Clinical trial NCT02821117: FreeStyle Libre Glucose Monitoring System Paediatric Study
Official title: An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Paediatric
Sensing Technology
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Time in Range
timeFrame: Baseline and days 56 to 70
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Kinder- und Jugendkrankenhaus
city: Dublin
country: Ireland
facility: National Children's Hospital
city: Dublin
country: Ireland
facility: Temple Street Children's University Hospital
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: County Antrim
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital
city: Belfast
country: United Kingdom
facility: Ulster Hospital
city: Leeds
country: United Kingdom
facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust
city: Londonderry
country: United Kingdom
facility: Altnagelvin Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital NHS Trust
Study officials:
References: