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

Overview

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.

Eligibility

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 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 consciousness or seizure.
          2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in
             the previous 6 months.
          3. Subjects with gastroparesis.
          4. Female subjects of childbearing capacity (defined as of child bearing age and as not
             surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant,
             intending to become pregnant, or not practicing birth control during the course of the
             study.
          5. A condition preventing or complicating the placement, operation, or removal of the
             sensor or wearing of transmitter, including upper extremity deformities or skin
             condition.
          6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient
             ischemic attack or stroke in the past 6 months; uncontrolled hypertension
             (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive
             heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects
             with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty)
             may participate if negative stress test within 1 year prior to screening and written
             clearance from Cardiologist documented.
          7. Hematocrit <38% or >60% at screening
          8. History of hepatitis B, hepatitis C, or HIV
          9. Current treatment for a seizure disorder unless written clearance by neurologist to
             participate in study.
         10. History of adrenal insufficiency
         11. Currently receiving (or likely to need during the study period): immunosuppressant
             therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin);
             topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g.,
             osteomyelitis, endocarditis)
         12. For subjects inserted with the ROME CGM System: A condition requiring or likely to
             require magnetic resonance imaging (MRI)
         13. Known topical or local anesthetic allergy
         14. Known allergy to glucocorticoids
         15. Any condition that in the investigator's opinion would make the subject unable to
             complete the study or would make it not in the subject's best interest to participate
             in the study. Conditions include but are not limited to psychiatric conditions, known
             current or recent alcohol abuse or drug abuse by subject history, a condition that may
             increase the risk of induced hypoglycemia or risk related to repeated blood testing.
             Investigator will supply rationale for exclusion
         16. Participation in another clinical investigation (drug or device) within 2 weeks prior
             to screening or intent to participate during the study period
         17. The presence of any other active implanted device (as defined further in protocol)