Incidence and severity of new onset diabetes associated with SARS-CoV-2 infection

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We of and will use data from t he National COVID Cohort Collaborative (N3C) to “conduct an epidemiologic study diabetes incidence and severity at onset and its potential association with the COVID-19 pandemic the causative virus SARS-CoV-2”The N3C data enclave is the largest publicly available HIPAA-limited data set in U.S. history, over 13 million patients from 72 contributing sites. Due to its scale, demographic and geographic diversity of inpatient and ambulatory data, N3C is uniquely suited to address our research objectives. Hypothesis: COVID-19 infection is associated with an increased incidence of diabetes and severe disease presentation, and there are patient- and infection-related factors that increase patient risk and impact long-term outcomes. Specific Aim 1: Test the hypothesis that COVID-19 infection and infection- related factors are associated with increased incidence of diabetes and severe presentation at diagnosis. We will examine the effect of COVID-19 and infection-related factors, including COVID-19 disease severity, corticosteroid treatment, biochemical markers and virus variant (based on timing in the pandemic or direct measurement), in adult and pediatric patients. We will analyze time to incident diabetes and association of infection-related factors in patients with COVID-19 infection compared to matched controls with acute upper respiratory infection (AURI). Specific Aim 2: Test the hypothesis that COVID-19 infection and patient- related factors are associated with increased incidence of diabetes and severe presentation at diagnosis. We will explore the effect of patient-related factors, including demographics, BMI, HbA1c and lipids prior to COVID-19, comorbidities (e.g., dyslipidemia, hypertension, autoimmune/inflammatory conditions), vaccination status, medication use and social determinants of health (SDOH) on incident diabetes and severe disease presentation in adult and pediatric patients with COVID-19 and matched controls with acute upper respiratory infection (AURI). Specific Aim 3: Test the hypothesis that patients with incident diabetes after COVID-19 will have worse long-term outcomes compared to those without COVID-19 infection. We will compare outcomes in adult and pediatric patients with incident diabetes diagnosed within 90 days of their index date with prior COVID-19 infection compared to matched controls with AURI. Long-term outcomes over 12-18 months will include diabetes remission, glycemic control and treatment with insulin and other glucose lowering medications. Impact: The NIH-supported N3C Data Enclave, with its demographic and geographic diversity, was created precisely to address the long-term consequences of the pandemic. The proposed studies will 1. Establish and characterize increased incidence and severity of diabetes with COVID-19 infection; 2. Elucidate infection- and patient-related factors associated with incident diabetes and severe disease presentation at diagnosis, and 3. Evaluate the long-term outcomes of patients with incident diabetes in a nationally representative population.