Screening for advanced liver fibrosis due to metabolic dysfunction-associated steatotic liver disease alongside retina scanning in people with type 2 diabetes: a cross-sectional study
Andrea Lindfors, Rickard Strandberg, Hannes Hagström
Lancet Gastroenterol Hepatol 2025; 10: 125–37
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https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4885143
ABSTRACT
Summary
Background
International guidelines suggest screening for advanced fibrosis due to metabolic dysfunction-associated steatotic liver disease in people with type 2 diabetes, but how to implement these guidelines in clinical care remains unclear. We hypothesise that examination with VCTE could be implemented simultaneously with retina scanning with a high acceptance rate in people with type 2 diabetes.
Methods
In this cross-sectional study, we offered VCTE to people with type 2 diabetes referred to routine retina scanning in a large retina scanning facility in Stockholm, Sweden.
We excluded people with type 1 diabetes, currently pregnant, with known liver disease, reporting high alcohol consumption, who did not speak Swedish, or younger than 18 years.
Between Nov 6, 2020, and June 20, 2023, we conducted surveys with included participants and collected data from medical records on diabetes retinopathy, sex, and VCTE measurements.
Increased liver stiffness was defined as at least 8·0 kPa, and possible advanced fibrosis as more than 12·0 kPa. Presence of metabolic dysfunction-associated steatotic liver disease was defined as a controlled attenuation parameter (CAP) value of 280 dB/m or higher.
Participants with a liver stiffness measurement of at least 8·0 kPa or those with unreliable measurements were subsequently referred for a secondary evaluation at a liver specialist, including a follow-up liver stiffness measurement with VCTE.
The primary outcome was the proportion of eligible people approached for screening who accepted.
Secondary outcomes were the prevalence of elevated liver stiffness (≥8·0 kPa or >12·0 kPa), presence of metabolic dysfunction-associated steatotic liver disease, and the proportion of elevated liver stiffness readings at the first VCTE examination that were not elevated in the secondary evaluation with a liver specialist.
Secondary outcomes were assessed in all participants who accepted screening, except false positives, which were assessed only in participants who had a second examination.
Findings
1301 participants were eligible to undergo assessment with VCTE, which was accepted by 1005 (77·2%). 973 (96·8%) participants had complete measurements, of whom 504 (51·8%) had CAP values of 280 dB/m or higher, indicating metabolic dysfunction-associated steatotic liver disease. Of 977 participants with reliable liver stiffness measurements, 154 (15·8%) had values of at least 8·0 kPa, suggestive of liver fibrosis, and 49 (5·0%) had values higher than 12·0 kPa, indicating possible advanced fibrosis.
However, upon reassessment with a second VCTE after referral, 56 (45·2%) of 124 individuals had values less than 8·0 kPa. 74 (7·4%) of 1005 participants had a final liver stiffness of at least 8·0 kPa; 29 (2·9%) had values greater than 12·0 kPa.
Interpretation
Simultaneous examination with VCTE alongside retina scanning had a high acceptance rate among people with type 2 diabetes and could be a strategy for case-finding of people with fibrosis due to metabolic dysfunction-associated steatotic liver disease.
However, a high proportion of participants in our study with elevated liver stiffness measurement at the screening visit did not have an elevated liver stiffness measurement at secondary evaluation, suggesting false-positive findings were common.
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Research in context
• Evidence before this study
More than half of people with type 2 diabetes have metabolic dysfunction-associated steatotic liver disease but only a minority progress to liver cirrhosis. International guidelines recommend screening for liver disease in people at risk of metabolic dysfunction-associated steatotic liver disease, including people with type 2 diabetes. If screening for liver disease in people with type 2 diabetes is to be implemented, one solution could be to integrate screening with existing health-care infrastructure.
We searched PubMed between Jan 1, 2019, and March 31, 2020, using the search terms “diabetic retinopathy” AND (“MASLD” OR “NAFLD”) AND (“VCTE” OR “fibroscan or elastography”). We found no examples of trials examining people with type 2 diabetes undergoing retinopathy screening with simultaneous liver fibrosis testing. Most studies among people with type 2 diabetes presented data on a two-step strategy with a blood-based liver fibrosis test, usually Fibrosis-4, as a first step and the more reliable vibration-controlled transient elastography (VCTE) measurement as a second step. Therefore, to our knowledge, there is no previous research into this topic.
• Added value of this study
We show that people with type 2 diabetes are willing to undergo screening for liver fibrosis with VCTE simultaneous to retina scanning, an established screening programme that is highly centralised in Sweden. Thus, we present a possible centralised screening solution and estimates on the prevalence of metabolic dysfunction-associated steatotic liver disease and high liver stiffness. We show that a high proportion of elevated VCTE liver stiffness results from the first reading at the retina scanning clinic were found to be not elevated in a follow-up VCTE measurement.
• Implications of all the available evidence
People with liver cirrhosis due to metabolic dysfunction-associated steatotic liver disease often have type 2 diabetes at diagnosis. Liver cirrhosis is often diagnosed at a late stage. Screening for liver fibrosis due to metabolic dysfunction-associated steatotic liver disease at retina scanning clinics is possible and broadly accepted in patients with type 2 diabetes but false positives with VCTE are common. To mitigate the risk of false-positives results, two VCTE examinations should be considered before making decisions on clinical management.
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We hypothesise
that examination with VCTE could be implemented simultaneously with retina scanning with a high acceptance rate in people with type 2 diabetes, leading to meaningful identification of people with metabolic dysfunction-associated steatotic liver disease and advanced fibrosis.
In this cross-sectional study
of more than 1000 people with type 2 diabetes, 77% accepted screening for liver fibrosis and metabolic dysfunction-associated steatotic liver disease in conjunction with retina scanning.
This high acceptance rate suggests that this approach might be a feasible screening method for liver fibrosis.
The prevalence of metabolic dysfunction-associated steatotic liver disease was around 52% and 3% had liver stiffness measurements higher than 12·0 kPa, signalling advanced liver fibrosis.
However, a high proportion of participants with an initial elevated liver stiffness measurement with VCTE did not have elevated liver stiffness measurements at the second visit, suggesting that false positives were common. This risk must be considered if implementing this method into clinical routine.
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