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FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

NCT03448367 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2021-02-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

FreeStyle Libre Flash Glucose Monitoring System

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).

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Shridhara A Karinka, PhD · Abbott Diabetes Care

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2020-07-17
Completion
2020-10-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448367 on ClinicalTrials.gov