FreeStyle Libre 2 Flash Glucose Monitoring System Intervention Phase Study for Pediatric Patients
- Study HIC#:2000030885
- Last Updated:12/17/2021
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.
- Age4 years - 17 years
- Start Date12/01/2021
- End Date05/31/2023
Trial Purpose and Description
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.
- 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.