Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- System performance on glucose measurement
研究概览
简要总结
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.
详细描述
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 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 T1DM on Continuous subcutaneous insulin infusion (CSII)
- •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 months
- •A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
- •Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
- •Severe skin conditions at the sensor wear site
- •Extensive systemic skin disorders
- •Having difficulty with wound healing, bleeding disorders, and/or taking anticoagulant medications
- •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
研究组 & 干预措施
Adult patients with T1DM
Adult patients with T1DM
干预措施: GK5 CGKM (Device)
结局指标
主要结局
System performance on glucose measurement
时间窗: 15 days
The CGK system performance for glucose measurement will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
System performance on ketone measurement
时间窗: 15 days
The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements
次要结局
- System-related Safety(15 days)
研究者
Peng Liu
Investigator
Henan University of Science and Technology