Status:
COMPLETED
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ 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 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects ...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
- Subject is currently using SMBG for managing their diabetes.
- Subject must be able to read and understand English
- In the investigator's opinion, the subject 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 must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
- Subject must be willing and able to provide written signed and dated informed consent.
Exclusion
- Subject 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 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 :
March 30 2021
Estimated Enrollment :
935 Patients enrolled
Trial Details
Trial ID
NCT03448380
Start Date
February 27 2018
End Date
March 30 2021
Last Update
June 16 2021
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
2
Baptist Diabetes Associates, P.A
Miami, Florida, United States, 33156
3
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
4
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404