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临床试验/NCT01435642
NCT01435642已完成不适用

Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
349
试验地点
1
主要终点
Mean HbA1c (glycosylated haemoglobin)

研究概览

简要总结

This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
  • Type 1 diabetes
  • Time since diabetes diagnosed at least 5 years
  • Followed for diabetes at consultation for at least 12 months

排除标准

  • Patient previously included in this study
  • Secondary diabetes
  • Pregnant patient
  • Patient consulting for an emergency

结局指标

主要结局

Mean HbA1c (glycosylated haemoglobin)

时间窗: At the first visit (only one study visit) after 12 month of follow up

次要结局

  • Mean number of insulin injections/day(At the first visit (only one study visit) after 12 month of follow up)
  • Mean insulin units per day(At the first visit (only one study visit) after 12 month of follow up)
  • Percentage of patients on insulin therapy(At the first visit (only one study visit) after 12 month of follow up)
  • Mean duration of insulin therapy(At the first visit (only one study visit) after 12 month of follow up)
  • Percentage of patients having complications (ophthalmological, peripheral, renal and others)(At the first visit (only one study visit) after 12 month of follow up)
  • To quantify quality of life(At the first visit (only one study visit) after 12 month of follow up)
  • Percentage of patients on OAD or other treatments(At the first visit (only one study visit) after 12 month of follow up)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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