The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
1 other identifier
observational
5,000
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2025
CompletedFirst Submitted
Initial submission to the registry
August 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
August 17, 2025
August 1, 2025
3.7 years
August 11, 2025
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Association Between Diabetic Metabolic Indicators and Cognitive Decline
From enrollment to the end of follow-up for 3-5 years
Predictive Value of Multimodal Data
From enrollment to the end of follow-up for 3-5 years
Study Arms (2)
Cognitive Normal Group
Healthy control group without significant cognitive impairment in the study
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (21)
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
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan Fifth Hospital
Wuhan, Hubei, China
Wuhan Fourth Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Xiangyang First People's Hospital
Xiangyang, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
Xiantao First People's Hospital
Xiantao, Hubei, China
Xiaogan Central Hospital
Xiaogan, Hubei, China
Renhe Hospital Affiliated to China Three Gorges University
Yichang, Hubei, China
Sinopharm Gezhouba Central Hospital
Yichang, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2025
First Posted
August 17, 2025
Study Start
April 22, 2025
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
August 17, 2025
Record last verified: 2025-08