Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
DEVICEContinuous Glucose Monitoring System
Eversense 524 CGM System and ROME CGM System.
Sponsors
Senseonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 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 ≥14 years of age 2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older 3. Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old 4. Subject has signed an informed consent or assent form and parent/guardian has signed an informed consent, as applicable, and subject is willing to comply with protocol requirements.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System. | 365 days | The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively. |
| Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System. | 365 days | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events |
Countries
United States
Contacts
Primary ContactMaggie Lewis
Backup ContactKatherine Tweden
Outcome results
None listed