Testing for liver scarring at the diabetes annual review

Feasibility and acceptability of a primary care liver fibrosis testing pathway centred on the diabetes annual review

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14585543

Enrollment

5300

Registered

2022-04-27

Start date

2022-05-02

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver fibrosis Digestive System Fibrosis and cirrhosis of liver

Interventions

This is a prospective cohort study of automated fibrosis testing in patients with type 2 diabetes linked to a trial of hospital-based versus community-based second-tier testing. The overall strategy i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. General practice with >4000 registered patients 2. Practice lead, or representative, confirms agreement to participate in the study after reading the practice information sheet 3. Practice lead, or representative, confirms practice support introduction of Fib-4 testing for all patients with type 2 diabetes attending for annual review 4. Track record of >85% of patients with type 2 diabetes attending for diabetes review 5. Practice uses EMIS computer system 6. Referral route for fibroscan based on primary care non-invasive score agreed Patient inclusion criteria: 1. Type 2 diabetes 2. Serum biochemistry sample taken alongside diabetes annual review

Exclusion criteria

Exclusion criteria: 1. Inclusion criteria not met 2. Practice participating in other screening or case-finding study related to liver fibrosis

Design outcomes

Primary

Measure	Time frame
Proportion of individuals with type 2 diabetes with indeterminate or high-risk Fib-4 scores at the diabetes annual review	—

Secondary

Measure	Time frame
1. Proportion of patients referred for Fibroscan who attend in community vs hospital, measured at the end of the study 2. Exploratory cost-utility analysis of protocolled versus historic opportunistic testing for fibrosis, measured at the end of the study 3. Qualitative analysis of attitudes among primary care physicians towards NASH and liver fibrosis in diabetes, testing for fibrosis in primary care, and assessment guidelines, using structured interviews/focus groups at the end of the study 4. Proportion of individuals with indeterminate or high-risk Fib-4 who have raised fibroscan scores measured at the end of the study	—

Measure

Time frame

1. Proportion of patients referred for Fibroscan who attend in community vs hospital, measured at the end of the study 2. Exploratory cost-utility analysis of protocolled versus historic opportunistic testing for fibrosis, measured at the end of the study 3. Qualitative analysis of attitudes among primary care physicians towards NASH and liver fibrosis in diabetes, testing for fibrosis in primary care, and assessment guidelines, using structured interviews/focus groups at the end of the study 4. Proportion of individuals with indeterminate or high-risk Fib-4 who have raised fibroscan scores measured at the end of the study

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026