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

NCT05131139 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-04-26

No results posted yet for this study

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

Interventions

DEVICE

Continuous Glucose Monitoring System

Eversense 524 CGM System and ROME CGM System.

Sponsors & Collaborators

  • Senseonics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2025-03-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131139 on ClinicalTrials.gov