Limited Competition: Revision to the Longitudinal Monitoring of Pancreas Architecture in the Type 1 Diabetes in Acute Pancreatitis Consortium - Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional) | RFA DK 21 501

Opportunity Information: Apply for RFA DK 21 501

This grant opportunity (RFA-DK-21-501) is a limited-competition NIH cooperative agreement that adds support to an existing, already-funded clinical research program focused on diabetes that develops during or after acute pancreatitis. It is specifically a revision/supplement for the Type 1 Diabetes in Acute Pancreatitis Consortium Data Coordinating Center (T1DAPC-DCC), and only the current Program Director/Principal Investigator (PD/PI) of that DCC is invited to apply. In other words, it is not an open competition for new teams; it is meant to expand the scope and capabilities of the current coordinating center for a study that began funding in September 2020 and, at the time of this announcement, was still in the planning phase.

The underlying parent project is a 5-year prospective, longitudinal observational clinical study designed to track the development of new-onset diabetes in people experiencing an acute pancreatitis (AP) episode and in the period that follows. While it looks broadly at diabetes after AP, it places particular emphasis on type 1 diabetes (T1D). The goal is to clarify how often diabetes occurs in this setting (incidence), how it unfolds over time in real patients (clinical evolution), what might be causing it (etiology), which diabetes subtype it represents in different individuals (type), and what biological mechanisms may be involved (pathophysiology). By following participants over time rather than relying on one-time snapshots, the consortium aims to separate short-term metabolic changes around an acute illness from sustained diabetes development, and to better understand how pancreatic injury and immune or metabolic pathways may contribute to T1D and other diabetes forms after AP.

The Data Coordinating Center plays a central operational role in making a multi-site longitudinal study work. As described, the DCC supports coordination and study design and is responsible for data and biosample acquisition and management. That typically includes building and maintaining the study database and data standards, implementing quality control procedures, overseeing data collection schedules, ensuring consistent definitions and measurements across clinical sites, and supporting regulatory and operational workflows needed to run a prospective observational study. A notable responsibility called out in the announcement is that the DCC also distributes funds to participating clinical centers to cover participant costs, which underscores that the DCC functions as the hub for both study operations and certain budgetary pass-through activities tied to participant enrollment and follow-up.

What this particular revision/supplement adds is targeted funding to strengthen longitudinal imaging and biomarker components for enrolled participants. The announcement explicitly highlights longitudinal Magnetic Resonance Imaging (MRI) of the pancreas architecture, along with other biomarker studies. Practically, this means the DCC would support the infrastructure and coordination needed to collect, manage, and analyze imaging and biomarker data repeatedly over time, not just once. Longitudinal MRI can help characterize structural and possibly functional changes in the pancreas after acute pancreatitis, and when paired with biomarker collection, can improve the study's ability to link anatomical changes with immune, metabolic, or inflammatory signals that might predict or explain new-onset diabetes and specifically T1D development.

Administratively, the opportunity is issued by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), with the activity aligned to health-focused research (CFDA 93.847). The award mechanism is a cooperative agreement (U01), which generally means NIH program staff will have substantial involvement in the conduct and oversight of the project compared to a standard research grant. The clinical trial designation is listed as "Clinical Trial Optional," which fits with the fact that the parent effort is a longitudinal observational study rather than an interventional trial, while still acknowledging that clinical research procedures and follow-up are involved.

Key logistics included in the source information are: the FOA was created April 5, 2021, with an original closing date of August 17, 2021. The expected number of awards is one, consistent with the limited-competition structure. The award ceiling is $1,500,000. Eligibility is restricted to public and state-controlled institutions of higher education, but in practice the decisive eligibility constraint is that the applicant must be the current T1DAPC DCC PD/PI, since the FOA invites only that individual to submit the application.

Overall, this funding opportunity is best understood as a focused enhancement to an established consortium study: it keeps the original purpose of tracking and understanding diabetes onset after acute pancreatitis, but specifically injects resources so the coordinating center can implement and sustain repeated MRI-based monitoring of pancreas architecture and expanded biomarker work across enrolled participants. The intent is to deepen the biological and clinical insight the study can generate by pairing rigorous longitudinal follow-up with richer imaging and biospecimen-based measurements, all coordinated through the existing DCC structure.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Revision to the Longitudinal Monitoring of Pancreas Architecture in the Type 1 Diabetes in Acute Pancreatitis Consortium - Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on Apr 05, 2021.
• Applicants must submit their applications by Aug 17, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Public and State controlled institutions of higher education.

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