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. 2025 Sep 23;38(4):467-475.
doi: 10.2337/ds25-0024. eCollection 2025 Fall.

System Failure in Type 1 Diabetes: What Stakeholders Need to Know to Expedite Therapeutic Options

Colin M Dayan  1 , Chantal Mathieu  2 , Douglas Lowenstein  3 , Lawrence Soler  4
Affiliations

System Failure in Type 1 Diabetes: What Stakeholders Need to Know to Expedite Therapeutic Options

Colin M Dayan et al. Diabetes Spectr. .

Abstract

There has been a systemic failure in type 1 diabetes. Regulatory barriers and clinical trial design challenges discourage development of new type 1 diabetes therapies and can compromise the potential for securing approval of new treatments. As a result, there continues to be a pervasive unmet need for those living with type 1 diabetes, resulting in long-term complications, extreme disease management burdens, and psychosocial consequences. People with type 1 diabetes continue to make multiple daily decisions about dosing insulin, a drug that can kill with a single mistake and that at best only manages symptoms without changing the underlying progression of the disease. Furthermore, beyond regulatory challenges, gaps in health care professionals' (HCPs') knowledge and understanding of the disease affect quality of care. The goal of this article is to educate stakeholders on the extent of this systemic failure and to encourage consideration and dialogue among industry, regulatory agencies, patients, and HCPs to expedite approval of breakthrough therapies that fundamentally change the equation in type 1 diabetes.

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Conflict of interest statement

C.M.D. has been a speaker for or an advisor to Amarna, AstraZeneca, Immunocore, Provention Bio, Quell, SAB Therapeutics, Sanofi, Shoreline Bio, Vielo Bio, and Vertex and holds a patent jointly with Midatech plc and Provention Bio/Sanofi. C.M. has served on advisory boards for Abbott, Bayer, Biomea Fusion, Boehringer Ingelheim, Dexcom, Eli Lilly and Company, Insulet, Medtronic, Novartis, Novo Nordisk, Roche, SAB Bio, Sanofi, and Vertex, and financial compensation for these activities has been received by KU Leuven. KU Leuven has received research support for C.M. from Medtronic, Novo Nordisk, and Sanofi. C.M. has served on speaker’s bureaus for Abbott, Boehringer Ingelheim Dexcom, Eli Lilly and Company, Insulet, Medtronic, Novo Nordisk, Sanofi, and Vertex, and financial compensation for these activities has been received by KU Leuven. She is president of the European Association for the Study of Diabetes, for which all external support can be found online at www.easd.org. D.L. has served on the International Board of Directors of Breakthrough T1D and is a Director Emeritus of the organization. He is comanager of the T1D Collaborative and is a consultant to Breakthrough T1D, Novo Nordisk, and Sanofi US. L.S. has served on the International Board of Directors of Breakthrough T1D and is a Director Emeritus of the organization. He is comanager of the T1D Collaborative and is a consultant to Breakthrough T1D, Novo Nordisk, and Sanofi US. No other potential conflicts of interest relevant to this article were reported.

References

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