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System Failure in Type 1 Diabetes: What Stakeholders Need to Know to Expedite Therapeutic Options
Colin M Dayan1, Chantal Mathieu2, Douglas Lowenstein3
1Department of Endocrinology, Cardiff University School of Medicine, Cardiff, Wales, U.K.
Diabetes Spectrum : a Publication of the American Diabetes Association
|November 19, 2025
Summary
Systemic failures hinder type 1 diabetes (T1D) treatment development and approval, leaving patients with unmet needs. Addressing regulatory and knowledge gaps is crucial for advancing T1D therapies.
Area of Science:
- Endocrinology and Metabolism
- Clinical Therapeutics
- Regulatory Science
Background:
- Type 1 diabetes (T1D) management remains challenging due to systemic issues.
- Current treatments primarily manage symptoms, failing to alter disease progression.
- Patients face significant daily burdens, long-term complications, and psychosocial distress.
Purpose of the Study:
- To highlight systemic failures in T1D therapy development and approval.
- To identify regulatory and clinical trial design barriers.
- To advocate for improved healthcare professional (HCP) knowledge and dialogue among stakeholders.
Main Methods:
- Qualitative analysis of systemic barriers.
- Review of regulatory pathways and clinical trial challenges.
- Identification of knowledge gaps among HCPs.
Main Results:
- Regulatory hurdles and trial design issues impede new T1D therapy development.
- Significant unmet needs persist for T1D patients.
- Gaps in HCP knowledge impact quality of care.
Conclusions:
- A systemic failure exists in advancing T1D treatments.
- Collaboration between industry, regulators, patients, and HCPs is essential.
- Expediting approval of breakthrough therapies is critical for improving T1D patient outcomes.
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