The incidence of Type 1 diabetes (T1D) has been increasing 3-5% per year for decades, most rapidly in the very young. A prevention strategy is essential to alleviate the tremendous personal and public health burden of diabetes and will likely also influence strategies to cure or reverse the disease in those already afflicted. As the only new Clinical Center admitted to the TrialNet consortium in 2009, Vanderbilt University has an extremely strong record of participant recruitment and engagement and is well-positioned among Clinical Centers to continue to make a difference in the success of TrialNet. Our center brings abundant resources for the work proposed. We have a very large and carefully followed T1D patient and family base from which to continue to draw participants. We have gained substantial community involvement and endorsement of our efforts and have a very strong record of participant engagement and retention in clinical trials, currently being the leading recruitment site for the two ongoing prevention trials that were initiated since our entry. We have developed a widely distributed and enthusiastic group of 14 Affiliates, well supported by our Center, to bring TrialNet to a broad spectrum of small communities and metropolitan areas throughout the US. Our experience will allow us to take advantage of opportunities to add new affiliates and expand and enhance the activities of underperforming affiliates. We propose novel directions to further our reach: an extension of our Center's presence to multiple autoimmune patient communities at the local and national levels, a hitherto underutilized reservoir of T1D families eligible for screening. We have developed a partnership with the Tennessee Department of Health to bring TrialNet into all public health centers of the state of Tennessee, which if successful, could be a network model for outreach in other states. The media outreach of our center has been extensive and we propose an expanded national and international media presence that will continue to benefit the entire network. We document the leadership roles that our PI and coordinators have had at the network level in the development and execution of new prevention studies, in public relations, in affiliate management and engagement, and in study coordination. We document strong institutional support of our application by both the Vanderbilt Diabetes Center and the Department of Pediatrics in ways that amplify the financial investment by the NIDDK. Vanderbilt University will support any options the network endorses to expedite IRB approval of studies. Finally, we demonstrate a strong pool of early stage investigators whose careers have already been influenced by TrialNet at Vanderbilt. We outline a plan to more vigorously engage them intellectually and scientifically in the work of the network while furthering their careers. Using this broad and diverse set of TrialNet-inspired resources, the TrialNet Clinical Center at Vanderbilt is well positioned to be a leader in T1D prevention and in improving the lives of people with T1D throughout the world.

Public Health Relevance

Type 1 diabetes (T1D), which is caused by immune system destruction of the insulin-producing cells of the pancreas, affects as many as 3 million Americans of all ages, including the majority of the 215,000 children under the age of 20 who have diabetes. The incidence of T1D has been increasing 3-5% per year for decades, most rapidly among toddlers, and the disease has an immense impact on the economy as well as on the lives of those who must live with the disease. Vanderbilt University passionately endorses the mission of the Type 1 Diabetes TrialNet consortium to identify individuals at risk to develop T1D and to engage them to enter into clinical trials to develop a strategy to prevent them and future generations from developing T1D, and, in the process, engaging an even greater number of young investigators to enter the field of T1D prevention research.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1-GRB-J (M2))
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Leschek, Ellen W
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Vanderbilt University Medical Center
Schools of Medicine
United States
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Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham, Bruce A et al. (2013) The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther 15:401-8
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