Cooperative Multicenter Diabetes Research Network for Hypoglycemia Prevention

预防低血糖的多中心糖尿病合作研究网络

• 批准号: 7502077
• 负责人: ROY W. BECK
• 金额: $ 95.42万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7502077
• 关键词: Accountability; Adherence; Adverse event; Ancillary Study; Certification; Child; Clinic; Clinical; Clinical Protocols; Clinical Trials Data Monitoring Committees; Communication; Conduct Clinical Trials; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Devices; Diabetes Mellitus; Drug Packaging; Enrollment; Goals; Hypoglycemia; Institution; Insulin-Dependent Diabetes Mellitus; Internet; Label; Laboratories; Manuals; Manuscripts; Measures; Monitor; Numbers; Patient Recruitments; Patients; Phase; Preparation; Prevention; Procedures; Protocols documentation; Public Health; Publications; Publishing; Purpose; Quality Control; Randomized; Rate; Records; Reporting; Research; Research Design; Research Ethics Committees; Role; Safety; Site Visit; System; Systems Integration; Training; Treatment Efficacy; United States National Institutes of Health; Validation; abstracting; cost; data management; drug distribution; experience; glucose monitor; innovation; programs; quality assurance; response; success

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.

本申请是为了响应RFA而提交的数据协调中心（DCC）， 糖尿病预防合作多中心研究网络（Cooperative Multicenter Diabetes Research Network for Hypoxia Prevention）的 该网络预计将包括五个临床中心（CC）和一个中心实验室。的主要目标 该网络将通过以下方式推进1型糖尿病患者低血糖预防领域： 开展多中心临床方案，研究治疗的安全性和有效性， 管理战略。DCC在多中心项目中的作用是其成功的关键。 正如将显而易见的那样，我们对项目的目标和范围有着清晰的理解，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 根据该议定书，本提案将侧重于Jaeb中心作为该项目DCC的能力。 对于项目的基本所有方面，我们将借鉴我们作为项目协调委员会的经验， 儿童糖尿病研究网络（DirecNet）和我们其他先前和当前的研究。作为当前 DirectNet DCC，我们已经有了一个协调中心，可以无缝过渡到 第二阶段的DirecNet。通过DirectNet和我们指导的其他多中心项目，我们 具备本项目所需的所有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，这是DirectNet的一个强大功能，通过参与DirectNet，我们拥有广泛的 儿童1型糖尿病研究经验，包括数据管理和分析 连续血糖监测数据。正如将显而易见的，我们一直在创新，我们的方法，临床 审判的进行和管理，并广泛依赖于使用互联网，不仅增加了 效率，而且还加强质量控制措施。我们相信我们已经非常成功， DirectNet第1阶段的DCC，已执行的协议数量和 已出版的手稿数量。在这个应用程序中，我们将突出的成就 第一阶段的DirectNet和Jaeb中心继续作为第二阶段的DCC的能力。我们 我认为，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继续作为DCC的理由。 第二阶段。