NCT05924932招募中不适用
Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes
Masaryk Hospital Usti nad Labem1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- glycated hemoglobin
研究概览
简要总结
The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.
详细描述
Rationale for the Study:
According to our hypothesis, even T1D patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability.
There are very few clinical studies from real practice in a larger group of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •patients with T1D
- •Type 1 diabetes for > 1 years
- •≥ 18 years old
- •CSII (without HCL) or MDI
排除标准
- •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.
- •Conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).
结局指标
主要结局
glycated hemoglobin
时间窗: 12 month
The difference and changes in glycated hemoglobin (HbA1c, % DCCT \[mmol/mol\]) between baseline and at 12 months after using HCL.
次要结局
- time spent in hyperglycemia(12 month)
- tim spent in TIR(12 month)
- glycemic variability(12 m,onth)
- time spent in hypoglycemia(12 month)
- mean sensor glucose value(12 month)
研究者
Lucie Radovnická
MD
Masaryk Hospital Usti nad Labem
研究点 (1)
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