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Study Protocol for Multicentric Hospital-Based Diabetes Registry-Clinical Trial Network.

Pramila Kalra1, Gurinder Mohan2, Prasanta K Bhattacharya3

  • 1Department of Endocrinology, Ramaiah Medical College, Ramaiah University of Applied Sciences, Mathikere, Bengaluru, Karnataka, India.

Indian Journal of Endocrinology and Metabolism
|November 13, 2025
PubMed
Summary
This summary is machine-generated.

A new diabetes registry in India aims to collect real-world data on diabetes mellitus progression and outcomes. This initiative will support future clinical trials and improve patient care through systematic data collection.

Keywords:
Diabetes mellitusdiabetes registryhospital registryreal world

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Area of Science:

  • Endocrinology
  • Public Health
  • Clinical Research

Background:

  • Diabetes mellitus (DM) poses a significant public health challenge in India.
  • Existing data on diabetes progression, complications, and outcomes in India is limited.
  • A diabetes registry is crucial for gathering real-world evidence.

Purpose of the Study:

  • To establish a national diabetes registry for comprehensive data collection.
  • To create a cohort for future clinical trials in diabetes mellitus.
  • To understand real-world practices and standards of care for diabetes in India.

Main Methods:

  • Multi-center approach with sites across diverse geographical regions in India.
  • Standardized protocols, training, and data management for harmonization.
  • Screening of Type 1 and Type 2 diabetes mellitus patients from hospital outpatient departments after informed consent.

Main Results:

  • Development of a common IT platform for data entry and a central database.
  • Establishment of a harmonized process for data collection across all participating sites.
  • Creation of a ready patient pool for future clinical studies.

Conclusions:

  • A national diabetes registry will yield critical insights into diabetes epidemiology, risk factors, and outcomes in India.
  • Data from the registry will inform evidence-based therapies and resource allocation.
  • The registry is expected to enhance the quality of care for diabetes patients in India.