NCT05165615Unknown不适用
Comparison of the Two Different Closed-loop Hybrid Systems - AndroidAPS and Control-IQ 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 20 人开始时间: 2020年12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
- 20
- 试验地点
- 1
- 主要终点
- Percentage of time in target ranges
研究概览
简要总结
The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Type 1 diabetes diagnosed >2 years
- •≥ 18 years old
- •written informed consent prior to starting study related activity
- •previous user of AndroidAPS at least for 3 months
排除标准
- •severe noncompliance
- •lactation, pregnancy, intending to become pregnant during study
- •use of medication with effects on carbohydrate metabolism
结局指标
主要结局
Percentage of time in target ranges
时间窗: Up to 28 weeks
3.9-10.0 mmol/L (70-180 mg/dl)
次要结局
- Changes in glycemic variability(Up to 28 weeks)
- Changes in glycated haemoglobin (HbA1c)(Up to 28 weeks)
- Percentage of time in hypoglycemic ranges(Up to 28 weeks)
- Percentage of time in hyperglycemic ranges(Up to 28 weeks)
- Incidence of severe hypoglycaemia(Up to 28 weeks)
- Diabetes Distress Scale (DDS)(Up to 28 weeks)
- The 5-item World Health Organization well-being index (WHO-5 index)(Up to 28 weeks)
- Hypoglycemia Attitudes and Behavior Scale (HABS)(Up to 28 weeks)
研究者
Jan Soupal, MD
Principal Investigator
Charles University, Czech Republic
研究点 (1)
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