16 September 2026 editorial review · Trial
Low-dose anti-thymocyte globulin (ATG) ± GCSF in new-onset T1D (Haller / TrialNet): review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT02215200; COMPLETED; updated 2020-03-02; enrollment 89 (ACTUAL); results posted.
Endpoint comparison: Change in Area Under the Stimulated C-peptide Curve From Baseline to 12 Months. (-10, 0 15, 30, 60, 90, and 120 minutes post-dose at baseline and 12 months).
Sources for this record: Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA<sub>1c</sub>, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data. (peer-reviewed); Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA<sub>1c</sub> in New-Onset Type 1 Diabetes. (peer-reviewed); National Institute of Diabetes and Digestive and Kidney Diseases (TrialNet). Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes. ClinicalTrials.gov NCT02215200 (2014–2018) (registry).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.
Selected historical trial audit
Correction: Primary 89-participant study and 29/29/31 allocation verified. ATG+GCSF's p=0.031 at one year misses the prespecified one-sided p<0.025 threshold; the two-year p=0.032 also misses it. Added threshold explicitly, removed teplizumab relationship and overstated winner wording. Added serum sickness in most ATG recipients from the full follow-up report. C-peptide preservation is partial and does not establish prevention before diagnosis.
Sources: 2018 primary trial, 2019 full follow-up, registry.
Limit: Mechanistic cell ratios are correlates, not independently demonstrated mediators of benefit. No independent patient-level reanalysis.