FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

Study Overview
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Brief Summary
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This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.

Detailed Description
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Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. 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 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: SMBG


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 parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate. Exclusion Criteria: Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months. 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

| Intervention/Treatment |
| --- |
|Device: SMBG|Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events | Rate of Serious Adverse events associated with Hypoglycemia and Hyper glycaemia will be determined. (e.g severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person [e.g. as a result of confusion, coma, or seizure] during the study. | six months |