NCT07128186Recruiting
The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- Apr 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Tongji Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07128186
What you commit to
- Study type: Observational
- Planned participants: 5000
- From Apr 2025 to the primary completion date, Dec 2028
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent medication use (within 1 month):
- Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.
- Cognitive-enhancing drugs (e.g., donepezil, memantine).
Other illness
- Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
- 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.
Age
- Education level \<6 years.
Other
- Substance abuse (past 2 years), including nicotine/alcohol dependence.
- Inability to complete AI screening or follow-up due to:
- Speech/hearing/visual impairments or other disabilities
Who the study is looking for
- 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).
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Minda Hospital Affiliated to Hubei Minzu University Coordinator of this site? Confirm its status | Enshi | China | Recruiting |
| Huanggang Central Hospital Coordinator of this site? Confirm its status | Huanggang | China | Recruiting |
| Huangshi Central Hospital Coordinator of this site? Confirm its status | Huangshi | China | Recruiting |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Recruiting |
| Sinopharm Dongfeng General Hospital Coordinator of this site? Confirm its status | Shiyan | China | Not yet recruiting |
| Suizhou Central Hospital Coordinator of this site? Confirm its status | Suizhou | China | Not yet recruiting |
| Wuhan Fourth Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuhan Central Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Hubei Provincial Hospital of Integrated Chinese & Western Medicine Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tianyou Hospital Affiliated to Wuhan University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| China Resources WISCO General Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuhan Fifth Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xiangyang First People's Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Recruiting |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Not yet recruiting |
| Xianning Central Hospital Coordinator of this site? Confirm its status | Xianning | China | Recruiting |
| Xiantao First People's Hospital Coordinator of this site? Confirm its status | Xiantao | China | Not yet recruiting |
| Xiaogan Central Hospital Coordinator of this site? Confirm its status | Xiaogan | China | Recruiting |
| Sinopharm Gezhouba Central Hospital Coordinator of this site? Confirm its status | Yichang | China | Not yet recruiting |
| Renhe Hospital Affiliated to China Three Gorges University Coordinator of this site? Confirm its status | Yichang | China | Recruiting |
| Yichang Central People's Hospital Coordinator of this site? Confirm its status | Yichang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.