FreeStyle Libre Glucose Monitoring System Paediatric Study

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinder- und Jugendkrankenhaus, Hanover, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Freestyle LIbre Flash Glucose Monitoring System

Device

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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

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

Acronym: SELFY

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Jul 1, 2016
Registry last updated: Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed