ArticleJMIR research protocols2026
An Explainable AI Tool (FibroX) for Detecting Advanced Liver Fibrosis in Adults With Type 2 Diabetes: Protocol for a Pilot Crossover Trial.
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07305324 (Validation of an AI Tool for Improving MASLD Advanced Liver Fibrosis Diagnosis in Primary Care), which is not on this map. Not yet cited in PubMed.
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Validation of an AI Tool for Improving MASLD Advanced Liver Fibrosis Diagnosis in Primary Care: A Provider-Level Crossover Randomized Controlled Trial Pilot
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2 authors.
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Abstract
backgroundMetabolic dysfunction-associated steatotic liver disease is highly prevalent in adults with type 2 diabetes, and advanced fibrosis is its strongest prognostic marker. However, existing noninvasive tools may underperform in diabetes care and are inconsistently used in practice.
objectiveThis study aims to evaluate the feasibility, usability, and preliminary diagnostic effectiveness of FibroX, an explainable artificial intelligence tool for identifying metabolic dysfunction-associated steatotic liver disease-associated advanced fibrosis in adults with type 2 diabetes.
methodsThis 12-month health care provider-level randomized crossover pilot trial will enroll at least 36 primary care clinicians managing adults with type 2 diabetes. Participants will complete 2 simulated care periods: one with FibroX-enabled care and one with usual care, separated by a 1-week washout. FibroX generates individualized advanced fibrosis risk estimates from routine clinical data, provides guideline-aligned triage categories, and displays case-level explanatory outputs using Shapley Additive Explanations. FibroX is an investigational tool and is not currently used in routine clinical practice. Primary outcomes are feasibility and usability, while secondary and exploratory outcomes include workflow efficiency, preliminary diagnostic performance, and implementation measures.
resultsInstitutional review board approval has been obtained. The protocol was registered on ClinicalTrials.gov (NCT07305324) on December 1, 2025. At the time of submission, recruitment had not yet begun. The study is currently unfunded. Preparatory activities, including platform development and case validation, are ongoing. Recruitment is expected to begin in June 2026, with primary completion anticipated in May 2027 and results expected to be available in late 2027.
conclusionsThis pilot study will provide preliminary evidence on the feasibility, usability, and diagnostic performance of an explainable artificial intelligence tool for fibrosis risk stratification in diabetes care and will inform the design of a future larger trial.
trial registrationClinicalTrials.gov NCT07305324; https://clinicaltrials.gov/study/NCT07305324. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/90456.
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