User's Manual

99
Eversense CGM User Guide
17
17. 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 (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.
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 Dierence (MARD) measured throughout
the 90 days was 11.4% for glucose values over 75 mg/dL.
Overall System Performance Compared to YSI
The study demonstrated that 83.8% of overall CGM System readings were within ± 20% of YSI values, 93.9% were within ± 30% of YSI values, and 97.5%
were within ± 40% of YSI values. The chart below provides a percentage breakdown by glucose range.
Dierence between CGM System readings and YSI Measurements by Glucose Level
YSI Glucose Range
(mg/dL)
Number of paired
CGM-YSI Readings
Percent within
20% of YSI
Percent within
30% of YSI
Percent within
40% of YSI
≤ 70* 422
80.6% 93.4% 96.7%
71-180
6633
80.6% 92.2% 96.7%
> 180
3387
90.4% 97.3% 99.1%
Overall
10442
83.8% 93.9% 97.5%
*The absolute dierence from the YSI reading is measured in mg/dL if the YSI reading is ≤ 70 mg/dL.
LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 99 7/22/16 11:39 AM