Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how AI-based fundus imaging affects blood glucose control and the rate at which diabetic patients complete fundus eye exams. This randomized controlled trial involves 200 diabetic patients to see if using AI imaging improves diabetes management and early detection of complications. The study is led by Jie Li and takes place at Sichuan Provincial People's Hospital. Participants are randomly divided into two groups of 100 each. The intervention group receives AI fundus photography using a specialized Canon camera that captures images of both eyes without pupil dilation. This imaging takes about 5 minutes and happens once. The control group receives standard eye health education but does not undergo AI imaging. Patients will be followed up after 3 and 6 months to measure fasting blood glucose levels, overall blood glucose control, and fundus exam completion rates. Assessments include systemic indicators related to diabetes management. The study aims to determine if AI fundus imaging can add value in preventing diabetic complications. Participation lasts at least 6 months with evaluations at scheduled intervals.
CONDITIONS
Brief Title
The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years or older
- Diagnosis of Type 2 Diabetes Mellitus
- Glycated hemoglobin (HbA1c) level greater than 7%
- Ability to comply with all required examinations
- Signed informed consent provided
You will not qualify if you...
- No previous diabetic fundus examination
- No known diabetic retinopathy
- Presence of other ocular diseases that could cause retinopathy
- Unable to obtain clear fundus photographs
- Diagnosis of malignant tumors or severe cardiovascular diseases
- Difficulty with follow-up or living in other provinces
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive AI-based fundus photography imaging as part of the study device intervention.
Visits at enrollment, 3 months, and 6 months for reexaminations
Trial Site Locations
Total: 1 location
1
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610014
Actively Recruiting
Research Team
J
Jie Li, doctor
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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