CTRI/2012/08/002925已完成4 期
Glycemic control and quality of life in children, adolescents and young adults with type-1 diabetes mellitus described in a world-wide cross-sectional study in 2012: Impact of age-patient-related, treatment-related, behavior and structure of care-related variables. - TEENs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients aged > 8 to < 25 years old, diagnosed at least 1 year prior to
- •the study entry with type-1 diabetes mellitus.
- •2. Signed written informed consent obtained from the patient if
- •applicable or from the parent(s)/guardian.
排除标准
- •1. T1DM diagnosed after 18 years of age for patients 18 years old.
- •2. Diabetes other than type-1 diabetes (e.g. type-2 diabetes, secondary
- •diabetes mellitus (pancreatic history, drug- or chemical-induced
- •diabetes), genetic defects in β-cell function or insulin action).
- •3. Use of systemic glucocorticoids (excluding topical application or
- •inhaled forms) for 7 consecutive days or more within the last 3
- •4. Patients with known uncontrolled or inadequately controlled
- •hyperthyroidism or hypothyroidism.
- •5. Change from pump regimen to multiple insulin injections regimen
- •within the last 3 months.
- •6. Change from multiple insulin injections regimen to pump regimen
- •within the last 3 months.
- •7. Treatment with oral antidiabetic drugs (OAD) (except metformin
- •which is permitted) at any time from the diagnosis.
- •8. Treatment with any investigational drug within the last 3 months.
- •9. Any known medical condition impacting red blood cells production
- •or destruction such as hemoglobinopathy, polycythemia, splenectomy,
- •iron deficiency anemia, hemorrhage, myelodysplastic disease or
- •receipt or donation of blood or plasma products within the last 3
- •10. Patient or parent/legally authorized representative(s) unable to
- •understand the nature and scope of the study, unable to read and write
- •or unlikely to comply with the protocol, e.g. inability and
- •unwillingness to complete the questionnaires.
- •11. Children or relatives of the Investigators, research assistants, study
- •coordinator or other staff directly involved in the conduct of the
- •protocol, employee of the Sponsor or of Sponsorâ??s representatives.
研究者
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