Single Source for the Continuation of the Type 1 Diabetes in Acute Pancreatitis Consortium - Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional)

This Notice of Funding Opportunity (NOFO) solicits U01 applications for the establishment of a clinical consortium, the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC), composed of one Data Coordinating Center (DCC) and up to 10 Clinical Centers (CC), to conduct studies on Type 1 diabetes mellitus (T1D) that occurs after or as a consequence of one or more episodes of acute pancreatitis. Applications for the Clinical Centers (CC) are submitted in response to a separate FOA: RFA-DK-25-017: Type 1 Diabetes in Acute Pancreatitis Consortium Clinical Centers (T1DAPC-CC) (U01). The applicant for the Data Coordinating Center (DCC) must have experience serving as the DCC for studies on complex, clinical conditions, like the occurrence of diabetes mellitus (DM) after or as a consequence of one or more episodes of acute pancreatitis. The Consortium will form multi-disciplinary teams composed of members from the CCs and the DCC to undertake a prospective longitudinal observational study of the occurrence of diabetes that occurs during an acute pancreatitis episode or subsequently, with an emphasis on type 1 diabetes (T1D). The study will be designed to gain insight into the incidence, clinical evolution, etiology, type and pathophysiology of the T1D and other forms of diabetes after acute pancreatitis. The Consortia will also undertake studies on the identification of immune and genetic risk factors and biomarkers which predict the development of T1D in a racially, ethnically, and geographically diverse population of subjects who have recovered from one or more episodes of acute pancreatitis due to various identifiable etiologies. The DCC will provide overall project coordination, administration, quality control, data management and biostatistical support.