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

Stopped early

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03448367

Run by

Abbott Diabetes Care

People needed

19

Starts

2018-02-27

Expected to finish

2020-10-13

Last updated by the study team

2021-02-05

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be 4 - 17 years of age.
• Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
• Subject is currently using SMBG for managing their diabetes.
• Subject and/or caregiver must be able to read and understand English .
• In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• Subject and/or caregiver must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
• Subject must have an overnight companion (caregiver 18 years or older) present in the same home during participation of the study.
• Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

You may not qualify if…

• Subject and/or caregiver is a member of the Site Staff.
• Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
• Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
• Subject is on dialysis at the time of enrollment.
• Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
• Subject currently is participating in another clinical trial.
• Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Barbara Davis Center for Diabetes — Aurora, Colorado, United States
• Rocky Mountain Diabetes & Osteoporosis Center — Idaho Falls, Idaho, United States
• Albuquerque Neuroscience Inc. — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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