Freestyle Libre User Manual 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 difference between the System and reference YSI
glucose values over the wear is presented in Table 9.
Table 9: Difference Measures by Day (YSI Reference)
Number of CGM- Median Absolute
Day
Reference Pairs Relative Difference (%)
1 1497
4 1470
7 1394
10 1411
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Mean Absolute
Relative Difference (%)
8.7 10.7
7.4 9.6
7.4 9.1
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- Within Within
Reference Pairs ±15% / ±20% /
±15mg/dL ±20mg/dL
1 1497 76.2 87.4
4 1470 82.3 91.4
7 1394 85.0 93.5
10 1411 85.3 92.3
Within Within Outside
±30% / ±40% / ±40% /
±30mg/dL ±40mg/dL ±40mg/dL
97.9 99.5 0.5
97.6 99.3 0.7
98.6 99.3 0.7
97.9 99.4 0.6
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