(prepared by applicant): This application is submitted in response to the RFA for a Data Coordinating Center (DCC) to serve the needs of the Type 1 Diabetes in Children Research Consortium. The objectives of this project are (1) to develop insight into the role of continuous glucose monitoring devices in the management of children with type 1 diabetes, (2) to develop a better understanding of glycemic control and hypoglycemia in children with type 1 diabetes, and (3) to gain knowledge of glucose homeostasis in children without diabetes. An ultimate objective is to develop age-appropriate treatment approaches to type 1 diabetes in children. The project is expected to include four clinical centers as well as the DCC. The role of the DCC in a multi-center project such as this one is key to its success. As it is not the purpose of the DCC application to justify the need for this research or to propose a specific protocol, this application will focus on the capabilities of the Jaeb Center to serve as the DCC for the project. The investigators will detail the approach they propose to take for the key elements of the project?s coordination, administration, and conduct. It will be apparent that the principal investigator has extensive knowledge of type 1 diabetes in children, its treatment, and the role of glucose monitoring. He will be able to provide considerable input to protocol development as a member of the Steering Committee. In essentially all areas the investigators will draw upon their experience in past and current projects to develop procedures for this study. The investigators have coordinated numerous multi-center investigator groups and have experience with all of the DCC functions and responsibilities that will be part of this project. They have been innovative in their approach to clinical trial conduct and management and have relied extensively on using the Internet to not only increase efficiency but also in many ways to enhance quality control measures. For a number of years the investigators have strived to develop a data management system that is as generic as possible so a new study can be readily added to an existing database and data management structure. This extends to web-site development in which the web-based applications the investigators have developed for their prior and current studies will serve as a template for this project.
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