The Effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children With Type 1 Diabetes
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
- To determine if sucrose and fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
研究概览
简要总结
The purpose of this study is to determine the most effective treatment option for managing naturally occurring hypoglycemia in children with type 1 diabetes.
Hypotheses:
- Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
- Children and teens will use a variety of treatment practices for the management of hypoglycemia.
- Children and teens will prefer the mode of treatment that was most effective in treating hypoglycemia.
详细描述
An open labeled, randomized, cross-over design will be used. Each subject will treat 5 hypoglycemic events with glucose, 5 with sucrose and 5 with fructose. Subjects will be randomized into order of treatment.
Primary Objective:
- To determine if sucrose and fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
Secondary Objectives: 2. To determine present hypoglycemia treatment practices of children and teens with type 1 diabetes (prior to entry into the study). 3. To determine preferred mode of treatment for hypoglycemia after completing the study.
Inclusion Criteria:
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
- •Diagnosed 6 or more months ago
- •Patient of the Alberta Children's Hospital Diabetes Clinic
排除标准
- •Adrenal insufficiency
- •Uncompensated hypothyroidism
- •Clinical autonomic neuropathy
- •Celiac disease
- •Lack of family support
- •Unwilling or unable to follow the study protocol
- •Subjects with less than 4 hypoglycemic events per month
研究组 & 干预措施
Glucose
BD glucose tablets (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
干预措施: Ingestion of BD glucose tablets (TM) (Dietary Supplement)
Fructose
Fruit to Go (TM) is taken PO in response to a hypoglycemic event by participants randomized to this arm
干预措施: Ingestion of Fruit to Go (TM) (Dietary Supplement)
Sucrose
Skittles (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
干预措施: Ingestion of Skittles (TM) (Dietary Supplement)
结局指标
主要结局
To determine if sucrose and fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
时间窗: 15 minutes
次要结局
- To determine present hypoglycemia treatment practices of children and teens with type 1 diabetes (prior to entry into the study).
- To determine preferred mode of treatment for hypoglycemia after completing the study.