NCT04711382已完成不适用
The Use of Faster Acting Aspart in Type 1 Diabetes Patients: Multi-centre Real-world Experience
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Time in Range
研究概览
简要总结
Data on switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of switching from traditional mealtime insulin to Fiasp in a "real-world" clinical practice setting in people with type 1 diabetes in Belgium.
详细描述
The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dl) at 6 and 12 months. Secondary endpoints included change in HbA1c, BMI, insulin doses, time below range (T<70 and T<54 mg/dl) and time above range (T>180 and T>250 mg/dl).
Retrospective analysis Two-center study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes patients
- •Duration of diabetes > 2 years
- •Using CGM for > 6 months
排除标准
- •Using SMBG
- •Pregnancy
- •Using glucocorticoids or immunosuppressive agents
- •Active oncological problem
结局指标
主要结局
Time in Range
时间窗: 12 months
Time in target range at 12 months
次要结局
- Time above range(6 months & 12 months)
- Time below range(6 months & 12 months)
- Time in Range(6 months)
- Change in HbA1c(6 months & 12 months)
- Coefficient of variation(6 months & 12 months)
- Change in weight(6 months & 12 months)
- Change in insulin doses(6 months & 12 months)
研究者
研究点 (1)
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