Long Term Effects of Diabetes of Very Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Diabetes Control
研究概览
简要总结
To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. Outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life.
It is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years
- •Children recruited on pumps must have used pump therapy for at least 3 years
- •Parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years.
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 with the exception of treated autoimmune hypothyroidism.
结局指标
主要结局
Diabetes Control
时间窗: Data Collected at each study visit
HbA1c, number of severe low events, frequency of moderate and mild hypoglycemia, blood glucose averages, and variance of reported blood sugar
Ease of Injections versus Insulin pump Therapy
时间窗: Conclusion of study
Mechanical issues, site infections and errors of insulin administration
次要结局
未报告次要终点