Introduction and Objective: The American Diabetes Association (ADA) consensus report recommends risk stratification for liver fibrosis in individuals with Type 2 diabetes mellitus (T2DM). This multicenter study aimed to evaluate the performance of the DiabetesLiver score versus the fibrosis-4 index (FIB-4) for screening clinically significant fibrosis in T2DM. Methods: This multicenter study prospectively recruited individuals with T2DM from primary care, specialist clinics, including an independent Singaporean cohort. Clinically significant fibrosis was defined as liver stiffness measurement (LSM) ≥8 kPa by vibration controlled transient elastography (VCTE). Following the ADA recommended pathway of FIB-4 combined with VCTE, we assessed its diagnostic performance and then replaced FIB-4 with the DiabetesLiver score to establish a DiabetesLiver VCTE pathway. Diagnostic accuracy and missed diagnosis rates were compared across all cohorts. Results: A total of 2,540 T2DM patients were included. The DiabetesLiver score showed significantly higher discriminative accuracy than FIB-4 (AUC 0.79 vs. 0.53) and markedly lower missed diagnosis rates overall (5.6% vs. 17.4%). Notably, in clinics settings, DiabetesLiver score further reduced missed diagnosis rate compared with FIB-4 (11.1% vs. 26.6%, P 0.001). In the Singapore validation cohort, the DiabetesLiver score consistently outperformed FIB-4 (AUC 0.808 vs 0.478; missed diagnosis 5.2% vs. 18.5%; P 0.001). Consistent benefits were observed in both primary care- and clinics-based subgroups. Conclusion: The DiabetesLiver score, combined with VCTE, achieves superior accuracy and fewer missed cases of clinically significant fibrosis than the standard FIB-4-based strategy in Chinese and Singaporean individuals with T2DM. These findings support the DiabetesLiver score as a first-line, non-invasive screening tool for liver fibrosis in diabetes care. Disclosure X. Wang: None. C. Liu: None. S. Liu: None. Y. Chen: None. D. Yu: None. Z. Dai: None. Y. Zhang: None. H. Shi: None. K. Chen: None. J. Song: None. H. Xin: None. Y. Tang: None. Z. Meng: None. P. Liu: None. X. Liang: None. H. Fan: None. C. Gu: None. Z. Dai: None. F. Xu: None. X. Li: None. J. Zhang: None. J. Miao: None. Y. Liao: None. Y. Shen: None. X. Ma: None. H. Wang: None. M. Zheng: None. X. Zhou: None. X. Qi: None. Funding The Key Research and Development Program of Jiangsu Province (BE2023767a)
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