Clinical trial NCT03448367: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
Official title: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 19
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric subjects aged 4-17 years and older 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the FreeStyle Libre Flash Glucose Monitoring System
timeFrame: Approximately one year per subject.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes & Osteoporosis Center
state: Idaho
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc.
state: New Mexico
Study officials:
affiliation: Abbott Diabetes Care
name: Shridhara A Karinka, PhD
role: STUDY_DIRECTOR
References: