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

Not Applicable

• Conditions: Identifying significant liver disease in patients living with type 2 diabetes; Digestive System

• Registration Number: ISRCTN17017677
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-26
• Last Update Posted: 3 October 2023
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1. >18 years of age
2. Diagnosis of type 2 diabetes
3. In the Wessex Clinical Research Network (CRN) region
4. Able to provide informed consent

Exclusion Criteria

1. <18 years of age
2. Unable to provide informed consent
3. A known prior diagnosis of cirrhosis due to any cause

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The number of patients diagnosed with moderate or significant liver disease within a year of randomisation (defined as =8.2 kPa on VCTE)<br>2. The number of patients with significant liver disease (defined as =12.1 kPa* on VCTE) and referred for HCC surveillance<br><br>Both measured using vibration-controlled transient elastography (VCTE) at the following timepoints:<br>Intervention arm: one time only, at the time of liver assessment, there is no additional follow-up<br>Control arm: 12 months after consent (via patient records, one time only)

Secondary Outcome Measures

Name	Time	Method
1. ‘Costs per case’ of moderate and significant liver disease identified via reflex testing (i.e. testing all people living with T2DM as part of their routine diabetes care) for liver disease and usual care<br>2. The test or combination of tests for liver fibrosis with the lowest cost per case<br>3. The incremental cost-effectiveness ratio (ICER) of reflex testing and HCC surveillance for liver disease in people living with T2DM<br><br>Measured using micro-costs in pound sterling (£) of the following components of the pathway:<br>1. Item costs for ELF™ & FIB-4 tests and venepuncture cost<br>2. Nursing time for venepuncture, VCTE, results delivery and onward referral<br>3. Cost per VCTE assessment including equipment, equipment servicing and training<br>4. Community venue hire for liver assessment<br><br>Analysed 12 months after the last patient is recruited to the control arm.