Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06819423

The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients

This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT).

Using a random number table, 200 diabetic patients visiting the Department of Endocrinology at Sichuan Provincial People's Hospital between December 2024 and December 2025 will be equally divided into two groups: an intervention group and a control group. Each group will consist of 100 patients, assigned unique random numbers. The intervention group will undergo AI-based fundus imaging once, with the imaging process taking approximately 5 minutes. The control group will receive standard eye health education without AI fundus imaging.

The primary outcomes, including blood glucose control, systemic indicators, and fundus examination completion rates, will be assessed and compared between the two groups at 3-month and 6-month follow-ups. This study seeks to determine the value of AI-based fundus imaging in improving diabetes management and complication prevention in diabetic patients.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610014, China

Location status: Recruiting

Location contact

Jie Li, doctor

CONTACT

[email protected]

+86 13908094675

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of Type 2 Diabetes Mellitus.
  • Patients with a glycated hemoglobin (HbA1c) level > 7%.
  • Ability to comply with all required examinations and provide signed informed consent.

Exclusion criteria

  • No previous diabetic fundus examination.
  • No known diabetic retinopathy.
  • Absence of other ocular diseases that could lead to retinopathy.
  • Subjects from whom clear fundus photographs could not be obtained.
  • Patients with comorbid malignant tumors or severe cardiovascular diseases.
  • Patients anticipated to have difficulties with follow-up or those residing in other provinces.

Treatment and study plan

AI fundus photography

Device

In the dark room, Canon CR-2AF automatic mydria-free fundus camera was used to collect images of both eyes of the patients, and one fundus photo was taken with macula as the center of each eye

Primary outcomes

  1. fasting blood glucose level

    Time frame: From enrollment to reexamination at 3 months and 6 months

    Blood Glucose Control Status in Two Groups of Patients

  2. Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months

    Time frame: From enrollment to reexamination at 3 months and 6 months

    glycated hemoglobin (HbA1c) level

Study contacts

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

Jie Li, doctor

CONTACT

[email protected]

+86 139 0809 4675

Sponsors and collaborators

Lead sponsor

Jie Li

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 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.

Related clinical trials

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