This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.
Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
Study Type
OBSERVATIONAL
Enrollment
19
Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
Safety of the FreeStyle Libre Flash Glucose Monitoring System
The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population.
Time frame: Approximately one year per subject.
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