Multicenter Evaluation Study Comparing a New Factory-Calibrated Real-Time Continuous Glucose Monitoring System to Existing Flash Glucose Monitoring System.
This study reports a clinical evaluation of AiDEX CGM system featuring a 14-day sensor, real-time glucose monitoring and factory-calibration. A multicenter, prospective, masked clinical study was conducted at with a total of 120 participants. Each participant wore 4 studied sensors and had one in-clinic visit for venous blood reference tests. 40 out of the 120 participants wore additional Abbott Libre sensors and performed at least 7 capillary BG tests daily for additional reference and comparison. Continuous glucose error grid analysis (CG-EGA) showed that AiDEX and Abbott Libre had good agreement with venous blood glucose, with 98.69% and 98.96% accurate readings, respectively. Overall MARD of AiDEX CGM systems was 9.08% when compared to venous blood reference and 10.1% when compared to finger capillary BG reference.
['Ji|Linong|L|', 'Guo|Lixin|L|', 'Zhang|Junqing|J|', 'Li|Yufeng|Y|', 'Chen|Zhiyan|Z|https://orcid.org/0000-0002-9938-6518']
continuous glucose monitoring system flash glucose monitoring comparison study factory calibration