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.

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Publication Details

Journal
Diabetes Care
Published
2026-11-11
DOI
https://doi.org/10.2337/dci26-0061
Primary Topic
Diabetes and associated disorders
Type
article
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article

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

Kimber M. Simmons, Neha N Patel, Kevan C. Herold, Emily Kristen Sims et al.
Diabetes Care
Diabetes and associated disorders
article

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

Kimber M. Simmons, Neha N Patel, Kevan C. Herold, Emily Kristen Sims, Michael J. Haller, Kupper A. Wintergerst, Carla Demeterco‐Berggren, Emily Breidbart, Jennifer L. Sherr, Shideh Majidi, Stephen Eric Gitelman, Adriana Weinberg, Amara Ogbonnaya-Whittlesey, Daniel Moore
article en

Abstract

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.

Diabetes Care
Children's Hospital of Philadelphia (US), Children's National (US), University of Louisville (US), University of California, San Francisco (US), Vanderbilt University (US), University of Florida Health (US), Yale University (US), University of Florida (US), University of California San Diego (US), NYU Langone Health (US), Rady Children's Hospital-San Diego (US), Breakthrough T1D (US), Indiana University School of Medicine (US), University of Colorado Anschutz Medical Campus (US)
Diabetes and associated disorders
DOISourceOpenAlex
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