NCT06819423 The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
| NCT ID | NCT06819423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jie Li |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2025-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-12-26 with a primary completion date of 2025-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06819423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06819423 currently recruiting?
Yes, NCT06819423 is actively recruiting participants. Contact the research team at lijieyk@med.uestc.edu.cn for enrollment information.
Where is the NCT06819423 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06819423 clinical trial?
NCT06819423 is sponsored by Jie Li. The trial plans to enroll 200 participants.
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