Extended Follow-up of Type 1 Diabetes Immunotherapy Trial Participants Suggests Benign Side Effect Profile
Authors' conclusion
We observed no differences in self-reported health outcomes between those who received active immunotherapy versus placebo.
Study context
- Population
- Individuals with or at risk of T1D who participated in TrialNet or Immune Tolerance Network immunotherapy trials14 RCTs
- Comparison
- Active immunotherapy vs placebo
Methodological detailsself-reported health outcomes, participants from 14 RCTs
- Self-reported health outcomes
- Participants from 14 RCTs
Primary result
As reported in the abstract
Self-reported health outcomes:
- Moderate to severe hypoglycemia
- Hospitalizations
- Serious infections incl. COVID-19
- New allergic reactions
- Autoimmune disease
- Cancer incidence
- No differences in frequency of self-reported health outcomes between active and placebo therapy
- Active vs Placebo: P > 0.05 for all
- 47% of trial participants joined the extension study; 98% answered at least one health-related outcomes question
Original publication
Extended Follow-up of Type 1 Diabetes Immunotherapy Trial Participants Suggests Benign Side Effect Profile. Diabetes Care. Published 12 June 2026. doi:10.
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