U.S., April 9 -- ClinicalTrials.gov registry received information related to the study (NCT07518004) titled 'ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System' on April 01.
Brief Summary: The purpose of this clinical investigation is to demonstrate that the proposed physical changes to the ROME GS Sensor do not have any adverse impact on safety and performance when compared to the Eversense 365 Sensor.
Study Start Date: Feb. 12
Study Type: INTERVENTIONAL
Condition:
Diabetes
Diabetes Melletus, Type 1
Diabetes Mellitus, Type 2
Intervention:
DEVICE: Continuous Glucose Monitoring System
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
Recruitment Status: RECRUI...