Related Experiment Video
Updated: Apr 15, 2026
Author Spotlight: Advancing Hepatic Fibrosis Diagnosis Using Magnetic Resonance Elastography and AI
Published on: July 21, 2023
An Explainable AI Tool (FibroX) for Detecting Advanced Liver Fibrosis in Adults With Type 2 Diabetes: Protocol for a
Basile Njei1,2,3,4,5,6, Ulrick Sidney Kanmounye7
1Section of Digestive Diseases, Department of Medicine, Yale University, New Haven, CT, United States.
Background:
Metabolic 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.
Objective:
This 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.
Methods:
This 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.
Results:
Institutional 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.
Conclusions:
This 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 Registration:
ClinicalTrials.gov NCT07305324; https://clinicaltrials.gov/study/NCT07305324.
International Registered Report Identifier (Irrid):
PRR1-10.2196/90456.
