Steatotic Liver DiseaseMASLD-DIABNCT07270822
Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes
A study testing Collaborative care pathways group in people with Steatotic Liver Disease and Fibrosis of Liver, run by Hospices Civils de Lyon at 10 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatotic Liver Disease, Fibrosis of Liver
- What is being tested?
- Collaborative care pathways group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,714 participants
- Where
- 10 sitesFrance
- Study dates
- 1 May 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dominique DELAUNAY, PhD contact
10 sites in 1 country
France10 sites
Diabetology private center
Caluire-et-Cuire, 69300
Guillaume TREIBER, + 33 9 73 06 04 03, drtreiber.endocrinologie@gmail.com
Diabetology private center
Lyon, 69001
Annie CLAVIER, Doctor, +33 4 72 41 70 02, aclavier001@gmail.com
Diabetology private center
Lyon, 69001
Marine BENOIT, +33 4 72 41 70 02, dr.marine.benoit@gmail.com
Diabetology private center
Lyon, 69002
Laura BOGENMANN, drbogenmann@gmail.com
Diabetology private center
Lyon, 69005
CLARET-GARDETTE Mathilde, +33 6 13 65 00 10, docteurmcg@gmail.com
Diabetology private center
Lyon, 69009
Audrey VILLARD, +33 6 72 08 19 88, dr.audreyvillard@gmail.com
Diabetology private center
Lyon, 69009
JONCOUR MILLS Gwendoline, +33 4 72 41 70 02, drjoncourmills@gmail.com
Diabetology private center
Lyon, 69009
Sylvie RODE, +33 4 69 98 20 87, secretariat@endoclyon.fr
Diabetology private center
Saint-Maurice-l'Exil, 38550
Claire DAMATTE-FAUCHERY, +33 6 79 89 57 31, claire.damatte-fauchery@orange.fr
Diabetology private center
Sathonay-Camp, 69580
Sylvie MARSOT, +33 6 41 67 71 10, sylviemarsot@neuf.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Steatotic Liver Disease, Fibrosis of Liver
- Being tested
- Collaborative care pathways group, Control group without intervention
- Keywords
- Metabolic dysfunction-associated steatotic liver disease, hepatic transient elastography, hepatic fibrosis, type 2 diabetes mellitus, screening, non-invasive tests
- Medical subject headings
- Liver Cirrhosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative care pathways groupProcedure or surgery
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
Control group without interventionProcedure or surgery
Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care
| Study group | Role | What they receive |
|---|---|---|
| Collaborative care pathways group | Experimental | 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). Receives: Procedure: Collaborative care pathways group |
| Control group without intervention | Other | Current clinical routine practice with no specific intervention Receives: Procedure: Control group without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 OR
- Measurement 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
Measured: Between 6 and 12 months following inclusion
Secondary outcomes (41)
Proportion of patients undergoing transient elastography (TE) measurement
measurement among patients with a FIB-4 score ≥ 1.3, as documented in medical records
Measured: 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
Measured: Between 6 and 12 months following inclusion
Proportion of patients with TE values ≥ 8 kPa among those referred to specialized care.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 2 months after inclusion (strategy implementation period)
Description of the screening pathway (organization, care trajectory, professional training, patient information and education materials)
Measured: 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)
Measured: Between 6 and 12 months following inclusion
Number of diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients refusing the screening process
Reasons
Measured: 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.
Measured: 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.
Measured: Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process
Reasons
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Between 6 and 12 months following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized cluster study with two parallel arms: * Experimental group: Clusters or private diabetes clinics (five centers) in which a systematic and standardized screening pathway for hepatic AF in patients with T2D has been implemented: calculation of the FIB-4 score and transient elastography measurement performed in diabetes care 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) . * Control group: Clusters or private diabetes practices in which no specific intervention will be deployed (5 centers)
- Masking
- None (open label)
- Enrolment
- 1,714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270822
- Sponsor's protocol ID
- 69HCL24_0848
- Acronym
- MASLD-DIAB
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists
- ClinicalTrials.gov ID
- NCT07270822
- Acronym / sponsor ID
- MASLD-DIAB / 69HCL24_0848
- Conditions
- Steatotic Liver Disease, Fibrosis of Liver
- Keywords
- Metabolic dysfunction-associated steatotic liver disease, hepatic transient elastography, hepatic fibrosis, type 2 diabetes mellitus, screening, non-invasive tests
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,714 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cluster study with two parallel arms: * Experimental group: Clusters or private diabetes clinics (five centers) in which a systematic and standardized screening pathway for hepatic AF in patients with T2D has been implemented: calculation of the FIB-4 score and transient elastography measurement performed in diabetes care 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) . * Control group: Clusters or private diabetes practices in which no specific intervention will be deployed (5 centers)
| Arm | Type | Receives |
|---|---|---|
| Collaborative care pathways group | Experimental | Procedure: Collaborative care pathways groupCollaborative 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). |
| Control group without intervention | Other | Procedure: Control group without interventionCurrent clinical routine practice with no specific intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative care pathways groupCO-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 | Procedure or surgery | Collaborative care pathways group |
| Control group without interventionHepatic AF screening in patients with T2D in private diabetes clinics according to routine care | Procedure or surgery | Control group without intervention |
Primary outcome
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
1. Calculation of the FIB-4 score <1.30 (automatic calculation by the medical analysis laboratory or calculated by the liberal diabetologist). 2. 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 OR * Measurement 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
41 secondary outcomes
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)
Description of the screening pathway (organization, care trajectory, professional training, patient information and education materials)
Time frame: 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)
Time frame: Between 6 and 12 months following inclusion
Number of diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)
Time frame: 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
Time frame: Over a 12-month period
Net budget impact
Time frame: over a 3-year horizon
Transferability according to ASTAIRE criteria: nature of the intervention
Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Transferability according to ASTAIRE criteria: contextual environment
Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months.
Transferability according to ASTAIRE criteria: required implementation strategies.
Time frame: 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
Time frame: Throughout the implementation period up to 2 months after inclusion
Single standardized description of the intervention
Time frame: Throughout the implementation period, an average of 12 months
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 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 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 discontinuing the screening process
Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process
Time frame: Through the inclusion period (after implementation of the new care pathway), an average of 7 months
Number of patients discontinuing the screening process
Time frame: 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.
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
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
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
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
Underlying reasons for diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)
Time frame: Between 6 and 12 months following inclusion
Number of diabetologists not implementing the screening pathway (FIB-4 ± TE), and underlying reasons.
Time frame: 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.
Time frame: 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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominique DELAUNAY, PhD contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care pathways group in people with Steatotic Liver Disease and Fibrosis of Liver, run by Hospices Civils de Lyon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrielle CAUSSY, MD, PhD (+33 4 78 86 44 48, cyrielle.caussy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.