Extended Follow-up of Type 1 Diabetes Immunotherapy Trial Participants Suggests Benign Side Effect Profile
Year: 2026
Type: article
Abstract: OBJECTIVE: Long-term side effect surveillance after immunotherapy clinical trial participation in individuals with or at risk of type 1 diabetes is needed. RESEARCH DESIGN AND METHODS: Participants from 14 randomized controlled trials (47%) joined the Long-term Investigative Follow-up in Type 1 Diabetes TrialNet or Immune Tolerance Network Type 1 Diabetes Extension Study, and 98% answered at least one health-related outcomes question. RESULTS: Participants were observed for a median of 1.78 (interquartile range 0.89-4.04) years after original trial completion and, in some, up to 18 years. There were no differences in the frequency of self-reported health outcomes, including moderate to severe hypoglycemia events, hospitalizations, serious infections (including COVID-19 infection), new allergic reactions, autoimmune disease, and cancer incidence, between those receiving active and placebo therapy (n = 209-473 responses per question; P > 0.05 for all). CONCLUSIONS: We observed no differences in self-reported health outcomes between those who received active immunotherapy versus placebo. Continued long-term follow-up of immunotherapy trial participants is essential.
Source: Diabetes Care
DOI: 10.2337/dc26-0632
Institutions: University of Florida, University of South Florida, Indiana University Indianapolis, Indiana University School of Medicine, Indiana University – Purdue University Indianapolis, Yale University, University of Colorado Anschutz, University of Colorado Denver, Benaroya Research Institute, University of Toronto, Hospital for Sick Children, Rho (United States), Immune Tolerance Network, Richard L. Roudebush VA Medical Center
Language: English
Subfield: Genetics
Domain: Life Sciences
Open Access status: green
Awards: TrialNet: University of Florida Clinical Center and Network, Type 1 Diabetes-A Proposal for Prevention & Intervention, CLINICAL AFFILIATE OF THE TYPE 1 DIABETES TRIALNET, Chicagoland Diabetes TrialNet Clinical Center, G2942876743, Continuation of UCSF as a Clinical Center for TrialNet, Type 1 Diabetes TrialNet Clinical Centers - Kansas City, Prediction and Prevention of Type 1 Diabetes (TrialNet), Northwest Clinical Center for Type 1 Diabetes - TrialNet, Type 1 Diabetes TrialNet: Toronto Clinical Center, NIDDK Type 1 Diabetes TrialNet Data Coordinating Center, TrialNet at Stanford University, Vanderbilt University: Clinical Center Application, Type 1 Diabetes TrialNet, USF TrialNet Clinical Center, Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)USF: TrialNet UC4-3, Type 1 diabetes TrialNet Center at Yale University, TrialNet: Diabetes Type 1 Prevention, Type 1 Diabetes TrialNet at Indiana University Clinical Center, An Atlanta TrialNet Center: Building a Pathway to 70 Clinical Trial Subjects per Year, Texas Children's Hospital and Baylor College of Medicine TrialNet Clinical Center, Data Coordinating Center for Type 1 Diabetes TrialNet, Immune Tolerance Network, Type 1 Diabetes TrialNet Clinical Network Hub
OpenAlex ID: W7164531007