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

NCT06819423 | Recruiting

• 1 other identifier: 2024-KY652-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

EXPERIMENTAL

Device: AI fundus photography

Patients with diabetes who received health education in our hospital

NO INTERVENTION

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Li: lead

Study Sites (1)

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

Chengdu, Sichuan, 610014, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jie Li, doctor

CONTACT

+86 139 0809 4675; lijieyk@med.uestc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: December 26, 2024
• Primary Completion: December 26, 2025
• Study Completion: December 26, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2025 and forever
• Access Criteria: via https://pan.baidu.com

Locations

CN (1)