Efficacy and Safety of T Cell‐Targeted Immunotherapy in Newly Diagnosed Type 1 Diabetes: A Systematic Review and Meta‐Analysis
Authors' conclusion
T cell-targeted immunotherapy provides sustained preservation of β-cell function and improvements in HbA1c levels and insulin requirements for at least 24 months in patients with newly diagnosed T1D.
Study context
- Population
- Patients with newly diagnosed T1D; RCTs from PubMed, Embase, CENTRAL, Web of Science, Scopus and ClinicalTrials.gov up to 6 March 2026
- Participants
- 1,970 patients21 RCTs
- Comparison
- T cell-targeted immunotherapy vs placebo
- Outcome
- Change in C-peptide AUC
Pooled result
As reported in the abstract
6, 12, 18 and 24 months
T cell-targeted immunotherapy vs PlaceboSMD (95% CI)P value
6 months
0.38(0.19–0.57)
P < 0.00112 months
0.41(0.12–0.69)
P = 0.00518 months
0.48(0.32–0.65)
P < 0.00124 months
0.49(0.32–0.65)
P < 0.001Further pooled results
Change in HbA1c and daily insulin dose · all time points
- Immunotherapy reduced HbA1c and daily insulin dose at all time points
- all p < 0.05
Subgroups: age <18 years, worse baseline metabolic status, single-blind or open-label design · early phase of therapy
- Greater efficacy in the early phase of therapy
Safety
Total and serious adverse events
- Risks of total and serious AEs comparable between intervention and control
Original publication
Efficacy and Safety of T Cell‐Targeted Immunotherapy in Newly Diagnosed Type 1 Diabetes: A Systematic Review and Meta‐Analysis. Diabetes Obes Metab. Published 4 May 2026. doi:10.
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