Freestyle LIBRE PRO - Page 32

Accuracy by Day of Wear
The sensor can be worn for up to 14 days. To show sensor performance over time, the absolute
relative dierence between the System and reference YSI glucose and capillary blood glucose
values (BG) over the 14 day wear is presented in Table 10 and Table 11. The accuracy of GM
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 are
presented in Table 12 for GM vs. YSI reference and in Table 13 for GM vs. BG reference.
Table 10: Dierence Measures by Day (YSI Reference)
YSI Reference
Day
Number of GM-
Reference Pairs
Median Absolute
Relative Dierence (%)
Mean Absolute
Relative Dierence (%)
1 2117 11.4 13.8
2-5 4036 11.0 13.3
6-9 2919 10.2 12.3
10-13 2214 8.4 10.4
14 1037 7.3 9.6
Table 11: Dierence Measures by Day (BG Reference*)
BG Reference
Day
Number of GM-
Reference Pairs
Median Absolute
Relative Dierence (%)
Mean Absolute
Relative Dierence (%)
1 1087 11.9 15.0
2-5 4005 11.9 14.6
6-9 3432 11.7 14.5
10-13 2841 9.8 12.5
14 553 8.3 10.6
* Comparison to BG was performed using the FreeStyle Precision blood glucose meter. Dierent performance
may be expected when compared to other models of blood glucose meters.
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