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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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Eversense CGM Non-Adjunctive PAS


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General
Study Status Progress Inadequate
Application Number P160048 S006/ PAS001
Date Current Protocol Accepted 05/04/2022
Study Name Eversense CGM Non-Adjunctive PAS
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 Design Description The purpose of this post-approval study (PAS) is to evaluate the safety of non-adjunctive use of the Senseonics Eversense and Eversense E3 Continuous Glucose Monitoring (CGM) Systems relative to the use of glucose meters. This is a one-year prospective cross-over study in which all subjects will use a glucose meter (SMBG arm) for a 6-month period followed by 6 months of using the Eversense CGM Systems (CGM arm).

Study Population Description Subjects may be included in the PAS if they fit the following inclusion criteria:
1. Subject has diabetes
2. Subject is greater than or equal to 18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator’s opinion
5. Subjects is willing and able to provide written, signed and dated informed consent

Subjects may not be included in the PAS if they fulfill the following exclusion criteria:
1. Subject is critically ill or hospitalized
2. At least 4 weeks of continuous use of CGM experience in the last 12 months, and no more than 1 week of continuous use in the last 6 months
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing
Sample Size Up to 925 subjects will be enrolled in the United States at up to 60 sites.

Data Collection The primary safety endpoint is the rate of the composite of severe hypoglycemia and diabetic ketoacidosis.

Other safety endpoints include:
Rate of all device-related and insertion and removal procedure-related adverse events
Rate of adverse events related to use of the user interface, patient training, or labeling materials.
Change in HbA1c from baseline at 6 and 12 months
Average hours of use per day
Serious adverse events regardless of causality

Follow-up Visits and Length of Follow-up Patients will participate for up to 12 months (6 months in each of two study arms)
Interim or Final Data Summary
Interim Safety Information 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)


Eversense CGM Non-Adjunctive PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/05/2019 12/06/2019 On Time
1 year report 06/05/2020 06/05/2020 On Time
18 month report 12/04/2020 12/04/2020 On Time
2 year report 06/05/2021 06/04/2021 On Time
3 year report 06/05/2022 06/03/2022 On Time
4 year report 06/05/2023    
5 year report 06/04/2024    


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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