Performance and Safety of a 15-Day Real-Time Continuous Glucose Monitoring System in Chinese Adults With Diabetes: A Multicenter Trial.

BACKGROUND

This study evaluated the performance and safety of a 15-day real-time continuous glucose monitoring (rtCGM) system in Chinese adults with diabetes, focusing on its accuracy and clinical utility for long-term glucose management.

METHODS

A clinical evaluation was conducted using four rtCGM sensors per participant, with placement sites on both the upper arm and the abdomen. The system's accuracy was assessed using a factory-calibrated model. Primary outcomes included the mean absolute relative difference (MARD), the 20/20% agreement rate, and the proportions of Clarke and Consensus Error Grid in zones A+B.

RESULTS

A total of 74 participants were screened. The MARD values were 8.44% for the upper arm and 8.91% for the abdomen under factory-calibrated model. The 20/20% agreement rates were 95.78% for the upper arm and 94.41% for the abdomen under factory-calibrated model. The Clarke and Consensus Error Grid A+B proportions were 99.53% and 99.96% for the upper arm, and 99.46% and 99.82% for the abdomen under factory-calibrated model, respectively.

CONCLUSION

The CGM system showed high accuracy, robust alert performance, stable repeatability, and favorable safety over 15 days in Chinese adults with diabetes, supporting its clinical utility for glucose monitoring in these adult patients.