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

Recruiting

• Conditions: Cognitive Dysfunction

• Registration Number: NCT07128186
• Lead Sponsor: Tongji Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-22
• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Primary Completion: 2028-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes mellitus (T2DM).

2. Aged 40-75 years, with self-reported or informant-reported memory complaints.

3. Cognitive assessment scores consistent with either:

   • Cognitive Normal (CN) or
   • Mild Cognitive Impairment (MCI).

4. Preserved ability to perform basic activities of daily living (ADLs).

5. Memory-specific deficits only (e.g., partial forgetfulness), with intact other cognitive domains (e.g., reasoning, judgment, attention, and executive function).

Exclusion Criteria

1. Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).

2. Education level <6 years.

3. Metabolic disorders that may affect cognition, including:

   • Acute carbohydrate metabolism events within 3 months (e.g., severe hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state).
   • Hypothyroidism or other endocrine disorders.

4. Neurological/psychiatric conditions that may impair cognition:

   • History of head trauma, depression, anxiety, delirium, severe pulmonary/renal disease, heart failure, or malignancy.

5. Substance abuse (past 2 years), including nicotine/alcohol dependence.

6. Recent medication use (within 1 month):

   • Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.

7. Cognitive-enhancing drugs (e.g., donepezil, memantine).

8. Inability to complete AI screening or follow-up due to:

   • Speech/hearing/visual impairments or other disabilities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early Identification Accuracy of the AI System	From enrollment to the end of follow-up for 3-5 years	Sensitivity, specificity, and area under the ROC curve (AUC) of the AI system in detecting Mild Cognitive Impairment (MCI), compared with traditional scales (MMSE/MoCA).
Cognitive Deterioration Rate	From enrollment to the end of follow-up for 3-5 years	Conversion rates from:Cognitively Normal (CN) → MCI; MCI → Alzheimer's Disease (AD)

Secondary Outcome Measures

Name	Time	Method
Association Between Diabetic Metabolic Indicators and Cognitive Decline	From enrollment to the end of follow-up for 3-5 years	Correlation of glucose variability (e.g., MAGE) and glycated hemoglobin (HbA1c) with changes in cognitive scores.
Predictive Value of Multimodal Data	From enrollment to the end of follow-up for 3-5 years	Predictive efficacy of voice features, facial expressions, drawing trajectories, and other biomarkers in forecasting cognitive deterioration

Trial Locations

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

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