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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: AI fundus photography

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Li, doctor; Phone Number: +86 139 0809 4675; Email: lijieyk@med.uestc.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610014
      • Recruiting
      • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
      • Contact: Jie Li, doctor; Phone Number: +86 13908094675; Email: lijieyk@med.uestc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with diabetes who received health education and AI fundus photography in our hospital	Device: 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
No Intervention: Patients with diabetes who received health education in our hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose level	Blood Glucose Control Status in Two Groups of Patients	From enrollment to reexamination at 3 months and 6 months
Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months	glycated hemoglobin (HbA1c) level	From enrollment to reexamination at 3 months and 6 months

Collaborators and Investigators

• Sponsor: Jie Li

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2024
• Primary Completion (Estimated): December 26, 2025
• Study Completion (Estimated): December 26, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-KY652-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 2030, via https://pan.baidu.com
• IPD Sharing Time Frame: 2025 and forever
• IPD Sharing Access Criteria: via https://pan.baidu.com
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No