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

February 10, 2025 updated by: Jie Li

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610014
        • Recruiting
        • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From enrollment to reexamination at 3 months and 6 months
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
Time Frame: From enrollment to reexamination at 3 months and 6 months
glycated hemoglobin (HbA1c) level
From enrollment to reexamination at 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jie Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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