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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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Post-Approval Study


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General
Study Status Progress Adequate
Application Number P160048 / PAS001
Date Current Protocol Accepted 01/15/2019
Study Name Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting.



This is a prospective, multi-center study, whereby up to 400 subjects will be enrolled in the United States at up to 30 sites. The subjects will have one Sensor inserted by trained health care professionals approximately every 3 months. Sensors will be inserted in the upper arm of the subjects.



This is a new enrollment study.



Study Population Description Subjects may be included in the PAS if they fit the following inclusion criteria:

1. Subject has diabetes mellitus

2. Subject is greater than 18 years of age



Subjects may not be included in the PAS if they fulfill the following exclusion criteria:

1. Subject will require a planned MRI during the period of Sensor insertion

2. Subject is critically ill or hospitalized

3. Subject has a known contraindication to dexamethasone or dexamethasone acetate

4. Subjects requiring intravenous mannitol or mannitol irrigation solutions

5. Female subjects who are pregnant, planning on becoming pregnant or nursing

6. Subjects on hybrid closed loop systems or closed loop systems

7. Subjects on other CGM systems





The study will include an enrollment target of at least N=40 subjects aged >65 years.



Sample Size The PAS will enroll up to 400 subjects (to insert 350 subjects) to ensure adequate numbers of subjects for the primary safety endpoint.
Data Collection The primary safety endpoint is the rate of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity.



The primary effectiveness endpoint is Time in Range, which is defined as sensor glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first sensor insertion compared to the first month post-first sensor insertion.



Other safety endpoints include:

Rate of all device-related and insertion and removal procedure-related adverse events (serious and non-serious events) through 24 months post-first sensor insertion

Rate of device breakage through 24 months post-first sensor insertion

Rate of device-related and insertion and removal procedure-related serious adverse events through 24 months post-first sensor insertion

Subgroup analysis of safety endpoints based on: o Age (<65 years vs. >65 years, minimum 40 subjects)

Diabetes type (I vs. II)

Race (non-Caucasian vs. Caucasian)



Other effectiveness endpoints include:

Average hours of use per day

Change in HbA1c levels at each 6-month interval from baseline



Follow-up Visits and Length of Follow-up Patients will return to the clinic at approximately 3-month intervals for exchange of the Sensor and for routine follow up of their diabetes. Patients will participate for up to 24 months of CGM system use.





Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/20/2019 03/20/2019 On Time
one year report 06/21/2019 06/19/2019 On Time
18 month report 12/20/2019    
two year report 06/20/2020    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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