eversense E3 - Page 217

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Eversense E3 CGM User Guide
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Eversense E3 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, 89.7% of the Eversense E3 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 10 – Eversense E3 Calibration Stability Agreement in the PROMISE 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
Percent
> 40/40%
of
Reference
(0, 2) Hours 2,638 88.8 94.1 98.7 99.9 0.1
[2, 4) Hours 1,905 87.2 94.4 98.5 99.5 0.5
[4, 6) Hours 1,404 85.3 93.3 98.1 99.3 0.7
[6, 8) Hours 1,043 83.0 91.5 97.7 99.6 0.4
[8, 10) Hours 1,041 89.7 93.9 98.8 99.6 0.4
[10, 12) Hours 1,091 87.8 94.1 97.7 99.5 0.5
[12, 14) Hours 590 85.8 93.4 99.0 99.3 0.7
[14, 16) Hours 440 82.7 91.8 100.0 100.0 0.0
[16, 18) Hours 379 87.6 93.9 99.5 100.0 0.0
[18, 20) Hours 370 90.0 97.0 98.4 99.7 0.3