ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System
Senseonics, Inc.
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.
Description
A prospective, non-randomized, multi-center evaluation of accuracy and safety of the ROME GS system. 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. The investigation will also determine the accuracy of the ROME GS Sytem measurements compored to a reference glucose analyzer. Additionally, the study will demonstrate the safety of the ROME GS System post-sensor insertion or removal and follow-up by measuring the incidence of dev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: 1. Subjects ≥18 years of age 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year 3. Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study: 1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of conscious…
Interventions
- DeviceContinuous Glucose Monitoring System
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
Locations (4)
- Headlands Research - AMCR InstituteEscondido, California
- Flourish Research - Diablo Clinical ResearchWalnut Creek, California
- Flourish Research - San AntonioSan Antonio, Texas
- Rainier Clinical Research CenterRenton, Washington