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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OIR Lead-Post Approval Study


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General
Study Status Progress Adequate
Application Number P160017 / PAS001
Date Current Protocol Accepted 12/22/2016
Study Name OIR Lead-Post Approval Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, randomized, parallel, adaptive controlled trial in adult and pediatric patients with Type 1 Diabetes using Hybrid Closed Loop System (HCL) and/or control (CSII, MDI, or SAP) in the home setting. Three cohorts, each consisting of a control arm (CSII, MDI, or SAP) and an HCL arm and further divided by A1C group (A1C > 8% or A1C < 8%), will participate in the 6-month study period followed by a 6-month continuation period where all subjects will use HCL. The purpose of this study is to demonstrate the safety and effectiveness of the HCL in the study population.

This study includes the continued follow-up of premarket cohorts and new subject enrollment.
Study Population Description Adult and pediatric patients (2-80 years of age) with type 1 diabetes that meet the inclusion/exclusion criteria will be studied.

The device is investigational in ages 2-13 years. The 2-13 year age group will also be studied under an approved IDE.

Sample Size A minimum of 1120 subjects will be enrolled
Data Collection Primary Safety Endpoint

The primary safety endpoint is the event rate of severe hypoglycemia and DKA from both A1C Groups (baseline A1C > 8% and baseline A1C < 8%) during the first 6 months of study phase and second 6 months of continuation phase. The descriptive summary statistics will be presented by number of event and event rate (100 patient years) for severe hypoglycemia and DKA separately.

The safety of the study will be evaluated and summarized per arm, including but not limited to the following:

• Diabetic ketoacidosis (DKA)

• Severe hypoglycemia

• Severe hyperglycemia

• Serious adverse events (SAEs)

• Unanticipated adverse device effects (UADEs)

Descriptive analyses will be performed to assess the primary safety endpoint. Event rates of severe hypoglycemia and DKA will be compared to: (1) the target event rate (defined by the medical literature and other studies) and (2) the control groups (CSII, MDI, SAP).
Follow-up Visits and Length of Follow-up Follow-up visits are scheduled throughout the study period up to 6 months and throughout the continuation period up to 6 months.


OIR Lead-Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/29/2017 03/23/2017 On Time
one year report 09/28/2017 10/05/2017 Overdue/Received
18 month report 03/29/2018    
two year report 09/28/2018    
three year report 09/28/2019    
four year report 09/27/2020    
five year report 09/27/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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