Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

Pennsylvania State Univ Hershey Med Ctr, Hershey PA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY / ABSTRACT Type 1 diabetes mellitus (T1D) may develop after, or as a consequence of, one or more acute pancreatitis episodes. Elucidation of early biomarkers, clinical signs, biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D can help inform best practices in treatment for reducing incidence of T1D onset. In 2020, the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) formed the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC), consisting of 10 Clinical Centers (CCs), along with three satellite centers, and one Data Coordinating Center (DCC). The T1DAPC has developed an observational prospective cohort study, titled “Diabetes RElated to Acute Pancreatitis and its Mechanisms (DREAM).” The DREAM study is enrolling adults with a recent episode of acute pancreatitis (AP) to characterize and understand diabetes mellitus (DM) that develops following AP. The DREAM study will enroll 1200 individuals with the anticipation that up to 800 participants will enter longitudinal follow-up. As of November 2024, the DREAM study has enrolled 806 participants, 459 of whom have entered the longitudinal follow-up phase. The DREAM study has three specific aims: (1) Determine the cumulative incidence and clinical characteristics associated with the development of DM after one or more episodes of AP; (2) Comprehensively characterize beta cell function and endocrine alterations after AP and their relationship with the development of DM after AP; (3) Determine the immunologic mechanisms of DM after AP, including the contribution of β-cell autoimmunity. The NIDDK has issued RFA-DK-25-017 and RFA-DK-25-018 for the T1DAPC Principal Investigators to continue the DREAM study during the period 2025-2030. In response to RFA-DK-25-018, the Departments of Public Health Sciences (DPHS) and Medicine at the Penn State College of Medicine propose to continue serving as the DCC for the T1DAPC. The nine specific aims are as follows: (1) provide overall logistical support for the activities of the T1DAPC Steering Committee (SC) and its subcommittees and working groups; (2) support all the administrative, regulatory, managerial, logistic, analytic and financial functions for accrual and longitudinal observation of T1DAPC patients; (3) provide training and technical assistance to the CC in the course of their implementation of protocols; (4) collect, curate, manage and store all study data and provide it as needed to consortium members to support publications; (5) manage subawards for patient costs, biospecimen analysis and other tasks as needed; (6) develop, support and manage the T1DAPC biobank to process, safeguard and distribute the study biospecimens; (7) design and support new studies for the conduct of studies approved by the T1DAPC SC; (8) prepare reports and presentations for the T1DAPC’s DSMB and to collate replies to their questions; (9) prepare and transfer all study data and biospecimens to the NIDDK Central Repository at the close of the study.