A Prospective Study of the Impact of CSII Therapy in Young Children With Type 1 DM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in HgBA1c
研究概览
简要总结
The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with Type I diabetes:
- •Children must be 5 years of age or less at the time of entry into the study.
- •Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry.
- •Children must be receiving two or more insulin injections daily.
排除标准
- •Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
- •Children must not have any other chronic illness in addition to diabetes.
结局指标
主要结局
Change in HgBA1c
时间窗: Baseline and 6 months
次要结局
未报告次要终点