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

Study Overview
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Brief Summary
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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.

Official Title
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Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

Conditions
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Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: Subjects ≥14 years of age Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old 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: History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months. Subjects with gastroparesis. 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. A condition preventing or complicating the placement, operation, or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition. 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. Hematocrit <38% or >60% at screening History of hepatitis B, hepatitis C, or HIV Current treatment for a seizure disorder unless written clearance by neurologist to participate in study. History of adrenal insufficiency 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) For subjects inserted with the ROME CGM System: A condition requiring or likely to require magnetic resonance imaging (MRI) Known topical or local anesthetic allergy Known allergy to glucocorticoids 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 Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period The presence of any other active implanted device (as defined further in protocol)

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring Device<br>Eversense 524 CGM System and ROME CGM System. | Device: Continuous Glucose Monitoring System<br>* Eversense 524 CGM System and ROME CGM System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System. | 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. | 365 days | 
| Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System. | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events | 365 days |