Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07128186

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 intelligent screening system in early detection and intervention of cognitive impairment in T2DM patients, which constitutes the key focus of this research.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Minda Hospital Affiliated to Hubei Minzu University, Enshi, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

follow-up observation

Other

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

  1. Early Identification Accuracy of the AI System

    Time frame: From enrollment to the end of follow-up for 3-5 years

    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).

  2. Cognitive Deterioration Rate

    Time frame: From enrollment to the end of follow-up for 3-5 years

    Conversion rates from:Cognitively Normal (CN) → MCI; MCI → Alzheimer's Disease (AD)

Secondary outcomes

  1. Association Between Diabetic Metabolic Indicators and Cognitive Decline

    Time frame: From enrollment to the end of follow-up for 3-5 years

    Correlation of glucose variability (e.g., MAGE) and glycated hemoglobin (HbA1c) with changes in cognitive scores.

  2. Predictive Value of Multimodal Data

    Time frame: From enrollment to the end of follow-up for 3-5 years

    Predictive efficacy of voice features, facial expressions, drawing trajectories, and other biomarkers in forecasting cognitive deterioration

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Yang, Doctor

CONTACT

[email protected]

86-18827397697

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.