Status:
TERMINATED
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
4-17 years
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 Gluco...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03448367
Start Date
February 27 2018
End Date
October 13 2020
Last Update
February 5 2021
Active Locations (4)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
2
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
3
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
4
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States, 87109