Pilot and Feasibility Studies to Improve Technology Adoption and Reduce Health Disparities in Type 1 Diabetes Mellitus (R01 Clinical Trial Required) | RFA DK 21 018

Frequently Asked Questions (FAQs)

What is NIH RFA-DK-21-018 trying to fund?

This NIH funding opportunity supports pilot and feasibility clinical trials that test practical interventions designed to increase the adoption and effective use of diabetes-related technologies among people with type 1 diabetes (T1D) from underrepresented backgrounds, with a particular focus on minority racial and ethnic groups.

What is the main public health goal of this opportunity?

The long-term goal is to reduce disparities in T1D outcomes by improving access to, uptake of, and sustained engagement with diabetes technology in communities that have historically faced barriers to receiving and benefiting from these tools.

What kinds of technologies does this FOA focus on?

The FOA is oriented toward diabetes technology adoption, including tools such as continuous glucose monitors (CGMs), insulin pumps, automated insulin delivery systems, and related digital supports that help people manage T1D.

What does "technology adoption" mean in the context of this FOA?

In this announcement, technology adoption generally refers to helping people start using diabetes technologies, use them effectively, and continue using them over time. This includes addressing real-world barriers that interfere with initial uptake and sustained engagement.

Why is the NIH emphasizing underrepresented backgrounds and minority racial and ethnic groups?

The FOA is based on the idea that while diabetes technologies are associated with better glycemic outcomes and improved quality of life, their benefits are not evenly distributed. Structural barriers and differences in access and support can lead to lower technology uptake in some communities, contributing to persistent inequities in outcomes.

What types of barriers are projects expected to address?

Projects are expected to directly address barriers that can reduce technology uptake and effective use, such as structural barriers, cost and coverage issues, limited access to specialty care, lower health literacy, language barriers, and differences in trust and support.

Is this an effectiveness trial or something earlier-stage?

This FOA is specifically focused on smaller, early-stage pilot and feasibility work rather than a fully powered effectiveness trial. The goal is to show whether an intervention is workable in real-world settings and generates promising signals that justify a larger, more pragmatic follow-on trial.

Does the application have to include a clinical trial?

Yes. This is an R01 that has a clinical trial requirement, meaning applicants are expected to propose and conduct a clinical trial as part of the study, even though the emphasis is on pilot and feasibility outcomes.

What does NIH likely expect from the study design?

The study design should be rigorous enough to generate credible feasibility metrics and implementation lessons. The focus is on whether the intervention and technology-use approach can be implemented as intended, and whether the trial can successfully recruit and retain participants from the target communities.

What are examples of feasibility outcomes mentioned or implied in the description?

Examples include recruitment rates from target communities, retention over the study period, adherence and engagement with devices, training completion, usability and acceptability, fidelity of intervention delivery, and the practicality of integrating the approach into clinics, community programs, or other service settings.

What does "implementation as intended" mean here?

It refers to whether the technology and the intervention strategies (such as training, support, or workflow changes) can be delivered consistently and correctly in real-world settings, rather than only under ideal research conditions.

What is the expected next step after completing a project funded by this FOA?

The results are intended to position the research team to plan a larger pragmatic trial that can more definitively test clinical outcomes and real-world impact on disparities.

Who is eligible to apply?

Eligibility is broad and includes many domestic U.S. organizations and governmental entities, including state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; special district governments; and public housing authorities/Indian housing authorities.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are included among eligible applicants.

Are nonprofits eligible (including those without 501(c)(3) status)?

Yes. Nonprofits with or without 501(c)(3) status are included in the listed eligible applicant types.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are included, and small businesses are also listed as eligible.

Are certain institution types specifically highlighted as encouraged or eligible?

Yes. The FOA explicitly highlights additional applicant types that are encouraged or considered eligible, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; and U.S. territories or possessions.

Can a non-U.S. (foreign) organization apply?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this opportunity.

Can a U.S. organization include a non-domestic component in the project?

No. Non-domestic components of U.S. organizations are not eligible, and foreign components are not allowed under NIH policy as referenced in the announcement.

What is the assistance listing / CFDA number associated with this opportunity?

The opportunity is identified as CFDA 93.847 in the provided description.

How is this opportunity categorized?

The source description characterizes it as a discretionary NIH grant in the health-related area and categorizes it under food and nutrition/health.

What are the key dates shown in the provided excerpt?

The excerpt indicates a creation date of July 28, 2021 and an original closing date of March 3, 2022.

Does the provided excerpt list the award ceiling or the expected number of awards?

No. The excerpt does not specify an award ceiling or the expected number of awards.

What details are not included in the excerpt that applicants may need to confirm in the full FOA?

Based on the excerpt, applicants would typically need to consult the full FOA for budget expectations, project period limits, review criteria, and any required components such as data sharing, inclusion plans, recruitment targets, and how health disparities and underrepresented populations should be defined and measured in the application.

What makes a project a good fit for this FOA, based on the description provided?

A strong fit is a targeted, culturally and contextually responsive strategy that helps people in underserved communities start using and keep using T1D technologies, while generating practical evidence about feasibility and implementation that can support a larger pragmatic trial focused on narrowing inequities in diabetes care and outcomes.