CClinicalTrials.gg
Sign In
TerminatedNCT03448367Updated Feb 5, 2021

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

An observational study in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Terminated at 4 sites in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-02-05.

Sponsored by Abbott Diabetes Care · Observational

Why this study was terminated
Due to lower than anticipated enrollment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
4 Years to 17 Years
Sex
All
01

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.

Read the detailed description

Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

02

Conditions studied

  • Diabetes Mellitus
03

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceFreeStyle 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).

05

What researchers measure

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.

    Time frame: Approximately one year per subject.

06

Study locations

4 sites
  • Sansum Diabetes Research Institute
    Santa Barbara, California 93105, United States
  • Barbara Davis Center for Diabetes
    Aurora, Colorado 80045, United States
  • Rocky Mountain Diabetes & Osteoporosis Center
    Idaho Falls, Idaho 83404, United States
  • Albuquerque Neuroscience Inc.
    Albuquerque, New Mexico 87109, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448367
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Feb 27, 2018
Primary completion
Jul 17, 2020
Completion
Oct 13, 2020
Last update
Feb 5, 2021

Study contacts

Shridhara A Karinka, PhD
study director · Abbott Diabetes Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Abbott Diabetes Care

Start the discussion