NCT04959552

FSL2 Post Approval Study for Pediatric and Young Adults Patients

FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study- FreeStyle Libre 2

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.

Detailed description

Approximately 550 pediatric and young adult subjects aged 4-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize he FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Conditions

• Diabete Mellitus

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre 2	The FreeStyle Libre 2 Flash Glucose Monitoring

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2021-07-13
• Last updated: 2026-04-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study