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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 PAS


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 PAS
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 Safety Results:
This 42-month interim status report, which now includes 135 subjects with 6 months of historical medical data, shows a slight uptick in glycemic incidents compared to the 36-month report (e.g. moderate hypoglycemia events now includes 18 subjects and 28 events, up from 17 subjects, 26 events and severe hyperglycemia events now 42 subjects and 71 events, up from 40 subjects, 67 events). A similar trend was observed among the 147 subjects enrolled in the intervention phase (e.g. severe hypoglycemia now 3 subjects and 3 events, up from 2 subjects and 2 events and severe hyperglycemia now 1 subject and 1 event, up from 0 subjects/events previously).
Actual Number of Patients Enrolled 147
Actual Number of Sites Enrolled 13
Patient Follow-up Rate Out of the 147 subjects enrolled in the Intervention Phase, 6 withdrew consent, 1 was withdrawn from the study by the investigator, 2 were removed due to screening failure, 1 was discontinued from the study due to protocol deviation, and 29 were lost to follow-up. 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 would enroll additional subjects if the subjects lost to follow-up exceed the protocol's allowed percentage (up to 20%).


FreeStyle Libre Flash Glucose Monitoring PAS 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 12/23/2024 On Time
42 month report 06/23/2025 06/20/2025 On Time
4 year report 12/23/2025    


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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