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Type 1 Diabetes TrialNet: Support Facilities

1 型糖尿病 TrialNet：支持设施

基本信息

批准号：
7281754
负责人：
JAY S SKYLER
金额：
$ 83.59万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-29 至 2009-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7281754
关键词：
Address American Ancillary Study Antigens Arts Autoimmunity Beta Cell Categories Cell physiology Chronic Class Clinical Clinical Research Clinical Trials Communication Consult Controlled Clinical Trials Core Facility Daily Data Data Collection Data Coordinating Center Development Diabetes Mellitus Diabetes prevention Disease Dose Early Intervention Electronics End Point Enrollment Ensure Fostering Genetic Goals Immune Individual Infusion procedures Injection of therapeutic agent Institution Insulin Insulin-Dependent Diabetes Mellitus International Intervention Intravenous Islets of Langerhans Laboratories Masks Mediating Methodology Methods Monitor Natural History New Agents Numbers Operative Surgical Procedures Oral Outcome Pathogenesis Patient Care Persons Pharmacy facility Placebos Policies Population Population Intervention Principal Investigator Procedures Process Protocols documentation Public Relations Quality Control Randomized Recommendation Relative (related person)Reporting Research Research Infrastructure Research Personnel Risk Risk Assessment Sampling Series Site Structure Support Groups Symptoms System Testing Time Translating Vision Work base clinical research site cohort concept cost day design disorder prevention experience follow-up improved non-diabetic novel strategies prevent programs response subcutaneous

项目摘要

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型糖尿病发生在遗传易感个体中，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发作代表了 β细胞功能慢性进行性下降的终点，当大部分的β细胞都丢失了。糖尿病预防试验 1型糖尿病（DPT-1）一直在进行研究，使用基于抗原的治疗（胃肠外或口服胰岛素）进行早期干预在1型糖尿病患者的非糖尿病亲属中， 1型糖尿病作为一种临床疾病的发展，并进行长期对患有糖尿病的受试者进行随访。人们认识到，有必要评估不同队列中的多种干预策略 1型糖尿病的发病原因是什么？完全中断。为此，1型糖尿病TrialNet创建了一个扩大国家糖尿病临床研究合作试验网络团体和支持设施。预计TrialNet将进行开展试点和扩大研究，以评估预防或改善筛查人群中的1型糖尿病、自然史和遗传学研究或入组这些研究，以及其他可能导致提高对1型糖尿病和预防疾病的认识。本申请旨在提供核心支助设施，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适当的经验丰富的核心支持设施申请人已成为运营协调中心（OCC）以及通过一个数据库，DPT-I的数据监测单元（DMU），成立初期，提供行政、统计和业务支助; 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 1型糖尿病的基础设施建设平台 TrialNet.因此，这些核心设施提供了一个正在进行的一系列临床试验。本申请描述了一种经验丰富的团队，在设计和执行方面的专家，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。