The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
研究概览
简要总结
Post-meal glucose excursions may contribute to the development of diabetes-related complications. These glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal. The best timing for insulin bolus (by pump) is controversial.
The aim of the study is to examine three different timings of insulin bolus in three types of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat. The 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system. The results obtained in the diabetic patients will be compared to those obtained in a group of healthy individuals that will consume similar meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetes patients:
- •Type 1 diabetes
- •Age 8 to 20 years
- •Both genders
- •Control group:
- •Age 18 to 30 years
- •Both genders
排除标准
- •Diabetes patients:
- •Less than a year from the diagnosis of type 1 diabetes
- •Less than 6 months from the time of insulin pump introduction
- •Control group:
- •Pregnancy
- •Any diagnosed or suspected chronic diseases
- •Current or recent (within 1 month) use of drugs (not including oral contraceptives and inhaled steroids for asthma).
研究组 & 干预措施
Timing of insulin administration
干预措施: insulin (Drug)
结局指标
主要结局
Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
时间窗: outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
Each diabetes patient will be assigned for one of three breakfast meals, differed by their content: carbohydrates, carbohydrates + proteins or carbohydrates + fat. Post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring at three different days. In each day insulin bolus will be administrated at a different timing before meal. Each healthy participant will consume the three types of breakfast meals at three different days, and post-meal blood glucose excursions will be recoded by continuous blood glucose monitoring.
次要结局
未报告次要终点
研究者
Amnon Zung
MD
Kaplan Medical Center