Diabetes, Diabetes Melletus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Detailed 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 device-related and insertion/removal procedure-related serious adverse events during the investigation.
Interventions
DEVICEContinuous Glucose Monitoring System
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
Sponsors
Senseonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion. | 365 days post-insertion | To determine accuracy of the ROME GS System measurements compared to a reference glucose analyzer. The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively. Neither inferential analysis nor hypothesis testing will be performed. |
| Number of device-related or sensor insertion/removal procedure-related serious adverse events | 365 days post-insertion and follow-up | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events in clinic and during home use post-sensor insertion or removal and follow-up. |
Countries
United States
Contacts
CONTACTMaggie Lewis
CONTACTSusan Huynh
Outcome results
None listed