FreeStyle Libre Glucose Monitoring System Paediatric Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Libre Flash Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>FreeStyle Libre Flash Glucose Monitoring System | Device: FreeStyle Libre Flash Glucose Monitoring System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time in Range | 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). | Baseline and days 56 to 70 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Paediatric, Sensing Technology