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

This notice of funding opportunity (NOFO) invites applications designed to examine the efficacy and clinical effectiveness of multimodality digital health technology approaches to the remote management of diabetes.

Funding Opportunity Number: RFA-DK-26-315. Assistance Listing: 93.847. Funding Instrument: G. Category: FN,HL.

Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required) | RFA DK 26 315 Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required) | RFA DK 26 315 Food and Nutrition, Health National Institutes of Health 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.

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: Your browser does not support the video tag. Frequently Asked Questions (FAQs) What is this funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity soliciting R01 grant applications under Funding Opportunity Number (FON) 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)." It is a discretionary grant opportunity associated with CFDA 93. 847.

Which agency is offering this grant? The funding agency is the National Institutes of Health (NIH). What is the grant mechanism?

The mechanism is an NIH R01 research project grant. What does "Clinical Trial Required" mean for applicants? "Clinical Trial Required" means the proposed project is expected to include a clinical trial component.

Projects that are purely observational, descriptive, or focused only on technology development (without a clinical trial that tests the intervention) are not aligned with what is described in the summary information provided. What health condition and population is the opportunity focused on?

The opportunity focuses on remote management of type 2 diabetes, with the intent to improve outcomes and care processes for people with type 2 diabetes using digital health technology approaches delivered at a distance. What is the main purpose of the research supported by this opportunity?

The purpose is to test whether multimodality digital health technology approaches can improve the remote management of type 2 diabetes and to generate evidence about both efficacy (performance under more controlled conditions) and clinical effectiveness (performance in real-world care settings). What is meant by "multimodality digital health technology" in this opportunity?

What are examples of digital health modalities that could be part of a multimodality intervention?

Examples mentioned include combinations such as continuous glucose monitoring (CGM) 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 (EHRs) or care teams.

Is the opportunity limited to a specific type of digital health tool (like an app only or CGM only)? Based on the description provided, the emphasis is on combining multiple digital modalities as part of a coordinated intervention. Single-modality-only approaches are not what is highlighted in the summary, which stresses multimodality strategies.

Does the opportunity emphasize remote care over in-person care? Yes. The central goal described is to evaluate how combined digital tools affect diabetes outcomes and care processes when patients are managed remotely rather than relying solely on in-person visits.

What types of outcomes are expected to be measured? The summary indicates that projects would typically measure clinically meaningful endpoints related to type 2 diabetes management. While the summary does not list required endpoints, it provides common examples used in this area.

What are examples of clinically meaningful endpoints mentioned or implied? Examples provided include 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. Beyond biometric outcomes, what else should strong applications consider measuring?

The description emphasizes clinical effectiveness in real-world settings and notes that strong applications often include implementation-relevant outcomes such as patient engagement, retention, usability, equity and access, workflow fit, and the reliability of delivering the intervention in routine practice. Is the opportunity focused more on feasibility pilots or on rigorous evaluation?

The opportunity is described as aiming to move beyond simple feasibility studies. It supports well-designed clinical trials intended to demonstrate whether combining digital health modalities improves remote type 2 diabetes management and whether such approaches are effective in real-world clinical or community settings. Who is eligible to apply?

Eligibility is broad across U.S.-based organizations.

Eligible applicants listed 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.

Are federal agencies eligible applicants? Yes. The summary explicitly notes that eligible agencies of the federal government are included among eligible applicants.

Are faith-based or community-based organizations eligible? Yes. The summary explicitly notes faith-based or community-based organizations as eligible applicants.

Are U.S. territories eligible to apply? Yes. The summary states that U.S. territories or possessions are among the explicitly noted eligible applicants.

Are foreign organizations eligible to apply? No. The summary states that foreign organizations are not eligible to apply. Can a U.S. organization include a non-U.S. component in the project?

No. The summary states that non-U.S. components of U.S. organizations are not eligible. Are foreign components allowed under this opportunity? No. The summary states that foreign components (as defined by the NIH Grants Policy Statement) are not allowed, meaning the work and participating components must be domestic.

What is the closing date for applications? The summary lists an original closing date of 2026-10-06. What is the creation date of this opportunity?

The summary lists a creation date of 2025-09-17. What is the CFDA number associated with this opportunity? The opportunity is associated with CFDA 93.

847. What funding activity category is this opportunity associated with? The activity aligns with the "Food and Nutrition, Health" funding activity category.

Is the award ceiling (maximum budget) provided in the summary information? No. The summary indicates that it does not specify an award ceiling. Does the summary specify the expected number of awards?

No. The summary indicates that it does not specify the expected number of awards. Where would applicants typically find budget expectations and project period limits? Based on the information provided, applicants would need to consult the full NOFO text for budget expectations, project period limits, and any institute- or mechanism-specific caps or guidance.

What types of study designs are implied to be a good fit? The description implies that a good fit would be a rigorous clinical trial designed to evaluate a coordinated, multimodality digital intervention for remote type 2 diabetes management, with meaningful outcomes and attention to real-world delivery (clinical effectiveness). What elements are described as typical of competitive proposals?

Competitive proposals are generally described as 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 populations most affected by type 2 diabetes within the U.S. context required by the funding rules.

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