Freestyle Libre 2 Manual Del Usuario página 143

ART46983-001_rev-A 24-Aug-2022 2:30pm
Table A-8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=139)
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 A-9a provides data from 146 subjects in the Adult study; Table A-
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 A-9a: Overall between Sensor Precision (Adult; n=146)
Table A-9b: Overall between Sensor Precision (Pediatric; n=137)
B. Performance Characteristics of FreeStyle Libre 2 Flash Glucose Monitoring System with
FreeStyle Libre 2 MediRx Sensor (10 day wear duration)
Overview of Clinical Studies
Two studies were conducted in the United States (US) to evaluate the performance, safety,
e!ectiveness, and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System) with the
FreeStyle Libre 2 MediRx Sensor. These studies were originally performed for the evaluation of the