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This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in a pediatric patient population.
Condition or disease
Device: FreeStyle Libre 2
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 he FreeStyle Libre 2 Flash Glucose Monitoring System 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.
Characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in a pediatric patient population [ Time Frame: Six Months ]
Incidence rate of 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 will be collected.
The incidence rate of severe hypoglycemia associated with FSL2 use from this study will be compared with the incidence rate observed from self-monitoring blood glucose (SMBG) use observed during clinical study NCT04577976.
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Layout table for eligibility information
Ages Eligible for Study:
4 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.
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 Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
Subject has completed participation in clinical study ADC-US-PMS-20194.
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.
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.