Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)

Recruiting

• Conditions: Chronic Disease

• Registration Number: NCT06861283
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

Chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. The investigators have developed a digital twin-based clinical research system (termed X Town) for chronic diseases, to predict clinical outcomes under various interventions. In this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-06
• Study Start: 2025-04-13
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-07-10
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Age≥18 years old
2. Receiving care at a community health service centre
3. Able to understand and comply with the study procedures
4. Agrees to participate in the study and signs the informed consent form

Exclusion Criteria

1. Patients with severe mental illness
2. Patients expected to be unable to complete follow-ups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The agreement between the simulated short-term clinical outcomes in the virtual clinical studies and the real-world short-term clinical outcomes in the real-world clinical studies	Within 3 months	We will use three predefined binary metrics to evaluate the agreement: (1) full statistical significance agreement, defined by effect estimates and CIs of the virtual and real-world clinical studies on the same side of the null; (2) estimate agreement, defined by whether effect estimates for the virtual clinical studies fell within the 95% CI for the real-world clinical study results; (3) standardized difference agreement between treatment effect estimates from the real-world clinical studies and the virtual clinical studies, defined by standardized differences (Reference: JAMA. 2023;329(16):1376-1385. doi:10.1001/jama.2023.4221).

Trial Locations

Locations (1)

Shanghai Health and Medical Center; 🇨🇳 Wuxi, Jiangsu, China