This application, in response to RFA-DK-16-503, describes a comprehensive Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR) for 2017-2022. Continuing from 2013- 2017 as the CITR-DSCC, The Emmes Corporation will collaborate with the NIDDK Program Office, the Oversight Committee and the CITR investigators to support the established CITR Registry of allogeneic and autologous pancreatic islet transplantation, as well as any other beta cell replacement therapies that should be followed for efficacy and safety in the resolution of refractory glycemic lability marked by severe hypoglycemic episodes in persons with Type 1 diabetes or lacking pancreatic islets for any reason including therapeutic pancreatectomy or any loss of islet cell function.
The aims of the CITR DSCC will be to maintain and expand: 1) Collaboration and communication among stakeholders in allo- and auto- islet transplantation, total pancreatectomy alone (TPA), and any other study groups approved by the NIDDK Program Office, to advance collection of the appropriate data and dissemination of timely and useful results for the medical care community. 2) Identifying all sites active in allogeneic or autologous ITx, or total pancreatectomy alone (TPA), in the existing CITR geographical regions to invite their registration in CITR, contribution of their data, and participation in organizational, scientific and analytic activities, and expand CITR?s geographical regions as may be indicated by the Program Office. 3) Providing mechanism(s) for securely and confidentially collecting and reporting data on any clinical beta-cell replacement or artificial pancreas therapies, through the existing CITR data and study administration portal. For CITR, this comprises an internet-based system including CITR-specific electronic case report forms (CRFs), electronic data uploads, built-in, customized data quality procedures, and real-time, professional management of data quality issues including resolution of errors detected from range checks and logical consistency checks, in a 21 CFR-compliant database for internal and external research efforts. 4) Providing biostatistical leadership to answer CITR committee and investigator-initiated research questions utilizing the CITR database, for publication in peer-reviewed journals, presentation at national and international scientific meetings in diabetes and transplantation, and use by the participating sites. 5) Providing continued logistical support to a NIDDK-designated Data and Safety Monitoring Board. 6) Providing the administrative, organizational and contractual support necessary to conduct all the activities of the CITR.
The continuation of CITR under Emmes? professional, multi-disciplinary management will assure the most up- to-date information on allogeneic and autologous islet transplantation/beta cell replacement therapies, as well as pancreatectomy-alone as a comparator group, to continually assess health outcomes for the ultimate validation of efficacious, safe therapies for persons with Type 1 diabetes and glycemic lability.
