NCT04836546

Eversense® Non-adjunctive Use Post Approval Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 925 (estimated)
• Sponsor: Senseonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Blood glucose meter	First phase: SMBG for 6 months
DEVICE	Eversense CGM System	Second phase: CGM for 6 months

Timeline

• Start date: 2021-04-13
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2021-04-08
• Last updated: 2025-08-13

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study