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

Opportunity Information: Apply for RFA DK 20 032

The Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required) opportunity (Funding Opportunity Number RFA-DK-20-032) is a discretionary NIH grant from the U.S. Department of Health and Human Services, National Institutes of Health. It supports early-stage, real-world testing of new, practical ways to increase the use of Diabetes Self-Management Education and Support (DSMES) among people living with diabetes mellitus. The central aim is not simply to study DSMES in theory, but to design and pilot an approach that directly tackles the on-the-ground barriers that prevent patients from enrolling in, accessing, completing, or benefiting from DSMES, and to do so in a manner that could realistically be sustained and spread to other settings.

This FOA is specifically focused on pilot and feasibility work, meaning the funded project is expected to generate strong preliminary evidence and operational lessons that would justify and inform a later, larger full-scale dissemination and implementation trial. Applicants are expected to propose an innovative and pragmatic strategy, then run a pilot clinical trial to test whether that strategy is workable in real care environments. In practice, this means the study should emphasize 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 that could support powering and designing a future definitive trial.

A key requirement is stakeholder engagement. Applications are expected to involve the people and organizations who will actually use, deliver, refer to, pay for, or be affected by DSMES. That can include patients, caregivers, diabetes educators, primary care and endocrinology clinicians, clinic administrators, community health workers, pharmacists, payers, health systems leadership, and community-based organizations. The intent is to ensure the proposed strategy is practical, culturally and contextually appropriate, and aligned with the constraints of routine care, so that if it works, it can be sustained after the grant and has a clear pathway to broader dissemination.

The award mechanism is an R34, and the FOA indicates that a clinical trial is required, so the project must include a prospective trial component rather than only formative research or program development. The award ceiling is listed as $225,000, and the FOA anticipated making about 2 awards. While the summary information provided does not list the project period, R34s are generally intended for time-limited pilot work rather than multi-year large trials, reinforcing that this is a planning and proof-of-concept step toward a subsequent larger study.

Eligibility is broad and includes many types of domestic organizations that could realistically conduct 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. This wide eligibility reflects the reality that DSMES access and delivery can be influenced by health systems, community organizations, public health agencies, and educational or housing-related community infrastructure, not just academic medical centers.

The opportunity falls under the Health and Food and Nutrition activity areas and is associated with CFDA number 93.847. The FOA was created on January 6, 2021, and the original closing date listed is June 22, 2023. In summary, the program is designed for teams that can co-develop a sustainable, stakeholder-informed strategy to boost DSMES use, then run a pragmatic pilot clinical trial that produces actionable feasibility data and early outcome signals strong enough to support a future, larger dissemination and implementation trial aimed at expanding DSMES utilization at scale.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot and Feasibility Studies to Facilitate the Use of Diabetes Self-Management Education and Support to Improve Diabetes Care (R34 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on Jan 06, 2021.
• Applicants must submit their applications by Jun 22, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

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