NCT01840358Unknown不适用
Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes
St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency of hypoglycemias
研究概览
简要总结
The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
- •Patient about to start insulin pump therapy at the CHU Sainte-Justine
- •Last HbA1c between 7.2 and 9.7%
- •Informed and signed consent
排除标准
- •Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day
- •Home of the patient at more than 50km of the CHU Sainte-Justine
- •Refusal to consent
结局指标
主要结局
Frequency of hypoglycemias
时间窗: 6 days
Frequency of hypoglycemias defined as blood sugars \< 4.0mmol/l
次要结局
- Frequency of hyperglycemias(6 days)
研究者
Patricia Olivier
Pediatric endocrinologist
St. Justine's Hospital
研究点 (2)
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