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Recruiting NCT07128186

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

— Observational Cognitive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: follow-up observation.
Who it may be relevant to
Registry conditions: Cognitive Dysfunction. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 outcome measures

  • Early Identification Accuracy of the AI System [Time frame: From enrollment to the end of follow-up for 3-5 years]
  • Cognitive Deterioration Rate [Time frame: From enrollment to the end of follow-up for 3-5 years]
Secondary outcome measures (2)
  • Association Between Diabetic Metabolic Indicators and Cognitive Decline [Time frame: From enrollment to the end of follow-up for 3-5 years]
  • Predictive Value of Multimodal Data [Time frame: From enrollment to the end of follow-up for 3-5 years]

Eligibility criteria

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:
  • 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).

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 21 centers
  • Minda Hospital Affiliated to Hubei Minzu University — Enshi
  • Huanggang Central Hospital — Huanggang
  • Huangshi Central Hospital — Huangshi
  • Jingzhou Central Hospital — Jingzhou
  • Sinopharm Dongfeng General Hospital — Shiyan
  • Suizhou Central Hospital — Suizhou
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • China Resources & WISCO General Hospital — Wuhan
  • … and 13 more centers

Identifiers

NCT: NCT07128186 · TJ-IRB202503076

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗