Last updated on August 2018

FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations


Brief description of study

This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.

Detailed Study Description

Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make two (2) to five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects age and weight, subjects will have up to two (2) in-clinic visits during which intravenous blood draws and Yellow Springs Instrument (YSI) reference testing will occur.

Clinical Study Identifier: NCT03369899

Contact Investigators or Research Sites near you

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Kristin Castorino, DO

Sansum Diabetes Research Institute
Santa Barbara, CA United States

Recruitment Status: Closed


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