Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required) | RFA DK 26 315

Opportunity Information: Apply for RFA DK 26 315

The National Institutes of Health (NIH) is soliciting R01 grant applications under Funding Opportunity Number RFA-DK-26-315, titled "Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01 - Clinical Trial Required)." This discretionary grant opportunity (CFDA 93.847) supports clinical research that tests whether multimodality digital health technology approaches can improve the remote management of diabetes, with a clear emphasis on generating evidence about both efficacy (does it work under more controlled conditions) and clinical effectiveness (does it work in real-world care settings). Because the NOFO specifies "Clinical Trial Required," proposed projects are expected to include a clinical trial component rather than being purely observational, descriptive, or technology-development-only studies.

The scientific focus is on multimodality digital health technology, meaning interventions that combine more than one digital channel, tool, or data source to support diabetes management at a distance. In practical terms, this can include combinations such as continuous glucose monitoring and connected blood glucose meters, smartphone applications, text messaging, telehealth visits, remote patient monitoring platforms, digital coaching, medication adherence supports, decision aids, algorithm-driven feedback, and integration with electronic health records or care teams. The central goal is to rigorously evaluate how these tools, when used together as part of a coordinated intervention, affect diabetes outcomes and care processes when patients are managed remotely rather than relying solely on in-person visits.

Projects responsive to this opportunity would typically be expected to measure clinically meaningful endpoints related to type 2 diabetes management. While the NOFO summary does not list specific endpoints, common examples in this area include improvements in glycemic control (such as HbA1c), time-in-range for patients using CGM, hypoglycemia events, weight or cardiometabolic risk factors, medication adherence, engagement with self-management behaviors, quality of life, and health care utilization. Since the NOFO highlights "clinical effectiveness," strong applications often go beyond biometric outcomes to address implementation-relevant outcomes such as patient engagement, retention, usability, equity and access, workflow fit, and the extent to which the intervention can be delivered reliably in routine practice.

Eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, and local 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other qualified entities. The NOFO also explicitly notes additional eligible applicants such as eligible agencies of the federal government, faith-based or community-based organizations, Indian/Native American tribal governments other than federally recognized, regional organizations, and U.S. territories or possessions. In contrast, foreign organizations are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed, which means the work and participating components must be domestic.

Key administrative details provided include an original closing date of 2026-10-06 and a creation date of 2025-09-17. The agency is NIH, and the activity aligns with the "Food and Nutrition, Health" funding activity category. The summary data provided does not specify an award ceiling or the expected number of awards, so applicants would need to consult the full NOFO text for budget expectations, project period limits, and any institute- or mechanism-specific caps or guidance.

Overall, this opportunity is aimed at moving beyond simple feasibility studies by supporting well-designed clinical trials that can demonstrate whether combining digital health modalities truly improves remote type 2 diabetes management, and whether such approaches are effective when deployed in real-world clinical or community settings. Competitive proposals will generally be those that pair a clear clinical question with a rigorous trial design, meaningful outcomes, a credible remote-care workflow, and a thoughtful plan for reaching and retaining the populations most affected by type 2 diabetes within the U.S. context required by the funding rules.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail 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 2025-09-17.
• Applicants must submit their applications by 2026-10-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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