Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 Clinical Trial Required) | RFA DK 19 021

Opportunity Information: Apply for RFA DK 19 021

The National Institutes of Health (NIH) funding opportunity announcement RFA-DK-19-021, titled "Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 Clinical Trial Required)," supports full-scale, hypothesis-driven clinical trials that test interventions specifically designed to reduce diabetes distress among people with type 1 diabetes and/or their caregivers. The central purpose is to determine whether successfully lowering diabetes-related emotional burden leads to measurable improvements in glycemic outcomes (for example, better blood glucose control) and enhanced quality of life. This announcement is positioned around the idea that diabetes distress is common, clinically meaningful, and potentially modifiable, and that addressing it may have downstream benefits for both day-to-day management and longer-term health outcomes in type 1 diabetes.

A key expectation is that proposed projects mirror how real clinical care works. Because clinical guidelines recommend that diabetes distress be screened for within the context of medical care, applications are expected to include practical, clinic-ready approaches to both screening and treatment. In other words, NIH is not looking for interventions that only function under highly specialized research conditions; they want studies that reflect a realistic care team model that could be implemented in typical diabetes clinics. This implies an emphasis on feasible workflows, coordination across disciplines (such as endocrinology, nursing, diabetes education, psychology/behavioral health, and social work), and interventions that can be integrated into routine visits or standard care pathways without unrealistic staffing or infrastructure demands.

The required mechanism is an R01 grant, and the FOA explicitly requires a clinical trial, meaning applicants must be prepared to conduct a rigorous trial design with appropriate comparison conditions, outcomes, recruitment and retention plans, fidelity monitoring, and analytic approaches. While the FOA summary highlights glycemic control and quality of life as major endpoints, the underlying logic suggests that applications should thoughtfully link the intervention to both psychosocial outcomes (reductions in distress) and biomedical/behavioral outcomes (improved self-management behaviors, technology use, adherence, or other pathways that plausibly drive glycemic improvement). Including caregivers recognizes that distress and diabetes management often involve family systems, particularly for children, adolescents, or others who rely on caregiving support, and the FOA allows interventions aimed at either the individual with type 1 diabetes, their caregivers, or both.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and city or township governments; 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as 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. At the same time, it draws a clear boundary around foreign participation: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, meaning certain discrete collaborations or project elements may occur outside the U.S. when appropriately justified and structured under NIH rules.

From an administrative standpoint, the opportunity is categorized as a discretionary grant under NIH, with the funding activity aligned to health (and listed under Food and Nutrition, Health) and CFDA number 93.847. The posted award ceiling is $500,000 (as provided in the source data). The original closing date listed is June 26, 2020, and the FOA creation date is January 2, 2020. Overall, the announcement is aimed at generating strong clinical trial evidence on whether treating diabetes distress is not only beneficial psychologically, but also translates into better glycemic outcomes and improved daily functioning for people living with type 1 diabetes, using models of care that can realistically be adopted in clinical practice.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 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 2020-01-02.
• Applicants must submit their applications by 2020-06-26. (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 $500,000.00 in funding.
• 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.

Apply for RFA DK 19 021

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: