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

NCT03448367 | Terminated FDA Device

• 1 other identifier: ADC-US-PMS-17168-002
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 4

Brief 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

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Safety of the FreeStyle Libre Flash Glucose Monitoring System

  The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population.

  Approximately one year per subject.

Study Arms (1)

SMBG/FreeStyle Libre

During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.

Device: FreeStyle Libre Flash Glucose Monitoring System

Interventions

FreeStyle Libre Flash Glucose Monitoring System DEVICE

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).

SMBG/FreeStyle Libre

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.

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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (4)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Diabetes & Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, 87109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara A Karinka, PhD

  Abbott Diabetes Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: February 27, 2018
• Primary Completion: July 17, 2020
• Study Completion: October 13, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)