eversense CGM - Page 188

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Eversense CGM User Guide
Calibration Stability Agreement
The table below compares the percentage of sensor glucose values to the YSI reference at various time points
after a calibration entry. As an example, in the table below, 88% of the Eversense values were within 15 mg/dL
(for reference readings of 80 mg/dL or less), and within 15% (for reference readings over 80 mg/dL) of the
reference value 8 to 10 hours after a calibration entry.
Table 16 – Eversense Calibration Stability Agreement in the PRECISION Study
Percent of CGM System Readings Within
Time
from
Calibration
Number of
Paired
CGM-YSI
Percent
15/15%
of
Reference
Percent
20/20%
of
Reference
Percent
30/30%
of
Reference
Percent
40/40%
of
Reference
> 40/40%
of
Reference
0 - 2 Hours 4,034 86.0% 93.6% 98.0% 99.3% 0.7%
2 - 4 Hours 3,979 85.6% 92.8% 98.4% 99.5% 0.5%
4 - 6 Hours 2,308 84.3% 92.2% 97.7% 99.0% 1.0%
6 - 8 Hours 1,614 84.3% 92.7% 97.8% 99.4% 0.6%
8 - 10 Hours 1,372 88.0% 94.4% 98.5% 99.6% 0.4%
10 - 12 Hours 1,295 86.1% 92.9% 98.1% 99.2% 0.8%
LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1.indd 186LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1.indd 186 2/26/20 12:59 PM2/26/20 12:59 PM