NCT05131139

Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Senseonics, Inc. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring System	Eversense 524 CGM System and ROME CGM System.

Timeline

• Start date: 2021-10-20
• Primary completion: 2025-03-30
• Completion: 2025-09-30
• First posted: 2021-11-23
• Last updated: 2023-04-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study