Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,714
- 试验地点
- 1
- 主要终点
- 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
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
次要结局
- Proportion of patients undergoing transient elastography (TE) measurement(Between 6 and 12 months following inclusion)
- Proportion of patients referred for specialized consultation for the management of MASLD(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),(Through the inclusion period (after implementation of the new care pathway), an average of 7 months)
- Number of patients refusing the screening process(Through the inclusion period (after implementation of the new care pathway), an average of 7 months)
- Number of patients discontinuing the screening process(Through the inclusion period (after implementation of the new care pathway), an average of 7 months)
- Number of patients eligible for the 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.(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(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.(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(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.(Through the inclusion period (after implementation of the new care pathway), an average of 7 months)
- Unreliable TE 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)
- Single standardized description 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).(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.(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.(Through the inclusion period (after implementation of the new care pathway), an average of 7 months)
- 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(Over a 12-month period)
- Net budget impact(over a 3-year horizon)
- Transferability according to ASTAIRE criteria: nature of the intervention(Through the inclusion period (after implementation of the new care pathway), an average of 7 months.)
- Transferability according to ASTAIRE criteria: contextual environment(Through the inclusion period (after implementation of the new care pathway), an average of 7 months.)
- Transferability according to ASTAIRE criteria: required implementation strategies.(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(Throughout the implementation period up to 2 months after inclusion)
- Reasons for diabetologists discontinuing participation in the pathway (Follow-up period for maintaining the care pathway)(Between 6 and 12 months following inclusion)