Novel Technologies and Approaches to Improve Hormone Replacement Therapies for Type 1 Diabetes (T1D)

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Topic Description

Post Date: September 2, 2026

Expiration Date: September 2, 2028

Purpose:

 

This topic encourages applicants to advance research on novel technologies—mechanical, digital, biological, or biochemical—to enhance hormone replacement (HR) therapies for people with T1D.

Background

Type 1 diabetes occurs when the immune system destroys pancreatic cells that produce insulin, leading to high blood sugar (glucose) and serious complications. Insulin replacement is vital, but other hormones such as glucagon and amylin may also need to be supplemented for optimal diabetes management.

The NIH has supported advances in automated insulin delivery, cell replacement therapies, and treatments to protect insulin-producing cells. Recent innovations include glucose-responsive insulin (GRI)/glucagon platforms, gene therapy, and artificial intelligence (AI)-driven synthetic biology. However, these advances are insufficient; more work is needed to mimic natural physiology, ease disease management, and address behavioral and accessibility factors for all people with T1D.   Examples of individuals with T1D who would especially benefit from this additional work include individuals such as shift workers – who may be affected by circadian rhythm disruption, significant changes of patterns of activity, and not have access to facilities suitable for injection - and persons with disabilities, such as those who are visually, hearing, or cognitively impaired. 

A new generation of technologies resulting from this research will improve the daily management of the disease, prevent acute and chronic complications, and improve quality of life at all ages.

Areas of Interest

Innovative research on all the modalities of hormone replacement (HR) for T1D is considered a priority for this topic. Examples include but are not limited to:

  • Novel cell replacement therapies and related technologies (immune protection, immune-evasion engineering, smart biomaterials/scaffolds, functional organoid development)
  • Gene therapy strategies
  • Advanced digital systems for automated closed-loop sensing and delivery
  • Glucose-responsive insulin (GRI) and glucagon platforms
  • AI and synthetic biology applied to empower HR research/therapies
  • Developing/adapting novel diabetes management technologies for older adults and/or populations with special needs 
  • Building multidisciplinary research teams to support novel approaches
This topic is being issued as part of the Make America Healthy Again initiative, which is expanding NIH and agency research into specific areas.

It aligns with:

  • NIH MAHA Chronic Disease Initiative : The National Institutes of Health (NIH) will launch an Initiative on Chronic Disease to leverage and align existing NIH research projects, improve NIH coordination on chronic disease research, and generate actionable results for diseases arising in childhood and adulthood.
  • NIH MAHA Chronic Disease Initiative : The NIH will launch a new Whole-Person-Health approach to chronic disease prevention research and leverage collective expertise across the agency to catalyze transformative discovery science and intervention strategies that promote wellness, resilience, and optimal health, including metabolic health, at all stages of life.
  • Real World Data Platform (RWDP) : The NIH will link multiple datasets, such as claims information, electronic health records, and wearables data, into a single integrated dataset for researchers studying the causes of, and developing treatments for, the chronic disease crisis. The RWDP will eliminate redundancies from data collection, linkage, and compute infrastructures (including artificial intelligence (AI)/machine learning and high-throughput analytics) while maintaining rigorous privacy protections and consent protections. It will also dramatically reduce administrative overhead by relying on a unified set of data use and governance agreements.
  • New Approach Methodologies (NAMs) : The expanded use of NAMs can enable earlier, more predictive insights into chronic disease mechanisms using human-relevant models such as organoids, computational simulations, and real-world data integration. This improves prevention, diagnosis, and personalized treatment strategies while reducing reliance on animal studies that often fail to replicate complex human conditions. The Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and NIH have all committed to using NAMs moving forward, when appropriate.

Participating ICOs

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Research that would be responsive to this Topic includes, but is not limited to: 

  • Cell Replacement:
    • Immune evasion cell engineering
    • Biocompatible materials for immune isolation/modulation
    • Enhanced vascularization/oxygenation
    • Automation for cell generation and functional stability assessment
    • Interventions to prevent exhaustion and preserve function
    • Novel in vitro and in vivo pre-clinical testing for cellular products
  • Gene Therapies & Editing for HR:
    • Gene reprogramming for alternative cells
    • DNA-based insulin gene therapy
    • Targeted gene delivery for GRI production
    • Gene-edited cells for sustained HR
  • GRI & Glucagon Platforms:
    • Dual smart insulin-glucagon closed loop (CL) systems
    • Glucose responsive implantable formulations
  • Technologies for Older Adults (OA) & Persons with Disabilities:
    • Algorithms and tools tailored for varying impairments
    • Telemonitoring/remote systems compatible with open/CL systems

    • Clinical validation of technologies including CL systems for OA

IC may dedicate funds available to support applications in this Topic area depending upon the availability of funds, the number of meritorious applications, and competing ICO priorities.
IC may give special consideration to support meritorious applications in this topic area.
ICO Scientific Contact:
Guillermo Arreaza-Rubin, M.D, Ph.D.
[email protected]

Office of Research on Women's Health (ORWH)

The Office of Research on Women’s Health (ORWH) is interested in supporting the following research: 

  • Understanding sex-specific dynamics of hormone therapies and how this influences responsiveness to new therapeutics and technologies for Type 1 diabetes    
  • Evaluating how new therapies address women across the life course, accounts for hormonal status, is responsive to both reproductive and aging-related needs, and is more likely to improve outcomes for women and men. 

The Office of Autoimmune Disease Research in ORWH (OADR-ORWH) is interested in supporting the following research:  

  • Development of novel therapies for Type I diabetes 

Supporting the implementation science of novel therapies for Type I diabetes

This office does not award grants. Applications must be relevant to the objectives of at least one of the participating Institutes or Centers listed in this topic.
ICO Scientific Contact:
Annina Burns, PhD, RD
[email protected]

Victoria Shanmugam, MBBS, FRCP, FACR, CCD
[email protected]

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