跳至主要内容
临床试验/CTRI/2021/04/032817
CTRI/2021/04/032817招募中不适用

Hospital based Multi-Centric Diabetes Registry

BIRAC7 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
7
主要终点
The findings from diabetes registry will provide important insights into the various aspects of Diabetes Mellitus and its management in Indian Population

研究概览

简要总结

The study is a hospital based, prospective, longitudinal , observational study which will be conducted without any intervention. Data for this registry will be collected at 7 sites identified by BIRAC across India. The data of patients visiting the Out Patient Departments (OPD) of the hospital of all the collaborating sites who are known case of Diabetes Mellitus will be assessed for eligibility, consecutively invited to enroll for the study after obtaining their informed consent or assent form (if applicable)/ Re consent form already enrolled participants. Thereafter are being followed up after a minimum period of 3 months from the date of enrollment. No additional mandatory follow-up visits, nor interventions will happen.

The aim of the study is to develop a Diabetes Mellitus Registry to facilitate recruitment for clinical trials pertaining to Diabetes Mellitus by matching potential subjects interested in participating in clinical research. The primary objective of this registry is to collect data on the demographics, anthropometry, and management of patients with Diabetes Mellitus that can be used to improve the knowledge of epidemiology clinical presentation, management, and complications of Diabetes Mellitus in India.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Male female and transgender patients aged greater than or equal to 1 year.
  • Patient visiting the out patient department of the hospital who is a known case of Type 1 or Type 2 Diabetes Mellitus as per their medical records.
  • Patient or parent willing to provide written Assent and or Informed Consent.

排除标准

  • Patients with Gestational Diabetes Mellitus.
  • Patients with Drug induced Diabetes Mellitus.
  • Patients with Secondary Diabetes Mellitus.
  • Patients not having Indian citizenship.

结局指标

主要结局

The findings from diabetes registry will provide important insights into the various aspects of Diabetes Mellitus and its management in Indian Population

时间窗: After 3 years

次要结局

  • Data base generated by this registry will be able to clarify various aspects of Type 1 & Type 2 Diabetes Mellitus.(Providing a real-world view of clinical practices of Diabetes Mellitus.)

研究者

发起方
BIRAC
申办方类型
Government funding agency

研究点 (7)

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