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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 Delayed
Application Number /
Requirement Number		 P160030 / PAS001
Date Original Protocol Accepted 12/08/2017
Date Current Protocol Accepted 04/05/2024
Study Name FreeStyle Libre Flash Glucose Monitoring
Device Name Freestyle Libre Flash Glucose Monitoring System
Clinical Trial Number(s) NCT02082184 NCT02232698 NCT02283411 NCT02388815 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Interim Results Compared to the previous 24-month report, there was no change in the total number of primary endpoint adverse events in both the 6
months historical medical record data and the intervention phase data. Twenty-one (21) subjects had severe hypoglycemia (observed
in 28 events) and fifteen (15) subjects had moderate hypoglycemia (observed in 15 events) based on 6 months of medical record data.
Compared to the previous 24-month report, there was no change in the total number of secondary endpoint adverse events in both 6-
month historical medical record data and intervention phase data as compared to the last report period.
Forty (40) subjects had severe hyperglycemia (observed in 67 events) that required healthcare professional intervention based on 6
months of medical record data.
Actual Number of Patients Enrolled 81
Actual Number of Sites Enrolled 13
Patient Follow-up Rate Five subjects withdrew consent after being enrolled in the intervention phase and 23 subjects were lost to follow-up (see Table
3). The subjects who were lost to follow-up failed to show up for a study visit and/or became unreachable despite multiple attempts by
the sponsor (phone calls, emails, and/or text messages) to locate each subject. The sponsor did not identify measures to prevent the
loss/withdrawal of additional subjects, however they did state that they will enroll additiona


FreeStyle Libre Flash Glucose Monitoring Reporting Schedule

Reporting 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
6 month report 05/25/2022 05/25/2022 On Time
1 year report 11/25/2022 11/22/2022 On Time
18 month report 06/23/2023 06/23/2023 On Time
2 year report 12/23/2023 12/18/2023 On Time
30 month report 06/23/2024 06/21/2024 On Time
3 year report 12/23/2024    


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

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