Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 77
- 主要终点
- Glycaemia difference in time in range (TIR) 70-180mg/dl
研究概览
简要总结
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥1 year of a history of type 1 diabetes;
- •treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
- •using continuous glucose monitoring system for at least 1 month;
- •HbA1c<8%;
- •consent to participate in the study obtained from the parent and the patient (>16 years of age).
排除标准
- •diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
- •concomitant medical problems which might significantly affect glucose levels;
- •the withdrawal of the consent to participate in the study.
研究组 & 干预措施
Insulin Aspart
Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.
干预措施: Insulin faster aspart (Fiasp, Novo Nordisk) (Drug)
Insulin Fiasp
Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks.
干预措施: Insulin faster aspart (Fiasp, Novo Nordisk) (Drug)
结局指标
主要结局
Glycaemia difference in time in range (TIR) 70-180mg/dl
时间窗: at week 8 of the study
次要结局
- Glycaemia difference in the coefficient of variation (CV)(at weeks 4 and 8 of the study)
- Difference in the basal rate of insulin(at weeks 4 and 8 of the study)
- Glycaemia difference in time below range (TBR)(at weeks 4 and 8 of the study)
- Glycaemia difference in time above range (TAR)(at weeks 4 and 8 of the study)
- Difference in the average glycemia levels + standard deviation(at weeks 4 and 8 of the study)
- Difference in Total Daily Dose (TDD) of insulin(at weeks 4 and 8 of the study)