A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled T1DM.
详细描述
The Diabetes Control and Complications Trial (DCCT), for type 1Diabetes (T1DM), showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes. However, adolescents with T1DM continue to be a high-risk population due to the difficulties in coping with the physical, emotional, and social demands associated with managing diabetes themselves.
We propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and with a lunchtime insulin injection. We want to see if this will improve blood sugar control, improve school grades, and decrease absences from school in adolescents with poorly controlled diabetes. Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control. We hope to improve blood sugar control, school grades and decrease absences from school in teens with poorly controlled diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with T1DM for at least 1 year
- •Age 10-19 years
- •Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months.
- •School must have a school nurse
排除标准
- •Child who has Type 2 diabetes
- •Subject receiving home schooling
结局指标
主要结局
Hemoglobin A1c
时间窗: At the start of the study and again in 3 months
次要结局
- Urine microalbumin(At the beginning and the end of the study)
研究者
Sponsored Programs
Principal Investigator
Baylor College of Medicine