临床试验/NCT02382757

NCT02382757终止不适用

Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India

Novo Nordisk A/S0 个研究点目标入组 3,089 人开始时间: 2011年9月最近更新: 2015年3月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: Novo Nordisk A/S
入组人数: 3,089
主要终点: Patient assessments: Number of days on insulin

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

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

入选标准

•Children diagnosed with type 1 diabetes
•Parents/caretakers agree to participate in the study
•Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study)

排除标准

•Children with type 2 diabetes
•Children from higher economic status
•Those getting coverage under other government / private schemes

研究组 & 干预措施

Children

干预措施: insulin human (Drug)

结局指标

主要结局

Patient assessments: Number of days on insulin

时间窗: After 40 months

Long-term complications

时间窗: After 40 months

Number of episodes of severe hypoglycaemia

时间窗: After 40 months

Number of days with home blood glucose monitoring

时间窗: After 40 months

HbA1c (glycosylated haemoglobin)

时间窗: After 40 months

Number of episodes of ketoacidosis

时间窗: After 40 months

次要结局

Percentage of children who died during the study(After 40 months)
Percentage of children lost to follow-up(After 40 months)
Percentage of children with HbA1c equal to or below 8.0(After 40 months)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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