FreeStyle Libre Glucose Monitoring System Paediatric Study

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.

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).