This application proposes that the Clinical Trials Statistical and Data Management Center (CTSDMC) at The University of Iowa continue as the Data Coordinating Center (DCC) for the Clinical Islet Transplantation (CIT) Consortium. The DCC has served the CIT Consortium since its inception in 2004. Enrollment and initial transplants have been completed on all North American Islet Alone protocols. Recruitment continues in the Islet After Kidney protocol and the Nordic Group Protocol. During the previous funding periods, the DCC provided comprehensive services in the areas of project design and implementation, information technology, data monitoring, data management, statistical analysis, project coordination, regulatory control, quality assurance, and administration for all eight of th CIT clinical trial protocols. The Information Technology and Biostatistics teams created and continue to support electronic database systems for data acquisition, data quality control, and data analysis for the CIT trials. The DCC has also developed effective electronic systems for the collection, monitoring, and submission of regulatory documents. Our certified Protocol Coordinators collaborate closely with the investigators and staff at the clinical sites and the NIH to ensure that the Consortium's studies are provided with excellent logistical, administrative, and technical support. This proposal describes our progress, and provides evidence that the CTSDMC is uniquely qualified to continue as the Data Coordinating Center for the Clinical Islet Transplantation Consortium. This proposal requests a five-year extension of funding so that the CTSDMC may support the completion and reporting phases of the CIT clinical trials.

Public Health Relevance

Type 1 Diabetes affects as many as 3 million Americans. Through collaboration, the Clinical Islet Transplantation Consortium has developed clinical trials relevant to the improvement of health and strategies for treatments to improve the health and wellbeing of those with Type 1 Diabetes. The Clinical Trials Statistical and Data Management Center at The University of Iowa has served as the Data Coordinating Center for the consortium since its inception in 2004. We have a strong team of professionals who have successfully assisted with the design and implementation of 8 CIT protocols and continue to support enrollment, data acquisition, data management, data analysis, and regulatory functions of the consortium. We are eager to complete these activities that will lead to successful licensure of islet transplantation in the United States and will inform the development of islet transplantation in the future.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Study Section
Special Emphasis Panel (ZDK1-GRB-7 (O1))
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Arreaza-Rubin, Guillermo
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University of Iowa
Biostatistics & Other Math Sci
Schools of Public Health
Iowa City
United States
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Hering, Bernhard J; Bridges, Nancy D; Eggerman, Thomas L et al. (2017) Comment on Harlan. Islet Transplantation for Hypoglycemia Unawareness/Severe Hypoglycemia: Caveat Emptor. Diabetes Care 2016;39:1072-1074. Diabetes Care 40:e111-e112
Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N et al. (2016) National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 65:3418-3428
Hering, Bernhard J; Clarke, William R; Bridges, Nancy D et al. (2016) Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 39:1230-40
Senior, Peter A; Bellin, Melena D; Alejandro, Rodolfo et al. (2015) Consistency of quantitative scores of hypoglycemia severity and glycemic lability and comparison with continuous glucose monitoring system measures in long-standing type 1 diabetes. Diabetes Technol Ther 17:235-42
Ricordi, Camillo (2014) The path for tolerance permissive immunomodulation in islet transplantation. Transplantation 98:1260-1
Kitzmann, J P; O'Gorman, D; Kin, T et al. (2014) Islet oxygen consumption rate dose predicts insulin independence for first clinical islet allotransplants. Transplant Proc 46:1985-8
Singh, Rajan; Bhasin, Shalender; Braga, Melissa et al. (2009) Regulation of myogenic differentiation by androgens: cross talk between androgen receptor/ beta-catenin and follistatin/transforming growth factor-beta signaling pathways. Endocrinology 150:1259-68