NCT05995756已完成不适用
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sinocare
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- overall mean absolute relative difference (MARD)
研究概览
简要总结
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose & Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged ≥18 years, male or female;
- •Clinically diagnosed with diabetes;
- •Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
- •Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
排除标准
- •Disagree to wear the investigational device continuously according to the requirements of the trial;
- •Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
- •Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
- •With diffuse subcutaneous nodules at the wearing site of the investigational device;
- •Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
- •With mental disorders, lack of self-control and inability to express clearly;
- •Have participated in any other clinical trial within the past 1 month;
- •Where the investigator thinks not suitable for being enrolled.
结局指标
主要结局
overall mean absolute relative difference (MARD)
时间窗: 8 or 15 days
次要结局
未报告次要终点
研究者
研究点 (3)
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