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The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
C.10 Performance Characteristics of the FreeStyle
Libre 2 Flash Glucose Monitoring Sensor
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 Sensor (Libre 2 Sensor). 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 Libre 2
Sensor, 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 to evaluate the Libre 2 Sensor’s
performance.
Adult study: The FreeStyle Libre 2 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 over the range that the Libre 2 Sensor measures glucose
(40 – 400 mg/dL). All results from the FreeStyle Libre 2 Adult study are
presented here.
Pediatric study: The FreeStyle Libre 2 Pediatric study was conducted
at 4 centers with 139 subjects in total (98.6% Type 1, 1.4% Type 2);
87 of those subjects were aged 12 – 17 (i.e., within the age indication
of the Bigfoot Unity System). All subjects age 12 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, all subjects age 12 and older had their glucose
levels deliberately manipulated per the study protocol to raise or lower
glucose. This was done to assess performance over the range that
* The contents of this section are based on clinical studies conducted by Abbott Diabetes Care in support of
the FreeStyle Libre 2 Flash Glucose Monitoring System (K193371). This summary includes elements of the
studies that support features present in Bigfoot Unity. Data from these studies that do not support features
in Bigfoot Unity are not included.
*
