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

Diabetes Mellitus Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04577976
Study type Observational
Source Abbott Diabetes Care
Contact
Status Terminated
Phase
Start date September 23, 2020
Completion date July 14, 2022
View Details
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