Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) Biostatistics Research Center (Collaborative U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the funding opportunity number and title?

The funding opportunity is RFA-DK-15-505. It is an NIH limited competition cooperative agreement (U01) to continue the Diabetes Prevention Program Outcomes Study (DPPOS) through support of its Biostatistics Research Center.

Which federal agency is offering this opportunity?

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

What type of award mechanism is being used?

This opportunity uses a cooperative agreement mechanism (U01). That means NIH program staff are expected to have substantial involvement in coordinating activities and helping ensure the project meets scientific and operational goals.

Is this an open competition?

No. This is a limited competition solicitation. Eligibility is intentionally narrow and is restricted to the current awardee of the DPPOS Biostatistics Research Center.

What is the purpose of this FOA?

The purpose is to fund the statistical and data-coordinating functions required to continue long-term follow-up of the DPPOS cohort, enabling ongoing longitudinal observation and analysis of outcomes over time.

What is DPPOS, and how does it relate to the original DPP?

DPPOS is the long-term follow-up study of participants who were originally enrolled in the Diabetes Prevention Program (DPP), a multi-center randomized controlled clinical trial focused on preventing or delaying type 2 diabetes in people at high risk. After the DPP trial ended, participants transitioned into DPPOS to evaluate the durability of the original interventions and assess longer-term outcomes.

What did the original Diabetes Prevention Program (DPP) show?

The DPP reported landmark results: intensive lifestyle intervention reduced progression to type 2 diabetes by about 58%, and metformin reduced progression by about 31%, compared with placebo.

What is the central scientific emphasis of this continuation?

A key emphasis is examining whether early metformin exposure influences major long-term health outcomes beyond diabetes, particularly cardiovascular disease and cancer, using the strengths of a well-characterized cohort with many years of follow-up.

Why is long-term follow-up important for this project?

The FOA is designed to support sustained longitudinal observation of an established cohort to answer high-priority questions that require years of follow-up, including durability of early interventions and the development of later outcomes and complications.

What outcomes does DPPOS track according to this opportunity description?

The description highlights longer-term diabetes outcomes and the development of microvascular complications, and it emphasizes examining longer-term outcomes beyond diabetes, especially cardiovascular disease and cancer, in relation to early metformin exposure.

What is being funded under RFA-DK-15-505 specifically?

This FOA targets the Biostatistics Research Center and the coordinating infrastructure needed to run the study as an integrated multi-site outcomes network. It is focused on statistical and data-coordinating functions rather than operating the clinical sites.

What kinds of responsibilities are implied for the Biostatistics Research Center?

The announcement implies responsibilities typical for a large multi-site outcomes study, including data management, data harmonization across clinical sites, statistical design and analysis, support for outcome ascertainment, quality control, and coordination of reporting and governance activities.

How does this FOA relate to the companion FOA RFA-DK-15-503?

RFA-DK-15-503 is identified as supporting continuation of the DPPOS clinical sites. RFA-DK-15-505 focuses on the biostatistical and coordinating center functions that allow those clinical sites to operate together as a unified research network.

How many awards did NIH anticipate making under this announcement?

NIH anticipated making a single award under this FOA.

Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

What is the funding category and health area for this opportunity?

The opportunity is categorized as discretionary funding, falls under the health area, and lists an activity category of Food and Nutrition Health.

What CFDA number is associated with this opportunity?

The CFDA number provided is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

Who is eligible to apply?

Although general applicant categories listed include public or state-controlled institutions of higher education and private institutions of higher education, eligibility is explicitly limited to the current awardee of the DPPOS Biostatistics Research Center.

Why is eligibility restricted to the current awardee?

The description indicates the intent is to maintain uninterrupted operations and preserve institutional knowledge, data systems, and analytic continuity for this specific long-running cohort and its established coordinating infrastructure.

When was the FOA posted, and what were the key dates?

The FOA was posted on February 6, 2015. The application closing date was April 9, 2015. The archive date was May 10, 2015.

Is this opportunity still active?

Based on the provided dates, the FOA was time-limited and has an archive date of May 10, 2015, indicating it is no longer an active solicitation.

Where were additional details provided?

Additional details were provided through the NIH grants guide. The description also notes that NIH Office of Extramural Research web support contacts were listed for access or linking issues.

What does it mean that this FOA is aimed at continuity rather than launching a new study?

The description frames the solicitation as supporting continuity of an ongoing, established study to avoid disruption, rather than creating a broad, open call to launch a new research program.