Cooperative Multicenter Diabetes Research Network for Hypoglycemia Prevention

描述（由申请人提供）：本申请是为了响应RFA的数据协调中心（DCC），以满足糖尿病预防合作多中心研究网络的需求。该网络预计将包括五个临床中心（CC）和一个中心实验室。该网络的主要目标是通过开展多中心临床方案，研究治疗和管理策略的安全性和有效性，推进1型糖尿病患者低血糖预防领域。DCC在此类多中心项目中的作用是其成功的关键。显而易见，我们清楚地了解该项目的目标和范围，我们认识到其重要性和潜在的公共卫生影响。由于DCC申请的目的不是证明这项研究的必要性或提出具体的方案，因此本提案将侧重于Jaeb中心作为项目DCC的能力。对于该项目的基本所有方面，我们将借鉴我们作为儿童糖尿病研究网络（DirecNet）的DCC角色以及我们之前和当前的其他研究的经验。作为当前的DirecNet DCC，我们已经有了一个协调中心，可以无缝过渡到DirecNet的第二阶段。通过DirecNet和我们指导的其他多中心项目，我们对该项目所需的所有DCC功能和责任都有经验。重要的是，我们在执行多个并发和顺序协议的网络方面拥有丰富的经验，这是迄今为止DirecNet的一个强大功能，通过参与DirecNet，我们在儿童1型糖尿病研究方面拥有丰富的经验，包括连续葡萄糖监测数据的数据管理和分析。显而易见的是，我们在临床试验的开展和管理方面一直采取创新方法，并广泛依赖互联网，不仅提高了效率，而且加强了质量控制措施。我们相信，我们作为DirecNet第1阶段的DCC非常成功，已经进行的协议数量和已发表的手稿数量证明了这一点。在本应用程序中，我们将重点介绍DirecNet在第1阶段的成就以及Jaeb中心继续作为第2阶段DCC的能力。我们认为，我们在第一阶段作为发展协调委员会的业绩记录完全证明我们有理由继续在第二阶段作为发展协调委员会。

DESCRIPTION (provided by applicant): This application is submitted in response to the RFA for a Data Coordinating Center (DCC) to serve the needs of the Cooperative Multicenter Diabetes Research Network for Hypoglycemia Prevention. The network is expected to include five clinical centers (CCs) and a central laboratory. The main objective of this network will be to advance the field of hypoglycemia prevention in patients with type 1 diabetes through the conduct of multi-center clinical protocols that investigate the safety and efficacy of treatment and management strategies. The role of the DCC in a multi-center project such as this one is key to its success. As will be evident, we have a clear understanding of the project's goals and scope, and we recognize its importance and potential public health impact. As it is not the purpose of the DCC application to justify the need for this research or to propose a specific protocol, this proposal will focus on the capabilities of the Jaeb Center to serve as the DCC for the project. For essentially all aspects of the project, we will draw upon our experience from our role as the DCC for the Diabetes Research in Children Network (DirecNet) and our other prior and current studies. As the current DirecNet DCC, we have a coordinating center already in place to provide for a seamless transition into phase 2 of DirecNet. Through DirecNet and the other multi-center projects we have directed, we have experience with all of the DCC functions and responsibilities this project will entail. Importantly, we have considerable experience with networks that conduct multiple concurrent and sequential protocols, which has been a strong feature of DirecNet to date, and through participation in DirecNet, we have extensive experience in studies of type 1 diabetes in children, including the data management of and analysis of continuous glucose monitoring data. As will be apparent, we have been innovative in our approach to clinical trial conduct and management and have relied extensively on using the Internet not only to increase efficiency, but also to enhance quality control measures. We believe we have been very successful as the DCC for phase 1 of DirecNet as evidenced by the number of protocols that have been conducted and the number of manuscripts that have been published. In this application, we will highlight the accomplishments of DirecNet in phase 1 and the capabilities of the Jaeb Center to continue as the DCC for phase 2. We believe that our track record as the DCC in phase 1 overwhelmingly justifies our continuing as the DCC in phase 2.