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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK070431-11S1
Application #
8897636
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (O1))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2004-09-30
Project End
2015-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
11
Fiscal Year
2014
Total Cost
$20,000
Indirect Cost
$6,755
Name
University of Iowa
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
von Zur-Mühlen, Bengt; Lundgren, Torbjörn; Bayman, Levent et al. (2018) Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation. Transplantation :
Rickels, M R; Markmann, E; Naji, A (2018) Successful pregnancies after islet transplantation for type 1 diabetes. Am J Transplant :
Foster, Eric D; Bridges, Nancy D; Feurer, Irene D et al. (2018) Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 41:1001-1008
Hanley, Patrick; Sutter, Jennifer A; Goodman, Noah G et al. (2017) Circulating B cells in type 1 diabetics exhibit fewer maturation-associated phenotypes. Clin Immunol 183:336-343
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
Vallabhajosyula, Prashanth; Korutla, Laxminarayana; Habertheuer, Andreas et al. (2017) Tissue-specific exosome biomarkers for noninvasively monitoring immunologic rejection of transplanted tissue. J Clin Invest 127:1375-1391
Eriksson, Olof; Selvaraju, Ramkumar; Eich, Torsten et al. (2016) Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation. Diabetes 65:2482-9
Rickels, Michael R; Peleckis, Amy J; Markmann, Eileen et al. (2016) Long-Term Improvement in Glucose Control and Counterregulation by Islet Transplantation for Type 1 Diabetes. J Clin Endocrinol Metab 101:4421-4430
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

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