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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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OSB Lead-PAS of TS Feat w/sensor-aug w/comm data


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General
Study Status Study Pending
Application Number P120010 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-PAS of TS Feat w/sensor-aug w/comm data
General Study Protocol Parameters
Study Design Other Study Design
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the study is to demonstrate that home use of the Medtronic MiniMed 530G System with utilization of the Threshold Suspend feature is not associated with glycemic deterioration. The objective will be demonstrated using two substudies.



Substudy 1: Multi Center Trial

This prospective, multi center, new enrollment study will compare measured baseline HbA1c to end of study (12 months) HbA1c, and will also summarize adverse events and provide results broken down by patient characteristics of interest.



Substudy 2: Commercial Data Evaluation

This retrospective cohort study of a real world data set will evaluate data from a subcohort of the CareLink commercial database of MiniMed 530G users to verify that use of the MiniMed 530G System is not associated with glycemic deterioration over time.

Study Population Description Substudy 1: Subjects aged 16 or older currently diagnosed with diabetes mellitus and having required insulin for over a period of one year.

Substudy 2: Subjects from the CareLink data set who have all of the following: demographic information, been followed through the Outreach program for at least one year, have two self reported HbA1c values at least 30 days apart, have uploaded device data via CareLink, and do not overlap with the new enrollment study cohort.

Sample Size Substudy 1: A total of 426 subjects have been enrolled. A total of 100 subjects is needed to test the hypothesis for this substudy.



Substudy 2: A total of 1402 subjects fit the inclusion criteria for the CareLink commercial analysis cohort. A sample size of 200 subjects is needed to test each prespecified hypothesis for this substudy.

Data Collection Substudy 1:

Primary Endpoint: Overall mean change in HbA1c from baseline to 12 month follow-up.

Secondary Endpoint: Overall mean change in HbA1c from baseline to 12 month follow-up stratified by baseline HbA1c measurement (less than 7 percent, 7 to 9 percent, greater than 9 percent).

Safety Endpoints: Serious Adverse events, Unanticipated Adverse Device Effects, Incidence of Severe Hypoglycemia, Incidence of Severe Hyperglycemia, Incidence of Diabetic Ketoacidosis.



Substudy 2:

Primary Endpoint: The difference between self reported first HbA1c and subsequent HbA1c.



Effectiveness Endpoints:

1. The difference in time spent with sensor glucose level less than 70 mg per dL with the Threshold Suspend Feature ON versus with the Threshold Suspend Feature OFF.

2. The difference in time spent with sensor glucose level greater than 180 mg per dL with the Threshold Suspend Feature ON versus with the Threshold Suspend Feature OFF.



Secondary Endpoints will include: reporting of adverse events collected through Medtronic’s Outreach program, stratifications of the primary and effectiveness endpoints by baseline patient characteristics, and other descriptive endpoints related to subjects’ utilization of the Threshold Suspend Feature and subjects’ adherence to CGM and adjunctive fingerstick glucose readings.



Follow-up Visits and Length of Follow-up Substudy 1: Follow-up will be 12 months.



Substudy 2: Follow-up was up to one year.



OSB Lead-PAS of TS Feat w/sensor-aug w/comm data Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/11/2018    


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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