Freestyle Libre - Page 63

Accuracy by Day of Wear
After the 12 hour start-up period, the sensor can be worn for up to 10 days. To show sensor
performance over time, the absolute relative dierence between the System and reference YSI
glucose values over the wear is presented in Table 9.
Table 9: Dierence Measures by Day (YSI Reference)
Day
Number of CGM-
Reference Pairs
Median Absolute
Relative Dierence (%)
Mean Absolute
Relative Dierence (%)
1
1497 8.7 10.7
4
1470 7.4 9.6
7
1394 7.4 9.1
10
1411 7.5 9.3
The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and 40% for reference values
80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below
80 mg/dL. The results for CGM vs. YSI reference are presented in Table 10.
Table 10: Number and Percent of Results within YSI Reference
Day Number of CGM-
Reference Pairs
Within
±15% /
±15mg/dL
Within
±20% /
±20mg/dL
Within
±30% /
±30mg/dL
Within
±40% /
±40mg/dL
Outside
±40% /
±40mg/dL
1
1497 76.2 87.4 97.9 99.5 0.5
4
1470 82.3 91.4 97.6 99.3 0.7
7
1394 85.0 93.5 98.6 99.3 0.7
10
1411 85.3 92.3 97.9 99.4 0.6
117 118
ART38553-101_rev-A_manual.indd 117-118 2/1/18 2:13 PM