Performance Characteristics
Overview of Clinical Studies
Three studies were conducted in the United States (US) to evaluate the
performance, safety, effectiveness, and precision of the FreeStyle Libre 3
Continuous Glucose Monitoring System (System). One study included adults
(Study 1), one study included pediatrics (Study 2) and one study included both
adults and pediatrics (Study 3).
All subjects 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. For subjects 4-5 years old, System
performance was compared against a self-monitoring blood glucose meter.
Study 1: Study 1 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).
Study 2: Study 2 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 manipulated per the study
protocol to raise or lower glucose. This was done to assess performance of the
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