When viewing this topic in a different language, you may notice some differences in the way the content is structured, but it still reflects the latest evidence-based guidance.

Type 1 diabetes mellitus

  • Overview
  • Theory
  • Diagnosis
  • Management
  • Follow up
  • Resources
Evidence last reviewed: 8 Aug 2026
Topic last updated: 22 May 2026
22 May 2026

FDA expands approval of teplizumab to include children aged ≥1 year

Teplizumab can delay progression from stage 2 to stage 3 type 1 diabetes and is now approved in younger children.

The Food and Drug Administration (FDA) has expanded the indication for teplizumab to include children age ≥1 year with stage 2 type 1 diabetes (previously ≥8 years). This extends access to the only approved disease-modifying therapy for delaying progression to clinical (stage 3) type 1 diabetes.

The expanded approval was supported by interim findings from the PETITE-T1D study, which evaluated teplizumab in children age <8 years with stage 2 type 1 diabetes. In this ongoing study, teplizumab was generally safe and well tolerated, with no new safety signals identified.

Implications for clinical practice:

  • Consider earlier identification of at-risk individuals through screening programs to enable eligibility for treatment

  • Refer eligible patients (including young children) to specialist centers for assessment and management

  • Discuss potential benefits (delay in disease onset) and risks (including adverse effects and treatment burden) with patients and caregivers.

See Management: prevention

Original source of update

Summary

Definição

História e exame físico

Principais fatores diagnósticos

  • polyuria
  • polydipsia
  • diabetic ketoacidosis
Detalhes completos

Outros fatores diagnósticos

  • young age
  • weight loss
  • blurred vision
  • nausea and vomiting
  • abdominal pain
  • tachypnea
  • clinical dehydration
  • lethargy
  • altered mental status
Detalhes completos

Fatores de risco

  • genetic predisposition
  • geographic region
  • infectious agents
  • dietary factors
  • use of immunotherapy
Detalhes completos

Investigações diagnósticas

Primeiras investigações a serem solicitadas

  • HbA1c
  • fasting plasma glucose
  • 2-hour post-glucose load plasma glucose
  • random plasma glucose
Detalhes completos

Investigações a serem consideradas

  • plasma or urine ketones
  • random C-peptide
  • autoimmune markers
Detalhes completos

Algoritmo de tratamento

CONTÍNUA

nonpregnant

pregnant

Colaboradores

Autores

Rajesh K. Garg, MD
Rajesh K. Garg

Professor of Medicine

David Geffen School of Medicine at UCLA

Harbor-UCLA Medical Center

Torrance, CA

Declarações

RKG is an author of a number of references cited in this topic.

Agradecimentos

Dr Rajesh K. Garg would like to gratefully acknowledge Dr Varsha Vimalananda, previous contributor to this topic.

Declarações

VV declares that she has no competing interests.

Revisores

Zachary Bloomgarden, MD

Clinical Professor

Medicine/Endocrinology

Diabetes and Bone Disease

Mount Sinai School of Medicine

New York, NY

Declarações

ZB declares that he has no competing interests.

Alicia Jenkins, MB, BS, MD, FRACP, FRCP

Associate Professor

Department of Medicine

University of Melbourne

Melbourne

Australia

Professor

Harold Hamm Oklahoma Diabetes Center

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Declarações

AJ has been a (non-salaried) co-investigator on multi-center clinical trials supported by Novo, Eli Lilly, Sanofi-Aventis, and Medtronic. She does not hold any stocks or shares in these companies. She has received a speaker's honorarium from Novo Nordisk.

Créditos aos pareceristas

Os tópicos do BMJ Best Practice são constantemente atualizados, seguindo os desenvolvimentos das evidências e das diretrizes. Os pareceristas aqui listados revisaram o conteúdo pelo menos uma vez durante a história do tópico.

Declarações

As afiliações e declarações dos pareceristas referem--se ao momento da revisão.

Referências

Nossas equipes internas de editoria e de evidências trabalham em conjunto com colaboradores internacionais especializados e pares revisores para garantir que forneçamos acesso às informações o mais clinicamente relevantes possível.

Principais artigos

American Diabetes Association. Standards of care in diabetes - 2025. Diabetes Care. 2025 Jan;48(1):S344-52.Texto completo

Norris JM, Johnson RK, Stene LC. Type 1 diabetes-early life origins and changing epidemiology. Lancet Diabetes Endocrinol. 2020 Mar;8(3):226-38.Texto completo  Resumo

International Society for Pediatric and Adolescent Diabetes. ISPAD clinical practice consensus guidelines 2024. Dec 2024 [internet publication].Texto completo

Holt RIG, DeVries JH, Hess-Fischl A, et al. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021 Dec;64(12):2609-52.Texto completo  Resumo

International Society for Pediatric and Adolescent Diabetes. ISPAD clinical practice consensus guidelines 2024. Dec 2024 [nternet publication].Texto completo

Artigos de referência

Uma lista completa das fontes referenciadas neste tópico está disponível para os usuários com acesso total ao BMJ Best Practice.
  • Type 1 diabetes mellitus images

  • Diagnósticos diferenciais

    • Monogenic diabetes: maturity onset diabetes of the young
    • Monogenic diabetes: neonatal diabetes mellitus
    • Type 2 diabetes
    Mais Diagnósticos diferenciais

  • Diretrizes

    • Standards of care in diabetes - 2025
    • Management of individuals with diabetes at high risk for hypoglycemia
    Mais Diretrizes

  • Folhetos informativos para os pacientes

    Diabetes type 1: what is it?

    Diabetes type 1: what are the treatment options?

    Mais Folhetos informativos para os pacientes
  • padlock-lockedConectar-se ou assinar para acessar todo o BMJ Best Practice

O uso deste conteúdo está sujeito ao nosso aviso legal