CODA: COvid and Diabetes Assessment

CODA：新冠肺炎和糖尿病评估

基本信息

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
项目类别：
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

项目摘要

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.

项目概要多项研究发现，感染 SARS-CoV-2 和 COVID-19 的诊断与 1 型 (T1D) 和 2 型糖尿病 (T2D) 的发生和进展，可能是通过感染 β细胞、胰岛素抵抗增加、炎症和纤维化以及其他生物过程增加。拟议的研究将利用强大的现有基础设施来快速识别、招募和保留最近诊断出 T1D 或 T1D 的不同群体的讲英语和西班牙语的儿科和成人患者 T2D。该研究将包括 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 天内曾感染过已知的 COVID-19，以及最近诊断出患有糖尿病但没有感染过的人过去一年已知感染过 COVID-19。该研究将利用 PCORnet，这是一个独特的国家网络 60 多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招募研究。我们将查询 EHR 记录，以快速识别潜在的研究对象最近诊断出糖尿病，并通过患者门户、电话、面对面交流等方式与他们联系其他方法。我们还将利用 T1D Exchange (T1DX)，这是一个由 54 个糖尿病中心组成的全国网络以及包含 17,000 名 T1D 患者的在线患者登记。同意的参与者将定期参加利用先前开发的 REDCap/Twilio 平台进行网络/移动或电话调查。参与者将也来到现场进行定期血清学检测，子样本将参与更稳健的检测葡萄糖耐量、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。参与者将被跟踪两年。目标 1 将检查是否最近患过 COVID-19 的 T2D 患者的血糖控制更差的可能性更大，与近期未患过 COVID-19 的患者相比，炎症和胰岛素抵抗增加。目标 2 将检查是否最近患有 COVID-19 的 T1D 患者的血糖控制更差的可能性更大，与近期未患过 COVID-19 的患者相比，炎症和 β 细胞功能下降更快。目标3将评估一部分糖尿病患者，以检查 COVID-19 是否与较差的血管功能相关，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。目标 5 将利用 EHR 数据探索 COVID-19 的作用以及 COVID-19 在整个大流行期间对糖尿病发展和糖尿病相关结果的治疗。这该研究将由在 COVID-19、COVID-19 急性后遗症相关方面拥有丰富经验的团队领导（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、患者和家庭参与以及其他领域。拟议的这项工作将使人们更深入地了解 COVID-19 和糖尿病之间的关系，这可以支持未来改善健康的干预措施和公共卫生方法。