eversense XL - Clarke Error Grid Analysis

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Eversense XL CGM User Guide
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18. Device Performance
This section lists Device Performance Characteristics.
Clinical Study Performance - PRECISE STUDY
The performance of the Eversense XL CGM System was evaluated in a multi-site, non-randomised clinical study.
Adult (18 years and older) subjects with diabetes were enrolled at 7 dierent sites in 3 dierent 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. Twenty-three (23) subjects were followed for 180 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 Dierence (MARD) measured throughout the 180 days was 11.1% for glucose values
over 4.2 mmol/L and 11.6% for glucose values between 2.2 and 22.2 mmol/L.