Performance of Freestyle Libre® 2 System in Adult and Pediatric Populations

Objectives:

The purpose of these studies was to evaluate the performance of Freestyle Libre 2 system in adult and pediatric populations compared to venous plasma reference.

Methods:

Two independent studies were conducted in the USA to evaluate the performance of Freestyle Libre 2 in adult (≥18 years old) and pediatric (4 – 17 years old) populations, respectively. Subjects wore two sensors, one on the back of each upper arm, for up to 14 days. Ninety-five (95) adult subjects underwent up to four in-clinic sessions of up to 7 hours, while 62 pediatric subjects ≥6 years old had up to 2 in-clinic sessions of up to four hours to collect venous reference samples. All subjects performed capillary blood glucose tests throughout the wear period. Sensor readings were masked to the study subjects.

Results:

Accuracy of the system was demonstrated with 90.3% of sensor glucose results from adult population and 90.1% of sensor glucose results from pediatric population within ± 20% or 20 mg/dL of YSI plasma reference glucose values. The percentage of readings within Consensus Error Grid Zone A were 89.0% and 90.3% for adult and pediatric populations, respectively. The overall mean absolute relative difference (MARD) was 9.5% and 9.4% in the adult and pediatric studies, respectively. No serious adverse events or unanticipated adverse device effects were reported during the studies.

Conclusions:

The sensor results were found to be accurate when compared to venous plasma reference over the 14 days wear period in both adult and pediatric populations.