M120 Risk Score Improves Identification of Children at High Risk of Developing Clinical Type 1 Diabetes and Reports Short-term Response to Preventive Immunotherapy

Le, MV; Harrison, LC; Spelman, T; Wentworth, JM

Author(s): Le, MV; Harrison, LC; Spelman, T; Wentworth, JM;
Details: Publication Year 2025-08-01,Volume 48,Issue #8,Page 1352-1355
Journal Title: Diabetes Care
Abstract: OBJECTIVE: Approval of teplizumab as disease-modifying therapy for type 1 diabetes heralds a new therapeutic era. To facilitate prevention trials, we determined if the M120 risk score could enrich for type 1 diabetes risk and define early treatment effects. RESEARCH DESIGN AND METHODS: M120, based on age, sex, BMI, IA-2 antibody status, HbA1c, blood glucose, and C-peptide 120 min after oral glucose, was determined in TrialNet participants with multiple islet autoantibodies and those who joined the teplizumab prevention trial. RESULTS: Compared with the oral glucose tolerance test, M120 identified 26% more children at high risk of progression. When applied to data from the teplizumab trial, M120 improved after teplizumab (P = 0.0362) and deteriorated after placebo (P = 0.0489) to reveal a significant treatment effect after 6 months (P < 0.001). CONCLUSIONS: M120 improves risk stratification and identifies early effects of immunotherapy. It could be applied to increase prevention trial efficiency and guide treatment decisions in the clinic.
Publisher: ADA
Keywords: Humans; *Diabetes Mellitus, Type 1/prevention & control/immunology; Child; Male; Female; Adolescent; *Antibodies, Monoclonal, Humanized/therapeutic use; *Immunotherapy/methods; Blood Glucose/metabolism; Glycated Hemoglobin/metabolism; Glucose Tolerance Test; Autoantibodies/blood; C-Peptide/blood/metabolism; Child, Preschool
Research Division(s): Immunology
PubMed ID: 40208750
Publisher's Version: https://doi.org/10.2337/dc24-2794
Open Access at Publisher's Site: https://doi.org/10.2337/dc24-2794
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-07-28 03:09:55

Last Modified: 2025-09-23 11:13:54