This application requests support for the continuing operations of the TrialNet Coordinating Center (TNCC) at the University of South Florida. The University of South Florida has served as the Coordinating Center for TrialNet since October, 2008. The primary objective of TrialNet is to prevent or delay initial onset and/or progression of type 1 diabetes (T1DM) by preserving insulin-producing beta cells in individuals at elevated risk and those who have been newly diagnosed with T1DM. To achieve this goal, TrialNet designs and implements prevention and interventional clinical trials intended to test treatments that may preserve remaining insulin secretion in recently diagnosed individuals (new-onsets). The TNCC provides epidemiological, biostatistical, operational and administrative expertise and advice to the clinical centers, reference laboratories and the NIDDK which include the following tasks: 1) study-wide communications, procurement and dissemination of study materials, and related activities 2) data management and records maintenance; 3) clinical site and central laboratories monitoring; 4) data analyses; 5) preparation of study reports and papers for publication; 6) implementation of procedures to evaluate management, methodology, and cost-effectiveness of procedures utilized by the TNCC; and 7) periodic meetings. This new application provides additional support to focus on the design and conduct of new-onset trials (as selected by the TrialNet Steering Committee) and associated mechanistic studies that can lead to targeted trials to prevent or delay progression of T1D, provide enhancements and upgrades for communication, data collection, editing, processing, analysis, and reporting for TrialNet studies and operations including data quality, protocol adherence and data confidentiality, and provide for implementation and upgrading of procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository.
The goal of Type 1 Diabetes TrialNet is the prevention of type 1 diabetes in individuals at- risk for its development. Identification of individuals at elevated risk of developing the disease will provide more information about risk factors, leading to a better understanding of disease pathogenesis. The conduct of trials in individuals recently diagnosed with type 1 diabetes will provide important insights into the safety of new drugs and their ability to preserve insulin secretary capability. This proposal addresses support of trials for new onset cases of diabetes and the design and implementation of mechanistic studies to add to our understanding of mechanisms that contribute to ?responders? versus ?non-responders?.. Enrolling at-risk individuals in intervention studies to test treatments intended to delay or prevent the onset of type 1 diabetes and enrolling newly diagnosed individuals in intervention studies to test treatments intended to preserve remaining insulin secretion may result in new strategies to prevent, delay or reverse T1DM. A better understanding of the characteristics or biomarkers that distinguish responders may allow more targeted intervention strategies. This project will enrich this process by supporting new approaches to the design and conduct of new- onset trials and mechanistic investigations. The TrialNet Coordinating Center will contribute to the design of new protocols to replace existing studies or to target new populations (such as individuals diagnosed asymptomatically) with new and innovative end points. Funds are also requested for operations to maintain study protocols, provide project oversight, coordination, communication, statistical analyses, quality control and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at-risk for diabetes.
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