Analysis of the Individual Variation of the Carbohydrate Amount at Each Meal in Children and Adolescents With Type 1 Diabetes Using the Carbohydrate Counting Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
研究概览
简要总结
The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic response in children and adolescents with type 1 diabetes. Carbohydrate counting is a technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal. Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend to improve. Carbohydrate counting is a recommended technique in the adult diabetic population. There is little data on the use of this methode in youth with diabetes. There are no studies on the change of carbohydrates content at meals in children and adolescents with diabetes practicing counting carbs, while it is the main interest of this technique. The aim of this study is to assess how children and adolescents with type 1 diabetes use the possibility to change their carbohydrate amount at each main meal when they use the counting carb method. The investigators hypothesize that children vary their amount of CHO greatly. This is an argument for using this technique in pediatrics
详细描述
The chalenge of the treatment of children and adolescents with type 1 diabetes is to maintain a normoglycemia to prevent the complications of diabetes. The post prandial glycemic control is directly inflenced by the CHO content of the meal and the carbohydrates must represent about 55% of the daily needs. There is a linear relation between carbohydrate intake and insuline need. CHO counting is a technique to match a bolus insuline dose to the total carbohydrate content of the meal. An insulin to carbohydrate ratio is used. The method contrasts with fixed insulin regimen. There is a lack of studies on CHO counting particulary in pediatric population. However, there are currently international recommendations supporting the use of CHO counting in the management of type 1 diabetes because it improves the quality of life, tends to improve the HbA1c and limits hypoglycemia without increasing the BMI. There is no pediatric study on the variation of the amount of CHO at each of the main 4 daily meals.
Aims The investigators hypothesize that children vary greatly their total meal CHO .This is an argument for this technique.
Primary aim :
To assess how children and adolescents (aged 1 to 18) use this possibility to change the amount of CHO at breakfast, at lunch, at snack, at dinner and from day to day.
Secondary aims :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated for type 1 diabetes with a basal bolus regimen and practicing counting carbohydrates for nine months or more
- •With autoantibodies positive (anti-gad, anti-ia2, anti-islets ) or HLA typing predisposing to type 1 diabetes
- •Aged 1 to 18 years
- •affiliation to a social security scheme
- •Less than three oversights of bolus insulin in the week prior to inclusion
排除标准
- •Aged less than 1 or more than 18 years
- •Autoantibody negative and HLA does not predispose to type 1 diabetes
- •No affiliation to a social security scheme
- •More than two omissions of bolus insulin in the week before the inclusion
研究组 & 干预措施
carbohydrate counting
patients must fill their logbook during 28 days
干预措施: carbohydrate counting (Other)
结局指标
主要结局
The individual variation of CHO amount at each main meal : Breakfast, Lunch, Snacks, Dinner
时间窗: each day during 28 days
the patients must fill their logbook during 28 days
次要结局
未报告次要终点