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. 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.

Public Health Relevance

The goal of Type 1 Diabetes TrialNet is the identification of individuals at- risk for development of type 1 diabetes (T1DM). 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. 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. The TrialNet Coordinating Center maintains study protocols, provides project oversight, coordination, communication, statistical analyses and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at-risk for diabetes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
High Impact Research and Research Infrastructure Cooperative Agreement Programs—Multi-Yr Funding (UC4)
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Special Emphasis Panel (ZDK1-GRB-7 (O1))
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Leschek, Ellen W
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University of South Florida
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Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group; Krischer, Jeffrey P; Schatz, Desmond A et al. (2017) Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 318:1891-1902
Sosenko, Jay M (2016) Staging the progression to type 1 diabetes with prediagnostic markers. Curr Opin Endocrinol Diabetes Obes 23:297-305
Xu, Ping; Krischer, Jeffrey P; Type 1 Diabetes TrialNet Study Group (2016) Prognostic Classification Factors Associated With Development of Multiple Autoantibodies, Dysglycemia, and Type 1 Diabetes-A Recursive Partitioning Analysis. Diabetes Care 39:1036-44
Chase, H Peter; Boulware, David; Rodriguez, Henry et al. (2015) Effect of docosahexaenoic acid supplementation on inflammatory cytokine levels in infants at high genetic risk for type 1 diabetes. Pediatr Diabetes 16:271-9
Ismail, Heba M; White, Kama S; Krischer, Jeffrey P et al. (2015) First test effect in intravenous glucose tolerance testing. Pediatr Diabetes 16:129-37
Herold, Kevan C; Usmani-Brown, Sahar; Ghazi, Tara et al. (2015) ? cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest 125:1163-73
Sosenko, Jay M; Skyler, Jay S; Beam, Craig A et al. (2015) The development and utility of a novel scale that quantifies the glycemic progression toward type 1 diabetes over 6 months. Diabetes Care 38:940-2
Sosenko, Jay M; Skyler, Jay S; DiMeglio, Linda A et al. (2015) A new approach for diagnosing type 1 diabetes in autoantibody-positive individuals based on prediction and natural history. Diabetes Care 38:271-6
Hao, Wei; Greenbaum, Carla J; Krischer, Jeffrey P et al. (2015) The Effect of DPT-1 Intravenous Insulin Infusion and Daily Subcutaneous Insulin on Endogenous Insulin Secretion and Postprandial Glucose Tolerance. Diabetes Care 38:891-6
Insel, Richard A; Dunne, Jessica L; Atkinson, Mark A et al. (2015) Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 38:1964-74

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