1. Institute for Medical Device Control, National Institutes for Food and Drug Control, Beijing 102629, China丨
2. Shenzhen Sisensing Co., Ltd., Shenzhen Guangdong 518101, China
Abstract：Objective To explore the idea of quality evaluation of continuous glucose monitoring (CGM) system performance, and
design the corresponding detection method. Methods This paper analyzed the working principle of CGM system and the basic
principle of electrochemical reaction, determined the key components and performance indicators. At the same time, combined with
the potential risk points in the process of clinical use to explore the interference factors. The detection platform was built by using
electrochemical workstation, constant temperature water bath, simulated glucose solution and precision current source. Through these
to achieve the detection of key performance indicators. Results A CGM system was tested and the results met the manufacturer’s
claims, which proved the feasibility of detection method. Conclusion The quality evaluation ideas and detection methods of CGM
system proposed in this paper have certain practical significance and can provide technical support for supervision.
