Data Coordinating Center for Type 1 Diabetes TrialNet

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 (T1D) 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. 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 application provides support for enhancing perspectives, managing current trials and studies and developing new interventions to delay or prevent T1D. It builds upon innovative successes in trial design, applications of artificial intelligence and machine learning and deep experience and expertise in study designs, conduct and analysis.