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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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FreeStyle Libre Flash Glucose Monitoring


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General
Study Status Progress Inadequate
Application Number P160030 / PAS001
Date Current Protocol Accepted 01/19/2022
Study Name FreeStyle Libre Flash Glucose Monitoring
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, nonrandomized, single-arm, post-approval study of the FreeStyle Libre 2 Flash CGM intended to characterize the safety of the device when used to manage diabetes in young adult patients.
Subjects and/or their caregivers will utilize the FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of adverse events during each phase. Assessment of
adverse events will occur via self-reporting at each monthly visit and/or phone call. Subjects will also complete a Quality of Life questionnaires (DTSQs and DTSQc).
Study Population Description Young adult subjects aged 18-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manager their diabetes.
Sample Size Up to approximately 150 subjects will be enrolled to obtain at least 118 subjects who complete the final visit.
Data Collection
Primary Endpoints: Incidence rate of severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person (e.g. as a result of confusion, coma, or seizure) during the study. Relative risk of severe and moderate hypoglycemia associated with FSL2 use from this study and SMBG use.

Secondary Endpoints: Incidence rate of severe hyperglycemic occurrences (with or without diabetic ketoacidosis or hyperglycemic hyperosmolar nonketotic syndrome) requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization during the study. Relative risk of severe hyperglycemic events associated with FSL2 use from this study and SMBG use. Sensor scan frequency, quality of life measures, and change in HbA1c.
Follow-up Visits and Length of Follow-up Approximately six months per subject. Approximately three years for study execution and completion.
Interim or Final Data Summary
Interim Safety Information N/A
Actual Number of Patients Enrolled As of April 25, 2022, no subjects of ages 18-30 have been enrolled in
the study.
Actual Number of Sites Enrolled 4
Patient Follow-up Rate N/A


FreeStyle Libre Flash Glucose Monitoring Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/28/2018 03/26/2018 On Time
1 year report 09/27/2018 09/17/2018 On Time
18 month report 03/28/2019 03/28/2019 On Time
2 year report 09/27/2019 09/20/2019 On Time
3 year report 09/26/2020 09/22/2020 On Time
final report 05/19/2021 05/19/2021 On Time
interim report 05/25/2022 05/25/2022 On Time
interim report 11/25/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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