Identifying significant liver disease in patients living with type 2 diabetes Digestive System
Conditions
Interventions
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 i
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/02/2025: Any adult (=18 years) patient with a known diagnosis of T2DM according to the primary care record in the Hampshire, Wiltshire, Dorset, and the Isle of Wight (all UK) areas will potentially be eligible to participate. Non-English speaking patients will be eligible for inclusion. Previous 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
Exclusion criteria: Current exclusion criteria as of 07/02/2025: 1. <18 years of age 2. Evaluated for liver disease with either an ELF™ test or VCTE in the 2 years prior to the date of consent 3. A known prior clinical diagnosis of significant liver disease* due to any cause 4. A known diagnosis of autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis or viral hepatitis (irrespective of whether this has progressed to fibrosis or cirrhosis) *Significant fibrosis or cirrhosis and in active hospital follow-up Previous exclusion criteria: 1. <18 years of age 2. Unable to provide informed consent 3. A known prior diagnosis of cirrhosis due to any cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/02/2025: The number of participants referred to specialist services with suspected liver disease within 12 months of randomisation who are subsequently enrolled in HCC surveillance. The clinical decision to refer for HCC surveillance is made by hospital-based specialists who are independent of the research team. Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/02/2025: 1. The test or combination of tests for liver cirrhosis with the lowest cost per case diagnosed* 2. The sub-group with the lowest cost per case diagnosed* 3. The incremental cost-effectiveness ratio (ICER) of screening for liver cirrhosis in people with T2DM (incremental cost-effectiveness is calculated from a Markov model) 4. The number of cancer deaths avoided by screening (as per Markov modelling) 5. The number of patients diagnosed on VCTE at baseline with =F2 disease (liver stiffness is measured in kPa using VCTE, =F2 is measured as a liver stiffness of =8.2 kPa) *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 Previous secondary outcome measures: 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 2. The test or combination of tests for liver fibrosis with the lowest cost per case 3. The incremental cost-effectiveness ratio (ICER) of reflex testing 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. | — |
Countries
England, United Kingdom
Outcome results
None listed