A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 34
- 主要终点
- The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
研究概览
简要总结
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System
详细描述
The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.
The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.
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
- •Subject has diabetes
- •Subject is greater than 18 years of age
排除标准
- •Subject is critically ill or hospitalized
- •Subject has a known contraindication to dexamethasone or dexamethasone acetate
- •Subjects requiring intravenous mannitol or mannitol irrigation solutions
- •Female subjects who are pregnant, planning on becoming pregnant or nursing
- •Subjects on hybrid closed loop systems or closed loop systems
- •Subjects on other CGM systems
结局指标
主要结局
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
时间窗: up to 27 months
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
时间窗: Baseline and Month 12
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.
次要结局
- The Additional Effectiveness Endpoint of Average Hours of Use Per Day(up to 27 months)
- The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline(Baseline, Month 6, Month 12, Month 18, and Month 24)
- HCP Feedback Questionnaire Regarding Removal(up to 27 Months)
- Patient Satisfaction With CGM System Use (CGM-SAT Scale)(up to 27 months)
- Success Rate of Insertion Procedures: Overall and by HCP Experience(up to 27 months)
- Patient Reported Diabetes Distress Scale (DDS)(Screening, Day 180, Day 360, and Day 720)
- Success Rate of Removal Procedures: Overall and by HCP Experience(up to 27 months)
- HCP Feedback Questionnaire Regarding Insertion(up to 27 Months)
- Rate of Insertion Procedures With Serious Adverse Events(up to 27 months)
- Rate of Removal Procedures With Serious Adverse Events(up to 27 months)
- Residual Dexamethasone Level in Explanted Sensors(up to 27 months)