The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
About this study
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.
- Condition
- Cognitive Dysfunction
- Tested
- follow-up observation
- Sponsor
- Tongji Hospital
Who can join
- Age
- 40 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 10
- Minimum age: 40 years
- Maximum age: 75 years
- Study condition: Cognitive Dysfunction
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Aged 40-75 years, with self-reported or informant-reported memory complaints.
- Cognitive assessment scores consistent with either:
- Cognitive Normal (CN) or
- Mild Cognitive Impairment (MCI).
- Preserved ability to perform basic activities of daily living (ADLs).
- Memory-specific deficits only (e.g., partial forgetfulness), with intact other cognitive domains (e.g., reasoning, judgment, attention, and executive function).
Exclusion 13
- Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
- Education level \<6 years.
- 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.
- Neurological/psychiatric conditions that may impair cognition:
- History of head trauma, depression, anxiety, delirium, severe pulmonary/renal disease, heart failure, or malignancy.
- Substance abuse (past 2 years), including nicotine/alcohol dependence.
- Recent medication use (within 1 month):
- Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.
- Cognitive-enhancing drugs (e.g., donepezil, memantine).
- Inability to complete AI screening or follow-up due to:
- Speech/hearing/visual impairments or other disabilities
Where
21 sites, 21 recruiting
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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
China Resources & WISCO General Hospital
Wuhan, Hubei, China
and 15 more sites on ClinicalTrials.gov
Contact
-
Prof. Yang, Doctor
86-18827397697 yangyantj@qq.com
Potential match only. Final eligibility is determined by the study team.