Actively Recruiting

Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT07128186

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

Led by Tongji Hospital · Updated on 2025-08-17

5000

Participants Needed

21

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes mellitus (T2DM).
  • Aged 40 to 75 years with self-reported or informant-reported memory complaints.
  • Cognitive assessment consistent with cognitive normal or mild cognitive impairment.
  • Able to perform basic activities of daily living.
  • Memory-specific deficits only, with other cognitive functions intact.
Not Eligible

You will not qualify if you...

  • Diagnosed with other types of diabetes such as type 1 or gestational diabetes.
  • Education level less than 6 years.
  • Metabolic disorders affecting cognition, including severe hypoglycemia, diabetic ketoacidosis, or hyperglycemic hyperosmolar state within the past 3 months.
  • Hypothyroidism or other endocrine disorders.
  • Neurological or psychiatric conditions impairing cognition, including history of head trauma, depression, anxiety, delirium, severe pulmonary or renal disease, heart failure, or malignancy.
  • Substance abuse including nicotine or alcohol dependence within the past 2 years.
  • Use of anti-Parkinsonian drugs, antiepileptics, or sedatives/hypnotics within the past month.
  • Use of cognitive-enhancing drugs such as donepezil or memantine.
  • Speech, hearing, visual impairments, or other disabilities that prevent completion of AI screening or follow-up.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 21 locations

1

Minda Hospital Affiliated to Hubei Minzu University

Enshi, Hubei, China

Actively Recruiting

2

Huanggang Central Hospital

Huanggang, Hubei, China

Actively Recruiting

3

Huangshi Central Hospital

Huangshi, Hubei, China

Actively Recruiting

4

Jingzhou Central Hospital

Jingzhou, Hubei, China

Actively Recruiting

5

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

Not Yet Recruiting

6

Suizhou Central Hospital

Suizhou, Hubei, China

Not Yet Recruiting

7

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

Wuhan, Hubei, China, 430030

Actively Recruiting

8

China Resources & WISCO General Hospital

Wuhan, Hubei, China

Actively Recruiting

9

Hubei Provincial Hospital of Integrated Chinese & Western Medicine

Wuhan, Hubei, China

Actively Recruiting

10

Tianyou Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, China

Not Yet Recruiting

11

Wuhan Central Hospital

Wuhan, Hubei, China

Actively Recruiting

12

Wuhan Fifth Hospital

Wuhan, Hubei, China

Actively Recruiting

13

Wuhan Fourth Hospital

Wuhan, Hubei, China

Actively Recruiting

14

Xiangyang Central Hospital

Xiangyang, Hubei, China

Not Yet Recruiting

15

Xiangyang First People's Hospital

Xiangyang, Hubei, China

Actively Recruiting

16

Xianning Central Hospital

Xianning, Hubei, China

Actively Recruiting

17

Xiantao First People's Hospital

Xiantao, Hubei, China

Not Yet Recruiting

18

Xiaogan Central Hospital

Xiaogan, Hubei, China

Actively Recruiting

19

Renhe Hospital Affiliated to China Three Gorges University

Yichang, Hubei, China

Actively Recruiting

20

Sinopharm Gezhouba Central Hospital

Yichang, Hubei, China

Not Yet Recruiting

21

Yichang Central People's Hospital

Yichang, Hubei, China

Actively Recruiting

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Research Team

P

Prof. Yang, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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