Cooperative Multicenter Diabetes Research Network for Hypoglycemia Prevention

此申请是对RFA的响应，要求数据协调中心(DCC)为 合作多中心糖尿病研究网络对低血糖预防的需求。这个 网络预计将包括五个临床中心(CCS)和一个中心实验室。这项工作的主要目标是 网络将通过以下途径推进1型糖尿病患者低血糖预防领域 实施多中心临床方案，调查治疗和治疗的安全性和有效性 管理策略。DCC在这样一个多中心项目中的作用是其成功的关键。 很明显，我们清楚地了解项目的目标和范围，并认识到其 重要性和潜在的公共卫生影响。 由于DCC申请的目的不是为了证明这项研究的必要性或提出具体的 根据协议，该提案将侧重于Jaeb中心作为该项目的DCC的能力。 基本上，就项目的所有方面而言，我们将借鉴我们作为 儿童糖尿病研究网络(DirecNet)和我们以前和现在的其他研究。作为当前的 DirecNet DCC，我们已经建立了一个协调中心，为无缝过渡到 DirecNet的第二阶段。通过DirecNet和我们指导的其他多中心项目，我们拥有 具有本项目所涉及的所有DCC职能和职责的经验。重要的是，我们有 在执行多个并发和顺序协议的网络方面具有丰富的经验， 到目前为止一直是DirecNet的一个强大功能，通过参与DirecNet，我们拥有广泛的 儿童1型糖尿病研究的经验，包括数据管理和分析 连续的血糖监测数据。正如显而易见的，我们在临床方法上一直是创新的 审判行为和管理，并广泛依赖于使用互联网不仅增加了 既要提高效率，又要加强质量控制措施。我们相信我们是非常成功的 DirecNet第1阶段的DCC，已执行的协议数量和 已出版的手稿数量。在本应用程序中，我们将突出显示 第一阶段的DirecNet和Jaeb中心继续作为第二阶段的DCC的能力。我们 相信我们在第一阶段作为DCC的记录压倒性地证明了我们在 第二阶段。

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.