NCT03428932已完成不适用
Glycemic Control and the Brain in Children With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Changes in Gray Matter Volume in the Brain
研究概览
简要总结
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 14 and not yet 18 years old
- •Must have been diagnosed with T1D prior to 5 years old but after 6 months
- •For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
- •Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
- •Be in puberty
排除标准
- •History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
- •ADD/ADHD and/or on stimulant medication
- •Any known genetic or medical problem that could impair brain development
- •Abnormalities of the brain/nervous system, visual or hearing problem
- •History of seizures not associated with fever before diabetes diagnosis
- •Previous inpatient psychiatric treatment
- •Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip
结局指标
主要结局
Changes in Gray Matter Volume in the Brain
时间窗: 6 months
Trends in total and regional grey matter volume
次要结局
- Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)(6 months)
- Changes in WASI-II Perceptual Reasoning Index (PRI)(6 months)
研究者
研究点 (10)
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