This application, in response to RFA-DK-12-002, describes a comprehensive Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR) for 2013-2017. Continuing from 2001-2012 as the CITR -DSCC, The EMMES Corporation will collaborate with the NIDDK Program Office, the Oversight Committee and the CITR investigators in support of continuing the established CITR Registry of allogeneic and autologous pancreatic islet transplantation and any other beta cell replacement therapies that should be followed for efficacy and safety in the resolution of refractory glycemic liability 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 1) Promote collaboration and communication among stakeholders in islet transplantation and other beta cell replacement therapies, to advance collection of the appropriate data and dissemination of timely and useful results for the ultimate benefit of the Type 1diabetes patient and medical care community. 2) Continually identify sites active in beta cell replacement in the existing CITR geographical domains to facilitate their registration in CITR, contribute their data, and participate in organizational, scientific and analytic activities. 3) Provide mechanism(s) for securely and confidentially collecting and reporting data on clinical ITx and other beta-cell replacement therapy approved by the Registry oversight committees, primarily through the existing CITR data and study administration portal which is a specific instance of the EMMES proprietary data management system, Advantage-EDC(R). This is a secure, internet-based system including CITR-specific electronic case report forms (CRFs), built-in data quality procedures and real- time, professional management of data quality issues, resulting in a 21 CFR-compliant database for internal and external research efforts. 4 ) Provide bio-statistical and analytical leadership t answer CITR Steering Committee and investigator-initiated questions and research mythology issues utilizing the CITR database, for publication in peer-reviewed journals, presentation at national and international scientific meetings in diabetes and transplantation, and local use by the participating sites.5) Provide the administrative, organizational and contractual support necessary to 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 and other designated comparator groups such as pancreatectomy-alone, to continually assess health outcomes for the ultimate validation of efficacious, safe therapies for people with Type 1 diabetes and glycemic liability.
|Jolissaint, Joshua S; Langman, Linda W; DeBolt, Claire L et al. (2016) The impact of bacterial colonization on graft success after total pancreatectomy with autologous islet transplantation: considerations for early definitive surgical intervention. Clin Transplant 30:1473-1479|
|Naziruddin, Bashoo; Wease, Steve; Stablein, Donald et al. (2012) HLA class I sensitization in islet transplant recipients: report from the Collaborative Islet Transplant Registry. Cell Transplant 21:901-8|