User's Manual
135
Eversense CGM User Guide
19
19. Device Performance
This section lists Device Performance Characteristics.
Clinical Study Performance
The performance of the Eversense CGM System was evaluated in a multi-site, non-randomized clinical study.
Adult (older than 17 years old) subjects with diabetes were enrolled at 7 dierent sites in 3 dierent countries.
Each subject had 2 separate sensors inserted, one in each upper arm. One sensor was used to display glucose
data on the subject’s mobile device and the other sensor was used to collect glucose data but was not displayed
to the subject. Forty-four (44) subjects were followed for 90 days following the insertion of the sensor. Accuracy
assessments were made at various points during the study, and subjects were asked to report any adverse events
throughout the study. The Mean Absolute Relative Dierence (MARD) measured throughout the 90 days was 11.4%
for glucose values over 4.2 mmol/L.
LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.indd 135 11/4/16 2:44 PM