Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required) | RFA DK 20 032

FAQs: Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support (DSMES) to Improve Diabetes Care (R34 Clinical Trial Required)

What is this grant opportunity?

This opportunity is the NIH funding announcement titled "Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required)," Funding Opportunity Number RFA-DK-20-032. It is a discretionary grant program from the U.S. Department of Health and Human Services, National Institutes of Health.

What is the main goal of the program?

The central goal is to support early-stage, real-world testing of new, practical approaches that increase the use of Diabetes Self-Management Education and Support (DSMES) among people living with diabetes mellitus. The emphasis is on designing and piloting an approach that directly addresses real-world barriers that keep patients from enrolling in, accessing, completing, or benefiting from DSMES, in ways that could realistically be sustained and spread to other settings.

Is this program about studying DSMES in theory or implementing it in practice?

This program is focused on practical implementation in real care environments. The intent is not simply to study DSMES conceptually, but to develop and pilot a strategy that overcomes on-the-ground barriers and fits routine care constraints, with a clear pathway to broader dissemination if the pilot is successful.

What type of research is NIH expecting under this FOA?

The FOA is specifically focused on pilot and feasibility work. Funded projects are expected to produce strong preliminary evidence and operational lessons that can justify and inform a later, larger full-scale dissemination and implementation trial.

What does "pilot and feasibility" mean in this context?

It means the project is expected to test whether an innovative and pragmatic strategy to increase DSMES use is workable in real-world settings. The study should prioritize feasibility outcomes (such as recruitment, reach into priority populations, acceptability, fidelity, referral and uptake workflows, retention, and implementation cost considerations) while also collecting early signals of impact on diabetes care processes and patient-centered outcomes.

Is a clinical trial required?

Yes. The award mechanism is an R34 and the FOA indicates "Clinical Trial Required." This means the project must include a prospective pilot clinical trial component and cannot be limited to formative research or program development alone.

What kinds of outcomes should the pilot study emphasize?

The pilot should emphasize feasibility and implementation-focused outcomes, including (as examples described in the opportunity): recruitment, reach into priority populations, acceptability, fidelity, referral and uptake workflows, retention, and implementation cost considerations. The project should also collect early signals of impact on diabetes care processes and patient-centered outcomes to help design and power a future definitive trial.

What is meant by "pragmatic" in this funding opportunity?

"Pragmatic" here refers to strategies and study approaches that work in real care environments under routine constraints, rather than highly controlled conditions. The goal is to test a strategy that could realistically be sustained after the grant and potentially scaled to other settings.

Why is stakeholder engagement required?

Stakeholder engagement is a key requirement because the strategy is intended to be usable, practical, culturally and contextually appropriate, and aligned with real-world workflows and constraints. Engaging the people and organizations involved in DSMES delivery and use helps ensure that, if the approach works, it can be sustained and disseminated.

Who counts as a stakeholder for this program?

Stakeholders can include the people and organizations who will use, deliver, refer to, pay for, or be affected by DSMES. Examples listed include patients, caregivers, diabetes educators, primary care and endocrinology clinicians, clinic administrators, community health workers, pharmacists, payers, health systems leadership, and community-based organizations.

What is the funding mechanism for this opportunity?

The funding mechanism is an NIH R34, which is intended for time-limited pilot and feasibility work rather than a large, multi-year definitive trial.

How much funding is available per award?

The award ceiling listed in the opportunity summary is $225,000.

How many awards does NIH expect to make?

The FOA anticipated making about 2 awards.

What is the expected project duration?

The summary information provided does not specify a project period. It does indicate the mechanism is an R34, which is generally intended for time-limited pilot work and supports the idea that this is a proof-of-concept step toward a later, larger trial.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations capable of conducting pragmatic health services and implementation research. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as clarified in the FOA.

Why does the FOA include such a wide range of eligible organization types?

The eligibility is broad because DSMES access and delivery can be influenced by many kinds of institutions and community infrastructure, including health systems, community organizations, public health agencies, and educational or housing-related organizations, not only academic medical centers.

What disease area and intervention does this program focus on?

The focus is on diabetes mellitus and increasing the utilization and benefit of Diabetes Self-Management Education and Support (DSMES).

What does success look like for an R34 project under this FOA?

Success is producing actionable feasibility data and operational lessons, plus early outcome signals, that are strong enough to justify and inform a future full-scale dissemination and implementation trial intended to expand DSMES utilization at scale.

What activity areas is this opportunity associated with?

The opportunity is listed under the Health and Food and Nutrition activity areas.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 93.847.

When was this FOA created and when was it scheduled to close?

The FOA was created on January 6, 2021, and the original closing date listed is June 22, 2023.

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is RFA-DK-20-032.

What should applicants propose in their application?

Applicants are expected to propose an innovative and pragmatic strategy to increase DSMES use and to run a pilot clinical trial to test whether that strategy is workable in real care environments. The application should reflect stakeholder engagement and focus on feasibility outcomes while gathering early signals of impact on diabetes care processes and patient-centered outcomes.

Does the program emphasize sustainability and future scale-up?

Yes. A core expectation is that the strategy, if successful, could be sustained after the grant and has a clear pathway to broader dissemination and implementation in other settings.