Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes (MASLD-DIAB)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibrosis of Liver; Steatotic Liver Disease
• Intervention / Treatment: Procedure: Collaborative care pathways group; Procedure: Control group without intervention

• Study Type: Interventional
• Enrollment (Estimated): 1714
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cyrielle CAUSSY, MD, PhD; Phone Number: +33 4 78 86 44 48; Email: cyrielle.caussy@chu-lyon.fr
• Study Contact Backup: Name: Dominique DELAUNAY, PhD; Phone Number: +33 4 72 11 00 64

Study Locations

• France
  • Caluire-et-Cuire, France, 69300
    • Diabetology private center
    • Contact: Guillaume TREIBER; Phone Number: + 33 9 73 06 04 03; Email: drtreiber.endocrinologie@gmail.com
  • Lyon, France, 69001
    • Diabetology private center
    • Contact: Marine BENOIT; Phone Number: +33 4 72 41 70 02; Email: dr.marine.benoit@gmail.com
  • Lyon, France, 69002
    • Diabetology private center
    • Contact: Laura BOGENMANN; Email: drbogenmann@gmail.com
  • Lyon, France, 69005
    • Diabetology private center
    • Contact: CLARET-GARDETTE Mathilde; Phone Number: +33 6 13 65 00 10; Email: docteurmcg@gmail.com
  • Lyon, France, 69009
    • Diabetology private center
    • Contact: Sylvie RODE; Phone Number: +33 4 69 98 20 87; Email: secretariat@endoclyon.fr
  • Saint-Maurice-l'Exil, France, 38550
    • Diabetology private center
    • Contact: Claire DAMATTE-FAUCHERY; Phone Number: +33 6 79 89 57 31; Email: claire.damatte-fauchery@orange.fr
  • Sathonay-Camp, France, 69580
    • Diabetology private center
    • Contact: Sylvie MARSOT; Phone Number: +33 6 41 67 71 10; Email: sylviemarsot@neuf.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collaborative care pathways group; Collaborative development of a care pathway for the implementation of a systematic and standardized screening for hepatic AF in patients with T2D in private diabetes clinics. The care pathway will include calculation of the FIB-4 score and transient elastography measurement performed in diabetes clinics if FIB-4≥1.30, in accordance with the recommendations of the French Association for the Study of the Liver (AFEF) and the European Association for the Study of the Liver (EASL).	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 ensure a smooth care pathway without overloading the health system . IMPLEMENTATION: Definition of patient care pathway Training of private diabetologists to integrate FIB-4 and TE measurement into their practices Provision of the FibroScan® Monitoring of patients included in the screening program and of the number of TE measurements performed Validation of TE measurements ≥ 8 kPa in a specialized center Definition of referral procedures for patients towards the specialized center
Other: Control group without intervention; Current clinical routine practice with no specific intervention	Procedure: Control group without intervention; Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Calculation of the FIB-4 score <1.30 (automatic calculation by the medical analysis laboratory or calculated by the liberal diabetologist).; Calculation of the FIB-4 score ≥ 1.30 (automatic calculation by the medical analysis laboratory or calculated by the liberal diabetologist) and realization of a measurement of hepatic TE with either:TE measurement less than 8 kPa ORMeasurement of TE greater than or equal to 8kPa and referral for specialized care to a private hepatologist, a hospital hepatology department or the Institute of Hepatology of Lyon at HCL According to the recommendations of the EASL (European Association for the Study of the Liver) and the AFEF (French Association for the Study of the Liver), screening includes both the calculation of the FIB-4 score, a transient (TE) measurement, and referral, if indicated, for specialized care. ET and FIB-4 measurements cannot be separated	Between 6 and 12 months following inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients undergoing transient elastography (TE) measurement	measurement among patients with a FIB-4 score ≥ 1.3, as documented in medical records	Between 6 and 12 months following inclusion
Proportion of patients referred for specialized consultation for the management of MASLD	This include referral to a private hepatologist, a hospital-based hepatology department, or the Hepatology University Hospital Institute (IHU) of Lyon at the Hospices Civils de Lyon (HCL), among those identified through screening	Between 6 and 12 months following inclusion
Proportion of patients with TE values ≥ 8 kPa among those referred to specialized care.		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.		Between 6 and 12 months following inclusion
Number of diabetologists not initially participating in implementing the screening pathway (FIB-4 ± TE),	Statement of discontinuation under study.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients refusing the screening process	Follow-up data	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients eligible for the pathway.	Number of patients included in the care pathway.	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.	Interviews with patients	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	Interviews with patient's perception of risk, uncertainty, anxiety induced by screening).	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.	% of patients with a compliant care pathway	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	ASTAIRE comprises 23 transferability criteria classified in four categories to analyse the comparability of settings and to facilitate transfer including : Category 1 = Typology of the included population : collection and assessment of descriptive data on the population during the initial assessment	Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Unreliable TE measurements	Unreliable TE measurements are defined by IQR/Median ratio ≥0,30. Results will be expressed in number of unreliable measurements	2 months after inclusion (strategy implementation period)
Description of the screening pathway (organization, care trajectory, professional training, patient information and education materials)		10 months
Proportion of screening compliance among patients with type 2 diabetes (T2D) included in the study (Follow-up period for maintaining the care pathway)		Between 6 and 12 months following inclusion
Number of diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)		Between 6 and 12 months following inclusion
Incremental cost-effectiveness ratio (ICER) of implementing a new screening pathway for AF on patients with type 2 diabetes followed in private diabetology practices, compared with usual care	The outcome measure will be the rate of screenings compliant with the recommendations. The ICER will be interpreted as the additional cost generated by the new screening pathway per additional patient screened	Over a 12-month period
Net budget impact	Net budget impact will be assessed in euros for the Mandatory Health Insurance (MHI) at 3 years following the deployment of the new screening strategy for AF in patients with type 2 diabetes managed in private diabetology practices	over a 3-year horizon
Transferability according to ASTAIRE criteria: nature of the intervention	ASTAIRE comprises 23 transferability criteria classified in four categories to analyse the comparability of settings and to facilitate transfer including : Category 3 =Typology of the intervention in terms of defining objectives and planning to collect and assess descriptive elements of implementation	Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Transferability according to ASTAIRE criteria: contextual environment	ASTAIRE comprises 23 transferability criteria classified in four categories to analyse the comparability of settings and to facilitate transfer including : Category 2 = Typology of the environment : collection and assessment of descriptive data on the environment during the initial assessment	Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Transferability according to ASTAIRE criteria: required implementation strategies.	ASTAIRE comprises 23 transferability criteria classified in four categories to analyse the comparability of settings and to facilitate transfer including : Category 4 = Typology of the implementation strategies required . continuously throughout the project cycle, collect information relating to the terms and conditions of support for the transfer	Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Inter-observer agreement between measurements performed by diabetologists and by an experienced operator in expert center	Inter-observer agreement between measurements will explore the procedure for implementing TE in private diabetes clinics. Results will be expressed in percentage of concordant measurements	Throughout the implementation period up to 2 months after inclusion
Single standardized description of the intervention	The Template for Intervention Description and Replication (TIDIER reporting grid, 12 items, BMJ 2014;348:g1687) will be used. This approach ensures comprehensive and reproducible reporting of all components of the intervention.	Throughout the implementation period, an average of 12 months
Number of diabetologists not initially participating in implementing the screening pathway (FIB-4 ± TE).	Number of inclusions in the post-implementation phase.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of diabetologists not initially participating in implementing the screening pathway (FIB-4 ± TE).	Percentage of screenings compliant with the recommendations.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients refusing the screening process	Non-realisation of prescribed procedures.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients refusing the screening process	Reasons	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process	Follow-up data.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process	Non-realisation of prescribed procedures.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process	Reasons	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Perceived appropriateness according to community-based and hospital-based professionals.	Professionals' perception of the relevance and alignment of the pathway with their needs (interviews).	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.	Interviews with private practitioners.	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.	Focus group with specialists from the reference center (diabetologists, endocrinologists, hepatologists)	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.	Description of non-compliances	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.	Modification of the pathway	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Underlying reasons for diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)		Between 6 and 12 months following inclusion
Number of diabetologists not implementing the screening pathway (FIB-4 ± TE), and underlying reasons.	Statement of discontinuation under study.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of diabetologists not implementing the screening pathway (FIB-4 ± TE), and underlying reasons.	Number of inclusions in the post-implementation phase.	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of diabetologists not initially participating not implementing the screening pathway (FIB-4 ± TE), and underlying reasons.	Percentage of screenings compliant with the recommendations.	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.	Reasons for delays between procedures.	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.	Patient-professional and interprofessional relationships within the framework of the care pathway (interviews)	Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Reasons for diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)		Between 6 and 12 months following inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; screening; hepatic fibrosis; non-invasive tests; Metabolic dysfunction-associated steatotic liver disease; hepatic transient elastography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Liver Cirrhosis; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 69HCL24_0848

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No