Indian journal of endocrinology and metabolism · 2025
Study Protocol for Multicentric Hospital-Based Diabetes Registry-Clinical Trial Network.
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Kalra Pramila, Mohan Gurinder, Bhattacharya Prasanta K, Tiewsoh Iada, Ramamurthy Raveendra K, Kiran Ravi M, Kumar Sreejith N, Ghosh Sujoy, Dharmalingam Mala, Selvan Chitra, Pandit Kaushik, Thaman Richa G, Lyngdoh Monaliza, Mukhopadhyay Pradip, Chandey Manish, Jain Smitha, Rajagopalan Sundararaman, Srinivas Vedantha J, Sreejith Veena, Singh Reetu, Sekhar Theertha, Elizabeth Mercy R, Ramakrishnan Sreelakshmi P
Аннотация
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.
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.