---
title: "Immunotherapy for Type 1 Diabetes Mellitus: 2026 Clinical Guidance and Teplizumab Use"
id: "pubmed-42778314"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42778314"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42778314/"
doi: "10.3760/cma.j.cn112137-20260617-01569"
published_at: "2026-09-29T00:00:00.000Z"
evidence_level: "English Abstract"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Immunotherapy for Type 1 Diabetes Mellitus: 2026 Clinical Guidance and Teplizumab Use
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42778314
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42778314/)
- **DOI:** [10.3760/cma.j.cn112137-20260617-01569](https://doi.org/10.3760%2Fcma.j.cn112137-20260617-01569)
- **Published At:** 2026-09-29T00:00:00.000Z
- **Evidence Rating:** English Abstract
## Executive GIST (TL;DR)
- Type 1 diabetes mellitus (T1DM) is a chronic disease driven by progressive autoimmune destruction of pancreatic beta cells leading to insulin dependence. - The field has adopted a three-stage classification for T1DM and expanded early screening to identify presymptomatic or early-stage disease. - Disease-modifying therapies (DMTs), led by **immunotherapy**, are shifting care from pure insulin replacement toward interventions that target disease mechanisms. - A multidisciplinary guidance statement was developed jointly by adult and pediatric endocrinology experts and national metabolic disease centers to inform clinicians on clinical application of immunotherapies in T1DM. - The guidance systematically reviews immune pathogenesis, disease staging, and the development and mechanisms of five categories of immunotherapeutic agents for T1DM. - The document provides detailed recommendations on the eligible patient population, pre-treatment evaluation, dosing regimens, adverse event recognition and management, and follow-up strategies specifically for **teplizumab** in patients with stage 2 T1DM. - The guidance is intended as a standardized clinical reference to promote **precision medicine** and improved patient outcomes in T1DM management. - The article is published in Zhonghua Yi Xue Za Zhi (2026) with English and Chinese abstracts and declares that all authors report no conflicts of interest. - Full text is available via Chinese Medical Association Publishing House; PubMed PMID 42778314 and DOI 10.3760/cma.j.cn112137-20260617-01569.
## Clinical Analysis & Structured Key Points
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Zhonghua Yi Xue Za Zhi. 2026. Show details Display options Display options Format Abstract PubMed PMID Zhonghua Yi Xue Za Zhi Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Zhonghua+Yi+Xue+Za+Zhi%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Zhonghua+Yi+Xue+Za+Zhi%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42778314/) . 2026 Sep 29;106(36):3832-3845. doi: 10.3760/cma.j.cn112137-20260617-01569. ### Authors [Endocrinology, Genetics and Metabolism Group, Society of Pediatrics, Chinese Medical Association](https://pubmed.ncbi.nlm.nih.gov/?term=Endocrinology%2C+Genetics+and+Metabolism+Group%2C+Society+of+Pediatrics%2C+Chinese+Medical+Association%5BCorporate+Author%5D); [Adolescent Health and Medicine Committee, Chinese Medical Doctor Association](https://pubmed.ncbi.nlm.nih.gov/?term=Adolescent+Health+and+Medicine+Committee%2C+Chinese+Medical+Doctor+Association%5BCorporate+Author%5D); [National Clinical Research Center for Metabolic Diseases (Changsha)](https://pubmed.ncbi.nlm.nih.gov/?term=National+Clinical+Research+Center+for+Metabolic+Diseases+%28Changsha%29%5BCorporate+Author%5D) * PMID: **42778314** * DOI: [ 10.3760/cma.j.cn112137-20260617-01569 ](https://doi.org/10.3760/cma.j.cn112137-20260617-01569) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID Linked Discoveries ## Abstract in [ English, ](https://pubmed.ncbi.nlm.nih.gov/42778314/#eng-abstract) [ Chinese ](https://pubmed.ncbi.nlm.nih.gov/42778314/#zho-abstract) Type 1 diabetes mellitus (T1DM) is a chronic disease characterized by progressive autoimmune-mediated destruction of pancreatic beta cells. With the establishment of the three-stage classification system for T1DM and the advancement of early screening, disease-modifying therapies (DMT), represented by immunotherapy, are driving a shift in clinical management from "insulin replacement" to "etiological intervention". This guidance statement was jointly developed by adult and pediatric endocrinology experts and is intended for clinical endocrinologists engaged in the diagnosis and management of T1DM. The guidance systematically reviews the immune pathogenesis of T1DM, disease staging, and the mechanisms of action and development progress of five categories of immunotherapeutic agents. It further elaborates on the eligible patient populations, pre-treatment assessment, dosing regimens, adverse event management, and follow-up strategies for teplizumab in patients with stage 2 T1DM. This insight aims to provide clinicians with standardized references for the application of DMT and immunotherapy in clinical practice, promote precision medicine, and improve patient outcomes. 1型糖尿病（T1DM）是由自身免疫介导的胰岛β细胞进行性破坏所致的慢性疾病。随着T1DM三期分期体系的确立和早期筛查的推进，以免疫治疗为代表的疾病修饰疗法（DMT）正推动临床诊疗从“胰岛素替代”向“病因干预”转变。为了给临床医师提供规范化的T1DM免疫治疗应用参考，推动精准诊疗和改善患者预后，中华医学会儿科学分会内分泌遗传代谢学组、中国医师协会青春期健康与医学专业委员会和国家代谢性疾病临床医学研究中心（长沙）联合发起，组织成人及儿童内分泌专家共同制订了该指导建议。系统介绍T1DM免疫发病机制、疾病分期及5类免疫治疗药物的作用机制与研发进展，详细阐述替利珠单抗在2期T1DM患者中的适用人群、治疗前评估、给药方案、不良反应管理及随访策略。. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement 所有作者声明不存在利益冲突 ## Similar articles * [ Diabetes type 1: Can it be treated as an autoimmune disorder? ](https://pubmed.ncbi.nlm.nih.gov/33730229/) Vallianou NG, Stratigou T, Geladari E, Tessier CM, Mantzoros CS, Dalamaga M.Vallianou NG, et al.Rev Endocr Metab Disord. 2021 Dec;22(4):859-876. doi: 10.1007/s11154-021-09642-4. Epub 2021 Mar 17.Rev Endocr Metab Disord. 2021.PMID: 33730229Review. * [ Immunotherapy as a treatment for type 1 diabetes mellitus in children and young adults: A comprehensive systematic review and meta-analysis. ](https://pubmed.ncbi.nlm.nih.gov/40215252/) Salame G, Hakim V, Dagher C, Daou RM, Dada AE, Nassif L, Ghadieh HE, Azar S, Bazzi S, Harb F.Salame G, et al.PLoS One. 2025 Apr 11;20(4):e0321727. doi: 10.1371/journal.pone.0321727. eCollection 2025.PLoS One. 2025.PMID: 40215252Free PMC article. * [ Emerging Immunotherapies for Disease Modification of Type 1 Diabetes. ](https://pubmed.ncbi.nlm.nih.gov/39873914/) Foster TP, Bruggeman BS, Haller MJ.Foster TP, et al.Drugs. 2025 Apr;85(4):457-473. doi: 10.1007/s40265-025-02150-8. Epub 2025 Jan 28.Drugs. 2025.PMID: 39873914Free PMC article.Review. * [ Advanced Delivery Strategies for Immunotherapy in Type I Diabetes Mellitus. ](https://pubmed.ncbi.nlm.nih.gov/37178431/) Huang M, Chen W, Wang M, Huang Y, Liu H, Ming Y, Chen Y, Tang Z, Jia B.Huang M, et al.BioDrugs. 2023 May;37(3):331-352. doi: 10.1007/s40259-023-00594-6. Epub 2023 May 13.BioDrugs. 2023.PMID: 37178431Free PMC article.Review. * [ Advances in immunotherapy of type I diabetes. ](https://pubmed.ncbi.nlm.nih.gov/30528629/) Ni Q, Pham NB, Meng WS, Zhu G, Chen X.Ni Q, et al.Adv Drug Deliv Rev. 2019 Jan 15;139:83-91. doi: 10.1016/j.addr.2018.12.003. Epub 2018 Dec 7.Adv Drug Deliv Rev. 2019.PMID: 30528629Review. 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