Abbott FreeStyle Libre 2 - Precision

Precision
Precision of the System was evaluated by comparing the results from two separate Sensors worn on
the same subject at the same time. Table 9a provides data from 146 subjects in the Adult study;
Table 9b provides data from 137 subjects in the Pediatric study. For adults, the paired absolute
relative dierence (PARD) between the two Sensors was 8.1% with coecient of variation (CV) of
5.7%. For children ages 4-5, PARD was 6.7% with CV of 4.8%. For children ages 6-17, PARD was 8.2%
with CV of 5.8%. Paired absolute dierence (PAD) is a measurement of absolute dierence (in mg/dL)
between paired CGM readings, while PARD is the absolute relative dierence (in %) between paired
CGM readings.
Table 9a: Overall between Sensor Precision (Adult; n=146)
Coecient of
Variation (%)
Paired Absolute
Dierence (mg/dL)
Paired Absolute
Relative Dierence
(%)
Number of Paired
Readings
Adults ages 18+
5.7 12.4 8.1 26791
Table 9b: Overall between Sensor Precision (Pediatric; n=137)
Coecient of
Variation (%)
Paired Absolute
Dierence (mg/dL)
Paired Absolute
Relative Dierence
(%)
Number of Paired
Readings
Children ages 4-5
4.8 10.7 6.7 248
Children ages 6-17
5.8 13.0 8.2 10623
212