Performance Characteristics; Overview Of Clinical Studies; Adult Study; Pediatric Study - Abbott FreeStyle Libre 2 User Manual

Performance Characteristics

Overview of Clinical Studies

Two studies were conducted in the United States (US) to evaluate the performance, safety,
effectiveness, 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 – 400 mg/dL).
Pediatric study: The Pediatric study was conducted at 4 centers with 139 subjects in total (98.6% Type
1, 1.4% Type 2), all aged four to seventeen. Subjects age six and older had their venous blood glucose
analyzed for up to 16 hours over one or two separate visits to the clinical center. Each visit lasted
up to eight hours. During each visit, subjects age 11 and older had their glucose levels deliberately
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