NCT04358263Unknown不适用
Comparison of CGM in Randomised Study of Real-time and Intermittently-scanned Systems in T1D With Normal Awareness of Hypoglycemia (CORRIDA)
Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of time in hypoglycemic ranges
研究概览
简要总结
The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •patients with T1D naive to rtCGM and isCGM
- •Type 1 diabetes for >2 years
- •≥ 18 years old
- •CSII or MDI
- •GOLD score < 4, no history of severe hypoglycemia within last 6 month
- •written informed consent prior to starting study related activity
排除标准
- •severe noncompliance
- •severe diabetic retinopathy and/or macular edema
- •lactation, pregnancy, intending to become pregnant during study
- •condition likely to require MRI
- •use of acetaminophen-containing medication
- •unwillingness to use the study device for >70% of time
结局指标
主要结局
Percentage of time in hypoglycemic ranges
时间窗: Up to 2 months
\<3,9 mmol/L (70 mg/dl) and \<3,0 mmol/L (54 mg/dl)
次要结局
- Percentage of time in hyperglycemic ranges(Up to 2 months)
- Mean sensor glucose concentration(Up to 2 months)
- Changes in glycated haemoglobin (HbA1c)(Up to 2 months)
- Percentage of time in target ranges(Up to 2 months)
- Changes in quality of life as assessed by validated questionnaire(Up to 2 months)
- Incidence of severe hypoglycaemia(Up to 2 months)
- Changes in glycemic variability(Up to 2 months)
研究者
Jan Soupal, MD
Principal Investigator
Charles University, Czech Republic
研究点 (1)
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