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RecruitingNCT07128186

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

Sponsor

Tongji Hospital

Enrollment

5,000 participants

Start Date

Apr 22, 2025

Study Type

OBSERVATIONAL

Conditions

Cognitive Dysfunction

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.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is developing an AI-based model to predict whether people with Type 2 diabetes will develop memory or thinking problems, by combining brain scans, blood tests, and cognitive assessments. **You may be eligible if...** - You have been diagnosed with Type 2 diabetes - You are between 40 and 75 years old - You or someone close to you has noticed memory concerns - Your thinking and memory testing shows either normal cognition or mild cognitive impairment (early memory difficulties) - You can still carry out daily activities independently **You may NOT be eligible if...** - You have Type 1 diabetes or gestational diabetes - You have fewer than 6 years of education - You have had a severe blood sugar crisis in the past 3 months - You have been diagnosed with dementia or have severely impaired cognition - You have a brain condition (e.g., stroke, brain tumor, Parkinson's disease) that could explain the cognitive changes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERfollow-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.

Locations(21)

Minda Hospital Affiliated to Hubei Minzu University

Enshi, Hubei, China

Huanggang Central Hospital

Huanggang, Hubei, China

Huangshi Central Hospital

Huangshi, Hubei, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

Suizhou Central Hospital

Suizhou, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

China Resources & WISCO General Hospital

Wuhan, Hubei, China

Hubei Provincial Hospital of Integrated Chinese & Western Medicine

Wuhan, Hubei, China

Tianyou Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, China

Wuhan Central Hospital

Wuhan, Hubei, China

Wuhan Fifth Hospital

Wuhan, Hubei, China

Wuhan Fourth Hospital

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Xiangyang First People's Hospital

Xiangyang, Hubei, China

Xianning Central Hospital

Xianning, Hubei, China

Xiantao First People's Hospital

Xiantao, Hubei, China

Xiaogan Central Hospital

Xiaogan, Hubei, China

Renhe Hospital Affiliated to China Three Gorges University

Yichang, Hubei, China

Sinopharm Gezhouba Central Hospital

Yichang, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

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NCT07128186

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