NCT07128186

The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The objective of this observational study is to evaluate the accuracy and feasibility of an artificial intelligence-based multimodal cognitive screening system in early identification of diabetes-related mild cognitive impairment (MCI) among type 2 diabetes mellitus (T2DM) patients through a 3-5 year follow-up. It also aims to analyze the correlation between diabetic metabolic indicators (such as glycemic variability and HbA1c levels) and cognitive function changes, thereby determining the value of this intelligent screening system in early detection and intervention of cognitive impairment in T2DM patients, which constitutes the key focus of this research.

Conditions

• Cognitive Dysfunction

Interventions

Type	Name	Description
OTHER	follow-up observation	In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.

Timeline

• Start date: 2025-04-22
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

21 sites across 1 country: China