The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- fasting blood glucose level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with diabetes who received health education and AI fundus photography in our hospital
干预措施: AI fundus photography (Device)
Patients with diabetes who received health education in our hospital
结局指标
主要结局
fasting blood glucose level
时间窗: 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
时间窗: From enrollment to reexamination at 3 months and 6 months
glycated hemoglobin (HbA1c) level
次要结局
未报告次要终点
研究者
Jie Li
Principal Investigator
Sichuan Provincial People's Hospital