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

Jie Li

Status

Enrolling

Conditions

Diabetes

Treatments

Device: AI fundus photography

Study type

Interventional

Funder types

Other

Identifiers

NCT06819423

2024-KY652-1

Details and patient eligibility

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.