User's Manual

136
Eversense CGM User Guide
19
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
(mmol/L)
Number of paired
CGM-YSI
Readings
Percent
within
20% of YSI
Percent
within
30% of YSI
Percent
within
40% of YSI
≤ 3.9* 422
80.6% 93.4% 96.7%
3.9 - 10.0
6633
80.6% 92.2% 96.7%
> 10.0
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 mmol/L if the YSI reading is ≤ 3.9 mmol/L.
Although device measurement errors may have been present in either YSI or sensor readings, and interstitial values
(sensor) are known to have time lags in responses to changing blood glucose levels compared to blood values (YSI),
it was demonstrated that 80% or greater of dierences were within 20%/1.1 mmol/L (20% for YSI values greater
than 3.9 mmol/L, within 1.1 mmol/L for YSI values ≤ 3.9 mmol/L). The level of agreement increased to above 92% for
dierences within 30%/1.7 mmol/L and above 96% for dierences within 40%/2.2 mmol/L.
LBL-0302-01-101 Rev 1_Eversense User Guide_mmolL_R5.indd 136 11/4/16 2:44 PM