ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the following inclusion criteria will be included in this study:
- •Subjects ≥18 years of age
- •Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- •Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
排除标准
- •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 childbearing 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 within 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; antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)
- •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 study period
- •The presence of another active implanted device* *An example of an active implanted device includes but is not limited to an implantable defibrillator. Passive implantable devices are allowed. An example of a passive implantable device includes, but is not limited to, a cardiac stent. The use of commercial transcutaneous CGM devices (e.g. Dexcom G6/G7 CGM and Abbott Libre) are allowed and not exclusionary. Note that FDA-approved Eversense CGM System (not study provided) use will not be allowed.
研究组 & 干预措施
Continuous Glucose Monitoring Device
Eversense 365 Continuous Glucose Monitoring System and ROME GS System
干预措施: Continuous Glucose Monitoring System (Device)
结局指标
主要结局
Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点