Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01 Clinical Trial Optional) | RFA DK 19 029

Opportunity Information: Apply for RFA DK 19 029

The grant opportunity "Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-DK-19-029) is a National Institutes of Health (NIH) discretionary grant that supports original research aimed at improving technologies for glucose control in people with type 1 diabetes (T1D). It focuses on overcoming the practical and technical barriers that still limit the performance, safety, usability, and affordability of open-loop and closed-loop hormone replacement systems, including what many people think of as artificial pancreas approaches. The FOA invites projects that push the field forward by developing new components and, importantly, integrating them into more complete and effective platforms rather than working in isolation.

The scientific emphasis is on tackling key bottlenecks across the full system pipeline. Applications are encouraged to address challenges in glucose sensing (for example, accuracy, reliability, calibration burden, lag time, durability, or performance under real-world conditions), hormone formulation and delivery (such as improved stability of insulin or other hormones, faster-acting or more predictable kinetics, infusion set or pump delivery problems, dual-hormone delivery concepts, or other advances that reduce variability and user burden), and self-management decision support (tools that help users interpret data, handle meals, exercise, illness, or device issues, and reduce cognitive load). Another major target area is the design of automated controllers and algorithms that can safely manage an integrated platform, meaning control strategies that better handle uncertainty, individual variability, and day-to-day disruptions while keeping glucose in range and minimizing hypoglycemia. The overall intent is to generate advances that can be translated into affordable, user-friendly systems that improve real-world glucose outcomes for patients with T1D.

This opportunity uses the NIH R01 mechanism, with clinical trials listed as optional, so proposals can be strictly preclinical/engineering and translational, or they can include a clinical study when justified by the maturity of the technology and the research aims. The activity category is listed under Food and Nutrition and Health, and the CFDA number associated with the program is 93.847. The posting indicates an award ceiling of $500,000, signaling the scale of support anticipated for individual projects under this announcement.

Eligibility is broad and includes many types of domestic applicants: 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. In addition, the FOA explicitly notes eligibility or inclusion of a range of institution types and organizations often highlighted in NIH announcements, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations). In practical terms, this means the program is designed to welcome multidisciplinary teams from academia, industry, nonprofits, government, and diverse institutional settings, reflecting the engineering, clinical, and human-factors complexity of automated glucose control.

Key administrative details from the source listing include a creation date of 2020-01-02 and an original closing date of 2020-07-07. The sponsor agency is the National Institutes of Health. Overall, the FOA is centered on accelerating meaningful improvements to the building blocks and integrated operation of open- and closed-loop hormone replacement platforms for T1D, with the end goal of better glucose control, improved safety, lower user burden, and solutions that are realistic for everyday use.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01 Clinical Trial Optional)" 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 2020-01-02.
• Applicants must submit their applications by 2020-07-07. (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.

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