CODA: COvid and Diabetes Assessment

项目摘要 多项研究发现，感染SARS-CoV-2和诊断为新冠肺炎与 1型糖尿病(T1D)和2型糖尿病(T2D)的发生和发展，可能是通过感染 β细胞，胰岛素抵抗增加，炎症和纤维化增加，以及其他生物过程。 拟议的研究将利用强大的现有基础设施来快速识别、招聘和保留 新近诊断为T1D或T1D的儿童和成人患者中讲英语和西班牙语的不同队列 T2D。这项研究将包括1600名在过去3个月内被诊断为糖尿病的研究参与者，他们有 在过去90天内已知感染新冠肺炎的患者以及最近诊断为糖尿病和无糖尿病的患者 已知在过去一年感染新冠肺炎。这项研究将利用PCORnet，一个独特的全国性网络 60多个医疗系统，具有8000多万名患者的电子健康记录(EHR)数据和跟踪记录 为了成功的招生。我们将查询电子病历记录，以快速识别潜在的研究对象 最近诊断出的糖尿病，并通过患者门户网站、电话、面对面接触和 其他方法。我们还将利用T1D交易所(T1DX)，这是一个由54个糖尿病中心组成的全国性网络 以及17,000名患有T1D的在线患者登记。经同意的参与者将定期参加 利用以前开发的RedCap/Twilio平台进行网络/移动或电话调查。参与者将 也会来现场进行常规的血清学检测，子样本将参与更可靠的检测 葡萄糖耐量、生物标志物和血管功能。该数据将由纵向EHR数据补充 来自参与站点和整个PCORnet。参与者将被跟踪2年。目标1将检查是否 最近服用新冠肺炎的T2D患者更有可能血糖控制更差，增加 炎症和胰岛素抵抗增加的患者比没有近期新冠肺炎的患者。目标2将检查是否 新近患有T1D并最近服用新冠肺炎的患者更有可能血糖控制较差，增加 与没有新近新冠肺炎的患者相比，炎症和β细胞功能下降更快。目标3将 评估一组糖尿病患者，检查新冠肺炎是否与血管功能恶化有关， 炎症和高凝状态增加。目标4将探索基因组/社会/环境的作用 影响炎症和代谢功能的因素。AIM 5将利用电子病历数据来探索新冠肺炎的作用 以及新冠肺炎治疗对糖尿病发展和糖尿病大流行相关结果的影响。这个 研究将由一个对新冠肺炎有丰富经验的团队领导，新冠肺炎的急性后遗症 (PASC)，儿童和成人肥胖和糖尿病，流行病学研究，信息学，卫生服务 研究、基因组学、代谢组学、生理学、患者和家庭参与等领域。建议数 这项工作将提供对新冠肺炎和糖尿病之间关系的更深层次的理解，这可以支持 未来的干预措施和公共卫生方法，以改善健康。

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.