precision
If frequent manual recalibration is required to maintain accurate therapy, then manufacturing precision is improved, but loss of time increases
Solution Approach 1:
The automated control unit performs self-calibration and self-adjustment functions by continuously analyzing glucose monitor data and automatically modifying insulin delivery parameters. This self-service capability maintains therapeutic parameter accuracy without requiring frequent manual recalibration by the patient or healthcare provider, thus reducing time loss.
Solution Approach 2:
The system performs preliminary calibration during initial setup and then uses automated algorithms to maintain accuracy over time. By establishing accurate baseline parameters in advance and using automated adjustments to maintain them, the system reduces the need for frequent manual recalibration while preserving manufacturing precision.
Data Source
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. Some methods and systems may be configured to adjust insulin delivery to a person with diabetes according to one or more conditions of an insulin delivery device. Some methods and systems may be configured to enable a lock-out mode where adjustment to insulin delivery to personalize automated insulin delivery is restricted.