Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06819423

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

Led by Jie Li · Updated on 2025-02-11

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years or older
  • Diagnosed with type 2 diabetes mellitus
  • Glycated hemoglobin (HbA1c) level above 7%
  • Able to comply with all required examinations
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • No previous diabetic fundus examination
  • No known diabetic retinopathy
  • Presence of other ocular diseases that could cause retinopathy
  • Inability to obtain clear fundus photographs
  • Comorbid malignant tumors or severe cardiovascular diseases
  • Expected difficulty with follow-up or residence in other provinces

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Chengdu, Sichuan, China, 610014

Actively Recruiting

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Research Team

J

Jie Li, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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