FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients
|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: NCT03448367|
Recruitment Status : Terminated (Due to lower than anticipated enrollment)
First Posted : February 28, 2018
Last Update Posted : February 5, 2021
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System|
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients|
|Actual Study Start Date :||February 27, 2018|
|Actual Primary Completion Date :||July 17, 2020|
|Actual Study Completion Date :||October 13, 2020|
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 pediatric patient population.
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): NCT03448367
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|United States, Colorado|
|Barbara Davis Center for Diabetes|
|Aurora, Colorado, United States, 80045|
|United States, Idaho|
|Rocky Mountain Diabetes & Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|United States, New Mexico|
|Albuquerque Neuroscience Inc.|
|Albuquerque, New Mexico, United States, 87109|
|Study Director:||Shridhara A Karinka, PhD||Abbott Diabetes Care|