FreeStyle Libre Glucose Monitoring System Paediatric Study (SELFY)

April 20, 2017 updated by: Abbott Diabetes Care

An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People

The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30173
        • Kinder- und Jugendkrankenhaus
  • Ireland
      • Dublin, Ireland, 24
        • National Children's Hospital
      • Dublin, Ireland, 7
        • Temple Street Children's University Hospital
  • United Kingdom
      • Antrim, United Kingdom, BT41 2RL
        • Antrim Area Hospital
      • Belfast, United Kingdom, BT16
        • Ulster Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital, Leeds Teaching Hospitals NHS Trust
      • Londonderry, United Kingdom, BT47 6SB
        • Altnagelvin Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital NHS Trust
    • County Antrim
      • Belfast, County Antrim, United Kingdom, BT12 6BE
        • Royal Belfast Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥4 years and ≤17 years.
  • Has an identified Caregiver of ≥18 years.
  • Type 1 diabetes using insulin (administered by injections or CSII) for at least 1 year.
  • Current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen.
  • Currently testing BG, on average at least 2 times per day.

Exclusion Criteria:

  • Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
  • Currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study).
  • Currently receiving dialysis treatment or planning to receive dialysis during the study.
  • Female participant known to be pregnant.
  • Participating in another device or drug study that could affect glucose measurements or glucose management.
  • Currently using or planning to use FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device during the study.
  • Has used the FreeStyle Libre Flash Glucose Monitoring System or a Continuous Glucose Monitoring (CGM) device in the previous 3 months.
  • Known (or suspected) allergy to medical grade adhesives.
  • In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Device: FreeStyle Libre Flash Glucose Monitoring System

Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear.

During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase.

Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time in Range
Time Frame: Baseline and days 56 to 70
Time in range (Sensor glucose 3.9-10.0 mmol/L [70-180 mg/dL]) in days 56-70 minus time in range at baseline (days 1-15).
Baseline and days 56 to 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

February 22, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-UK-PMS-16028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on FreeStyle Libre Flash Glucose Monitoring System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe