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FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

NCT03448380 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 935

Last updated 2021-06-16

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 people 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 Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2021-03-30
Completion
2021-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03448380 on ClinicalTrials.gov