Clinical, Behavioral, and Physiological Studies of Open- and Closed-loop Platforms: Toward Personalized, Fully Automated, Accessible Systems (R01 Clinical Trial Required) | RFA DK 22 020

Opportunity Information: Apply for RFA DK 22 020

This NIH grant opportunity (RFA-DK-22-020) supports human clinical research aimed at moving diabetes open- and closed-loop pancreatic hormone replacement technologies closer to being truly physiological, personalized, fully automated, and broadly accessible. In practical terms, the focus is on systems such as automated insulin delivery and related platforms that combine devices (like continuous glucose monitors, pumps, and control algorithms) to regulate glucose with minimal user burden. The overall goal is to overcome the real-world barriers that still limit performance, safety, reliability, uptake, and equitable access, ultimately improving metabolic outcomes and daily life for people with type 1 diabetes and their caregivers.

A major priority of the FOA is rigorous clinical testing that strengthens evidence for safety, reliability, and clinical efficacy of current and emerging technologies. Projects are expected to evaluate whether these systems actually improve glucose control in ways that matter clinically, such as reducing glycemic excursions (large swings high or low), improving time-in-range, and lowering the risk of severe hypoglycemia and hyperglycemia. The FOA is also interested in work that identifies and fixes failure points that prevent fully automated performance in everyday settings, including issues related to device performance, interoperability, algorithm behavior under stressors, and consistent operation across diverse users and environments.

Another key emphasis is that technology success is not only physiological; it is also behavioral and psychosocial. The announcement specifically calls for research that examines usability, user workload, trust in automation, acceptance, adherence, and other human factors that determine whether people can and will use these systems effectively over time. It also encourages validation of behavioral and psychosocial measures that could serve as meaningful study outcomes, helping the field demonstrate benefits beyond laboratory metrics. This can include quality of life, diabetes distress, sleep, caregiver burden, confidence in avoiding hypoglycemia, and other patient-centered outcomes that may drive long-term adoption and sustained benefit.

The FOA strongly encourages studies in subpopulations that are often underrepresented in clinical trials but may stand to benefit substantially from automation. This includes groups who might face higher risk, greater management burden, or unique barriers that make standard trial designs less inclusive. The intent is to generate evidence that generalizes to real clinical populations rather than only to the most resourced or most typical trial participants, and to understand how system design or clinical implementation may need to be adapted for different users.

Equity and access are also explicit aims. The FOA supports clinical research that tests these technologies in underserved individuals, including people with low income and/or racial and ethnic minority groups, and it calls for work that examines disparities in use and adoption. This includes understanding why certain communities have lower access or lower sustained use, whether due to cost, insurance coverage, digital literacy, language, clinic infrastructure, trust, geography, or other systemic barriers. Projects that can identify practical strategies to reduce inequities, improve engagement, and support implementation in resource-limited settings align well with the intent of the announcement.

Beyond device performance and implementation, the FOA also supports using open- and closed-loop platforms as scientific tools to advance understanding of glucose regulation and type 1 diabetes pathophysiology. This includes studies that leverage these systems to investigate counter-regulation and impaired awareness of hypoglycemia, which are major safety concerns and quality-of-life issues for many people with T1D. In other words, the technology is not only the intervention; it can also be a way to probe mechanisms of glucose control in humans under real or semi-controlled conditions, generating insights that could inform next-generation therapies and algorithms.

Only human studies are considered responsive to this FOA. Applications proposing animal studies or in vitro work are considered non-responsive, so proposals need to be built around clinical research in people, consistent with the "Clinical Trial Required" designation. The funding mechanism is an NIH R01 grant, and the opportunity lists an award ceiling of $500,000. The agency is the National Institutes of Health, and the opportunity falls under health and nutrition-related activity, with CFDA 93.847. The original closing date listed for this opportunity is 2023-10-26.

Eligibility is broad and includes many types of U.S. organizations and governments, such as state, county, and city governments; special districts; independent school districts; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; public housing authorities; and Native American tribal governments and organizations. The FOA also highlights additional eligible applicants that reflect a strong interest in inclusive participation and community-relevant research capacity, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, faith-based or community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations.

Taken together, this opportunity is centered on clinically testing and improving automated diabetes hormone replacement platforms while paying equal attention to human factors, inclusivity in trial populations, and real-world equity in access and adoption. The expected payoff is better metabolic control with fewer dangerous highs and lows, reduced risk of both acute and long-term complications, and a measurable improvement in day-to-day quality of life for people living with type 1 diabetes and those who support them.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Clinical, Behavioral, and Physiological Studies of Open- and Closed-loop Platforms: Toward Personalized, Fully Automated, Accessible Systems (R01 Clinical Trial 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 2022-09-01.
• Applicants must submit their applications by 2023-10-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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.

Apply for RFA DK 22 020

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