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 18 022

Opportunity Information: Apply for RFA DK 18 022

This funding opportunity, RFA-DK-18-022, is an NIH Small Business Innovation Research (SBIR) solicitation aimed at pushing forward next-generation technologies for type 1 diabetes therapy and monitoring, with a specific emphasis on both open-loop and closed-loop automated glucose control systems. The intent is to support small businesses in developing new devices, device components, or enabling technologies that meaningfully improve how glucose is monitored and managed, especially by increasing accuracy and reliability while reducing day-to-day burden on patients. The announcement highlights the need for real, practical advancements that translate into better safety and effectiveness in glucose control, including technologies used in automated hormone replacement approaches (for example, systems that automate insulin delivery and, more broadly, hormone delivery strategies used in artificial pancreas-type solutions). The scientific and technical audience the FOA is trying to energize includes bioengineers, physiologists, bio-behavioral researchers, and designers, reflecting NIH interest not only in core engineering performance but also usability and human factors that determine whether technologies actually work well outside the lab.

The award mechanism is an SBIR grant using the R43/R44 pathway, which typically maps onto a phased approach to product development: Phase I (R43) supports early feasibility and proof-of-concept work, while Phase II (R44) supports more advanced development toward a deployable product. A key restriction is embedded in the title: “Clinical Trial Not Allowed.” That means applicants need to frame the work so it does not include clinical trials as defined by NIH (generally, prospective assignment of human participants to interventions to evaluate health-related outcomes). Projects can still often involve preclinical testing, benchtop validation, algorithm development, simulation, and other non-clinical evaluation strategies, but the proposed activities must remain outside the clinical trial definition for this specific FOA.

The opportunity is categorized as discretionary funding and uses the grant funding instrument. It sits within NIH’s health-focused portfolio and is associated with CFDA number 93.847. The program focus is on improved glucose control technologies, which can include advances in sensing, control algorithms, device integration, automation, interoperability of components, robustness in real-world settings, and design features that reduce the workload and friction patients experience (for example, fewer calibrations, more stable performance across conditions, simpler setup and wear, fewer alarms, and better handling of sensor or infusion set issues). The wording about “devices/components with enhanced accuracy and less patient burden” makes it clear the agency is looking for innovations that are not incremental tweaks but instead address persistent limitations that affect safety, effectiveness, adherence, or quality of life.

Eligibility is limited to small businesses, consistent with SBIR rules. Foreign institutions (non-U.S. entities) are explicitly not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible as applicant organizations. However, the FOA notes that “foreign components” may be allowed as defined in the NIH Grants Policy Statement. In practice, that typically means a U.S. small business could potentially include a foreign component in a limited, well-justified way (such as a specialized service, unique resource, or collaboration) if it aligns with NIH policy and is explicitly permitted and appropriately justified in the application. The core applicant and the main performance of the work, though, must remain compliant with the domestic eligibility constraints stated in the announcement.

From an administrative standpoint, the FOA was created on 2018-11-26 and lists an original closing date of 2019-03-21. The listed award ceiling is $300,000, which suggests the funding level NIH expected for awards under this solicitation (applicants would still need to follow NIH SBIR budget rules and any FOA-specific budget guidance). The posting also lists “Expected Awards” but does not provide a number in the supplied source text. Overall, the program is essentially a targeted SBIR push from NIH to accelerate small-business-driven innovation in automated and semi-automated type 1 diabetes management technologies, prioritizing solutions that measurably improve accuracy, safety, effectiveness, and ease of use without proposing clinical trials under this specific 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 2018-11-26.
• Applicants must submit their applications by 2019-03-21. (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 $300,000.00 in funding.
• Eligible applicants include: Small businesses.

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