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

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…

ClinicalTrials.gov IDNCT07128186

PhaseNot Applicable

Enrollment5000

SponsorTongji Hospital

Age40 Years – 75 Years

SexALL

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Conditions studied

Cognitive Dysfunction

About this study

Interventions

Other: 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.

Primary outcomes

Early Identification Accuracy of the AI System (From enrollment to the end of follow-up for 3-5 years)
Cognitive Deterioration Rate (From enrollment to the end of follow-up for 3-5 years)

Eligibility information

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

Study locations

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
Sinopharm Dongfeng General Hospital, Shiyan, Hubei China
Suizhou Central Hospital, Suizhou, Hubei China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030 China
China Resources & WISCO General Hospital, Wuhan, Hubei China
Hubei Provincial Hospital of Integrated Chinese & Western Medicine, Wuhan, Hubei China
Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, Hubei China

Showing 10 of 21 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-23.