Best Timing of Insulin Bolus Before Meals of Different Contents
The Effect of Food Content and Optimal Timing of Pre-meal Insulin Bolus on the Postprandial Glycemic Control in Children With Type 1 Diabetes
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Rehovot、以色列、76100
- 招聘中
- Pediatric Endocrinology Unit, Kaplan Medical Center
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首席研究员：
- Amnon Zung, MD
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接触：
- Amnon Zung, MD
- 电话号码：972-8-9441260
- 邮箱：amnon_z@clalit.org.il
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副研究员：
- Nitza Vazana, RN
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副研究员：
- Lilach Hofi, R.Nutr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Diabetes patients:
- Type 1 diabetes
- Age 8 to 20 years
- Both genders
Control group:
- Age 18 to 30 years
- Both genders
Exclusion Criteria:
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Timing of insulin administration
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Three different timings of insulin delivered by a pump
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.
大体时间：outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
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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. |
outcome measures will be assessed for each particiapant after a week; the overall timeframe for all participants is 18 months
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合作者和调查者
调查人员
- 首席研究员：Amnon Zung, MD、Pediatric Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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