Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01- Clinical Trial Optional) | RFA DK 17 025

Opportunity Information: Apply for RFA DK 17 025

The NIH funding opportunity "Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01 - Clinical Trial Optional)" (RFA-DK-17-025) supports research aimed at moving type 1 diabetes (T1D) technology closer to practical, reliable, and widely usable hormone replacement systems. In plain terms, the program is focused on improving the building blocks and the full integration of devices and software used for open-loop (user-directed) and closed-loop (automated) glucose control, including systems often described as artificial pancreas technologies. The main goal is to overcome specific technical and practical barriers that keep these systems from delivering consistently strong glucose control in real-world settings, while also pushing toward solutions that are affordable and user-friendly for patients.

The FOA is built around the idea that better outcomes will come not only from improving any single component, but from addressing the weak links that limit the performance of an integrated platform. Applicants are encouraged to propose original research that targets important obstacles in several key areas: sensing, hormone formulation and delivery, decision support for self-management, and automated controllers and algorithms. On the sensing side, this can include work that improves how glucose (and potentially other relevant signals) are measured, with an emphasis on reliability, accuracy, responsiveness, and robustness to day-to-day conditions. On the hormone side, the announcement highlights the need for advances in formulations and delivery methods that make hormone replacement more predictable and easier to manage, recognizing that limitations in stability, absorption timing, and delivery mechanics can undermine even the best control algorithms. It also points to decision support systems that help users make better choices when full automation is not available or when human input is still needed, as well as controller design and algorithm development that can safely and effectively manage an integrated platform across variable situations like meals, exercise, illness, stress, and sleep.

A defining feature of the opportunity is its emphasis on integration and practical impact. The research is meant to help platforms work better as complete systems, not just as isolated technologies. That can mean improving how sensors communicate with pumps or delivery devices, how algorithms handle imperfect data and unpredictable physiology, and how user interfaces and workflow fit into daily life. The FOA frames this as a pathway to technologies that improve glucose control for people with T1D while also reducing burden, which is often a limiting factor in adoption and sustained use. The phrase "Clinical Trial Optional" signals that proposed projects may include clinical testing if appropriate, but a clinical trial is not required; the funding is intended to support the kind of translational and developmental research that can span from preclinical validation through human evaluation, depending on the maturity of the technology and the aims of the application.

From an administrative standpoint, this is an NIH discretionary grant using the R01 mechanism, which generally supports substantial, hypothesis-driven or milestone-driven research programs led by a principal investigator and team. The activity categories listed include health and food/nutrition, and the CFDA number is 93.847. The opportunity was created on February 15, 2018, with an original closing date of May 10, 2018. The award ceiling listed is $500,000, indicating an upper limit on the amount that can be requested under the announcement, although the specific budgeting structure in NIH awards typically depends on the FOA instructions and institute policies. The expected number of awards is not specified in the provided text.

Eligibility is broad and intentionally inclusive, spanning many types of organizations that can contribute to diabetes technology development. 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other organizations. The FOA also explicitly calls out additional eligible groups such as 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility list reflects the reality that progress in open- and closed-loop hormone replacement systems can come from academic engineering and clinical teams, community-based health organizations, established device developers, and international collaborators working on sensing, formulations, delivery hardware, software, human factors, or system integration.

Overall, the opportunity is aimed at accelerating meaningful improvements in T1D hormone replacement platforms by funding research that confronts the toughest real-world barriers: getting accurate and dependable sensing, ensuring stable and effective hormone delivery, providing useful decision support when needed, and building controllers and algorithms that perform safely and well when everything is combined into a single system used by real people in everyday life.

• 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 2018-02-15.
• Applicants must submit their applications by 2018-05-10. (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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