ISRCTN29255275已完成不适用
A randomised controlled trial of continuous subcutaneous insulin infusion (CSII) compared to multiple daily injection (MDI) regimens in children and young people at diagnosis of type I diabetes mellitus (TIDM)
Alder Hey Children's NHS Foundation Trust (UK)0 个研究点目标入组 316 人开始时间: 2010年11月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873144 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30109847
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Newly diagnosed TIDM using standard diagnostic practise (WHO Definition 2006)
- •2. Age 6 months - 15 years (inclusive)
- •3. Willing to give consent for the study
排除标准
- •1. Treated previously for diabetes
- •2. Haemoglobinopathy
- •3. Co-existing pathology conditions likely to affect glycaemic control, e.g. cystic fibrosis
- •4. Psychological or psychiatric disorders, e.g. eating disorder
- •5. Receipt of medication likely to affect glycaemic control, e.g. systemic or high dose topical corticosteroid or growth hormone therapy
- •6. Allergy to a component of insulin aspart or insulin glargine
- •7. Patient who have a first degree relative with existing TIDM
- •Patients previously diagnosed with coeliac disease or thyroid dysfunction will be eligible to join the study if they have maintained a gluten-free diet/been maintained in a euthyroid state for 3 months prior to the diagnosis of TIDM.
研究者
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