Impact of Two Different Hypoglycemia Thresholds on Rebound Hyperglycemia in Children With Type 1 Diabetes: A Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Blood glucose levels were measured at 1 and 2 hours post-treatment
研究概览
简要总结
The aim of this study is to compare the impact of hypoglycaemia treatment initiated at a blood glucose threshold of 65 mg/dL versus the internationally recommended threshold of 70 mg/dL on 2-hour post-treatment blood glucose levels and the subsequent development of rebound hyperglycaemia in children with type 1 diabetes. The main questions it aims to answer are:
Is there a statistically significant difference in 2-hour post-treatment blood glucose levels in children with type 1 diabetes when hypoglycaemia intervention is initiated at a threshold of 70 mg/dL compared to 65 mg/dL?"
In children with type 1 diabetes, does the standard hypoglycaemia treatment initiated at the internationally recommended threshold of 70 mg/dL lead to the development of rebound hyperglycaemia (<180 mg/dL) at the 2nd hour post-treatment?
Patients underwent two protocols: intervention at a 65 mg/dl threshold (hospital routine; experimental group) and 70 mg/dl (literature standard; control group). Both protocols utilised 0.3 g/kg of simple carbohydrates, supplemented with a standardised complex carbohydrate (12.8 g) once blood glucose exceeded the target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of type 1 diabetes.
- •Absence of any concurrent chronic illnesses.
- •Absence of any physiological conditions precluding oral intake.
- •Absence of significant cognitive or developmental disorders that would impede capacity to participate in the study.
- •Aged between 7 and 18 years (as children under 7 years of age may experience difficulty consuming whole grain crackers).
- •Possession of a personal blood glucose monitor.
- •Absence of persistent hyperglycaemia.
排除标准
- •Days characterised by unusually high levels of routine exercise or physical activity.
- •The requirement for a second dose of simple carbohydrates (sugar cubes) during a single hypoglycaemia intervention (as consuming two doses may induce hyperglycaemia following the snack).
- •Experiencing multiple hypoglycaemic episodes within the same day.
结局指标
主要结局
Blood glucose levels were measured at 1 and 2 hours post-treatment
时间窗: 1 and 2 hours post-treatment
Blood glucose levels were measured at 1 and 2 hours post-treatment to monitor for the occurrence of rebound hyperglycaemia.
次要结局
未报告次要终点