Accuracy and Reliability of the Sinocare Continuous Glucose Monitoring System.

INTRODUCTION

The Sinocare iCan i3 Continuous Glucose Monitoring (CGM) system, manufactured by Sinocare, is available in China and certain European markets. This study aimed to evaluate the performance of this system in a free-living environment.

METHODS

Thirty-six (36) participants, with a diagnosis of either type 1 or type 2 diabetes, wore one Sinocare iCan i3 CGM system on the abdomen for up to 15 days and performed up to eight capillary fingerstick blood glucose tests per day, over the wear period, in a home setting. The CGM sensor performance was compared to the blood glucose meter (BGM) reference and evaluated in terms of analytical and clinical accuracy, as well as sensor survival.

RESULTS

For the study period, the mean absolute relative difference (MARD) was 17.2%. 69.5% of the results were within 20 mg/dL or 20% of the BGM reference, with 98.8% of the data falling within zones A and B of the consensus error grid. 77.1% of the sensors lasted up to the 15 days of sensor wear.

CONCLUSIONS

In this real-world study of the Sinocare iCan i3 CGM system, the accuracy and reliability of the sensors were assessed in comparison to a capillary fingerstick blood glucose reference. The MARD was 17.2% while 77.1% of the sensors lasted the 15-day wear duration.