NIDDK: Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

NIH/NIDDK is seeking investigator teams to lead clinical trials testing digital health technologies in Type 2 Diabetes management. This R01 requires a clinical trial and aims to build evidence on how digital tools (e.g., continuous glucose monitors, mobile apps, telehealth, wearables) can improve glycemic and related outcomes in people with Type 2 Diabetes. Applications are due October 6, 2026 by 5:00 PM local time — plan ahead to prepare a full clinical trial proposal that adheres to NIH requirements.

How much funding would I receive?

Funds anticipated: Direct costs ~

• $1.5M in FY2026,

• $3.0M in FY2027-2030,

• $1.5M in FY2031.

Award budget: Not capped — must reflect actual needs of the proposed clinical trial project.

Project period: Up to 5 years.

What could I use the funding for?

General principles:

• Multimodality DHT interventions that for example, combine CGM concurrently with other digital interventions in a virtual remote continuous care intervention, though not required, are of particular interest to this NOFO.

• All investigators are expected to include meaningful engagement approaches with the relevant research population in designing and implementing the proposed trial. This may involve engagement with patients, family members or caregivers, community members, community-based organization, clinicians and other care providers, health care systems, or other relevant partners throughout the research process. Meaningful engagement must entail more than focus groups, surveys, or other activities where partners are only involved as participants or respondents. Engagement must be designed to ensure that the research is practical and aligns with partners' preferences and values. Meaningful collaboration will lead to optimal trial recruitment and conduct as well as potential for future dissemination and sustainability. 

• Multiple digital interventions have applicability to management of both T1 and T2 diabetes and these DHT interventions are of interest to this NOFO.

• Partnering with industry providers of virtual diabetes clinic offerings is allowed but not required.

• Clinical trials funded in response to this NOFO are expected to provide efficacy data that will enable future large multicenter clinical effectiveness studies on the application of DHT to PWD.

Examples of DHT interventions to be tested include, but are not limited to:

• Continuous glucose monitoring:

  • Studies on the efficacy of CGM in T2D, including in PWD not taking insulin

  • Studies on the utility of CGM in persons with prediabetes, for example, interventions that prevent the progression of prediabetes to diabetes

  • Studies examining the role of CGM in monitoring and adapting dietary interventions

  • Studies on the dose and duration of CGM usage necessary to effect change in health activation and healthy behaviors

  • Studies to assess and promote the accessibility, adoption and sustainability of CGM interventions

  • Studies assessing and improving the integration of CGM into clinic workflow, particularly in primary care settings

• Activity monitoring:

  • Studies examining the role of digital monitoring of activity on improvement of glycemia and other metabolic parameters in PWD

• Digital nutritional monitoring

  • The use of mobile applications to facilitate measures of macronutrient content of meals in PWD, and the impact of these interventions on diabetes-specific outcomes.

• Telemedicine, directed text messaging, patient portals, and peer-support

  • Studies assessing the incorporation of virtual communication into a multimodality virtual diabetes clinic model

  • Studies examining the influence of digital methods of multi-touchpoint peer support on glycemic and non-glycemic diabetes-specific outcomes

• Gaming and gamification

  • Studies examining the effect of digital gamification on the uptake and sustained adoption of diabetes education to improve knowledge and promote self-care behaviors (dietary, activity, and medication adherence) in a manner that improves diabetes-specific outcomes

• DHT adoption and sustainment

  • Studies examining factors predicting and improving patient engagement, adoption, and sustained use and utility of DHT interventions in PWD, and phenotyping according to acceptance of different modalities of DHT (CGM, wearables, telehealth, etc.) 

  • Studies examining the role of interventions to improve access of DHT for all PWD; to evaluate, measure, and improve digital literacy; and examine the influence of health beliefs and trust in the HCS on the successful utilization of all forms of DHT, including telemedicine 

  • Studies examining the influence of DHT interventions on patient engagement, self-empowerment, diabetes distress, and quality of life using validated measures.

  • Studies including a specific aim to determine the cost-effectiveness of specific DHT interventions in PWD 

  • Studies examining the effect of incentivizing PWD, providers and the health care system to incorporate DHT into diabetes management 

  • Studies examining the role of digital health navigators, including AI-based systems, in improving the acceptability and sustainability digital health interventions in PWD 

Are there any additional benefits I would receive?

• Potential to position your digital health intervention for future large multicenter effectiveness studies if early clinical evidence is strong.

• Grant support includes access to NIH peer review and scientific oversight.

Note: There’s no letter of intent required.

What is the timeline to apply and when would I receive funding?

Posted Date: September 17, 2025

Application Due: October 6, 2026 by 5:00 PM local time

Where does this funding come from?

NIH — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the U.S. Department of Health and Human Services.

CFDA: 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research.

Who is eligible to apply?

Eligible domestic applicants include:

• Higher education institutions (public/private)

• Nonprofits (with or without 501(c)(3) status)

• For-profit organizations (including small businesses)

• Local and state governments

• Tribal governments/organizations

• Public housing authorities

• Independent school districts

• U.S. Federal agencies are eligible

Foreign organizations are NOT eligible.

What companies and projects are likely to win?

Strong proposals will have:

• A clearly defined clinical trial plan with measurable outcomes.

• Meaningful patient, provider, and community engagement integrated into design and implementation.

• Digital interventions that are ready for testing, not just conceptual.

• Evidence of feasibility and mechanism for adoption in real-world settings.

Are there any restrictions I should know about?

Not responsive:

• Projects developing new digital devices or algorithms.

• Studies focused on automated insulin delivery, artificial pancreas, or hybrid closed-loop tech.

• Research using DHT data only for subtyping/classification.

• Mechanistic trials that are not testing an intervention’s effectiveness.

How long will it take me to prepare an application?

Typical NIH R01 applications take several months to:

• Develop a rigorous clinical trial design,

• Form research team + collaborations,

• Draft research strategy + human subjects sections,

• Complete registrations (SAM, eRA Commons).

Most institutions begin 6-12 months before due date.

How can BW&CO help?

BW&CO can assist with:

• Translating this technical RFA into a clinical trial proposal roadmap.

• Crafting aims, hypotheses, and outcomes tables tailored to NIH review criteria.

• Aligning digital intervention strengths with NIH priorities.

• Supporting human subjects/clinical trial documentation and compliance.

How much would BW&CO Charge?

We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.

Additional Resources

Review the solicitation here.