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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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MiniMed 780G New Enrollment Study


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General
Study Status Delayed
Application Number /
Requirement Number		 P160017 S091/ PAS001
Date Original Protocol Accepted 06/15/2023
Date Current Protocol Accepted 10/10/2024
Study Name MiniMed 780G New Enrollment Study
Device Name MiniMed 780G System
Clinical Trial Number(s) NCT03959423  
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Interim Results Safety Results:
The sponsor reported that there were 16 severe hypoglycemia, 11 diabetic ketoacidosis (DKA), and 37 hospitalization events related to the use of the MiniMed 780G system collected via biweekly surveys and/or Technical Support during the analysis period. A total of 2,212 adverse events (AE) were reported through surveys or Technical Support during the analysis period, including 5 deaths, 29 occurrence of inflammation and blister formation affecting the skin, 1,454 occurrences of hematoma/hemorrhage/bleeding, 358 hypoglycemia events, and 2 absence seizure event.

Effectiveness Results:
Participants demonstrated time in the target range (TIR) of 79.1±10.9% and a maximum mean TIR of 80.0±10.5% with use of the pump system 99.8±2.0% to 99.9±1.3%, and SmartGuard use 91.8±14.9% to 92.5±14.0% across the four 3-month periods observed after completion of the first survey. Participants reported a mean HbA1c of 6.8±0.7% across all four of the 3-month periods observed after completion of the first survey.
Actual Number of Patients Enrolled 2311
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate The sponsor reported that the biweekly survey return rate is 91.10%. The sponsor did not provide return rates for each age cohort or report whether any participants have been lost to follow-up.


MiniMed 780G New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/20/2023 10/19/2023 On Time
1 year report 04/20/2024 04/19/2024 On Time
18 month report 10/19/2024 10/18/2024 On Time
2 year report 04/20/2025 04/18/2025 On Time
3 year report 04/20/2026    
final report 07/20/2026    


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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