AI-driven multimodal tool to identify early cognitive problems in people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort follows people with type 2 diabetes for 3–5 years using an AI-driven multimodal cognitive screening system to detect early mild cognitive impairment. Participants with normal cognition or mild cognitive impairment at baseline undergo regular cognitive testing and collection of metabolic indicators such as HbA1c and measures of glycemic variability. The AI model integrates multimodal data to predict cognitive decline and the study analyzes correlations between metabolic measures and cognitive changes over time. Exclusions include other diabetes types, education <6 years, recent acute metabolic events, and major neurological or psychiatric disorders that could affect cognition.

Why it matters

Who can join: the full rules

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

Where it's running

• Minda Hospital Affiliated to Hubei Minzu University
  Enshi, Hubei, China Recruiting
• Huanggang Central Hospital
  Huanggang, Hubei, China Recruiting
• Huangshi Central Hospital
  Huangshi, Hubei, China Recruiting
• Jingzhou Central Hospital
  Jingzhou, Hubei, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• China Resources & WISCO General Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Prof. Yang, Doctor
• Email: yangyantj@qq.com
• Phone: 86-18827397697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.