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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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Post-Approval Study

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Study Status Progress Inadequate
Application Number P160017 S031/ PAS001
Date Current Protocol Accepted  
Study Name 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. The device is investigational in subjects ages 2-6 years and non-investigational in subjects 7 years and up.

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 2-6 years. The 2-6 year age group is also being 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.

Interim or Final Data Summary
Interim Safety Information The sponsor did not provide interim effectiveness results. Interim events of severe hyperglycemia and severe hypoglycemia are consistent for a pediatric and adult population with Type 1 diabetes.
Actual Number of Patients Enrolled 937
Actual Number of Sites Enrolled 35
Patient Follow-up Rate 799 total subjects have completed the final follow-up visit
Study Strengths & Weaknesses Strengths: Medtronic has exceeded the minimum number of subjects required to be enrolled in cohorts 1 and 3.
Weaknesses: Medtronic has not met their overall target enrollment goal and are lagging in enrollment for subjects 2-6 years of age and 7-13 years of age. Additionally, there is an underrepresentation of minorities in all cohorts, and gender discrepancy in cohort 2 in subjects
age greater than or equal to 14.

Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 09/28/2019 09/26/2019 On Time
two year report 09/27/2020 12/17/2020 Overdue/Received
3 year report 09/27/2021 09/28/2021 Overdue/Received
4 year report 09/27/2022    

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