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.
Study Type
OBSERVATIONAL
Enrollment
5,000
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.
Minda Hospital Affiliated to Hubei Minzu University
Enshi, Hubei, China
RECRUITINGHuanggang Central Hospital
Huanggang, Hubei, China
RECRUITINGHuangshi Central Hospital
Huangshi, Hubei, China
RECRUITINGJingzhou Central Hospital
Jingzhou, Hubei, China
RECRUITINGSinopharm Dongfeng General Hospital
Shiyan, Hubei, China
NOT_YET_RECRUITINGSuizhou Central Hospital
Suizhou, Hubei, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGChina Resources & WISCO General Hospital
Wuhan, Hubei, China
RECRUITINGHubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan, Hubei, China
RECRUITINGTianyou Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 11 more locations
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).
Time frame: 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)
Time frame: From enrollment to the end of follow-up for 3-5 years
Association Between Diabetic Metabolic Indicators and Cognitive Decline
Correlation of glucose variability (e.g., MAGE) and glycated hemoglobin (HbA1c) with changes in cognitive scores.
Time frame: From enrollment to the end of follow-up for 3-5 years
Predictive Value of Multimodal Data
Predictive efficacy of voice features, facial expressions, drawing trajectories, and other biomarkers in forecasting cognitive deterioration
Time frame: From enrollment to the end of follow-up for 3-5 years
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