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）而提交的，以满足多中心合作糖尿病研究网络预防低血糖的需求。该网络预计将包括五个临床中心（CCs）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型糖尿病患者的低血糖预防领域。DCC在这样一个多中心项目中的作用是其成功的关键。显然，我们对该项目的目标和范围有清楚的了解，我们认识到它的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一个特定的协议，因此该提案将侧重于Jaeb中心作为该项目的DCC的能力。对于该项目的所有方面，我们将从我们作为儿童糖尿病研究网络（DirecNet）的DCC的角色以及我们之前和当前的其他研究中吸取经验。作为目前的DirecNet DCC，我们已经有一个协调中心来提供DirecNet第二阶段的无缝过渡。通过DirecNet和我们指导的其他多中心项目，我们对该项目所需要的所有DCC功能和责任都有经验。重要的是，我们在开展多个并发和顺序协议的网络方面拥有丰富的经验，这是DirecNet迄今为止的一个强大特征，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，包括对连续血糖监测数据的数据管理和分析。显而易见的是，我们在临床试验进行和管理的方法上不断创新，广泛利用互联网，不仅提高效率，而且加强质量控制措施。我们相信，作为DirecNet第一阶段的DCC，我们已经非常成功，已经执行的协议数量和已经发表的手稿数量证明了这一点。在这个申请中，我们将强调DirecNet在第一阶段的成就，以及Jaeb中心继续作为第二阶段DCC的能力。我们相信，我们在第一阶段作为DCC的记录绝对证明了我们在第二阶段继续作为DCC的理由。

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.