NIH Highlighted Topic: Novel Technologies to Improve Hormone Replacement Therapies for Type 1 Diabetes
Executive Summary
The National Institutes of Health has published a Highlighted Topic titled "Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)." It signals that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), together with the Office of Research on Women's Health (ORWH) and the Office of Autoimmune Disease Research (OADR-ORWH), want to fund investigator-initiated research on mechanical, digital, biological, and biochemical technologies that make hormone replacement for T1D more physiologic, more automated, and more accessible.
For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, naming NIDDK as your assignment request, and aligning your Specific Aims to the topic language below.
The topic was posted on September 2, 2026 and expires on September 2, 2028, which gives small businesses roughly five standard SBIR submission cycles to compete against it. NIDDK generally considers Phase I budgets up to $350,000 and Phase II budgets up to $2,200,000 in total costs, with a Phase IIB pathway up to $3,000,000 for companies that have already completed a Phase II.
If you build cell therapy, gene therapy, closed-loop devices, glucose-responsive insulin or glucagon formulations, or AI-driven diabetes management tools, this is one of the clearest funding signals NIDDK has published for the small business community in this space.
At a Glance
Topic title: Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)
Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services
Funding Institute: NIDDK
Non-awarding participating offices: ORWH and OADR-ORWH
Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.
Post date: September 2, 2026
Expiration date: September 2, 2028
Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement
Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot
Standard annual due dates: January 5, April 5, and September 5
NIDDK Phase I guidance: up to $350,000 total costs, project period up to 2 years
NIDDK Phase II guidance: up to $2,200,000 total costs, project period up to 3 years
NIDDK Phase IIB guidance: up to $3,000,000 total costs, project period up to 3 years
Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.
Equity dilution: none. This is non-dilutive federal funding.
Scientific contact at NIDDK: Guillermo Arreaza-Rubin, M.D., Ph.D., guillermo.arreazarubin@nih.gov
Broader initiative alignment: Make America Healthy Again (MAHA) Chronic Disease Initiative
What Is an NIH Highlighted Topic?
An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that a specific area of science is a priority, without creating a separate funding announcement, a separate deadline, or a separate review process.
There are three things a Highlighted Topic does for a small business:
It tells you which Institute is receptive. In this case, NIDDK is the awarding IC, so your assignment request and your program officer conversations should point there.
It gives you validated language to write against. The "Areas of Interest" and the NIDDK responsiveness list are the vocabulary reviewers and program staff are already using internally.
It creates two possible funding advantages. NIDDK may dedicate funds to applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and NIDDK may give special consideration to meritorious applications in the topic area.
There are two things a Highlighted Topic does not do. It does not guarantee a set-aside, and it does not replace the peer review process. Your application still competes on scientific merit through the standard NIH study section route.
Which NIH Mechanism Should a Small Business Use?
Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to NIDDK.
The NIH small business programs are the right home for this topic because nearly every area of interest listed is a product development problem: a device, an implant, a biomaterial, a formulation, an algorithm, or a cell product that needs to reach patients. Here is how the mechanism map works.
NIH Parent SBIR, currently PA-27-100 (R43 and R44). This is the default route for most companies. It accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. NIDDK accepts SBIR clinical trial applications through the parent announcement.
NIH Parent STTR, currently PA-27-102 (R41 and R42). Use this when the project depends on a formal partnership with a U.S. nonprofit research institution such as a university. STTR requires that at least 40 percent of the research be performed by the small business and at least 30 percent by the single partner institution. This is the natural fit for university spinouts commercializing licensed islet encapsulation, gene therapy, or organoid technology. Note that NIDDK currently accepts clinical trial applications through SBIR only, not through STTR.
Direct to Phase II. If you already have feasibility data that would ordinarily come out of a Phase I, and you never received a Phase I award for that specific project, you can skip straight to Phase II. This authority applies to SBIR only. It is not available under STTR.
Fast-Track. Phase I and Phase II are submitted together and reviewed once. This compresses the funding gap but requires a fully developed Phase II plan at first submission. It is a poor fit when your Phase I result could materially change the Phase II design, which is often the case in early cell therapy and immune protection work.
Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that have finished an NIH SBIR or STTR Phase II and need to bridge to commercialization. NIDDK generally considers Phase IIB requests up to $3,000,000 in total costs. Applicants must document not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source. NIDDK strongly encourages Phase II awardees to consider Phase IIB, particularly where the product requires clinical evaluation or federal regulatory approval.
Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Funds late-stage technical assistance and product development activities that Phase II and Phase IIB cannot support, such as specialized regulatory and manufacturing work. It allows a higher degree of outsourcing than other mechanisms, though the small business must retain substantial project management and oversight.
Funding Allowance
The dollar ceiling depends on two layers: the statutory guideline set by the Small Business Administration, and the specific budget guidance published by NIDDK.
Layer one, the SBA statutory guidelines for the current cycle:
Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years
Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years
Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years
Layer two, what NIDDK generally considers:
Phase I: up to $350,000 in total costs, with a project period up to 2 years
Phase II: up to $2,200,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year
Phase IIB: up to $3,000,000 in total costs, with a project period up to 3 years, and generally not exceeding $1,100,000 in total costs in any single year
Total funding support includes direct costs, indirect costs, and fee. A reasonable profit or fee may be paid on SBIR and STTR awards, but it must be built into the budget at the time of application, not added later. Applicants seeking a budget above the NIDDK ranges are strongly encouraged to contact NIDDK program staff with a draft Specific Aims page before submitting.
Two points that founders regularly miss. First, budgets above the SBA guideline are possible where the science aligns with an SBA-approved waiver topic, and NIDDK will consider those requests with appropriate justification. Second, NIDDK may reduce the recommended budget or the award period for budgetary, administrative, or programmatic reasons even after a strong review score.
Timeline
The Highlighted Topic window runs from September 2, 2026 through September 2, 2028. Within that window, you submit against the NIH standard small business receipt dates.
Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.
Cycles available under this topic:
September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Given that the topic posted on September 2, this cycle is effectively closed for anyone starting from scratch.
January 5, 2027: the first realistic cycle for a company beginning preparation now.
April 5, 2027
September 5, 2027
January 5, 2028
April 5, 2028, which is the last full cycle before the topic expires in September 2028.
What the runway actually looks like: budget roughly 9 months from submission to money in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, which is one reason experienced applicants do not treat "wait for the next cycle" as a free option.
Work backwards from your target date:
14 to 16 weeks out: contact the NIDDK program officer, confirm responsiveness, and start or verify your federal registrations
12 weeks out: lock the Specific Aims page and circulate it to program staff
8 weeks out: complete the research strategy draft, the commercialization plan, and letters of support
4 weeks out: full internal review, budget finalization, and subaward paperwork
1 week out: submit early to leave room for eRA Commons error correction
Registrations are the most common cause of a missed deadline. You need SAM.gov, a Unique Entity ID, SBA Company Registry, eRA Commons, and Grants.gov, and eRA Commons access depends on the SBA registration being complete first. Allow six weeks or more, and start before you write anything.
Also note that the parent announcements are reissued periodically. The current SBIR parent, PA-27-100, carries a closing date in early April 2027, so applicants targeting later cycles should confirm the active parent announcement number at the time of submission.
Detailed Overview of What NIH Is Looking For
The problem NIH is trying to solve
Type 1 diabetes results from immune destruction of the insulin-producing cells of the pancreas, which leads to elevated blood glucose and serious long-term complications. Insulin replacement is essential, but NIH is explicit that insulin alone is not the whole picture: other hormones, including glucagon and amylin, may also need to be supplemented for optimal management.
NIH acknowledges that it has already funded substantial progress in automated insulin delivery, cell replacement, and beta cell protection, along with newer work in glucose-responsive insulin and glucagon platforms, gene therapy, and AI-driven synthetic biology. The stated position is that these advances remain insufficient. Three gaps are named directly:
Current technologies do not adequately mimic natural physiology.
Disease management is still too burdensome for patients.
Behavioral and accessibility factors have not been addressed for all people with T1D.
NIH calls out two underserved populations by name. Shift workers, who face circadian rhythm disruption, irregular activity patterns, and a lack of facilities suitable for injection. And persons with disabilities, including people with visual, hearing, or cognitive impairment. If your technology has a credible story for either group, say so in your Specific Aims. This is one of the most specific and least contested differentiators in the entire topic.
The stated goal for the resulting generation of technologies is threefold: better daily disease management, prevention of acute and chronic complications, and improved quality of life at all ages.
Areas of Interest as published
NIH lists the following as examples, and states that the list is not exhaustive:
Novel cell replacement therapies and related technologies, including immune protection, immune-evasion engineering, smart biomaterials and scaffolds, and functional organoid development
Gene therapy strategies
Advanced digital systems for automated closed-loop sensing and delivery
Glucose-responsive insulin and glucagon platforms
AI and synthetic biology applied to advance hormone replacement research and therapies
Developing or adapting novel diabetes management technologies for older adults and populations with special needs
Building multidisciplinary research teams to support novel approaches
The NIDDK responsiveness list, broken down
NIDDK published a more granular list of what it considers responsive. This is the section to write against, because it reflects how program staff think about the portfolio.
Cell replacement. Immune evasion cell engineering. Biocompatible materials for immune isolation or immune modulation. Enhanced vascularization and oxygenation of implanted constructs. Automation for cell generation and for functional stability assessment. Interventions to prevent cell exhaustion and preserve function over time. Novel in vitro and in vivo preclinical testing methods for cellular products.
What this tells you: NIDDK is interested in the unsolved engineering problems around cell therapy, not just the cells. Oxygen transport, graft survival, manufacturing consistency, and assay development are all fundable in their own right. A company with a biomaterial or a bioreactor rather than a cell line still has a clear lane here.
Gene therapies and editing for hormone replacement. Gene reprogramming to create alternative insulin-producing cells. DNA-based insulin gene therapy. Targeted gene delivery for production of glucose-responsive insulin. Gene-edited cells for sustained hormone replacement.
What this tells you: delivery and durability are the named pressure points. "Sustained" appears explicitly, so a Phase I aim that demonstrates persistence rather than only initial expression will read as responsive.
Glucose-responsive insulin and glucagon platforms. Dual smart insulin and glucagon closed-loop systems. Glucose-responsive implantable formulations.
What this tells you: NIDDK is signaling interest in bihormonal approaches, not insulin-only. If you have a glucagon component, or a platform that could accommodate one, foreground it.
Technologies for older adults and persons with disabilities. Algorithms and tools tailored for varying impairments. Telemonitoring and remote systems compatible with open-loop and closed-loop systems. Clinical validation of technologies, including closed-loop systems, for older adults.
What this tells you: this is where digital health and software companies fit most cleanly, and where clinical validation of an existing system is fundable rather than only novel hardware. Interoperability with open-source and commercial closed-loop systems is named directly.
What ORWH and OADR-ORWH add
ORWH and OADR-ORWH participate in this topic but do not award grants. Your application must still be relevant to the objectives of a participating Institute or Center, which in practice means NIDDK. Their participation matters because it defines a second axis on which your application can score well.
ORWH is interested in understanding sex-specific dynamics of hormone therapies and how those dynamics influence responsiveness to new T1D therapeutics and technologies. ORWH also wants to see evaluation of how new therapies serve women across the life course, accounting for hormonal status and responding to both reproductive and aging-related needs, in ways more likely to improve outcomes for women and men alike.
OADR-ORWH is interested in the development of novel therapies for Type 1 diabetes and in the implementation science of those novel therapies.
Practical read: build a sex-as-a-biological-variable analysis into your design that goes beyond the minimum NIH requirement, and if your product has an implementation or adoption question attached to it, name implementation science explicitly.
MAHA alignment and why it affects your framing
This topic is issued as part of the Make America Healthy Again initiative and is positioned against four named efforts. Referencing the right one in your Significance section is a low-cost way to demonstrate policy fluency.
NIH MAHA Chronic Disease Initiative. Aligning existing NIH chronic disease research and generating actionable results for diseases arising in childhood and adulthood. Also a new Whole-Person-Health approach to chronic disease prevention, promoting wellness, resilience, and metabolic health at all life stages.
Real World Data Platform. Linking claims data, electronic health records, and wearables into a single integrated dataset with rigorous privacy and consent protections. If your technology generates continuous glucose, activity, or device telemetry data, this is your hook.
New Approach Methodologies. Expanded use of human-relevant models such as organoids, computational simulations, and real-world data integration to reduce reliance on animal studies that fail to replicate complex human conditions. EPA, FDA, and NIH have all committed to using NAMs where appropriate. If your preclinical package leans on organoids, organ-on-chip, or in silico modeling, frame it as a NAM contribution rather than apologizing for the absence of animal data.
Eligibility Requirements
To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:
Organized for profit, with a place of business located in the United States
More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Multiple venture capital, hedge fund, and private equity ownership structures may be permitted under certain conditions for SBIR.
No more than 500 employees, including affiliates
For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PI may be primarily employed by the small business or by the partnering research institution.
For SBIR Phase I, the small business must perform at least two thirds of the research. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.
Companies with a large volume of prior Phase I awards should also confirm they meet the SBIR and STTR Phase I to Phase II Transition Rate benchmarks, which can restrict eligibility for a period of one year if not met.
What a Competitive Application Looks Like
Reviewers on this topic will be looking for evidence that you understand where the field already is. NIH has stated that automated insulin delivery, cell replacement, and beta cell protection have all received substantial prior investment. An application that proposes an incremental improvement to insulin-only delivery, without addressing physiologic fidelity, patient burden, or accessibility, is competing against NIH's own stated view that such work is insufficient.
Five things strengthen an application against this specific topic:
A named unmet population. Shift workers, persons with visual, hearing, or cognitive impairment, or older adults. NIH wrote these into the topic. Very few applications will use them well.
A bihormonal or multi-hormone story. Glucagon and amylin are named alongside insulin. A platform that can extend beyond insulin reads as more physiologic.
A durability or sustained-function endpoint. Cell exhaustion, graft survival, and sustained hormone replacement all appear in the responsiveness list. Milestones that measure persistence rather than initial function align directly.
A credible commercialization plan. NIH small business awards are product development awards. Regulatory pathway, reimbursement thinking, manufacturing scale, and a specific customer are all scored, and they are where most first-time academic applicants lose ground.
Program officer contact before you write. NIDDK explicitly directs applicants to contact program staff with a draft Specific Aims page, particularly for budgets above their standard ranges. That conversation is free and it is the single highest-return hour in the process.
Common Reasons Applications Miss
Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist
Submitting to the wrong Institute, or leaving the assignment request blank and letting the application route somewhere without a stake in T1D hormone replacement
Choosing Fast-Track when Phase I results would have changed the Phase II design
Choosing STTR for a project that includes a clinical trial, which NIDDK accepts through SBIR only
Starting federal registrations after the writing begins, then missing the receipt date on an eRA Commons error
Building the budget without the fee, then discovering it cannot be added after submission
A research strategy with no unresolved technical risk, which reads as development work rather than research
Omitting a Phase IIB matching funds plan when the technology clearly needs a later bridge, which signals a company that has not thought past the current award
Frequently Asked Questions
Is this a grant I can apply to directly?
No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement.
Which funding opportunity number do I actually use?
For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project requires a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active announcement number at the time you submit, since NIH reissues these periodically.
How much money can my company request?
NIDDK generally considers Phase I budgets up to $350,000 in total costs and Phase II budgets up to $2,200,000 in total costs. The underlying SBA statutory guidelines for the current cycle are $323,090 for Phase I and $2,153,927 for Phase II. Requests above these levels require justification and a conversation with NIDDK program staff.
When is the deadline?
There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic itself expires on September 2, 2028, so January 5, 2027 through April 5, 2028 represent the realistic competing cycles.
How long until I receive funding?
Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest start date in the fall of 2027.
Do I have to give up equity or match the funds?
No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a non-SBIR/STTR government source.
Which NIH Institute will fund this?
NIDDK is the awarding Institute for this topic. ORWH and OADR-ORWH participate and have stated interests, but they do not award grants. Your application must be relevant to the objectives of a participating Institute or Center, which means NIDDK.
Can I include a clinical trial?
Yes, through SBIR. NIDDK currently accepts SBIR clinical trial applications through the parent omnibus but does not accept STTR clinical trial applications. Review the NIH Clinical Trial Definition before deciding, because the definition captures more study designs than most founders expect.
I already have feasibility data. Do I still need a Phase I?
Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only, not STTR.
Does NIDDK set aside money for this topic?
Not guaranteed. NIDDK states that it may dedicate available funds to support applications in this topic area depending on the availability of funds, the number of meritorious applications, and competing priorities, and that it may give special consideration to meritorious applications in the topic area. Treat it as a favorable tilt, not a reserved pool.
My company builds software, not biology. Is there a place for us?
Yes. The topic explicitly names advanced digital systems for automated closed-loop sensing and delivery, AI and synthetic biology applied to hormone replacement, algorithms and tools tailored for varying impairments, and telemonitoring or remote systems compatible with open-loop and closed-loop systems. Clinical validation of closed-loop systems for older adults is also named as responsive.
We use organoids and computational models instead of animal studies. Is that a problem?
It is an advantage if framed correctly. The topic aligns with the New Approach Methodologies effort, under which EPA, FDA, and NIH have committed to using human-relevant models such as organoids, computational simulations, and real-world data integration where appropriate. Present your approach as a NAM contribution.
Who should I contact at NIH before applying?
The NIDDK scientific contact listed for this topic is Guillermo Arreaza-Rubin, M.D., Ph.D., at guillermo.arreazarubin@nih.gov. NIDDK also directs applicants considering larger budgets to contact program staff with a draft Specific Aims page before submitting.
What registrations do I need, and how long do they take?
SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA registration first. Allow at least six weeks, and start before you begin writing.
How BW&CO Helps
BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards. That work includes mechanism selection, program officer strategy, Specific Aims development, full proposal build, budget and fee construction, commercialization plan development, and Phase IIB matching capital positioning.
Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.
If you are developing hormone replacement technology for Type 1 diabetes and want an honest read on whether you are competitive for the January 2027 cycle, contact us for a fit assessment.
