Personalized Diabetes Management through iPSC-Derived β-cells: A Tailored Approach for Improving Treatment Efficacy in Economically Vulnerable Populations

About This Grant

Delphi Stem LLC. 7. PROJECT SUMMARY Diabetes mellitus (DM), a metabolic disorder caused by loss or dysfunction of insulin-producing β-cells, affects over 537 million individuals globally, with projections reaching 783 million by 2045. In 2021, 38.4 million Americans (11.6% of the population) were diagnosed with type 2 diabetes mellitus (T2DM), costing the U.S. economy $412.9 billion in direct and indirect expenses. This alarming trend underscores the urgent need for personalized therapies that enhance existing treatments by tailoring drug selection to individual patient profiles. Precision based approaches can optimize outcomes, reduce adverse effects, and improve long term disease management across diverse populations. Our approach to addressing health disparities in diabetes focuses on systemic barriers such as limited access to preventive care, delayed diagnoses, and insulin unaffordability, factors that disproportionately impact economically vulnerable populations regardless of race or background. To tackle these disparities, our project aims to build a framework for evaluating T2DM medication efficacy using patient derived cellular models. By generating personalized islet-like aggregates, we can predict drug responsiveness and tailor treatment regimens to maximize benefit for each individual. This strategy not only advances personalized diabetes care but also directly addresses unmet needs in disadvantaged communities. Our goal is to deliver evidence based healthcare solutions that improve outcomes and quality of life for all individuals living with diabetes. The project aims to reduce the economic and health burdens of diabetes through tailored interventions and better access to personalized care. Our research specifically targets the challenges faced by economically vulnerable populations in the U.S., who experience higher mortality rates due to limited healthcare access and preventive resources. This highlights a critical gap in our understanding of diabetes treatment and risk factors in these groups. We propose a novel platform using patient specific induced pluripotent stem cell (iPSC)-derived β-cells to evaluate diabetes medications and detect drug resistance. This approach optimizes therapeutic outcomes and offers a scalable model for reducing diabetes incidence and improving care in underserved communities. As the platform matures, we plan to partner with hospitals and diabetes clinics to conduct personalized assessments, enabling individualized treatment recommendations based on each patient’s cellular response, starting with economically disadvantaged populations and scaling to broader systems. Our Phase I project will validate the platform’s technical and commercial feasibility, reduce development risks, and strategically position the company for growth in a competitive market. Commercialization will begin with pilot studies in collaboration with clinics serving vulnerable populations, supported by payer engagement, pharmacoeconomic analysis, and CLIA compliant deployment to enable reimbursement and future FDA integration.