Glycemic Control Device with Security-Validated Insulin Dosing
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Solution Overview
Problem
Patients with diabetes face challenges in achieving glycemic control due to fluctuations in blood glucose levels, as current insulin titration methods often result in under-dosing, leading to suboptimal blood sugar management and potential long-term health issues.
Innovation Solution
A medical device and system that provides customizable glycemic control by storing data, receiving blood glucose values, and processing information to determine and set appropriate insulin doses, incorporating safety features to validate and execute insulin delivery based on validated security data.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If insulin titration is performed manually by patients or health care professionals, then the device complexity is reduced, but the manufacturing precision and reliability of glycemic control deteriorate due to under-dosing and suboptimal blood sugar management
Solution Approach 1:
The medical device enables patients to perform self-titration of insulin doses by automatically calculating and recommending dosage adjustments based on blood glucose measurements and patient-specific parameters, eliminating the need for manual calculation by health care professionals while ensuring precise and consistent dosing decisions
Solution Approach 2:
The system implements a feedback mechanism where blood glucose measurements are continuously monitored, compared against target ranges, and used to automatically adjust insulin dosage recommendations, creating a closed-loop control system that improves dosing precision while reducing manual intervention
2Ease of operation
If fixed insulin dosing is used, then the ease of operation is improved, but the adaptability to individual patient needs and blood glucose fluctuations deteriorates
Solution Approach 1:
The medical device transforms static fixed dosing into a dynamic system that automatically adjusts insulin dosage recommendations based on real-time blood glucose measurements, patient-specific parameters, and titration algorithms, enabling the dosing regimen to adapt continuously to individual patient needs and metabolic variations
3Reliability
If frequent blood glucose monitoring is performed to achieve perfect glycemic control, then the glycemic control quality is improved, but the loss of time and patient burden increases
Solution Approach 1:
The system implements selective monitoring strategies where blood glucose measurements are taken at specific intervals and under specific conditions defined by titration algorithms, rather than requiring continuous monitoring, thereby achieving sufficient glycemic control while reducing the time burden and patient fatigue associated with excessive testing
Data Source
AI summary
A medical device for providing information for glycemic control is provided, wherein the device comprises storage means arranged to store data, receiving means arranged to receive blood glucose value data and security data, data processing means arranged to execute a first processing function for modifying data retrieved from the storage means and to execute a second processing function for providing information for glycemic control based on the blood glucose value data and data retrieved from the storage means, validating means arranged to validate the received security data and to provide validation data corresponding to the validation of the received security data, and safety means arranged to control an execution of at least a predetermined function out of the first and second processing functions based on the validation data.