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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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General
Study Status Progress Inadequate
Application Number /
Requirement Number
P160048 / PAS001
Date Original Protocol Accepted 09/18/2018
Date Current Protocol Accepted 05/24/2022
Study Name Post-Approval Study
Device Name EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives 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 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 273 subjects) to ensure a total of at least 1400 Sensory cycles contributing to the analysis.
Key Study Endpoints 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 or 6-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.

Interim or Final Data Summary
Interim Results For P160048:
Two hundred seventy (270) adverse events (AE) have been reported as of the reporting period through May 2, 2022. Two hundred sixty-three (263) of these events have complete adjudication by CEC members. Of these events, 81 are related to the study device and/or the insertion or removal procedure.

For P160048/S006:
Twenty-two (22) adverse events (AE) have been reported as of the reporting period through 02 May 2022. Of these events, three (3) are related to the study device and/or the insertion or removal procedure.
Actual Number of Patients Enrolled For P160048: 273
For P160048/S006: 201
Actual Number of Sites Enrolled For P160048 (Adjunctive Use): 18
For P160048/S006 (Non-Adjunctive Use): 18
Patient Follow-up Rate For P160048: 97.4% (266/273)
For P160048/S006: 95.0% (191/201)


Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/20/2019 03/20/2019 On Time
1 year report 06/21/2019 06/19/2019 On Time
18 month report 12/20/2019 12/23/2019 Overdue/Received
2 year report 06/20/2020 06/19/2020 On Time
3 year report 06/05/2021 06/04/2021 On Time
4 year report 06/05/2022 06/03/2022 On Time
5 year report 06/05/2023    


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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