Limited Competition for the Continuation of Type 1 Diabetes in Acute Pancreatitis Consortium - Clinical Centers (T1DAPC-CCs) (U01 Clinical Trial Optional) | RFA DK 25 017

Frequently Asked Questions (FAQs)

What is the funding opportunity number and what is it for?

This opportunity is RFA-DK-25-017. It is an NIH cooperative agreement intended to continue and strengthen a multi-site clinical research consortium focused on diabetes that develops during or after acute pancreatitis, with special emphasis on Type 1 diabetes (T1D).

What funding mechanism is being used?

The award mechanism is a U01 cooperative agreement (clinical trial optional). A cooperative agreement means NIH expects substantial programmatic involvement and close coordination among NIH and awardee sites.

Is this a clinical trial opportunity?

Clinical trial participation is optional under this U01. The consortium’s core study described in the opportunity is a prospective, longitudinal, observational study.

What is the overall structure of the consortium?

The program is structured as a single coordinated consortium consisting of one Data Coordinating Center (DCC) and up to 10 Clinical Centers (CCs). The intent is to deliver a unified, coordinated study rather than a set of unrelated projects.

Am I applying to be a Data Coordinating Center (DCC) or a Clinical Center (CC) under this NOFO?

Applicants responding to RFA-DK-25-017 are applying to serve as a Clinical Center (CC). The Data Coordinating Center is competed separately under RFA-DK-25-018.

What is the main scientific focus of the consortium?

The consortium is being built to run a prospective, longitudinal, observational study that follows people who experience acute pancreatitis and then develop impaired glucose tolerance or diabetes either during the pancreatitis episode or later. The goal is to understand how often diabetes occurs in this context, how it evolves over time, and what forms it takes, with particular attention to identifying cases consistent with immune-mediated Type 1 diabetes.

What population is being studied?

The study tracks individuals who have experienced acute pancreatitis and are later observed to develop impaired glucose tolerance or diabetes either during the acute episode or after recovery. The NOFO emphasizes enrollment of a racially, ethnically, and geographically diverse study population and inclusion across acute pancreatitis cases with different identifiable causes.

Why is there a special emphasis on Type 1 diabetes (T1D)?

A major emphasis is distinguishing immune-mediated T1D from other diabetes subtypes that can follow pancreatic injury or inflammation. The consortium aims to carefully define and phenotype diabetes after acute pancreatitis and to collect data and biospecimens that can help clarify etiology and pathophysiology, including whether some cases represent true T1D.

What are the key research goals related to etiology and pathophysiology?

The NOFO emphasizes careful definition and phenotyping of diabetes after acute pancreatitis, documentation of clinical course over time, and collection of data and biospecimens needed to distinguish immune-mediated T1D from other mechanisms of hyperglycemia after pancreatic inflammation.

What does the NOFO mean by prediction and stratification?

The consortium is expected to identify immune and genetic risk factors, as well as measurable biomarkers, that can help predict who among acute pancreatitis survivors is most likely to develop T1D (and other forms of diabetes) afterward.

What are Clinical Centers expected to do in this consortium?

Clinical Centers are expected to identify and enroll participants, conduct standardized clinical characterization and longitudinal follow-up, collect and handle biospecimens under common protocols, and capture consistent clinical data that contribute to the consortium-wide dataset in partnership with the Data Coordinating Center.

How coordinated is the work expected to be across sites?

Because this is a U01 cooperative agreement, awardees should expect substantial NIH programmatic involvement and close coordination across sites. The expectation is a unified study with common protocols and standardized data and specimen approaches, rather than independent site-specific projects.

How many Clinical Centers may be supported?

The consortium design indicates up to 10 Clinical Centers, plus one separately funded Data Coordinating Center. The excerpt provided does not specify the exact number of anticipated awards, but the design signals that up to 10 CC awards are intended.

What is the award ceiling for this announcement?

The listed award ceiling for RFA-DK-25-017 is $350,000.

What is the application due date shown for this opportunity?

The original application due date shown is 2024-11-19.

Which agency is offering this funding opportunity?

The opportunity is offered by the National Institutes of Health (NIH).

What is the CFDA number and how is the opportunity categorized?

The opportunity is listed under CFDA 93.847 and is categorized under food and nutrition/health.

What types of organizations are eligible to apply?

Eligibility is broad and includes many domestic organization types, including state, county, and local governments; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; nonprofits (including 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses) and small businesses; independent school districts; special districts; and public housing/Indian housing authorities.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The announcement highlights categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based/community-based organizations, U.S. territories or possessions, and certain regional organizations.

Can non-U.S. entities apply as the applicant organization?

No. Non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply as applicants under the information provided.

Are foreign components allowed at all?

Foreign components (as NIH defines them) are allowed. This means a U.S.-based applicant could potentially include certain international elements if justified and compliant with NIH policy, even though non-U.S. entities cannot apply as the applicant.

What kinds of data and materials are expected to be collected?

The consortium is expected to collect standardized clinical data over time and to collect biospecimens under common protocols. This is intended to support careful phenotyping and to help distinguish immune-mediated T1D from other diabetes mechanisms following pancreatic inflammation, as well as to support immune, genetic, and biomarker analyses for prediction.

What is the long-term value or intended impact of this program?

The long-term value described is to clarify what post-acute-pancreatitis diabetes looks like across populations, why it happens in some people and not others, and which immune, genetic, or biomarker signals could support earlier identification, better classification, and ultimately more targeted prevention or intervention strategies.