RFA-DK-26-315: Advancing Research on Digital Health Technology for Type 2 Diabetes (R01)

RFA-DK-26-315: Advancing Research on Digital Health Technology for Type 2 Diabetes (R01)

If you are building diabetes interventions with digital tools, this notice is not a generic technology grant. It is a clinical research grant that expects outcomes evidence, human participant engagement, and trial-level rigor. The NOFO explicitly asks for studies using digital health technology (DHT) to improve management of diabetes and prediabetes, with practical questions about access, adherence, and sustained use at the center of the proposal.

NIH positioned this as a recurring opportunity with annual-type review cycles. As of the last official dates, two important milestones are visible: the 2026 due date on October 6, 2026 and the next open-cycle date on October 6, 2027. That makes it relevant for the 2026/2027 period, while also signaling that this is a sustained funding lane rather than a one-off one-cycle solicitation.

Key details table

What this opportunity is (and what it is not)

The clearest way to evaluate this NOFO is to treat it as a clinical-research pathway, not a software product award.

It is about proving that digital interventions improve outcomes for people with diabetes by reducing inertia in care and making routine management more feasible. The NOFO text repeatedly frames this as translational efficacy work in real patient populations, not speculative product development.

The following are explicitly in scope:

• multimodal interventions such as CGM use in combination with other digital modalities,
• telemedicine and virtual coaching,
• connected devices including activity monitors and digital scales,
• mobile health approaches to adherence, diet, medication behavior, mood, and coaching,
• bidirectional care team communication through text, portals, and clinician-facing workflows,
• peer-support structures with DHT components,
• and studies that assess patient engagement, adoption, sustainment, and equity of access.

The NOFO also states what is not in scope. Proposals are non-responsive if they:

• focus only on automated insulin delivery systems (such as artificial pancreas/hybrid closed-loop),
• focus on ketone monitoring for T1D-only use cases,
• are primarily new technology development without a near-term trial focus,
• are only disease-classification or subtype-discovery projects using DHT data,
• are mechanistic in nature with no applied effectiveness direction.

This is critical. The boundary between a valid proposal and a rejected one is not whether your team is innovative in engineering terms; it is whether your application is responsive to the announced translational and clinical framework.

Why this is a 2026/2027-relevant opportunity

The NOFO aligns to a practical funding schedule with two visible cycle dates and a multi-year allocation statement. Since the text includes due dates for 2026 and 2027, it is directly relevant to teams planning proposals in this planning window.

Budget signals in the NOFO are meaningful:

• NIH indicates three grants total for FY2026–FY2027.
• Direct-cost budget availability is stated as a pooled annual amount: $1.5M in FY2026, then $3.0M in FYs 2027-2030.
• Unlike programs with fixed award caps per applicant, this solicitation notes that budgets are not capped in a strict per-application amount but should reflect justified project needs.

For applicants, this matters because it shifts the strategy from “fit award size” to “fit reviewability and NIH priority alignment.”

What is usually underweighted in similar grants is the role of eligibility and compliance signals in this NOFO. This call is broad in organization types but narrow in required study design. If your organization can support clinical trial infrastructure, this can be a strong fit for teams with a strong implementation track and patient-facing evidence plan.

Who should apply and who should not

Use this section as a strict filter before writing anything.

Strong fits

• Academic teams in HEIs with established clinical trial and diabetes population access.
• Nonprofits and small businesses with clinical partners and IRB-ready protocols.
• Organizations already conducting diabetes interventions with digital care workflows and outcome metrics (A1c, adherence, quality-of-life proxies, engagement, healthcare utilization).
• Multidisciplinary teams where clinical, behavioral, and data elements are co-led.

Potentially weak fits

• Teams proposing a technology invention platform only (without human trial design and clinical endpoint evidence generation).
• Projects focused exclusively on T1D management without a clear path to the target populations in NOFO framing.
• Applications where DHT is a peripheral feature rather than the mechanism of change.
• Proposals that cannot demonstrate meaningful patient/community engagement from design onward.

Organization-level eligibility summary from NOFO

NIH listed a broad set of domestic eligible applicants:

• public and private higher-education institutions,
• nonprofits (501(c)(3) and non-501(c)(3)),
• for-profit organizations including small businesses,
• local and federal government entities,
• additional domestic organizations (e.g., housing authorities, faith-based/community-based orgs, regional organizations).

The notable exclusion: foreign organizations are not eligible as the applicant. Non-domestic components of U.S. entities are also disallowed as the NOFO wording describes.

Funding, budget, and review logic

The NOFO includes a concise but high-impact set of financial and structure details.

Funding and duration

• Funding instrument: Grant (R01).
• Clinical trial requirement: applications must propose clinical trials.
• Project duration: up to 5 years.
• Number of awards: 3 grants across the FY2026 and FY2027 windows.
• Budget scale: no fixed per-application cap stated; budgets must match project scope, but all proposals remain under NIH administrative and review scrutiny.

Review focus

The section on review criteria maps to standard NIH scientific review plus program-specific emphasis. Reviewers assess significance, innovation, approach, investigator, and environment, with feasibility and inclusion and human-subject quality emphasized for trial protocols.

Practical implication: because this is an effectiveness-focused translational call, “technology novelty” is not enough by itself. A modest intervention with a strong implementation plan, recruitment strategy, and credible outcome design can outscore a more technically complex but less executable proposal.

The NOFO also asks that teams include more than token engagement. It explicitly expects meaningful engagement throughout design and delivery with patients, caregivers, community organizations, and clinical systems. That expectation is evaluable evidence:

• Was engagement embedded in question framing?
• Are materials co-designed with user context in mind?
• Is communication workflow actually designed for clinicians and patients, rather than added as a checklist?

The non-responsive filters that can eliminate an otherwise strong proposal

In addition to thematic misalignment, NIH flags categories of non-responsive work:

• A closed-loop insulin delivery project in T1D-centric form,
• studies limited to ketone monitoring, DHT-based subtype classifications, algorithm generation only,
• mechanistic-only trials.

If any of these are central in your scope, you will be sent back before full review. This is one of those opportunities where this gate can waste months if not handled early.

Application requirements that change preparation timelines

The NOFO’s biggest operational constraint is systems compliance and timing.

Submit correctly

NIH points applicants to three channels:

1. NIH ASSIST,
2. institutional S2S submission to Grants.gov with eRA Commons,
3. Grants.gov Workspace with eRA Commons tracking.

The key phrase in practice: choose one official path early and test your institutional access flow before drafting near the deadline.

Registrations and pre-flight requirements

NIH warns that registrations can take time (it explicitly says six weeks or more) and must be complete before submission. Since this is a clinical R01 route, most institutions already have baseline registrations, but any missing piece can cause late/invalid submission risk.

Compliance guardrails

The 500K+ direct costs trigger is easy to miss. If your proposal expects $500,000+ in direct costs in any single year (excluding consortium F&A), you must contact NIH’s scientific/research contact at least 6 weeks before submission.

This rule has high process value. Teams often assume budget growth automatically accepted if justified, but NIH has additional review and disclosure gates. If this is a concern, build this into your timeline at least 10 weeks ahead.

Clinical trial obligations

Because the opportunity is explicitly clinical trial required:

• your protocol must be coherent across intervention design, inclusion/exclusion, and data collection,
• IRB and IEC requirements are mandatory and expected to be handled in implementation,
• NIH explicitly references monitoring and reporting rules relevant to trial standards,
• if applicable, FDA IND/IDE governance and clinical trials registry obligations are part of normal post-award compliance expectations.

Step-by-step preparation strategy for this NOFO

A practical timeline that fits this specific solicitation looks like this:

6–8 weeks before deadline

• Lock scope: choose one intervention hypothesis that directly addresses a DHT-enabled clinical question.
• Confirm applicant type (must be domestic U.S. entity).
• Confirm collaborators include at least one organization able to execute human trials and manage DHT workflow across clinics.

4–6 weeks before deadline

• Build out the engagement model, not as a paragraph but as a protocol section.
• Map outcomes: efficacy, adoption, adherence, diabetes distress, quality of life, healthcare use, cost effectiveness if included.
• Prepare a realistic recruitment and retention section.

3–4 weeks before deadline

• Freeze trial design narrative before budget.
• Verify budget rules and whether year-of-direct-costs >= $500k.
• If yes, complete the required pre-submission scientific contact process.

2 weeks before deadline

• Perform NIH-style internal compliance review:
  • completeness of registrations,
  • clinical trial plan,
  • data safety monitoring expectations,
  • inclusion and feasibility text,
  • investigator/PI eligibility and effort assumptions.

Final week

• Validate that no prohibited scope items accidentally remain (e.g., mechanistic-only claims, algorithm-first framing, T1D-only closed-loop focus).
• Run a dry run in your submission system to confirm submission components and response checks.

What a strong application should include beyond the obvious

This section is where applicants lose quality without knowing it.

1. Problem-to-measurement chain

NIH review for this opportunity is more likely to reward teams that can clearly connect intervention mechanics to measurable outcomes. Don’t stop at “we will test a mobile app”; show:

• what behavior is expected to change,
• how digital contact points reinforce adherence,
• how you will quantify impact,
• and how you will track sustainment beyond initial exposure.

2. Feasibility realism

In the review criteria, feasibility is as heavily weighted as scientific novelty. You should include:

• realistic recruitment assumptions by site,
• contingencies if uptake is lower than expected,
• and an explicit timeline for iterative adjustments.

3. Engagement and implementation evidence

Meaningful engagement is mandatory in language and in execution. This NOFO expects engagement to move beyond advisory listening. Consider:

• patient advisory input to refine protocol burden,
• clinician feedback on workflow integration,
• and system-level onboarding steps (support lines, training materials, data integration points).

4. Population and generalizability logic

Programs on DHT often overfit to a tech-optimized participant profile. The NOFO highlights adoption and digital literacy barriers, which means you should explicitly describe how the intervention accommodates low digital confidence, variable internet access, and diverse health literacy.

5. Health outcomes with practical endpoints

The source text points to outcomes like glycemia, distress, adherence, quality of life, and healthcare interaction burden. Reviewers read best when outcomes are clinically meaningful and operationally measurable with low ambiguity. Avoid overbroad endpoints that cannot be measured consistently across sites.

Common mistakes and how to avoid them

Mistake 1: Treating the NOFO as a software grant

Avoid this by anchoring the project as a clinical trial with measurable health endpoints, not just technology deployment.

Mistake 2: Building a non-responsive intervention

If your project includes closed-loop or pure ketone monitoring in T1D-only form, it can be rejected before review. Re-check this during proposal scoping.

Mistake 3: Underestimating due-date and registration lead times

The 5:00 PM local-time deadline plus mandatory registrations can cause preventable issues. Start registration and system path validation well in advance.

Mistake 4: Weak or token engagement

The NOFO is explicit that engagement must not be superficial. Include how engagement changes design and implementation, not only recruitment.

Mistake 5: Overspecifying budget without alignment

There is no explicit per-project cap in the text, but budget logic must be justified by protocol needs and timeline. If requesting $500,000+ in direct costs in any year, follow the pre-submission contact rule.

Eligibility questions before submission

If you are uncertain, answer these quickly:

• Are we a U.S.-eligible applicant?
• Is this definitely a clinical trial and not a feasibility-only or algorithm-development study?
• Are all required registrations active and current in eRA Commons, Grants.gov, and related systems?
• Are project outcomes clearly tied to DHT-enabled diabetes management improvements?
• Can we describe meaningful engagement as a process, not a statement?
• Does any part of the proposal fall in the explicit non-responsive categories?

If any answer is “no,” pause and revise scope before writing the methods section.

Timeline snapshot for 2026/2027 planning

• Posted: September 17, 2025
• Open: October 7, 2025
• Cycle 1 due date: November 7, 2025 (historical from NOFO table)
• Cycle 2 due date: October 6, 2026 (upcoming in current planning window)
• Next cycle date: October 6, 2027
• Peer review and award windows listed in the same table as advisory review and earliest start

The presence of a 2027 cycle is important for teams that do not finalize trial capacity by late 2026 but want to prepare with less pressure.

Official links

• Official NOFO: https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-26-315.html
• NIH application instructions and grants portal links are referenced directly in the NOFO text and should be followed as required for the current application year.
• For technical submission issues, NIH points applicants to the eRA Service Desk and Grants.gov support; for policy interpretation, use NIH publication and grants policy pages linked in the notice.

Practical next steps after initial pass

1. Build a one-page pre-application scope map with three sections: population, intervention, and outcomes.
2. Decide whether budget will exceed $500,000 in direct costs.
3. If yes, log the mandatory pre-submission contact timeline immediately.
4. Finalize patient and clinician engagement plan early enough for protocol writing.
5. Run one internal red-team review using only the non-responsive rules and review criteria before full drafting.

The NOFO is one of the more straightforward NIH clinical trial opportunities if handled as a trial-first proposal. Treat it as a healthcare implementation and effectiveness study first, a technology product release second. That order is where teams typically gain review credibility.