FreeStyle Libre Glucose Monitoring System Paediatric Study
This trial is active, not recruiting.
|Treatment||freestyle libre flash glucose monitoring system|
|Sponsor||Abbott Diabetes Care|
|Start date||June 2016|
|End date||December 2016|
|Trial size||76 participants|
|Trial identifier||NCT02821117, ADC-UK-PMS-16028|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Hannover, Germany||Kinder- und Jugendkrankenhaus||no longer recruiting|
|Dublin, Ireland||National Children's Hospital||no longer recruiting|
|Dublin, Ireland||Temple Street Children's University Hospital||no longer recruiting|
|Belfast, United Kingdom||Royal Belfast Hospital for Sick Children||no longer recruiting|
|Antrim, United Kingdom||Antrim Area Hospital||no longer recruiting|
|Belfast, United Kingdom||Ulster Hospital||no longer recruiting|
|Leeds, United Kingdom||St. James University Hospital, Leeds Teaching Hospitals NHS Trust||no longer recruiting|
|Londonderry, United Kingdom||Altnagelvin Hospital||no longer recruiting|
|Nottingham, United Kingdom||Nottingham University Hospitals NHS Trust||no longer recruiting|
|Southampton, United Kingdom||Southampton University Hospital NHS Trust||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Change in Time in Range
time frame: Baseline and days 56 to 70
Male or female participants from 4 years up to 17 years old.
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).
|Official title||An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People|
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