eversense CGM - Page 174

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Eversense CGM User Guide
Table 3 – Eversense Percentage of Readings in Agreement Overall in the PRECISION Study
Percent of CGM System Readings Within
CGM
System
Glucose
Range
(mg/dL)
Paired
CGM
and YSI
References
Percent
15/15%
of
Reference
Percent
20/20%
of
Reference
Percent
30/30%
of
Reference
Percent
40/40%
of
Reference
> 40/40%
of
Reference
Overall 15,170 85.4% 92.8% 98.1% 99.3% 0.7%
40 - 60 1,236 91.9% 96.0% 98.4% 99.3% 0.7%
61 - 80 2,003 87.3% 94.1% 99.1% 99.6% 0.4%
81 - 180 5,786 80.5% 89.9% 97.2% 99.0% 1.0%
181 - 300 3,566 84.8% 92.8% 98.1% 99.2% 0.8%
301 - 350 1,628 92.8% 97.5% 99.1% 99.9% 0.1%
351 - 400 951 91.5% 95.8% 98.6% 99.8% 0.2%
Performance was also measured by calculating the percentage of sensor glucose readings within 15 mg/dL or 15%
of the YSI reference. These tables show the percent agreement at multiple levels, at dierent glucose ranges, and
at dierent days during the sensor wear. Results in the glucose ranges of 80 mg/dL or less reflect the percentage of
values within mg/dL, and results in the glucose ranges over 80 mg/dL reflect the percentage within reference. As an
example, glucose values between 40 and 60 mg/dL were within 15 mg/dL of the reference value 91.9% of the time.
LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1.indd 172LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1.indd 172 2/26/20 12:59 PM2/26/20 12:59 PM