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.Apply for RFA DK 17 029
- 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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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is 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)."
Which agency is offering this grant opportunity?
This funding opportunity is offered by the National Institutes of Health (NIH).
What is the main goal of this SBIR funding opportunity?
The central aim is to advance next-generation, practical, engineering-driven technologies that improve type 1 diabetes therapy and monitoring. The focus is on innovations that make glucose monitoring and hormone delivery systems safer, more effective, more accurate, and less burdensome in day-to-day use.
What types of diabetes technologies does this FOA focus on?
The FOA emphasizes both open-loop technologies (where the user still makes key dosing decisions) and closed-loop or automated hormone replacement systems (often described as "artificial pancreas" approaches, where algorithms and connected devices automate more of the dosing process).
What is meant by open-loop versus closed-loop in this announcement?
Open-loop refers to systems where a person still performs important decision-making steps (such as determining insulin dosing). Closed-loop refers to more automated systems that use connected devices and algorithms to automate more of the dosing process.
What kinds of improvements is NIH looking for?
The opportunity stresses meaningful advancement rather than minor tweaks. Applicants are expected to propose developments that clearly improve safety and effectiveness and reduce workload, friction, and fatigue associated with current diabetes devices.
What does "enhanced accuracy" mean in the context of this FOA?
Accuracy can refer to sensing and measurement (such as more reliable glucose readings, fewer false readings, and improved performance across varying conditions) and also to improved performance of the overall control system (such as algorithmic decisions that better match physiological needs).
What does "reduced patient burden" mean in the context of this FOA?
Reduced patient burden points to improvements that make systems easier to wear, calibrate, maintain, and trust, and that reduce manual steps, alarms, interruptions, and troubleshooting events required for everyday use.
How does this FOA connect technology improvements to patient outcomes?
The FOA links better accuracy and lower burden to better outcomes and quality of life, including fewer severe highs and lows, improved time-in-range, and less cognitive load involved in managing type 1 diabetes.
Who is this FOA trying to engage or encourage to apply?
The FOA is designed to stimulate cross-disciplinary innovation and specifically calls out bioengineers, physiologists, bio-behavioral researchers, and designers working in academic settings and small businesses to develop new approaches and device components.
What is the funding mechanism used in this opportunity?
The award mechanism is SBIR under the R43/R44 pathways, which generally correspond to phased small business development (a feasibility stage and a development/expansion stage).
What do R43 and R44 indicate?
R43/R44 generally correspond to phased development: an early feasibility stage (often associated with R43/Phase I concepts) and a later development/expansion stage (often associated with R44/Phase II concepts).
Are clinical trials allowed under this funding opportunity?
No. The announcement is explicitly labeled "Clinical Trial Not Allowed," meaning the supported work should remain on the preclinical, technical development, and validation side rather than enrolling human participants in a clinical trial under this FOA.
If clinical trials are not allowed, what kinds of work does NIH intend to support?
NIH intends to support research and development steps needed to mature a technology toward readiness, focusing on technical development and validation, while excluding the execution of a clinical trial under this specific announcement.
Who is eligible to apply?
Eligibility is targeted to small businesses, consistent with the SBIR program intent to support U.S. small companies working to commercialize innovative biomedical technologies.
Are non-U.S. organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Can a U.S. organization include non-U.S. components in the application?
No. Non-domestic components of U.S. organizations are not eligible to apply under this opportunity.
Are any foreign activities allowed at all?
The opportunity notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed. This suggests limited, well-justified foreign involvement could be permissible under NIH rules, while the applicant organization must still meet SBIR eligibility requirements and the project must remain fundamentally U.S.-based under NIH policy.
What should applicants rely on to understand what foreign involvement is allowable?
Applicants would need to rely on the FOA text and NIH policy details (including the NIH Grants Policy Statement definition of "foreign components") to determine what is permissible in practice.
What is the funding opportunity number?
The funding opportunity number is RFA-DK-17-029.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.847.
What category of funding is this listed under?
It is listed as a discretionary grant.
What funding activity area is it associated with?
The opportunity is associated with a health and food/nutrition-related funding activity area.
When was this record created and what was the original closing date?
The record shows a creation date of December 21, 2017, and an original closing date of March 21, 2018.
Does the provided summary specify an award ceiling or the expected number of awards?
No. The summary data provided does not specify an award ceiling or the expected number of awards.
What overall types of technologies or components are encouraged?
The FOA is looking for ideas that can translate into tangible hardware and software improvements across the diabetes technology ecosystem, including improvements to device components and system-level performance for automated and semi-automated glucose control solutions.
What is the core theme across the FOA description?
The consistent theme is practical, real-world improvement: technologies that advance safety, effectiveness, accuracy, and usability in everyday type 1 diabetes therapy and monitoring, while keeping the work outside the scope of clinical trials for this specific announcement.
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| Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 Clinical Trial Not Allowed) Apply for RFA DK 17 030 Funding Number: RFA DK 17 030 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Underactive Bladder and Detrusor Activity in Aging (R01 Clinical Trial Optional) Apply for PA 18 570 Funding Number: PA 18 570 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Pilot and Feasibility Studies of HIV and Animal Models for HIV Infection within the Mission of NIDDK (R21 Clinical Trial Optional) Apply for PA 18 615 Funding Number: PA 18 615 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Limited Competition for the Continuation of the Clinical Centers for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (U01 Clinical Trial Not Allowed ) Apply for RFA DK 17 511 Funding Number: RFA DK 17 511 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,100,000 |
| Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Type 1 Diabetes Research (U01 Clinical Trial Not Allowed) Apply for RFA DK 17 019 Funding Number: RFA DK 17 019 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $350,000 |
| Immune System Engineering For Targeted Tolerance in Type 1 Diabetes (R01 Clinical Trial Not Allowed) Apply for RFA DK 17 020 Funding Number: RFA DK 17 020 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $300,000 |
| Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes (R01 Clinical Trial Required) Apply for RFA DK 17 028 Funding Number: RFA DK 17 028 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional) Apply for RFA DK 17 031 Funding Number: RFA DK 17 031 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Career Development Programs in Diabetes Research for Endocrinologists (K12 Clinical Trial Optional) Apply for RFA DK 17 026 Funding Number: RFA DK 17 026 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Incorporating Patient-Reported Outcomes into Clinical Care for Type 1 Diabetes (R01 Clinical Trial Required) Apply for RFA DK 17 027 Funding Number: RFA DK 17 027 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $375,000 |
| High-Resolution Exploration of the Human Islet Tissue Environment [HIRN Human Pancreas Analysis Consortium (HPAC)] (U01 Clinical Trial Not Allowed) Apply for RFA DK 17 022 Funding Number: RFA DK 17 022 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $550,000 |
| Discovery of Early Type 1 Diabetes Disease Biomarkers in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 - Clinical Trial Not Allowed) Apply for RFA DK 17 021 Funding Number: RFA DK 17 021 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Impact of the Use of Glucose Monitoring and Control Technologies on Health Outcomes and Quality of Life in Older Adults with Type 1 Diabetes (T1D) (R01 Clinical Trial Required) Apply for RFA DK 17 024 Funding Number: RFA DK 17 024 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01- Clinical Trial Optional) Apply for RFA DK 17 025 Funding Number: RFA DK 17 025 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional) Apply for RFA DK 18 004 Funding Number: RFA DK 18 004 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| High Priority HIV/AIDS Research within the Mission of the NIDDK (R01 Clinical Trial Optional) Apply for PAS 18 698 Funding Number: PAS 18 698 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| New Directions in Hematology Research (SHINE-II) (R01 Clinical Trial Optional) Apply for PAS 18 730 Funding Number: PAS 18 730 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21 Clinical Trial Not Allowed) Apply for PA 18 741 Funding Number: PA 18 741 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| Mechanisms Underlying the Contribution of Type 1 Diabetes Disease-associated Variants (R01 Clinical Trial Not Allowed) Apply for RFA DK 18 005 Funding Number: RFA DK 18 005 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| Pilot and Feasibility Clinical Research Grants in Urologic Disorders (R21 Clinical Trial Optional) Apply for PAR 18 743 Funding Number: PAR 18 743 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
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