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

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.