FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
Completed
Conditions studied: Diabetes Mellitus
In brief
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 people with diabetes.
Key facts
- Study ID
- NCT03448380
- Run by
- Abbott Diabetes Care
- People needed
- 935
- Starts
- 2018-02-27
- Expected to finish
- 2021-03-30
- Last updated by the study team
- 2021-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
- Baptist Diabetes Associates, P.A — Miami, Florida, United States
- Metabolic Research Institute — West Palm Beach, Florida, United States
- Rocky Mountain Diabetes & Osteoporosis Center — Idaho Falls, Idaho, United States
- Iowa Diabetes & Endocrinology Research Center — Des Moines, Iowa, United States
- MassResearch, LLC — Waltham, Massachusetts, United States
- Henry Ford Medical Center — Detroit, Michigan, United States
- Albuquerque Neuroscience Inc. — Albuquerque, New Mexico, United States
- Texas Diabetes & Endocrinology — Round Rock, Texas, United States
- Clinical Trials of Texas — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.