Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index 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
- 72
- 试验地点
- 1
- 主要终点
- Postprandial Glycemia
研究概览
简要总结
The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).
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 12months,
- •insulin pump therapy longer than 3 months,
- •written informed consent to participate in the study signed by parents (and patient older than 16 years).
排除标准
- •celiac disease,
- •diabetes related complications (e.g. nephropathy),
- •BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
- •withdrawal of consent to participate in the study,
- •comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.
研究组 & 干预措施
Normal Bolus
Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
干预措施: Insulin Glulisine (Drug)
Normal Bolus
Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
干预措施: Insulin Aspart (Drug)
Normal Bolus
Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
干预措施: Insulin Lispro (Drug)
Super Bolus
Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.
干预措施: Insulin Glulisine (Drug)
Super Bolus
Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.
干预措施: Insulin Aspart (Drug)
Super Bolus
Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Postprandial Glycemia
时间窗: 90 minutes after the prandial bolus
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)
次要结局
- Hypoglycemia Episodes(3-hours after the prandial bolus)
- Glucose Area Under the Curve (AUC)(3-hours after the prandial bolus)
- Mean amplitude of glycaemic excursion (MAGE)(3-hours after the prandial bolus)
- Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus(3-hours after the prandial bolus)
- Glycemic rise (GR)(3-hours after the prandial bolus)
- Peak glucose level (PG)(3-hours after the prandial bolus)
- Time to glucose peak(3-hours after the prandial bolus)
- Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)(3-hours after the prandial bolus)