NCT04759495Unknown不适用
Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes
Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2019年6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
- 187
- 试验地点
- 1
- 主要终点
- Changes in glycated haemoglobin (HbA1c)
研究概览
简要总结
The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 rt-CGM and FGM
- •Type 1 diabetes for > 1 year
- •≥ 18 years old
- •CSII without automatic functions or MDI
排除标准
- •previous rtCGM or FGM use
- •treatment with insulin pump with automatic functions
- •severe noncompliance
- •known severe diabetic retinopathy and/or macular edema
- •lactation, pregnancy, or intending to become pregnant during the study
- •a 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
Changes in glycated haemoglobin (HbA1c)
时间窗: Up to 13 months
Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.
次要结局
- Percentage of time in hyperglycemic ranges(Up to 13 months)
- Percentage of time in hypoglycemic ranges(Up to 13 months)
- Changes in glycemic variability(Up to 13 months)
- Incidence of severe ketoacidosis(Up to 13 months)
- Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor(Up to 13 months)
- Mean sensor glucose concentration(Up to 13 months)
- Incidence of severe hypoglycaemia(Up to 13 months)
- Percentage of time in target ranges(Up to 13 months)
研究者
Jan Soupal, MD
Principal Investigator
Charles University, Czech Republic
研究点 (1)
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