FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

Study Overview
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Brief Summary
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This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in pediatric patients with diabetes.

Detailed Description
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Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 314 subjects who complete the final visit. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects and/or their caregivers will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Official Title
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FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

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: Subject must be 4 - 17 years of age. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment. Subject is currently using SMBG for managing their diabetes. Subject and/or caregiver must be able to read and understand English . In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. Subject and/or caregiver must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system. Subject must have an overnight companion (caregiver 18 years or older) present in the same home during participation of the study. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate. Exclusion Criteria: Subject and/or caregiver is a member of the Site Staff. Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment. Subject is on dialysis at the time of enrollment. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Subject currently is participating in another clinical trial. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMBG/FreeStyle Libre<br>During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes. | Device: FreeStyle Libre Flash Glucose Monitoring System<br>* Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the FreeStyle Libre Flash Glucose Monitoring System | The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the pediatric patient population. | Approximately one year per subject. |