Type 1 Diabetes TrialNet

1 型糖尿病 TrialNet

• 批准号: 6524777
• 负责人: JAY S SKYLER
• 金额: $ 176.15万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-29 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6524777
• 关键词: Internet; biomedical facility; biomedical registry /referral center; computer data analysis; computer system hardware; cooperative study; data management; diabetes mellitus therapy; genetic susceptibility; human therapy evaluation; informatics; insulin dependent diabetes mellitus; mathematical model; medical outreach /case finding; model design /development; statistics /biometry; technology /technique development

DESCRIPTION (provided by applicant): Type 1 diabetes mellitus arises in genetically predisposed individuals as a consequence of immune mediated destruction of the pancreatic islet insulin secreting beta cells. The onset of clinical symptoms of diabetes represents the end point of a chronic progressive decline in beta-cell function and occurs when the majority of beta-cells have been lost. The Diabetes Prevention Trial for Type 1 Diabetes (DPT-1) has been conducting studies to determine whether early intervention using antigen-based therapies (parenteral or oral insulin) in nondiabetic relatives of persons with Type 1 diabetes can delay the development of Type 1 diabetes as a clinical disease and to conduct long term follow-up of subjects developing diabetes. It is recognized that it is likely to be necessary to assess multiple intervention strategies in different cohorts of individuals before the disease process leading to Type 1 diabetes can be completely interrupted. To that end, Type 1 Diabetes TrialNet creates an expanded national diabetes trial network of cooperative clinical research groups and support facilities. It is envisioned that TrialNet will conduct pilot and expanded studies to evaluate new approaches to prevent or ameliorate Type 1 diabetes, natural history and genetics studies in populations screened for or enrolled in these studies, and other studies that may result in an improved understanding of Type 1 diabetes and the prevention of the disease. This application seeks to provide the core support facilities and infrastructure to complete the DPT-1 protocols and achieve their objectives and to provide Type 1 Diabetes TrialNet appropriate experienced core support facilities. The applicant has been the Operations Coordinating Center (OCC) and, through a subcontract, the Data Monitoring Unit (DMU) for DPT-I since its inception, providing administrative, statistical and operations support; and coordinating other core facilities, including core laboratories (to assure standardized, reliable methods), compounding and dispensing pharmacies, and public relations support. That network developed for DPT-1 provides the platform on which to build the enhanced infrastructure for Type 1 Diabetes TrialNet. Thus, these core facilities provide the basic structure for an ongoing series of clinical trials in TrialNet. This application describes an experienced team that is expert in the design and conduct of multi-institutional diabetes prevention trials, established policies and procedures, and an outstanding working relationship with clinical centers to meet the needs of TriaINet.

描述（由申请人提供）： 1 型糖尿病发生在有遗传倾向的个体中 免疫介导的胰岛胰岛素破坏的结果 分泌β细胞。糖尿病临床症状的出现代表 β细胞功能慢性进行性衰退的终点并发生 当大部分β细胞丢失时。糖尿病预防试验 1 型糖尿病 (DPT-1) 一直在进行研究以确定是否 使用基于抗原的疗法（肠胃外或口服胰岛素）进行早期干预 对于 1 型糖尿病患者的非糖尿病亲属来说，可以延缓 将 1 型糖尿病发展为临床疾病并进行长期研究 对患有糖尿病的受试者进行随访。据了解，有可能 有必要评估不同人群的多种干预策略 在导致 1 型糖尿病的疾病过程之前，个体的 完全被打断。为此，1 型糖尿病 TrialNet 创建了一个 扩大国家糖尿病临床合作试验网络 团体和支持设施。预计 TrialNet 将进行 试点和扩大研究以评估预防或改善的新方法 筛选人群的 1 型糖尿病、自然史和遗传学研究 参加或参加这些研究，以及其他可能导致 提高对 1 型糖尿病及其预防的认识。 该应用程序旨在提供核心支持设施和 完成 DPT-1 协议并实现其目标的基础设施 提供 1 型糖尿病 TrialNet 适当且经验丰富的核心支持 设施。申请人为运营协调中心（OCC） 以及通过分包合同，DPT-I 的数据监控单元 (DMU) 自成立以来 成立以来，提供行政、统计和运营支持；和 协调其他核心设施，包括核心实验室（以确保 标准化、可靠的方法）、配制和配药药房，以及 公共关系支持。为 DPT-1 开发的网络提供了 为 1 型糖尿病构建增强型基础设施的平台 试用网。因此，这些核心设施为 TrialNet 上正在进行的一系列临床试验。该应用程序描述了一个 经验丰富的团队，擅长设计和执行 多机构糖尿病预防试验、既定政策和 程序以及与临床中心的良好工作关系 满足TriaINet的需求。