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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03448367|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
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
|Contact: Mohamed A Nada, PhDfirstname.lastname@example.org|
|United States, California|
|Sansum Diabetes Research Institute||Recruiting|
|Santa Barbara, California, United States, 93105|
|Contact: Kristin Castorino, DO 805-682-7638|
|United States, Idaho|
|Rocky Mountain Diabetes & Osteoporosis Center||Recruiting|
|Idaho Falls, Idaho, United States, 83404|
|Contact: David Liljenquist, MD|
|Principal Investigator: David Liljenquist, MD|
|Study Director:||Shridhara A Karinka, PhD||Abbott Diabetes Care|