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: 7683837
• 负责人: ROY W. BECK
• 金额: $ 208.6万
• 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/7683837
• 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; Patient Recruitments; Patients; Phase; Preparation; Prevention; Procedures; Protocols documentation; Public Health; Publications; Publishing; Quality Control; Randomized; 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; flexibility; glucose monitor; innovation; programs; quality assurance; response; success; web site

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.

该申请是针对数据协调中心（DCC）的RFA提交的 合作多中心糖尿病研究网络的需求预防低血糖症。这 预计网络将包括五个临床中心（CCS）和一个中央实验室。主要目标 网络将推进1型糖尿病患者的低血糖预防领域 进行多中心临床方案的进行，以研究治疗的安全性和功效 管理策略。 DCC在这样的多中心项目中的作用是成功的关键。 很明显，我们对项目的目标和范围有清晰的了解，我们认识到它 重要性和潜在的公共卫生影响。 因为这不是DCC申请的目的，以证明对这项研究的需求或提出特定的目的 协议，该提案将重点介绍JAEB中心作为该项目的DCC的能力。 对于项目的所有方面，我们将从作为DCC角色的经验来借鉴我们的经验 儿童网络中的糖尿病研究（Direcnet）以及我们的其他先前和当前研究。作为电流 Direcnet DCC，我们已经建立了一个协调中心，可以无缝过渡到 Direcnet的2阶段。通过Direcnet和我们指导的其他多中心项目，我们有 具有所有DCC功能和责任的经验，该项目将需要。重要的是，我们有 具有执行多个并发和顺序协议的网络的丰富经验， 迄今为止是Direcnet的重要特征，通过参与Direcnet，我们有广泛的 在儿童中对1型糖尿病的研究经验，包括对数据的数据管理和分析 连续葡萄糖监测数据。很明显，我们的临床方法一直是创新的 试用和管理，并广泛依赖使用互联网来增加 效率，但也可以增强质量控制措施。我们相信我们一直很成功 DIDECNET阶段1的DCC可以证明已进行的协议数量和 已出版的手稿数量。在此应用程序中，我们将重点介绍成就 Direcnet在第1阶段和JAEB中心的功能中继续担任DCC的第2阶段。我们 相信我们作为第一阶段的DCC的往绩压倒性地证明了我们继续作为DCC的继续 第2阶段。