Ireland
--:--IST
Starting soon Not applicable

Liver Fibrosis Assessment in Diabetic Patients

NCT06694974 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2024-11-22
Last updated
2024-11-22

Condition(s) studied

Type 2 DiabetesMetabolic Dysfunction-Associated Steatotic Liver Disease

Investigational drug(s) / intervention(s)

APP calculation for FIB-4Standard Care (in control arm)

APP calculation for FIB-4: the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients.

Standard Care (in control arm): The standard group proceeds as regular practice

Study summary

The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).

Eligibility

Sex
ALL
Min age
35 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Type 2 diabetes patients, regular follow-up in OPD every 3 months 2. Age 35-65 (Because FIB-4 is not accurate in people with age \<35 or \> 65) Exclusion Criteria: 1. Patients are regularly follow the investigators at the liver clinic for liver disease 2. Active malignancy 3. Hematology disease with thrombocytopenia 4. Pregnant patients with type 2 diabetes

Primary outcome measure(s)

  • The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3) — through study completion, an average of 1 year
    Number of patients with FIB-4 ≥ 2.67 being referred to hepatology clinic, divided by total number of patients with FIB-4 ≥ 2.67.

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06694974 on ClinicalTrials.gov ↗ ← All trials in Taiwan