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临床试验/NCT01209312
NCT01209312已完成不适用

Timing of Pre-meal Insulin Versus Accurate Carbohydrate Counting in Youth With Type 1 Diabetes

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Blood glucose area under the curve

研究概览

简要总结

The investigators are hoping to figure out how youth with type 1 diabetes can best control their blood glucose levels after meals, by determining whether accurate carbohydrate dosing or the timing of the bolus is more important. There is evidence to suggest that each strategy is important for blood glucose control. Unfortunately, for some people, prebolusing is difficult, because they may not know how much they are going to eat. To give an exact dose of insulin 20 minutes before a meal can be difficult. In this study, the investigators would like to show that taking even just part of the insulin bolus 20 minutes before the meal is preferable to waiting until mealtime and taking the entire bolus. To do this, the investigators will have 24 patients in the study, who will each spend 4 mornings at The investigators clinic. The order of the visits will be selected randomly. The visits will include: taking full bolus at mealtime, taking full bolus 20 minute before mealtime, taking ½ bolus at mealtime, and taking ½ bolus 20 minutes before mealtime. At each visit, the person will eat the same meal, but the timing and amount of the bolus will be different. The investigators will measure the blood glucose levels with a blood glucose meter, and also with a laboratory test called YSI. The investigators will also be measuring the glucose levels under the person's skin with a continuous glucose monitor. The investigators will compare the area under the curve for the different visits, as well as the glucose levels at different points after the meal.

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
None

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 7-21, inclusive
  • Diagnosis of type 1 diabetes for >1 year
  • Using carbohydrate counting to dose mealtime insulin
  • Using an insulin pump and continuous glucose monitor to control diabetes
  • HbA1c <10%

排除标准

  • Celiac disease or other GI abnormality
  • Severe hypoglycemia in the past 6 months
  • Pregnancy
  • Documented hypoglycemia unawareness

结局指标

主要结局

Blood glucose area under the curve

时间窗: 4 hours post-meal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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