NCT04577976

FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.

Detailed description

Approximately 400 subjects aged 4-17 years and older 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 capillary SMBG 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

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	SMBG	Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months.

Timeline

• Start date: 2020-09-23
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2020-10-08
• Last updated: 2022-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study