Diabetes
Conditions
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.
Interventions
DEVICEAI 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
Sponsors
Jie Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose level | From enrollment to reexamination at 3 months and 6 months | Blood Glucose Control Status in Two Groups of Patients |
| Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months | From enrollment to reexamination at 3 months and 6 months | glycated hemoglobin (HbA1c) level |
Countries
China
Contacts
Primary ContactJie Li, doctor
Outcome results
None listed