Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System Across Varying Blood Glucose Ranges
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- System performance
研究概览
简要总结
The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.
详细描述
The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements. No less than 36 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •Diagonsed with T1D
- •Venous blood sampling access can be established in the forearm
- •Capable of independently reading instructions and complying with the clinical trial requirements
- •Willing to sign the Informed Consent Form (ICF)
排除标准
- •Severe hypoglycemia within the past 6 month
- •Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
- •Severe skin conditions at the sensor wear site
- •Extensive systemic skin disorders
- •Coagulation disorders confirmed by the investigator
- •Anemia or abnormal hematocrit
- •Blood donation within the past 6 months
- •Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days
- •Current or recent (≤1 month) participation in other clinical trials
- •Planned MRI/CT scans during sensor wear
- •Allergy to medical adhesives or alcohol
- •Conditions impairing comprehension of informed consent or study procedures
- •Other exclusionary conditions per investigator's discretion
结局指标
主要结局
System performance
时间窗: 15 days
The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
System-related Safety
时间窗: 15 days
The CGM system will be characterized by adverse device effects experienced by the study participants
次要结局
未报告次要终点