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

NCT ID: NCT06819423

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-26
• Study Completion Date: 2025-12-26

Brief Summary

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Patients with diabetes who received health education and AI fundus photography in our hospital

Group Type: EXPERIMENTAL

AI fundus photography

Intervention Type: 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

Patients with diabetes who received health education in our hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AI fundus photography

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jie Li

OTHER

Sponsor Role: lead

Responsible Party

Jie Li

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Li, doctor

Role: CONTACT

lijieyk@med.uestc.edu.cn

+86 139 0809 4675

Facility Contacts

Jie Li, doctor

Role: primary

lijieyk@med.uestc.edu.cn

+86 13908094675

Other Identifiers

2024-KY652-1

Identifier Type: -

Identifier Source: org_study_id