Clinical Guidance for Disease-Modifying Immunotherapy in Children and Adolescents With New-Onset (Stage 3) Type 1 Diabetes

The 2026 U.S. approval of teplizumab, for children and adolescents aged 8-17 years with recently diagnosed stage 3 type 1 diabetes, changes the first weeks after diagnosis. Clinicians must treat hyperglycemia and teach lifelong care skills while considering whether to preserve residual β-cell function. Teplizumab is the current clinical exemplar, although the implementation challenges extend beyond one agent. This article addresses who should lead care, how to approach eligibility and timing, how to assess β-cell reserve and infection risk, how to sequence treatment with diabetic ketoacidosis recovery and early education, and how to monitor treatment safely. Teplizumab-specific recommendations are identified, with broader principles framed for adaptation across health systems.