Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System

Abstract

Background: Blood glucose monitoring (BGM) is essential for glycemic control in diabetic therapy. Followingly, accurate sensors are required for both daily personal and clinical use. The frequency of sensor use in patients with diabetes facilitates the use of disposable components. However, BGM systems are not exempt from green innovation sustainability initiatives. Methods: Clinical study of a high-accuracy green design blood glucose monitor using an innovative optical transmission absorbance system was carried out. Venous blood samples were collected from 104 patients with type II diabetes. The heat resistance of sensor strips was evaluated by storing sensor strips at 25℃ and 60℃ for approximately 3 months. Accuracy of the BGM system was evaluated via the ISO 15197:2013 protocol. Results: The BGM system achieved ±7.1% accuracy in glycemic level measurement, with 84% of all measurements within ±5% of the reference values. Furthermore, the sensor strip demonstrated heat resistance for more than 3 months when stored at 60℃. Conclusions: A new, highly accurate BGM system was developed based on the latest optical measurement system, introducing a rare metal-free “green-strip.” The developed BGM system achieved the highest reported accuracy in clinical research, using venous blood from patients with diabetes. The sensor strip also exhibited high heat resistance, reducing limitations on storage conditions.