Global Collaborative For Changing Diabetes in Children: Using Data to Create the Largest Cohort Study of Individuals with Type 1 Diabetes Worldwide

Abstract

This report presents the foundational steps and anticipated challenges in establishing a virtual global cohort study focused on individuals with T1D. Although the initial study targets T1D, the design and methodologies outlined here are adaptable to any chronic medical condition, providing a blueprint for future virtual cohort studies. The goal of this initiative is to create the largest cohort study of children and adolescents with T1D by implementing a data collection system across six Phase 1 countries in Africa and South Asia. This system will facilitate the formation of national registries of adolescents with T1D, which will then be adapted for international data sharing and collaborative analysis. Leveraging a virtual cohort design allows for the inclusion of a diverse patient population from a wide geographic area with reduced costs and resource demands, enabling contextually relevant data collection led by local experts. The cohort seeks to address the gap in the diagnosis and management of T1D in low- and middle-income countries (LMICs), where many cases remain undiagnosed and untreated. In order to form the cohort, a data collection system was developed by Dure Technologies, comprising electronic health records (EHRs) at the clinic level which feed into national registries. This system enables the further pooling of data from the registries into the global cohort for in-depth analysis led by the Harvard research team in conjunction with key clinicians from each research country. Four high-priority research questions were identified for the first phase analysis in the cohort study, focusing on disease incidence and prevalence, factors influencing disease control, mortality rates and causes, and demographic influences on disease progression. Throughout the study, compliance with international data protection laws and institutional agreements is critical. The report outlines data use agreements (DUAs) and data security measures to protect personal information and maintain data integrity. This report sets the stage for a groundbreaking approach to studying T1D and other chronic conditions through virtual cohort studies. By leveraging technology and international collaboration, it aims to enhance understanding, optimize health systems, and improve health outcomes for individuals with T1D worldwide.