NCT03908125

Post Approval Study of the Eversense® Continuous Glucose Monitoring

A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Senseonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System

Detailed 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. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days. The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Eversense® CGM System	Continuous Glucose monitoring device

Timeline

• Start date: 2019-03-19
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2019-04-09
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study