Closed Loop Insulin Infusion System with Real-Time Sensor Calibration
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Solution Overview
Problem
Current closed loop/semi-closed loop systems for diabetes management lack sufficient safeguards to prevent over/under delivery of insulin and do not provide robust real-time calibration adjustments, making them ineffective in maintaining target blood glucose levels.
Innovation Solution
A closed loop/semi-closed loop infusion system that triggers an alarm when blood glucose values or insulin delivery is inconsistent, allowing for selective calibration of the glucose sensor system and adjustment of therapy delivery parameters within predetermined boundaries, enabling the system to revert to open-loop therapy if necessary and resume closed-loop delivery once conditions are corrected.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If closed loop/semi-closed loop systems are used for diabetes management, then automated insulin delivery is achieved, but the systems lack sufficient safeguards to prevent over/under delivery of insulin
Solution Approach 1:
The system applies preliminary anti-action by implementing predictive algorithms that forecast future blood glucose levels and preemptively adjust insulin delivery parameters. The system predicts potential hypoglycemic or hyperglycemic events before they occur and takes corrective action by adjusting basal rates or triggering alarms, thereby preventing harmful outcomes rather than merely responding to them after occurrence.
Solution Approach 2:
The system performs preliminary action by conducting real-time calibration adjustments of glucose sensor sensitivity and offset parameters based on continuous monitoring data. The controller proactively modifies sensor calibration factors before significant measurement errors can lead to incorrect insulin delivery decisions, ensuring the sensor system remains accurate throughout its operational lifecycle without requiring manual recalibration.
Solution Approach 3:
The system implements multiple feedback mechanisms including continuous monitoring of blood glucose levels, insulin delivery amounts, and sensor performance metrics. The controller compares actual measurements against predicted values and automatically adjusts therapy parameters when deviations exceed predetermined thresholds. This closed-loop feedback ensures continuous safety monitoring and automatic correction of potential errors in insulin delivery.
2Measurement precision
If real-time calibration adjustments are implemented, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The glucose sensor system performs self-service calibration by automatically adjusting its own sensitivity and offset parameters based on continuous monitoring of the relationship between sensor readings and actual blood glucose levels. The sensor system autonomously detects calibration drift and corrects it without requiring external intervention or complex manual calibration procedures, thereby improving measurement precision while minimizing added complexity.
Solution Approach 2:
The system changes sensor parameters dynamically by adjusting sensitivity factors and offset values in real-time based on observed measurement patterns. The controller modifies these calibration parameters algorithmically when deviations are detected, allowing the sensor system to adapt to changing conditions and maintain accuracy without requiring physical reconfiguration or complex calibration hardware.
3Reliability
If alarm triggers are implemented for inconsistent blood glucose values, then reliability is improved, but loss of time occurs due to calibration interruptions
Solution Approach 1:
The system performs preliminary calibration adjustments automatically when alarm conditions are detected, eliminating the need for manual calibration interruptions. The controller proactively modifies sensor calibration parameters and therapy delivery settings in response to alarm triggers, maintaining therapy continuity while ensuring safety. This preliminary automated action resolves the contradiction by preventing the time loss that would otherwise occur during manual calibration procedures.
Data Source
AI summary
A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to trigger an alarm based on a measured blood glucose value or amount of insulin delivered, selectively perform calibration of the glucose sensor system when the alarm is triggered, and adjust a therapy delivery parameter when the alarm is triggered, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.