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

Abstract

Introduction: Diabetes mellitus (DM) is a major public health concern in India. A diabetes registry provides a reliable method for collecting real-world data on patients in a variety of situations. Despite the high prevalence of diabetes in India, there is a lack of systematic data on the disease's progression, complications, treatment patterns, and outcomes.

Methods: This registry is planned to create a readymade set of patients who will be ready for future clinical trials and will be able to continuously provide data on real-world practices and standards of care for diabetes mellitus in India. To ensure the correct blend in site selection, the centers have been chosen from different geographical regions across India, with a combination of government and private sectors. All sites will use the same protocol, training, SOPs, and data management to achieve harmonization in the process. Patients with known instances of Type 1 and Type 2 diabetes mellitus who will attend seven hospitals' outpatient departments (OPD) will be screened for eligibility and willingness to participate in future clinical studies after signing an informed consent or assent form (if minor). A common IT platform for entering and preserving registry data has been developed, which will enable us to establish a central database.

Conclusion: A national diabetes registry can provide useful insights into the epidemiology, risk factors, and outcomes of diabetes in India by combining clinical, demographic, and behavioral data. This information is critical for designing evidence-based therapies, optimizing resource allocation, and increasing the quality of care for diabetes patients.