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.