Prospective Validation of a FibroScan^®-based Stratification Algorithm for Advanced Liver Disease Detection in Patients with Type 2 Diabetes and MASLD in Diabetology Clinic

Amiama, et al. Prospective validation of the EASL-EASD algorithm for risk stratification in patients with metabolic dysfunction-associated steatotic liver disease and type 2 diabetes.

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) affects 1 in 4 people globally, with particularly high rates among those with type 2 diabetes, where 2 in 3 have fatty liver and up to 38% develop advanced fibrosis or cirrhosis. Since 2024, updated European guidelines recommend a two-step screening approach: a simple blood test (FIB-4) followed by Liver Stiffness Measurement (LSM) by FibroScan^® device to identify high-risk patients.

This study tested the algorithm on over 1,000 adults with type 2 diabetes who visited a diabetes clinic. Those with a result suggesting increased liver risk received further testing, including imaging and, when needed, liver biopsy. The study evaluates the systematic implementation of the EASL-EASD screening algorithm within a real-world diabetology clinic setting.

• FIB-4 was calculated from routine blood tests in all type 2 diabetes adult patients who visited diabetology clinic between October 2024 and March 2025.

• Those with FIB-4 ≥ 1.3 (≥ 2.0 if over 65) were referred to Hepatology for further evaluation, including FibroScan device, ultrasound, ELF score, and biopsy when needed.

• At-risk disease was defined as Liver Stiffness Measurement (LSM) ≥ 8 kPa or FIB-4 > 2.67; advanced disease as ≥ F3 fibrosis on biopsy, LSM > 12 kPa, or cirrhosis on ultrasound.

• 1,108 patients were screened. Of 984 eligible patients, 248 (25.2%) had elevated FIB-4, triggering further hepatology evaluation.

• Among these, 76.2% had hepatic steatosis (CAP >=248 dB/m).

• LSM by VCTE^®, showed that 69% were low-risk (<8 kPa), 15.3% intermediate (8–12 kPa), and 15.7% high-risk (>12 kPa).

• 11.7% had LSM >15 kPa, suggesting compensated advanced chronic liver disease.

• In the intermediate group (8–12 kPa, n=38), 36.8% confirmed significant fibrosis (F2-F4) according to biopsy and clinical criteria.

• Overall, 53 patients (21.4%; 95% CI: 16.7–26.9) had clinically significant or advanced MASLD-related liver fibrosis, who were previously undiagnosed and at the rates exceeding the general population.

• This confirms that serious liver disease is both common and systematically missed in type 2 diabetes.

• 1 in 5 patients in a diabetology clinic have significant at-risk liver disease, a prevalence markedly higher than the general population and largely undiagnosed until screening.

• MASLD is more severe in type 2 diabetes, confirming that this population warrants dedicated, systematic liver surveillance beyond standard care.

• The EASL-EASD algorithm proves effective when applied systematically, reliably identifying high-risk patients, with a LSM by VCTE^® ≥ 8 kPa threshold proving sufficiently specific to justify specialist referral.

• The intermediate zone (8–12 kPa) should not be underestimated, as 36.8% of these patients had F2–F4 fibrosis, placing them at real risk of cirrhosis, hepatocellular carcinoma, and liver-related mortality.

• Not all liver diseases in type 2 diabetes are caused by MASLD, as 6% of patients were found to have other previously undiagnosed chronic liver conditions, underscoring the value of comprehensive screening.

Systematic liver screening using FIB-4 and FibroScan^® device in over 1,000 patients with type 2 diabetes revealed that 1 in 5 had clinically significant liver fibrosis, who were previously undiagnosed and at the rates far exceeding the general population. These findings support routine implementation of the EASL-EASD algorithm in diabetology clinics as an effective tool to identify advanced liver disease and refer those patients to specialized care.