Opportunity Information: Apply for RFA DK 14 502
Apply for RFA DK 14 502
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Continuation of the 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 21, 2014 and posted on Mar 21, 2014.
- Applicants must submit their applications by Jun 19, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $10,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Organizations) This FOA is a limited competition for continuation of the TODAY study, which was previously reviewed in response to RFA DK 08 502. Only the currently funded DCC is eligible to apply. Only the currently funded CCs are eligible to be CCs as subcontracts to the DCC.
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Opportunity Summary:
This grant opportunity, RFA-DK-14-502, is a National Institutes of Health (NIH) cooperative agreement (U01) designed to extend and deepen the long-term follow-up of participants from the landmark Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. The core aim is not to launch a new trial, but to continue monitoring the already-established TODAY cohort in order to describe, in a rigorous and standardized way, how type 2 diabetes that begins in adolescence or early youth progresses over time. In practical terms, the FOA is focused on defining the long-term clinical course of youth-onset type 2 diabetes, including how quickly complications emerge, how durable early treatment effects are, and what patterns of disease progression look like as participants age into young adulthood and beyond.
The opportunity builds directly on findings from the original multi-center controlled clinical trial, which studied treatment approaches for youth aged 10 to 17 years who had been recently diagnosed with type 2 diabetes. That earlier work compared three strategies: metformin alone, metformin combined with an intensive lifestyle intervention, and metformin combined with rosiglitazone. A key outcome from TODAY was that the combination of metformin plus rosiglitazone maintained glycemic control for a longer period than either metformin alone or metformin plus lifestyle intervention. The original results also raised an important clinical concern that is central to the rationale for this continuation award: type 2 diabetes appears to behave more aggressively when it starts at a younger age, suggesting faster deterioration of metabolic control and potentially earlier onset of diabetes-related complications than typically seen with adult-onset disease.
Because this is a cooperative agreement, NIH is expected to have substantial scientific and programmatic involvement in the conduct of the continued follow-up activities, rather than acting only as a passive funder. The structure is intended to support coordinated operations and consistent data collection across the established network, preserving the integrity of the cohort, the comparability of longitudinal measures, and the ability to answer long-horizon questions that require sustained infrastructure. The FOA sits within NIH’s diabetes research portfolio and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), reflecting administration through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
A defining feature of this announcement is that it is a limited competition continuation, meaning eligibility is restricted to the already-funded TODAY infrastructure. Only the currently funded Data Coordinating Center (DCC) is eligible to apply as the primary applicant, and only the currently funded Clinical Centers (CCs) may participate as clinical sites through subcontracts to the DCC. While the eligibility language notes that non-U.S. (foreign) organizations can be eligible in general terms, this particular FOA is effectively closed to new entrants because it is tied to continuity of the existing TODAY award structure previously reviewed under RFA-DK-08-502. The intent is continuity and stability: keeping the cohort intact, maintaining standardized protocols, and leveraging the investment already made in trial infrastructure, data systems, and participant relationships.
In terms of scale and logistics, the FOA anticipates a single award, with an estimated total funding amount of $10,000,000 and an award ceiling set at $10,000,000, and it does not require cost sharing or matching. The announcement was posted and created on March 21, 2014, with an original and current closing date of June 19, 2014, and it was archived on July 20, 2014. The activity category is listed under Food and Nutrition/Health, consistent with diabetes research that often intersects clinical care, metabolic health, and lifestyle factors.
Overall, the grant’s public health value is tied to the reality that youth-onset type 2 diabetes has become a more visible and concerning condition, and the scientific community needs high-quality longitudinal evidence to understand its trajectory. By continuing to follow the TODAY cohort, NIH aims to generate long-term data that can inform clinical guidelines, anticipate complication risk, shape preventive and therapeutic strategies, and clarify whether the aggressive patterns suggested by the original results translate into measurable long-term outcomes. The full announcement and details were made available through NIH’s grants guide at the link provided in the source, and NIH’s Office of Extramural Research (OER) provides technical support contacts for access and linking issues.
FAQs: NIH Cooperative Agreement RFA-DK-14-502 (TODAY Study Long-Term Follow-Up)
What is RFA-DK-14-502?
RFA-DK-14-502 is a National Institutes of Health (NIH) funding opportunity for a cooperative agreement (U01) to extend and deepen the long-term follow-up of participants from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.
What is the main purpose of this funding opportunity?
The purpose is to continue monitoring the already-established TODAY cohort to describe, using rigorous and standardized methods, how type 2 diabetes that begins in adolescence or early youth progresses over time, including the timing of complications and long-term patterns of disease progression.
Is this grant intended to start a new clinical trial?
No. The core aim is not to launch a new trial. It is designed to continue follow-up of the existing TODAY cohort and preserve continuity of long-term data collection.
What specific scientific questions is the long-term follow-up meant to address?
Based on the information provided, the follow-up is focused on defining the long-term clinical course of youth-onset type 2 diabetes, including how quickly complications emerge, how durable early treatment effects are, and what disease progression looks like as participants age into young adulthood and beyond.
What is the TODAY Study that this opportunity builds on?
The TODAY Study was a landmark, multi-center controlled clinical trial that evaluated treatment approaches for youth ages 10 to 17 who had been recently diagnosed with type 2 diabetes.
What treatments were compared in the original TODAY Study?
The original study compared three strategies: metformin alone, metformin plus an intensive lifestyle intervention, and metformin plus rosiglitazone.
What key finding from TODAY helps explain why this continued follow-up is important?
A key outcome described is that metformin plus rosiglitazone maintained glycemic control for a longer period than either metformin alone or metformin plus lifestyle intervention. The original results also raised concern that type 2 diabetes may behave more aggressively when it starts at a younger age.
Why does the FOA emphasize youth-onset type 2 diabetes as potentially more aggressive?
The rationale presented is that when type 2 diabetes begins in adolescence or early youth, it may lead to faster deterioration of metabolic control and potentially earlier onset of diabetes-related complications than is typically seen in adult-onset disease. The continued follow-up is meant to clarify whether those patterns translate into measurable long-term outcomes.
What does it mean that this is an NIH cooperative agreement (U01)?
It means NIH is expected to have substantial scientific and programmatic involvement in how the continued follow-up activities are conducted, rather than serving only as a passive funder.
Why is a cooperative agreement structure used for this effort?
The structure is intended to support coordinated operations and consistent data collection across the established network, helping preserve the integrity of the cohort, maintain comparability of longitudinal measures, and support long-horizon research that requires sustained infrastructure.
Which NIH institute is associated with this opportunity?
The opportunity is within NIH's diabetes research portfolio and is administered through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What CFDA number is associated with this FOA?
The announcement is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
Is this opportunity open to any eligible organization?
No. This is described as a limited competition continuation. Eligibility is restricted to the already-funded TODAY infrastructure.
Who is eligible to apply as the primary applicant?
Only the currently funded Data Coordinating Center (DCC) is eligible to apply as the primary applicant.
Who can participate as clinical sites under this award?
Only the currently funded Clinical Centers (CCs) may participate as clinical sites, and they do so through subcontracts to the DCC.
Can new clinical centers or new institutions join the network under this FOA?
Based on the information provided, the FOA is effectively closed to new entrants because it is tied to continuity of the existing TODAY award structure previously reviewed under RFA-DK-08-502.
Does the FOA allow foreign (non-U.S.) organizations to apply?
The eligibility language notes that non-U.S. (foreign) organizations can be eligible in general terms, but this specific FOA is effectively limited to the existing TODAY infrastructure, which restricts participation to the currently funded DCC and Clinical Centers.
How many awards does NIH expect to make?
The FOA anticipates a single award.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount is $10,000,000.
What is the award ceiling?
The award ceiling is set at $10,000,000.
Is cost sharing or matching required?
No. The FOA does not require cost sharing or matching.
When was this funding opportunity posted?
The announcement was posted and created on March 21, 2014.
What was the application closing date?
The original and current closing date listed is June 19, 2014.
Is this funding opportunity still active?
No. The announcement was archived on July 20, 2014.
What activity category is associated with this announcement?
The activity category is listed under Food and Nutrition/Health, consistent with diabetes research that intersects clinical care, metabolic health, and lifestyle factors.
What is the public health value of continuing follow-up of the TODAY cohort?
The stated value is to generate high-quality longitudinal evidence on youth-onset type 2 diabetes to inform clinical guidelines, anticipate complication risk, shape preventive and therapeutic strategies, and clarify long-term outcomes suggested by earlier findings.
Where were the full announcement and details made available?
The full announcement and details were made available through NIH's grants guide at the link provided in the source.
Who provides technical support for access or linking issues related to the announcement?
NIH's Office of Extramural Research (OER) provides technical support contacts for access and linking issues.
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| Funding Opportunity |
|---|
| Accelerating Medicines Partnership (AMP) in Type 2 Diabetes (U01) Apply for RFA DK 14 003 Funding Number: RFA DK 14 003 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $300,000 |
| Limited Competition for the Data Coordinating Center of Accelerating Medicines Partnership (AMP) in Type 2 Diabetes (U01) Apply for RFA DK 14 503 Funding Number: RFA DK 14 503 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $2,500,000 |
| Reagents for Glucagon and Incretin Research (R41/R42) Apply for PA 14 204 Funding Number: PA 14 204 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Reagents for Glucagon and Incretin Research (R43/R44) Apply for RFA DK 14 008 Funding Number: RFA DK 14 008 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Impact Award Closed Loop Technologies Clinical, Physiological and Behavioral Approaches to Improve Type 1 Diabetes Outcomes (DP3) Apply for RFA DK 14 014 Funding Number: RFA DK 14 014 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Impact Award Closed Loop Technologies Development and Integration of Novel Components for an Automated Artificial Pancreas System (DP3) Apply for RFA DK 14 015 Funding Number: RFA DK 14 015 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Nutrition Obesity Research Centers (NORCs) (P30) Apply for RFA DK 14 002 Funding Number: RFA DK 14 002 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Silvio O. Conte Digestive Diseases Research Core Centers (P30) Apply for RFA DK 14 012 Funding Number: RFA DK 14 012 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Increasing the Quality and Efficiency of Clinical Trials (R18) Apply for RFA FD 14 017 Funding Number: RFA FD 14 017 Agency: Food Drug Administration Category: Food and Nutrition Health Funding Amount: $7,500,000 |
| U.S. India Bilateral Collaborative Research Partnerships (CRP) on Diabetes Research (R21) Apply for RFA DK 14 006 Funding Number: RFA DK 14 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $275,000 |
| Polycystic Kidney Disease (PKD) Research and Translation Core Centers (P30) Apply for RFA DK 14 013 Funding Number: RFA DK 14 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) Apply for PAR 14 257 Funding Number: PAR 14 257 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $4,000,000 |
| Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3) Apply for PAR 14 258 Funding Number: PAR 14 258 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $7,000,000 |
| Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) (U01) Apply for RFA DK 14 011 Funding Number: RFA DK 14 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $450,000 |
| Improving Diabetes Management in Young Children with Type 1 Diabetes (DP3) Apply for RFA DK 14 022 Funding Number: RFA DK 14 022 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Critical Path Public Private Partnerships Apply for RFA FD 14 089 Funding Number: RFA FD 14 089 Agency: Food Drug Administration Category: Food and Nutrition Health Funding Amount: $10,500,000 |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 14 266 Funding Number: PAR 14 266 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Data Coordinating Center for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (UC4) Apply for RFA DK 14 505 Funding Number: RFA DK 14 505 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $20,000,000 |
| NIAID SBIR Technology Transfer Direct Phase II (SBIR TT) (R44) Apply for RFA AI 14 049 Funding Number: RFA AI 14 049 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| NIDDK Cooperative Hematology Specialized Core Centers (U54) Apply for RFA DK 14 001 Funding Number: RFA DK 14 001 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
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