P7 Screening for liver disease in patients living with type 2 diabetes versus additional risk factor-based testing: interim results from a multi-centre randomised controlled trial

<h3>Background</h3> People with type 2 diabetes mellitus (T2DM) and advanced liver fibrosis or cirrhosis face an increased risk of developing hepatocellular carcinoma (HCC). While international guidelines recommend routine liver disease screening in this population, current UK guidelines do not. <h3>Aim</h3> To evaluate whether routine liver disease screening for all adults with T2DM is more cost-effective than a risk factor-based approach in identifying individuals at high risk for HCC. <h3>Methods</h3> Adults with T2DM were recruited from 26 primary care practices in southern England. Individuals with a history of liver disease or a liver fibrosis assessment within the previous two years were excluded. Participants were identified using automated searches of primary care records and invited via text message. Eligible participants were randomised to either usual care (UC), based on the existing diagnostic pathway, or direct community-based assessment using vibration-controlled transient elastography (VCTE). Randomisation was stratified by age and alcohol consumption. The primary outcome is the number of patients referred for HCC surveillance within 12 months of randomisation. The secondary outcome is the incremental cost-effectiveness ratio of VCTE compared with UC, modelled using a Markov framework informed by trial-based clinical and cost data. The study received ethical approval (REC: 23/WS/0102), and the protocol was pre-registered and published. <h3>Results</h3> Recruitment targets were achieved (320 participants per arm). Median age was 69 years (IQR: 61–75), 58% were male, and 92.5% identified as white-Caucasian. Most participants were recruited from Bournemouth (29.1%) and Southampton (22.7%), and 67% were from affluent areas (IMD quintiles 4 and 5). Low-risk alcohol use (AUDIT-C) was reported by 79.4% of participants. In the VCTE arm, 315 of 320 participants completed a valid scan. Mean liver stiffness was 7.8 kPa (SD: 7.0), with 9.2% (n=29) recording values ≥12.1 kPa. In total, 13.0% (n=41) were referred to secondary care, with referral significantly associated with higher BMI (mean 33.6 (IQR 29.4–36.6) vs. 30.2 (IQR 27.0–34.7); p=0.021). Review of primary and secondary care records is ongoing to determine HCC surveillance eligibility and obtained detailed cost data. <h3>Conclusion</h3> Early findings demonstrate the feasibility and acceptability of identifying and engaging older adults with T2DM for liver disease assessment via primary care. However, limited racial and socio-economic diversity warrants consideration. The observed rate of elevated liver stiffness aligns with other Western population studies. Data collection and analysis to meet the primary and secondary outcomes are ongoing.