The COvid and Diabetes Assessment (CODA) Study

dc.contributorNational Institutes of Health
dc.contributor.authorRothman, Russell
dc.contributor.otherVanderbilt University Medical Center
dc.date.accessioned2024-10-25T21:12:01Z
dc.descriptionSeveral 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. This study takes 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 leverages 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. EHR records are queried 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. T1D Exchange (T1DX), a national network of 54 diabetes centers and an online patient registry of 17,000 individuals with T1D, will also be used. Consented participants will partake in regular web/mobile or telephone surveys leveraging a previously developed REDCap/Twilio platform. Participants come to sites for regular serological testing, and a subsample participate in more robust testing of glucose tolerance, biomarkers, and vascular function. This data is supplemented by longitudinal EHR data from participating sites and across PCORnet. Participants are followed for 2 years. #### Study Aims 1. 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. 2. 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. 3. Evaluate a subset of patients with diabetes to examine if COVID-19 is associated with worse vascular function, increased inflammation and hypercoagulability. 4. Explore the role of genomic/social/environmental factors on inflammation and metabolic function. 5. Leverage EHR data to explore the role of COVID-19 and COVID-19 treatments on diabetes development and diabetes-related outcomes across the pandemic. #### Cohort Description The study includes 1600 participants diagnosed with diabetes within 3 months prior to the study period, who have had a known COVID-19 infection within 90 days prior to the study period, and those with recent diagnosis of diabetes and no known COVID-19 infection in the year prior to the study period.
dc.description.abstractStudy to rapidly identify, recruit, and retain diverse cohorts of English and Spanish speaking pediatric and adult patients with recently diagnosed type one or type two diabetes (T1D or T2D) to examine the relationship between SARS-CoV-2 and COVID-19 infection and diabetes.
dc.identifier.urihttps://pedsnet.org/metadata/handle/20.500.14642/842
dc.publisherPEDSnet
dc.rightsa CC-BY 4.0 Attribution license.
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.subject.meshSARS-CoV-2
dc.subject.meshCOVID-19
dc.subject.meshPneumonia, Viral
dc.subject.meshRespiratory Tract Diseases
dc.subject.meshInfections
dc.subject.meshDiabetes Mellitus, Type 1
dc.subject.meshDiabetes Mellitus, Type 2
dc.subject.meshNutritional and Metabolic Diseases
dc.titleThe COvid and Diabetes Assessment (CODA) Study
dspace.entity.typeStudy
local.admin.notehttps://atlassian.chop.edu/jira/browse/PMO-858
local.subject.flatPEDSnet Data Source
local.subject.flatFederally Funded Research
project.startDate2023
relation.isStudyOfStudy4932bc8c-1f72-44ad-aeeb-b7922e38fad3
relation.isStudyOfStudy.latestForDiscovery4932bc8c-1f72-44ad-aeeb-b7922e38fad3

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