FreeStyle Libre Glucose Monitoring System Paediatric Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: FreeStyle Libre Flash Glucose Monitoring System

• Registration Number: NCT02821117
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-29
• Study Start: 2016-06-30
• Study First Posted: 2016-07-01
• Primary Completion: 2016-11-30
• Study Completion: 2017-02-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	FreeStyle Libre Flash Glucose Monitoring System	FreeStyle Libre Flash Glucose Monitoring System

Primary Outcome Measures

Name	Time	Method
Change in Time in Range	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).

Trial Locations

Locations (10)

Temple Street Children's University Hospital; 🇮🇪 Dublin, Ireland

National Children's Hospital; 🇮🇪 Dublin, Ireland

Kinder- und Jugendkrankenhaus; 🇩🇪 Hannover, Germany

Antrim Area Hospital; 🇬🇧 Antrim, United Kingdom

Royal Belfast Hospital for Sick Children; 🇬🇧 Belfast, County Antrim, United Kingdom

Ulster Hospital; 🇬🇧 Belfast, United Kingdom

St. James University Hospital, Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Altnagelvin Hospital; 🇬🇧 Londonderry, United Kingdom

Southampton University Hospital NHS Trust; 🇬🇧 Southampton, United Kingdom