Type 1 Diabetes TrialNet

描述(由申请人提供)： 1型糖尿病发生在遗传易感人群中，表现为 免疫介导的胰岛胰岛素破坏的后果 分泌β细胞。糖尿病临床症状的出现代表了 胰岛β细胞功能慢性进行性下降的终点 当大多数的β细胞已经消失的时候。糖尿病预防试验 对于1型糖尿病(DPT-1)一直在进行研究，以确定 使用基于抗原的治疗(肠外或口服胰岛素)进行早期干预 在1型糖尿病患者的非糖尿病亲属中可以延缓 1型糖尿病作为一种临床疾病的发展和长期治疗 对患糖尿病的受试者进行随访。人们认识到，很可能 有必要评估不同队列中的多种干预策略 在导致1型糖尿病的疾病过程之前的个体 完全被打断了。为此，1型糖尿病试验网创建了一个 扩大国家糖尿病试验合作临床研究网络 小组和支持设施。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 筛查人群中的1型糖尿病、自然病史和遗传学研究 参加或参加这些研究，以及其他可能导致 提高对1型糖尿病的认识和疾病的预防。 此应用程序旨在提供核心支持设施和 基础设施，以完成DPT-1协议并实现其目标和 为1型糖尿病试验网提供适当的经验丰富的核心支持 设施。申请人一直是运营协调中心(OCC) 通过分包合同，第一期数据监测股(DMU)自其 启动，提供行政、统计和业务支助；以及 协调包括核心实验室在内的其他核心设施(确保 标准化、可靠的方法)、配药和配药，以及 公关支持。为DPT-1开发的网络提供了 构建1型糖尿病增强型基础设施的平台 TrialNet。因此，这些核心设施为 TrialNet正在进行的一系列临床试验。此应用程序描述了一个 经验丰富的团队，擅长设计和实施 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，以 满足TriaINet的需求。

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.