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

Frequently Asked Questions (FAQs)

What is the funding opportunity title and number?

The National Institutes of Health (NIH) funding opportunity announcement is RFA-DK-19-021, titled "Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 Clinical Trial Required)."

What is the main goal of this NIH opportunity?

The central goal is to support full-scale, hypothesis-driven clinical trials that test interventions designed to reduce diabetes distress in people with type 1 diabetes and/or their caregivers, and to determine whether lowering diabetes-related emotional burden leads to measurable improvements in glycemic outcomes and quality of life.

What type of projects does this FOA support?

This FOA supports full-scale clinical trials that are hypothesis-driven and focused on interventions specifically designed to reduce diabetes distress, with evaluation of downstream effects such as glycemic outcomes (for example, improved blood glucose control) and quality of life.

Is a clinical trial required?

Yes. The FOA explicitly requires a clinical trial, and applicants must be prepared to conduct a rigorous trial with appropriate comparison conditions, outcomes, recruitment and retention plans, fidelity monitoring, and analytic approaches.

What grant mechanism is required?

The required mechanism is an NIH R01 grant.

Who is the intended population for the interventions?

Interventions may target people with type 1 diabetes and/or their caregivers. The FOA recognizes that distress and diabetes management often involve family systems, particularly for children, adolescents, or others who rely on caregiving support.

What is meant by "diabetes distress" in the context of this announcement?

Within this FOA, diabetes distress is framed as diabetes-related emotional burden that is common, clinically meaningful, and potentially modifiable. The announcement is built around testing whether reducing that burden improves both psychosocial outcomes and glycemic outcomes.

What outcomes is NIH most interested in?

The FOA emphasizes glycemic outcomes (such as better blood glucose control) and enhanced quality of life. It also reflects an expectation that studies will measure psychosocial outcomes (reductions in diabetes distress) and thoughtfully connect those changes to plausible pathways that influence glycemic outcomes.

Does the FOA expect studies to examine how distress reduction leads to glycemic improvement?

Yes. The FOA highlights the logic that interventions should link reductions in distress to biomedical and behavioral outcomes, such as improved self-management behaviors, adherence, technology use, or other plausible pathways that could drive glycemic improvement.

What does NIH mean by wanting projects to mirror real clinical care?

The FOA expects projects to reflect how care works in typical diabetes clinics. Because clinical guidelines recommend screening for diabetes distress in medical care settings, applications are expected to include practical, clinic-ready approaches to screening and treatment rather than interventions that only work under highly specialized research conditions.

Are applications expected to include screening for diabetes distress?

Yes. The announcement states that, since clinical guidelines recommend distress screening within medical care, proposed projects are expected to incorporate feasible approaches to both screening and treatment in real-world clinical contexts.

What kinds of care teams or disciplines are implied by the FOA?

The FOA implies coordination across typical diabetes clinic disciplines, such as endocrinology, nursing, diabetes education, psychology/behavioral health, and social work, with interventions that can be integrated into routine visits or standard care pathways.

Does NIH want interventions that require specialized research-only staffing or infrastructure?

No. The FOA emphasizes feasible workflows and realistic care team models that could be implemented in typical clinics, without unrealistic staffing or infrastructure demands.

What is the funding amount (award ceiling) listed for this opportunity?

The posted award ceiling in the provided source data is $500,000.

What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.847.

How is this opportunity categorized?

It is categorized as a discretionary grant under NIH, with the funding activity aligned to health (listed under Food and Nutrition, Health).

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations, including 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 higher education); for-profit organizations (other than small businesses); and small businesses.

Are specific institution types explicitly highlighted as eligible?

Yes. The FOA also highlights 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.

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

No. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply.

Can a U.S. organization apply if part of the work will be done outside the U.S.?

Non-U.S. components of U.S. organizations are not eligible to apply. However, the FOA states that 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.

What is the FOA creation date?

The FOA creation date listed is January 2, 2020.

What is the closing date listed for the opportunity?

The original closing date listed is June 26, 2020.

What overall question is NIH trying to answer through this FOA?

The announcement aims to generate strong clinical trial evidence on whether treating diabetes distress is not only psychologically beneficial, 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.