FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03448380|
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : June 16, 2021
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|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System|
|Study Type :||Observational|
|Actual Enrollment :||935 participants|
|Official Title:||FreeStyle Libre Flash Glucose Monitoring System Post Approval Study|
|Actual Study Start Date :||February 27, 2018|
|Actual Primary Completion Date :||March 30, 2021|
|Actual Study Completion Date :||March 30, 2021|
SMBG and FreeStyle Libre
During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.
Device: FreeStyle Libre Flash Glucose Monitoring System
Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).
- Safety of the FreeStyle Libre Flash Glucose Monitoring System [ Time Frame: Approximately one year per subject. ]The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the intended study population.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448380
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|United States, Florida|
|Baptist Diabetes Associates, P.A|
|Miami, Florida, United States, 33156|
|Metabolic Research Institute|
|West Palm Beach, Florida, United States, 33401|
|United States, Idaho|
|Rocky Mountain Diabetes & Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|United States, Iowa|
|Iowa Diabetes & Endocrinology Research Center|
|Des Moines, Iowa, United States, 50265|
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02453|
|United States, Michigan|
|Henry Ford Medical Center|
|Detroit, Michigan, United States, 48202|
|United States, New Mexico|
|Albuquerque Neuroscience Inc.|
|Albuquerque, New Mexico, United States, 87109|
|United States, Texas|
|Texas Diabetes & Endocrinology|
|Round Rock, Texas, United States, 78681|
|Clinical Trials of Texas|
|San Antonio, Texas, United States, 78229|
|Study Director:||Shridhara A Karinka, PhD||Abbott Diabetes Care Inc|
|Responsible Party:||Abbott Diabetes Care|
|Other Study ID Numbers:||
|First Posted:||February 28, 2018 Key Record Dates|
|Last Update Posted:||June 16, 2021|
|Last Verified:||June 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|