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

ConditionDiabetes

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJie Li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Patients with diabetes who received health education and AI fundus photography in our hospitalExperimental treatment 1 intervention

Group B: Patients with diabetes who received health education in our hospitalNo intervention 0 interventions

Trial outcomes

Primary outcomes

fasting blood glucose level

Blood Glucose Control Status in Two Groups of Patients

Time frame

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

Time frame

From enrollment to reexamination at 3 months and 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jie Li

Lead sponsor

Sichuan Provincial People's Hospital

Sponsor institution

Source ClinicalTrials.gov

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