The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 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 insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).
详细描述
Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Type 1 diabetes mellitus
- •CSII for at least 3 months
- •Duration of diabetes > 1 years
- •Informed consent
排除标准
- •Concomitant dietary restrictions (e.g. celiac disease or food allergy)
- •Diabetes related complications
- •Baseline hyperglycemia >150 mg/dl
- •Any disease judged by the investigator to affect the trial
研究组 & 干预措施
GLU_ASP
Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin glulisine
Second day: insulin aspart
干预措施: Insulin glulisine (Drug)
GLU_ASP
Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin glulisine
Second day: insulin aspart
干预措施: Insulin aspart (Drug)
ASP_GLU
Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin aspart
Second day: insulin glulisine
干预措施: Insulin glulisine (Drug)
ASP_GLU
Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin aspart
Second day: insulin glulisine
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Postprandial glycemia
时间窗: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
次要结局
- Hypoglycemia episodes(3-h study period)
- Glucose Area Under the Curve (AUC)(3-h study period)
- Mean amplitude of glycemic excursion (MAGE)(3-h study period)
- Difference between the maximum and baseline glycemia(3-h study period)