CODA: COvid and Diabetes Assessment

CODA：新冠肺炎和糖尿病评估

• 批准号: 10755899
• 负责人: Jason Perry Block
• 金额: $ 599.96万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-21 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10755899
• 关键词: 2019-nCoV; Adult; American; Antibodies; Area; Beta Cell; Biological Markers; Biological Process; Blood Vessels; CDC42 gene; COVID-19; COVID-19 diagnosis; COVID-19 impact; COVID-19 pandemic; COVID-19 patient; COVID-19 surveillance; COVID-19 test; COVID-19 treatment; Cell physiology; Cessation of life; Child; Childhood; Childhood diabetes; Clinical; Clinical Research; Consent; Data; Deterioration; Development; Diabetes Mellitus; Diagnosis; Electronic Health Record; Environmental Risk Factor; Epidemiology; Family; Fibrosis; Funding; Future; Genomics; Glucose tolerance test; Health; Health Services Research; Health system; Individual; Infection; Inflammation; Informatics; Infrastructure; Insulin Resistance; Insulin-Dependent Diabetes Mellitus; Internet; Intervention; Intervention Studies; Link; Long COVID; Metabolic; Multicenter Trials; Non-Insulin-Dependent Diabetes Mellitus; Nucleocapsid; Obesity; Observational Study; Outcome; Outpatients; Participant; Patients; Physiological; Physiology; Population; Post-Acute Sequelae of SARS-CoV-2 Infection; Process; Public Health; Records; Registries; Research; Resources; Risk; Role; SARS-CoV-2 exposure; SARS-CoV-2 infection; SARS-CoV-2 negative; Serology test; Site; Standardization; Structure; Study Subject; Surveys; Telephone; Testing; Thrombophilia; Time; United States National Institutes of Health; Work; cohort; community engagement; coronavirus disease; data hub; drug repurposing; electronic health data; epidemiology study; experience; glycemic control; improved; member; metabolomics; pandemic disease; patient oriented; patient portal; patient registry; patient subsets; recruit; social; type 2 diabetes in children; type I and type II diabetes

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.

项目摘要 几项研究发现，SARS-CoV-2感染和COVID-19诊断与 1型糖尿病（T1 D）和2型糖尿病（T2 D）的发展和进展，可能通过感染 β细胞、增加的胰岛素抗性、增加的炎症和纤维化以及其他生物过程。 拟议的研究将利用强大的现有基础设施来快速识别、招募和留住 最近诊断为T1 D或T1 D的讲英语和西班牙语的儿童和成人患者的不同队列 2型糖尿病这项研究将包括1600名在过去3个月内被诊断患有糖尿病的研究参与者，他们 在过去90天内有已知的COVID-19感染，最近诊断为糖尿病， 在过去一年中已知的COVID-19感染。这项研究将利用PCORnet，这是一个独特的国家网络， 超过60个卫生系统，拥有超过8000万患者的电子健康记录（EHR）数据和跟踪记录 成功的研究招募。我们将查询电子健康记录，以迅速确定潜在的研究对象， 最近诊断为糖尿病，并通过患者门户网站、电话、面对面接触与他们联系， 其他方法。我们还将利用T1 D交换（T1 DX），这是一个由54个糖尿病中心组成的全国网络 以及17，000名T1 D患者的在线患者注册表。参加者将定期参加 网络/移动的或电话调查利用先前开发的REDCap/Twilio平台。参与者将 还将到研究中心进行定期血清学检测，子样本将参加更有力的 葡萄糖耐量、生物标志物和血管功能。这些数据将由纵向EHR数据补充 从参与研究中心到PCORnet。参与者将被跟踪两年。目标1将检查是否 近期患有COVID-19的T2 D患者更有可能血糖控制较差， 炎症和胰岛素抵抗增加的患者比最近没有COVID-19的患者。目标2将检查是否 近期患有COVID-19的T1 D患者更有可能血糖控制较差， 炎症和β细胞功能的下降比最近没有COVID-19的患者更快。目标3将 评估糖尿病患者的一个子集，以检查COVID-19是否与血管功能恶化相关， 增加炎症和高凝状态。目标4将探讨基因组/社会/环境的作用 影响炎症和代谢功能的因素。Aim 5将利用EHR数据探索COVID-19的作用 和COVID-19治疗对糖尿病发展和糖尿病相关结果的影响。的 研究将由一个具有COVID-19相关丰富经验的团队领导，COVID-19急性后遗症 （PASC）、儿童和成人肥胖症和糖尿病、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、患者和家庭参与以及其他领域。拟议 这项工作将提供对COVID-19和糖尿病之间关系的更深入了解， 未来的干预措施和公共卫生方法，以改善健康。