Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes

Official title

Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists

Overview

Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 25% of the global adult population, 25-30% of whom suffer from metabolic dysfunction-associated steatohepatitis (MASH), increasing the risk of progression to advanced fibrosis (AF) (fibrosis stage F3 or cirrhosis F4). Screening for AF is justified because it is associated with an increased risk of overall, hepatic, and cardiovascular mortality and therefore constitutes a public health issue. Patients with type 2 diabetes (T2D) are identified as a priority target for screening because they are at high risk of AF related to MASLD. The recommendations of the French Association for the Study of the Liver 2020 (afef.asso.fr), the European Association for the Study of the Liver (2024), the American Association of Clinical Endocrinology (2022), and the American Association of Diabetes (2025) all recommend a two-step screening process involving the FIB-4 biological score, followed by transient elastography (TE) if the FIB-4 score is \> or = 1.30. Finally, if the TE is ≥8 kPa, the patient is considered to be at intermediate/high risk of AF requiring specialized care to confirm the diagnosis and implement appropriate management, including semi-annual screening for hepatocellular carcinoma in cases of cirrhosis Despite these recommendations, their application in clinical practice remains difficult and requires multidisciplinary collaboration between diabetologists and hepatologists, and between community and hospital sectors, particularly to access TE measures. Since 2018, the Lyon Sud diabetes department (Hospices Civils de Lyon) has implemented an in-hospital AF screening program using TE for T2D patients. However, this screening by private diabetologists has not yet been implemented, mainly due to the lack of a standardized care pathway and difficulty in accessing TE measurements. HYPOTHESIS The implementation of systematic and standardized AF screening in private diabetes practices, in two stages and using ET in diabetes care in accordance with recommendations, would significantly increase the identification of patients with AF and thus improve their access to specialized services and appropriate care.

Interventions

• Procedure Collaborative care pathways group
  CO-CONSTRUCTION OF THE CARE PATHWAY: Participatory approach according to scientific literature, professional practices, and experience of both healthcare providers and patients. Establishment of a working group (hospital endocrinologists, hepatologists, private practice diabetologists, representatives of patients with diabetes followed in the participating centers) to define implementation modalities, professional training, communication and information transfer between professionals, and to e
• Procedure Control group without intervention
  Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care

Primary outcome measures

• Proportion of T2D patients eligible for screening and having undergone AF screening according to the recommendations including assessment of the FIB-4 score, measurement of TE if indicated, and referral for specialized care if required [Time frame: Between 6 and 12 months following inclusion]

Secondary outcome measures (12)

• Proportion of patients undergoing transient elastography (TE) measurement [Time frame: Between 6 and 12 months following inclusion]
• Proportion of patients referred for specialized consultation for the management of MASLD [Time frame: Between 6 and 12 months following inclusion]
• Proportion of patients with TE values ≥ 8 kPa among those referred to specialized care. [Time frame: Between 6 and 12 months following inclusion]
• Time interval between successive steps of the screening pathway: FIB-4 assessment, TE measurement, and specialized consultation for the management of MASLD. [Time frame: Between 6 and 12 months following inclusion]
• Number of diabetologists not initially participating in implementing the screening pathway (FIB-4 ± TE), [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Number of patients refusing the screening process [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Number of patients eligible for the pathway. [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Barriers and facilitators to the implementation of the pathway at both individual and organizational levels, as reported by community-based practitioners, specialized care providers and patients. [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Patient perceptions of their participation in the implementation of the new care pathway [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Fidelity of the implemented pathway to the predefined specifications, and necessary adaptations. [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months]
• Transferability of the intervention according to ASTAIRE criteria : characteristics of the target population [Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months.]
• Unreliable TE measurements [Time frame: 2 months after inclusion (strategy implementation period)]

Eligibility criteria

Inclusion criteria

• Adult patient, male or female
• Type 2 diabetic patient, followed by a diabetologist in private practice participating in the study
• Patient affiliated to a French or European healthcare insurance
• Patient who agrees to be included in the study and who signs the informed consent form

Exclusion criteria

• Evidence of advanced fibrosis (F3 or F4 fibrosis based on the results from previous liver biopsy F3 ou F4 or evidence of cirrhosis).
• Evidence of other causes of chronic liver disease
• Patient who does not understand French/ is unable to give consent,
• Patient already included in a trial who may interfere with the study
• The subject is a pregnant or nursing female
• Minor patient
• Patient deprived of liberty,
• Patient admitted to a health or social establishment for purposes other than research
• Mentally unbalanced patients, under supervision or guardianship,
• Patient undergoing psychiatric care
• Patient not affiliated to a healthcare insurance plan
• Patient already included in this screening program in the previous 12 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 10 centers

• Diabetology private center — Caluire-et-Cuire
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• Diabetology private center — Lyon
• … and 2 more centers

Identifiers

NCT: NCT07270822 · 69HCL24_0848

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗