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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
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 Based on medical record data, the sponsor reported that 20 subjects had 27 severe (SH) hypoglycemia events and 14 subjects had moderate hypoglycemia events. In the intervention phase, one subject had one SH event and two subjects had moderate hypoglycemia (one event per subject). Based on medical record data, the sponsor also reported that 40 subjects had 67 severe hyperglycemia events that required healthcare provider intervention. There were no severe hyperglycemia events in the intervention phase.
Actual Number of Patients Enrolled 62
Actual Number of Sites Enrolled 10
Patient Follow-up Rate Fifteen subjects have completed the intervention phase, four subjects withdrew consent for the intervention phase, one subject screen failed, 16 subjects were lost to follow-up, and 26 subjects are currently participating in the intervention phase.


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    
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

Additional Resources

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