Reflex testing for metabolic-associated fatty liver disease in patients with type 2 diabetes

INTERVENTION: To ensure equal numbers of patients within each arm of the study the researchers will use block randomization with a block size of 4. Blocks will be used to ensure a balance between the participants in each arm of the study ‐ strata will be sex, age group and alcohol consumption. This will be managed by the Southampton NIHR BRC using randomisation software. Intervention arm: Vibration‐controlled transient elastography (VCTE) assessment and blood test (for enhanced liver fibrosis test (ELF) and Fibrosis‐4 score (FIB‐4) Control arm: Manage in accordance with the standard care offered at their GP practice. However, 12 months after consent to the study the researchers will invite these patients for a liver assessment as for the intervention arm. CONDITION: Identifying significant liver disease in patients living with type 2 diabetes ; Digestive System PRIMARY OUTCOME: 1. The number of patients diagnosed with moderate or significant liver disease within a year of randomisation (defined as =8.2 kPa on VCTE); 2. The number of patients with significant liver disease (defined as =12.1 kPa* on VCTE) and referred for HCC surveillance; ; Both measured using vibration‐controlled transient elastography (VCTE) at the following timepoints:; Intervention arm: one time only, at the time of liver assessment, there is no additional follow‐up; Control arm: 12 months after consent (via patient records, one time only) SECONDARY OUTCOME: 1. ‘Costs per case’ of moderate and significant liver disease identified via refle Xtesting (i.e. testing all people living with T2DM as part of their routine diabetes care) for liver disease and usual care; 2. The test or combination of tests for liver fibrosis with the lowest cost per case; 3. The incremental cost‐effectiveness ratio (ICER) of refle Xtesting and HCC surveillance for liver disease in people living with T2DM; ; Measured using micro‐costs in pound sterling (£) of the following components of the pathway:; 1. Item costs for ELF™ & FIB‐4 tests and venepuncture cost; 2. Nursing time for venepuncture, VCTE, results delivery and onward referral; 3. Cost per VCTE assessment including equipment, equipment servicing and training; 4. Community venue hire for liver assessment; ; Analysed 12 months after the last patient is recruited to the control arm. INCLUSION CRITERIA: 1. >18 years of age 2. Diagnosis of type 2 diabetes 3. In the Wesse XClinical Research Network (CRN) region 4. Able to provide informed consent