Therapy Delivery Interface for Sensor-Quality-Based Insulin Dosing
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Solution Overview
Problem
Current insulin infusion systems face challenges in accurately regulating blood glucose levels due to variations in patient activity and individual insulin response, particularly when continuous glucose sensor values are unreliable, leading to potential errors in therapy dosage calculations.
Innovation Solution
The system operates in multiple modes based on the quality of sensor-generated values, displaying and using valid meter-generated values or high-quality sensor-generated values for therapy dosage calculations, while inhibiting the use of unreliable sensor values to prevent errors and ensure safe glucose management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If the system uses continuous sensor-generated values for therapy dosage calculations, then glucose level monitoring becomes more continuous and autonomous, but reliability deteriorates when sensor values are unreliable or of poor quality
Solution Approach 1:
The system changes the parameter of data quality assessment by evaluating sensor quality metrics and dynamically adjusting whether sensor values are used for therapy calculations. When quality criteria are met, sensor values are used; when not met, the system switches to using meter-generated values instead, thus adapting the reliability parameter based on actual data quality.
Solution Approach 2:
The system introduces an intermediary quality assessment layer between the sensor and therapy calculation. Instead of directly using sensor values, the system first evaluates their quality through multiple criteria (signal stability, physiological plausibility, quality metrics) and only proceeds with therapy calculations if the values pass these intermediate quality checks.
2Loss of information
If the system displays all sensor-generated values on the therapy delivery control screen, then user information availability increases, but harmful factors increase due to potential display of unreliable values leading to user error
Solution Approach 1:
The system applies local quality control by selectively displaying sensor values based on their quality assessment. Rather than uniformly displaying all values, the system evaluates each value's quality locally and determines display appropriateness individually, showing only those values that meet quality criteria on the therapy delivery control screen while potentially showing lower-quality values elsewhere with appropriate context.
Data Source
AI summary
Disclosed is a method of controlling operation of a medical device that regulates delivery of a fluid medication to a user. The method receives meter-generated values that are indicative of a physiological characteristic of the user, and are produced in response to operation of an analyte meter device. The method obtains sensor-generated values that are indicative of the physiological characteristic of the user, and are produced in response to operation of a continuous analyte sensor device, different than the analyte meter device. The medical device is operated in different modes when: a valid meter-generated value is available; a valid meter-generated value is unavailable and a current sensor-generated value satisfies first quality criteria; or a valid meter-generated value is unavailable and the current sensor-generated value satisfies second quality criteria but does not satisfy the first quality criteria.