This proposal seeks to continue funding for the TRIGR (Trial to Reduce IDDM in the Genetically at Risk) Data Management Unit (DMU). Established in 2002, the DMU at the University of South Florida was initially funded by a two-year start-up grant from the Juvenile Diabetes Research Foundation. As the TRIGR project itself is NIH funded, continuation of the DMU is dependent upon obtaining NIH funding as well. The clinical and administrative parts of the project are contained in separate NIH applications from the University of Pittsburgh (Dorothy Becker, PI) and the University of Helsinki (Hans Akerbloom, PI). This application is one part of the three interlocking proposals. The DMU proposes to continue to play an active role in TRIGR and will continue to have responsibility for data management systems, study monitoring (protocol accrual, compliance, adverse events, and study outcomes), data analysis and reporting. The DMU provides a coordinated clinical data management system for the collection, storage and analysis of data from the multiple international clinical sites that comprise the study group. The data management system is a secure web based system that includes the capability to capture and integrate demographic, laboratory and clinical data.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Grave, Gilman D
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of South Florida
Schools of Medicine
United States
Zip Code
Writing Group for the TRIGR Study Group; Knip, Mikael; Ã…kerblom, Hans K et al. (2018) Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial. JAMA 319:38-48
Nucci, Anita M; Virtanen, Suvi M; Sorkio, Susa et al. (2017) Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial. Matern Child Nutr 13:
Knip, Mikael; Ã…kerblom, Hans K; Becker, Dorothy et al. (2014) Hydrolyzed infant formula and early ?-cell autoimmunity: a randomized clinical trial. JAMA 311:2279-87
Hadley, David; Cheung, Roy K; Becker, Dorothy J et al. (2014) Large-scale prospective T cell function assays in shipped, unfrozen blood samples: experiences from the multicenter TRIGR trial. Clin Vaccine Immunol 21:203-11
Franciscus, Margaret; Nucci, Anita; Bradley, Brenda et al. (2014) Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective. Clin Trials 11:150-8
Lehtonen, Eveliina; Ormisson, Anne; Nucci, Anita et al. (2014) Use of vitamin D supplements during infancy in an international feeding trial. Public Health Nutr 17:810-22
Kingery, Suzanne E; Wu, Yee Ling; Zhou, Bi et al. (2012) Gene CNVs and protein levels of complement C4A and C4B as novel biomarkers for partial disease remissions in new-onset type 1 diabetes patients. Pediatr Diabetes 13:408-18
Nucci, Anita M; Becker, Dorothy J; Virtanen, Suvi M et al. (2012) Growth differences between North American and European children at risk for type 1 diabetes. Pediatr Diabetes 13:425-31
Vehik, Kendra; Cuthbertson, David; Boulware, David et al. (2012) Performance of HbA1c as an early diagnostic indicator of type 1 diabetes in children and youth. Diabetes Care 35:1821-5
Knip, Mikael; Virtanen, Suvi M; Becker, Dorothy et al. (2011) Early feeding and risk of type 1 diabetes: experiences from the Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR). Am J Clin Nutr 94:1814S-1820S

Showing the most recent 10 out of 12 publications