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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Normal Group | Healthy control group without significant cognitive impairment in the study |
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| Mild Cognitive Impairment Group | An intermediate state with subjective or objective cognitive decline (e.g., memory, executive function) that does not meet the diagnostic criteria for dementia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow-up observation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Early Identification Accuracy of the AI System | 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). | From enrollment to the end of follow-up for 3-5 years |
| Cognitive Deterioration Rate | Conversion rates from:Cognitively Normal (CN) → MCI; MCI → Alzheimer's Disease (AD) | From enrollment to the end of follow-up for 3-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Diabetic Metabolic Indicators and Cognitive Decline | Correlation of glucose variability (e.g., MAGE) and glycated hemoglobin (HbA1c) with changes in cognitive scores. | From enrollment to the end of follow-up for 3-5 years |
| Predictive Value of Multimodal Data |
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Inclusion Criteria:
Inclusion Criteria
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:
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 Criteria:
Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
Education level <6 years.
Metabolic disorders that may affect cognition, including:
Neurological/psychiatric conditions that may impair cognition:
Substance abuse (past 2 years), including nicotine/alcohol dependence.
Recent medication use (within 1 month):
Cognitive-enhancing drugs (e.g., donepezil, memantine).
Inability to complete AI screening or follow-up due to:
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This study will enroll 5,000 eligible participants from 20 participating centers across Hubei Province for a 3- to 5-year longitudinal follow-up, with strict adherence to the predefined inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yang, Doctor | Contact | 86-18827397697 | yangyantj@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minda Hospital Affiliated to Hubei Minzu University | Recruiting | Enshi | Hubei | China |
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Predictive efficacy of voice features, facial expressions, drawing trajectories, and other biomarkers in forecasting cognitive deterioration |
| From enrollment to the end of follow-up for 3-5 years |
| Huanggang Central Hospital | Recruiting | Huanggang | Hubei | China |
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| Huangshi Central Hospital | Recruiting | Huangshi | Hubei | China |
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| Jingzhou Central Hospital | Recruiting | Jingzhou | Hubei | China |
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| Sinopharm Dongfeng General Hospital | Not yet recruiting | Shiyan | Hubei | China |
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| Suizhou Central Hospital | Not yet recruiting | Suizhou | Hubei | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| China Resources & WISCO General Hospital | Recruiting | Wuhan | Hubei | China |
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| Hubei Provincial Hospital of Integrated Chinese & Western Medicine | Recruiting | Wuhan | Hubei | China |
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| Tianyou Hospital Affiliated to Wuhan University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
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| Wuhan Central Hospital | Recruiting | Wuhan | Hubei | China |
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| Wuhan Fifth Hospital | Recruiting | Wuhan | Hubei | China |
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| Wuhan Fourth Hospital | Recruiting | Wuhan | Hubei | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | China |
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| Xiangyang First People's Hospital | Recruiting | Xiangyang | Hubei | China |
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| Xianning Central Hospital | Recruiting | Xianning | Hubei | China |
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| Xiantao First People's Hospital | Not yet recruiting | Xiantao | Hubei | China |
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| Xiaogan Central Hospital | Recruiting | Xiaogan | Hubei | China |
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| Renhe Hospital Affiliated to China Three Gorges University | Recruiting | Yichang | Hubei | China |
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| Sinopharm Gezhouba Central Hospital | Not yet recruiting | Yichang | Hubei | China |
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| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | China |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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