Diabetes care · 2025
M120 Risk Score Improves Identification of Children at High Risk of Developing Clinical Type 1 Diabetes and Reports Short-term Response to Preventive Immunotherapy.
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Le Minh V, Harrison Leonard C, Spelman Tim, Wentworth John M
Аннотация
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.
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.