TYPE 1 diabetes mellitus (T1D) in children remains a chronic condition with lifelong dependence on insulin. While insulin therapy manages blood glucose, it does not address the underlying autoimmune process. Immunotherapy has emerged as a potential adjunctive treatment aiming to preserve pancreatic function and reduce insulin needs. A recent study evaluating immunotherapy’s effects on glycaemic markers and insulin dependency in paediatric T1D patients provides insight into its clinical relevance. Notably, the data showed a statistically significant reduction in HbA1c levels with immunotherapy.
This systematic review and meta-analysis included twelve clinical trials evaluating the impact of various immunotherapies, such as Teplizumab, Imatinib, Etanercept, and others, on C-peptide levels, HbA1c, and daily insulin dosage. Trials were identified through structured searches across PubMed, Google Scholar, and Cochrane databases, and assessed using the PRISMA 2020 framework. Data synthesis was conducted via SPSS using random-effects modelling due to study heterogeneity.
Immunotherapy was associated with increased C-peptide levels (mean difference [MD] 1.26; 95% CI: –2.02–4.53), although this was not statistically significant (p = 0.42). However, a significant reduction in HbA1c levels was observed (MD –0.54; 95% CI: –0.99––0.08; p=0.02), suggesting improved glycaemic control. A decrease in daily insulin requirements was also noted (MD = –1.08; 95% CI: –2.30–0.13), but this finding did not reach statistical significance (p=0.07). The level of heterogeneity across studies was high, particularly in insulin dose and C-peptide results.
This analysis highlights the potential of immunotherapy to support glycaemic control in paediatric T1D by reducing HbA1c, a key marker of long-term glucose regulation. However, the impact on C-peptide preservation and insulin dosage reduction remains inconclusive. Variability in study design, follow-up duration, and baseline characteristics across trials limits the generalisability of findings. Further large-scale, long-term randomised controlled trials are needed to evaluate whether immunotherapy can be integrated effectively into standard paediatric diabetes care. In the meantime, clinicians may cautiously consider emerging immunotherapeutic options as adjunctive measures in specialised or investigational settings.
Reference
Salame G et al. Immunotherapy as a treatment for type 1 diabetes mellitus in children and young adults: A comprehensive systematic review and meta-analysis. PLoS One. 2025;DOI: 10.1371/journal.pone.0321727.
