The Impact of Carbohydrate Restriction on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using a Hybrid Closed-loop Insulin Delivery System: a Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent (ICF) (both children/adolescents and parents)
- •≥7 and ≤17 years old at moment of ICF signature
- •≥6 months type 1 diabetes diagnosis at moment of ICF signature
- •≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- •Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature
排除标准
- •<7 or >17 years old at moment of ICF signature
- •<6 months type 1 diabetes diagnosis at moment of ICF signature
- •<3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- •Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- •Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature
结局指标
主要结局
Time in range
时间窗: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Difference of time spent in range (70-180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
次要结局
- Time in tight range(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Time above range(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Daily insulin dose(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Carb ratio(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Time in level 2 hyperglycemia(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Hemoglobin A1c(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Meal composition(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Time in level 2 hypoglycemia(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Satisfaction with the diet in the context of diabetes treatment(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Number of severe hypoglycemic events(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Bioelectrical impedance analysis(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Time below range(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Mean blood glucose(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Number of diabetic ketoacidosis(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Active insulin time(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Glycemic variability: standard deviation and coefficient of variation(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Body mass index(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Body weight(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)
- Consumed carbohydrates(4 weeks moderate carbohydrate diet and 4 weeks traditional diet)