Opportunity Information: Apply for RFA DK 15 504
Apply for RFA DK 15 504
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Continuation of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Mar 17, 2015 and posted on Mar 17, 2015.
- Applicants must submit their applications by Jul 9, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $7,300,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses County governments Special district governments Small businesses Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession This FOA is a limited competition for the continuation of the TODAY study, which was previously funded from RFA DK 14 502. Only the currently funded Biostatistics Research Center (BRC) is eligible to apply. Only the currently funded Clinical Centers (CC) are eligible to be CCs as subcontracts to the BRC. Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Limited Competition Continuation of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (U01) is a National Institutes of Health cooperative agreement opportunity designed to extend and deepen what was learned from the original TODAY clinical trial by continuing long-term follow-up of the same participant cohort. The central aim is to define the long-term clinical course of type 2 diabetes that begins in childhood or adolescence, with particular attention to how quickly complications emerge, how durable early treatment responses are over time, and what the broader health trajectory looks like as these individuals move from adolescence into adulthood. The FOA is built around the idea that youth-onset type 2 diabetes is not simply the same disease seen in older adults at an earlier age, but may behave more aggressively, making longitudinal data essential for guiding future standards of care, screening practices, and prevention strategies.
The FOA’s scientific rationale comes directly from the original TODAY study, which was a multi-center controlled clinical trial in youth ages 10 to 17 who had been recently diagnosed with type 2 diabetes. In that trial, three treatment approaches were compared: metformin alone, metformin combined with an intensive lifestyle intervention, and metformin combined with rosiglitazone. A key finding was that the combination of metformin plus rosiglitazone maintained glycemic control for a longer period than either metformin alone or metformin plus lifestyle intervention. Another major takeaway was that type 2 diabetes appearing at younger ages tends to progress more rapidly, supporting the need to track outcomes over many years to understand the full burden of disease and the timing of adverse events. This continuation opportunity focuses less on testing new interventions and more on systematic follow-up to document outcomes, progression, and complications in a rigorously characterized cohort.
From an administrative and funding standpoint, this is a discretionary NIH award using the cooperative agreement mechanism (U01). That structure typically signals substantial NIH scientific and programmatic involvement compared with a standard research project grant, reflecting the complexity of coordinating a multi-center cohort follow-up, maintaining consistent protocols, and ensuring high-quality centralized data management. The opportunity is identified as Funding Opportunity Number RFA-DK-15-504, associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The announcement was posted on March 17, 2015, with an application due date of July 9, 2015, and an estimated total funding level of $7.3 million, supporting one expected award.
Eligibility is intentionally narrow because this is a limited competition continuation. While the general eligible applicant list includes a wide range of organizations (such as nonprofits, universities, state and local governments, tribal entities, and for-profit organizations), the FOA specifically restricts eligibility to the currently funded Biostatistics Research Center (BRC) from the prior TODAY funding announcement (RFA-DK-14-502). In practical terms, only that existing BRC can apply as the prime applicant, and only the currently funded Clinical Centers are eligible to participate as Clinical Centers through subcontracts to the BRC. Foreign institutions and non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible; however, foreign components as defined under NIH policy are allowed, which can matter for certain specialized analyses or collaborations, as long as they are structured within NIH rules.
The overall program can be understood as an effort to preserve and extend a uniquely valuable dataset and biospecimen-linked clinical record from a hard-to-recruit and highly informative population: adolescents with type 2 diabetes followed prospectively from near diagnosis onward. By continuing follow-up, the study can generate clearer evidence on long-term glycemic durability, cardiometabolic risk evolution, microvascular and macrovascular complication development, and other clinical outcomes that typically take years to manifest. That long view is especially important because clinicians and health systems need reliable guidance on monitoring frequency, early complication screening, and the intensity of treatment needed for youth-onset disease. The FOA’s focus is therefore on continuity, consistency, and long-term outcome definition, rather than reopening recruitment broadly or initiating an entirely new trial framework.
Key logistical details are straightforward: the award is a single cooperative agreement, there is no cost-sharing or matching requirement, and the administering agency is NIH. The full announcement and official instructions were provided through the NIH Grants Guide link at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-504.html, and NIH’s Office of Extramural Research contact pathway was listed for technical access or linking issues.
Frequently Asked Questions (FAQs)
What is the grant opportunity?
This opportunity is the Limited Competition Continuation of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study, using the NIH cooperative agreement mechanism (U01). It is designed to continue long-term follow-up of the same participant cohort from the original TODAY clinical trial.
What is the main purpose of this continuation study?
The central aim is to define the long-term clinical course of type 2 diabetes that begins in childhood or adolescence. The continuation emphasizes tracking outcomes over time, including how quickly complications emerge, how durable early treatment responses remain, and how overall health changes as participants transition from adolescence into adulthood.
Is this opportunity focused on testing new interventions or treatments?
No. Based on the information provided, the continuation focuses less on testing new interventions and more on systematic, long-term follow-up to document outcomes, progression, and complications in a rigorously characterized cohort.
Why is long-term follow-up important for youth-onset type 2 diabetes?
The FOA is built on the idea that youth-onset type 2 diabetes may behave more aggressively than adult-onset disease. Longitudinal follow-up is considered essential for understanding the full burden of disease, the timing of adverse events, and for informing future standards of care, screening practices, and prevention strategies.
What prior study does this continuation build on?
This continuation is based directly on the original TODAY study, a multi-center controlled clinical trial in youth ages 10 to 17 who were recently diagnosed with type 2 diabetes.
What treatments were compared in the original TODAY clinical trial?
Three approaches were compared in the original trial: metformin alone, metformin combined with an intensive lifestyle intervention, and metformin combined with rosiglitazone.
What were key findings from the original TODAY trial that motivate this follow-up?
One major finding was that metformin plus rosiglitazone maintained glycemic control longer than metformin alone or metformin plus lifestyle intervention. Another key takeaway was that type 2 diabetes appearing at younger ages tends to progress more rapidly, reinforcing the need for many years of follow-up to understand long-term outcomes and complications.
What funding mechanism is being used?
The award uses the NIH cooperative agreement mechanism (U01). This structure typically involves substantial NIH scientific and programmatic involvement compared with a standard research project grant, reflecting the complexity of coordinating a multi-center cohort follow-up, maintaining consistent protocols, and ensuring centralized data management.
Which NIH institute/agency is administering the award?
The administering agency is the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DK-15-504.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
When was the announcement posted, and when was the application due?
The announcement was posted on March 17, 2015. The application due date was July 9, 2015.
How much funding is expected to be available, and how many awards are expected?
The estimated total funding level is $7.3 million, and one award is expected.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
Is this a limited competition? What does that mean here?
Yes. Eligibility is intentionally narrow because this is a limited competition continuation. In practical terms, it is restricted to the currently funded Biostatistics Research Center (BRC) from the prior TODAY funding announcement (RFA-DK-14-502) as the prime applicant.
Who is eligible to apply as the prime applicant?
Only the currently funded Biostatistics Research Center (BRC) from the prior TODAY funding announcement (RFA-DK-14-502) is eligible to apply as the prime applicant.
Can other organizations participate at all if they are not the BRC?
Yes, but only in the limited way described: only the currently funded Clinical Centers are eligible to participate as Clinical Centers through subcontracts to the BRC.
Does the FOA list a broad set of eligible organization types even though the competition is limited?
Yes. While a wide range of organizations is listed as generally eligible (for example, nonprofits, universities, state and local governments, tribal entities, and for-profit organizations), the FOA specifically restricts eligibility for this continuation to the currently funded BRC from the prior TODAY announcement.
Are foreign institutions or non-U.S. entities eligible to apply?
No. Foreign institutions and non-U.S. entities are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible, based on the information provided.
Are foreign components allowed under NIH policy?
Yes. Foreign components (as defined under NIH policy) are allowed. This can support certain specialized analyses or collaborations, as long as they are structured within NIH rules.
What kinds of outcomes is the continuation study intended to track?
The continuation is intended to generate clearer evidence on long-term glycemic durability, cardiometabolic risk evolution, microvascular and macrovascular complication development, and other clinical outcomes that often take years to appear.
What is the broader value of continuing this cohort follow-up?
The program is positioned as a way to preserve and extend a uniquely valuable dataset and biospecimen-linked clinical record from a hard-to-recruit population: adolescents with type 2 diabetes followed prospectively from near diagnosis onward. Continuing follow-up strengthens evidence used to guide monitoring frequency, early complication screening, and treatment intensity for youth-onset disease.
Is this opportunity intended to reopen recruitment broadly or create an entirely new trial framework?
No. The focus is described as continuity, consistency, and long-term outcome definition, rather than reopening recruitment broadly or launching a new trial framework.
Where can applicants find the official FOA text and instructions?
The full announcement and official instructions were provided through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-15-504.html
Who should be contacted for technical access or linking issues related to the announcement?
The NIH Office of Extramural Research contact pathway was listed for technical access or linking issues, according to the information provided.
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