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

NCT07128186 · tracked via the Priya Life Science China tracker

Sponsor

Tongji Hospital

Phase

Observational

Started

2025-04-22

Last updated

2025-08-17

Condition(s) studied

Cognitive Dysfunction

Investigational drug(s) / intervention(s)

follow-up observation

follow-up observation: In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.

Study 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

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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)

Trial sites (21)

Facility	City	Region	Status
Minda Hospital Affiliated to Hubei Minzu University	Enshi	Hubei	Recruiting
Huanggang Central Hospital	Huanggang	Hubei	Recruiting
Huangshi Central Hospital	Huangshi	Hubei	Recruiting
Jingzhou Central Hospital	Jingzhou	Hubei	Recruiting
Sinopharm Dongfeng General Hospital	Shiyan	Hubei	Not Yet Recruiting
Suizhou Central Hospital	Suizhou	Hubei	Not Yet Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
China Resources & WISCO General Hospital	Wuhan	Hubei	Recruiting
Hubei Provincial Hospital of Integrated Chinese & Western Medicine	Wuhan	Hubei	Recruiting
Tianyou Hospital Affiliated to Wuhan University of Science and Technology	Wuhan	Hubei	Not Yet Recruiting
Wuhan Central Hospital	Wuhan	Hubei	Recruiting
Wuhan Fifth Hospital	Wuhan	Hubei	Recruiting
Wuhan Fourth Hospital	Wuhan	Hubei	Recruiting
Xiangyang Central Hospital	Xiangyang	Hubei	Not Yet Recruiting
Xiangyang First People's Hospital	Xiangyang	Hubei	Recruiting
Xianning Central Hospital	Xianning	Hubei	Recruiting
Xiantao First People's Hospital	Xiantao	Hubei	Not Yet Recruiting
Xiaogan Central Hospital	Xiaogan	Hubei	Recruiting
Renhe Hospital Affiliated to China Three Gorges University	Yichang	Hubei	Recruiting
Sinopharm Gezhouba Central Hospital	Yichang	Hubei	Not Yet Recruiting
Yichang Central People's Hospital	Yichang	Hubei	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07128186 on ClinicalTrials.gov ↗ ← All trials in China