Document text
Principal Investigator: Jason Perry Block
Organization: VANDERBILT UNIVERSITY MEDICAL CENTER
Fiscal Year: 2024
Award: $7,977,662
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Project Summary
Several studies have found that infection with SARS-CoV-2 and COVID-19 diagnosis are 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
diverse cohorts of English and Spanish speaking pediatric and adult patients with recently diagnosed T1D or
T2D. The study will include 1600 study participants diagnosed with diabetes in the last 3 months, who have
had a known COVID-19 infection in the past 90 days and those with recent diagnosis of diabetes and no
known COVID-19 infection in the past year. 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
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 54 diabetes centers
and an online patient registry of 17,000 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 2 years. Aim 1 will examine if
patients with recent T2D who have recent COVID-19 are more likely to have worse glycemic control, increased
inflammation and increased insulin resistance than patients without recent COVID-19. Aim 2 will examine if
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/social/environmental
factors on inflammation and metabolic function. Aim 5 will leverage EHR data to explore the role 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, informatics, health services
research, genomics, metabolomics, physiology, patient and family engagement and other areas. The proposed
work will provide a deeper understanding of the relationship between COVID-19 and diabetes, that can support
future interventions and public health approaches to improve health.
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