The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Postprandial glycemia
研究概览
简要总结
The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of type 1 diabetes longer than 12 months
- •insulin pump therapy longer than 3 months
- •treated by the same type of insulin longer than 3 months
- •written informed consent by patients and parents
排除标准
- •celiac disease
- •diabetes related complications (e.g. nephropathy)
- •any disease judged by the investigator to affect the trial
- •withdrawal of consent to participate in the study
研究组 & 干预措施
IPF
Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Glulisine (Drug)
IPF
Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Aspart (Drug)
IPF
Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Lispro (Drug)
30%IC
Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Glulisine (Drug)
30%IC
Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Aspart (Drug)
30%IC
Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Postprandial glycemia
时间窗: 300 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
次要结局
- Glucose Area Under the Curve (AUC)(5 hours study period)
- The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)(5 hours study period)
- Hypoglycemia Episodes(5 hours study period)
- Time in target postprandial glycemia(5 hours study period)