The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
Trial ID: NCT07128186
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-04-22
Completion date: 2028-12-30
Sponsor: Tongji Hospital
Conditions: Cognitive Dysfunction
Interventions: follow-up observation
Locations: Minda Hospital Affiliated to Hubei Minzu University; Huanggang Central Hospital; Huangshi Central Hospital; Jingzhou Central Hospital; Sinopharm Dongfeng General Hospital; Suizhou Central Hospital; Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; China Resources & WISCO General Hospital; Hubei Provincial Hospital of Integrated Chinese & Western Medicine; Tianyou Hospital Affiliated to Wuhan University of Science and Technology; Wuhan Central Hospital; Wuhan Fifth Hospital; Wuhan Fourth Hospital; Xiangyang Central Hospital; Xiangyang First People's Hospital; Xianning Central Hospital; Xiantao First People's Hospital; Xiaogan Central Hospital; Renhe Hospital Affiliated to China Three Gorges University; Sinopharm Gezhouba Central Hospital; Yichang Central People's Hospital
Countries: China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China
Enrollment: 5000
Age range: 40 Years - 75 Years
Sex: ALL

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 criteria:
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

Outcomes:
Early Identification Accuracy of the AI System; Cognitive Deterioration Rate