CODA: COvid and Diabetes Assessment

Several studies have found that infection with SARS-CoV-2 is associated with the development and progression of both Type 1 (T1D) and Type 2 Diabetes (T2D), possibly through infection of beta cells, increased insulin resistance, increased inflammation and fibrosis, and other biological processes. The proposed study will take advantage of robust existing infrastructure to rapidly identify, recruit, and retain pediatric and adult patients with recently diagnosed T1D or T2D. The study will include 1,000 study participants diagnosed with diabetes in the preceding 6 months. The study will leverage PCORnet, a unique national network of over 60 health systems with electronic health record (EHR) data on over 80 million patients and a track record for successful study recruitment. We will query EHR records to swiftly identify potential study subjects with a recent diagnosis of diabetes and contact them via patient portals, telephone, face-to-face encounters, and other approaches. We will also leverage the T1D Exchange (T1DX), a national network of diabetes centers and an online patient registry of individuals with T1D. Consented participants will partake in regular web/mobile or telephone surveys leveraging a previously developed REDCap/Twilio platform. Participants will also come to sites for regular serological testing, and a subsample will participate in more robust testing of glucose tolerance, biomarkers, and vascular function. This data will be supplemented by longitudinal EHR data from participating sites and across PCORnet. Participants will be followed for up to 2 years. Aim 1 will examine whether patients with recent T2D who have higher COVID-19 burden are more likely to have worse glycemic control, increased inflammation and increased insulin resistance than patients without recent COVID-19. Aim 2 will examine whether patients with recent T1D who have recent COVID-19 are more likely to have worse glycemic control, increased inflammation and more rapid reduction in beta cell function than patients without recent COVID-19. Aim 3 will evaluate a subset of patients with diabetes to examine if COVID-19 is associated with worse vascular function, increased inflammation and hypercoagulability. Aim 4 will explore the role of genomic, environmental, and other factors on inflammation and metabolic function. Aim 5 will leverage EHR data to explore the roles of COVID-19 and COVID-19 treatments on diabetes development and diabetes-related outcomes across the pandemic. The study will be led by a team with significant experience related to COVID-19, post-acute sequelae of COVID-19 (PASC), obesity and diabetes in children and adults, epidemiological research, biostatistics, informatics, health delivery research, genomics, physiology, patient and family engagement and other areas. The proposed work will provide a deeper understanding of the relationship between COVID-19 and diabetes and on the early progression of diabetes that will support future interventions and public health approaches to improve health.