Freestyle Libre 2 Manual Del Usuario página 134

by or on the order of a
physician.
This product contains
electronic equipment,
batteries, sharps and
materials that may contact
bodily fluids during use.
Dispose of product in
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regulations.
Performance Characteristics
The FreeStyle Libre 2 System can be used with either the FreeStyle Libre 2 MediRx Sensor (10 day wear
duration) or the FreeStyle Libre 2 Sensor (14 day wear duration). Other than the di!erence in wear
duration, the FreeStyle Libre 2 MediRx Sensor and FreeStyle Libre 2 Sensor are identical. Therefore, the
same clinical studies were used to evaluate the performance of the FreeStyle Libre 2 Flash Glucose
Monitoring System with the FreeStyle Libre 2 Sensor (See Part A) and the FreeStyle Libre 2 MediRx
Sensor (See Part B). Adverse event results and ascorbic acid interference results are applicable to the
FreeStyle Libre 2 System use with either FreeStyle Libre 2 Sensor or FreeStyle Libre 2 MediRx Sensor.
A. Performance Characteristics of FreeStyle Libre 2 Flash Glucose Monitoring System with
FreeStyle Libre 2 Sensor (14 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). One
study included adults (Adult study) and the other study included children (Pediatric study). All subjects
in both studies required insulin to manage their diabetes. To measure the precision of the System, each
subject wore two Sensors, one on the back of each upper arm, for a period of up to 14 days. While in
the clinic, subjects had their venous blood glucose analyzed using a laboratory reference method, the
Yellow Springs Instrument Life Sciences 2300 STAT Plus™ Glucose & Lactate Analyzer (YSI). Sensor
glucose readings were then compared to the YSI glucose results in subjects 6 years and older to
evaluate the System's performance. In the pediatric study, System performance was compared against
a self-monitoring blood glucose meter for subjects 4-5 years old.
Adult study: The Adult study was conducted at 5 centers with 146 subjects in total (91.1% Type 1, 8.9%
Type 2), all aged eighteen and older. Subjects had their venous blood glucose analyzed over three
separate visits to the clinical center. Each visit lasted up to ten hours. 144 subjects were analyzed during
the beginning of the Sensor wear period (day 1, 2, or 3), 91 subjects were analyzed during the early
middle period (day 7 or 8), 55 subjects were analyzed during the late middle period (day 9 or 12), and 76
subjects were analyzed during the end period (day 13 or 14). During each visit, adult subjects had their
glucose levels deliberately manipulated per the study protocol to raise or lower glucose. This was done
to assess performance of the System over the range that the System measures glucose (40 –
ART46983-001_rev-A 24-Aug-2022 2:30pm