Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44- Clinical Trial Not Allowed) | RFA DK 17 029

Opportunity Information: Apply for RFA DK 17 029

The funding opportunity titled "Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44 - Clinical Trial Not Allowed)" is an NIH small business grant program focused on advancing next-generation technologies for type 1 diabetes management. Its central aim is to push forward practical, engineering-driven innovations that can improve how glucose is monitored and how insulin (and potentially other hormones) is delivered, especially in automated systems. The emphasis is on real-world improvements that make diabetes technologies safer, more effective, more accurate, and less burdensome for patients to use day after day.

This FOA is designed to stimulate cross-disciplinary innovation, specifically calling out bioengineers, physiologists, bio-behavioral researchers, and designers, working in academic settings and small businesses, to develop new approaches and device components. In practical terms, that means the program is looking for ideas that can translate into tangible hardware and software improvements across the diabetes technology ecosystem. The opportunity highlights both open-loop technologies (where the user still makes key dosing decisions) and closed-loop or automated hormone replacement systems (often referred to as "artificial pancreas" approaches, where algorithms and connected devices automate more of the dosing process). The consistent theme is meaningful advancement, not minor tweaks: applicants are expected to propose developments that can clearly improve safety and effectiveness while reducing the workload, friction, and fatigue that many people experience when using current diabetes devices.

A major priority is enhanced accuracy and reduced patient burden. Accuracy can apply to sensing (for example, better glucose measurement reliability, fewer false readings, improved performance across varying conditions) and to the control system as a whole (for example, algorithmic decisions that better match physiological needs). Reduced patient burden points to improvements that make systems easier to wear, calibrate, maintain, and trust, and that reduce the number of manual steps, alarms, interruptions, and troubleshooting events required. In the context of type 1 diabetes, these qualities directly connect to better outcomes and quality of life: fewer severe highs and lows, improved time-in-range, and less cognitive load involved in managing a chronic condition.

The award mechanism is SBIR under the R43/R44 pathways, which generally correspond to phased small business development: a feasibility stage (often associated with R43/Phase I concepts) and a development/expansion stage (often associated with R44/Phase II concepts). The listing explicitly notes "Clinical Trial Not Allowed," which signals that the funded work should stay on the preclinical, technical development, and validation side rather than enrolling human participants in a clinical trial. In other words, the NIH is supporting the research and development steps needed to mature a technology toward readiness, but not the execution of a clinical trial under this specific announcement.

Eligibility is targeted to small businesses, consistent with the SBIR program intent of supporting U.S. small companies to commercialize innovative biomedical technologies. The opportunity also clearly restricts non-U.S. participation: non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, it notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed, which typically means limited, well-justified foreign involvement could be permissible under NIH rules (for example, specialized resources or collaborations), but the applicant organization itself must meet SBIR eligibility requirements and the project must remain fundamentally U.S.-based under NIH policy. Applicants would need to rely on the FOA text and NIH policy details to understand what is allowable in practice.

Administratively, the opportunity is offered by the National Institutes of Health, falls under a discretionary grant category, and is associated with the health and food/nutrition-related funding activity area. The funding opportunity number is RFA-DK-17-029, and the CFDA number listed is 93.847. The record shows a creation date of December 21, 2017, with an original closing date of March 21, 2018. While the summary data does not specify an award ceiling or the expected number of awards, the overall intent is clear: support small business-led innovation that advances device and component technologies for safer, more effective automated and semi-automated glucose control solutions for people living with type 1 diabetes, while keeping the supported work outside the scope of clinical trials under this particular announcement.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44- Clinical Trial Not Allowed)" 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 2017-12-21.
• Applicants must submit their applications by 2018-03-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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