Program for screening and preventing diabetic retinopathy
The Diabetic Retinopathy Screening, Prevention and Control Program
Shanghai Jiao Tong University School of Medicine · NCT04240652
This study is testing a new program that uses advanced technology to help find and manage diabetic retinopathy early in diabetes patients in China.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT04240652 on ClinicalTrials.gov |
What this trial studies
This program aims to address the high rates of diabetic retinopathy (DR) among diabetes patients in China by implementing an efficient workflow for early detection and management of the condition. Utilizing deep learning technology, the program seeks to enhance the sensitivity and specificity of DR screening through automated grading systems. Participants will be recruited from various medical institutes to explore the prevalence of DR and gather data on genetics, biomarkers, and lifestyle factors that may contribute to the disease. The ultimate goal is to establish a referral system for timely treatment and long-term follow-up of DR patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with type 2 diabetes and those from other medical institutes, including non-diabetic patients and healthy participants.
Not a fit: Patients with a history of drug abuse or active infectious diseases may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of blindness caused by diabetic retinopathy through early detection and intervention.
How similar studies have performed: Other studies utilizing deep learning for medical imaging have shown promising results, indicating potential success for this approach in diabetic retinopathy screening.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for type 2 diabetes according to the World Health Organization (WHO) in 1999; Type 1 diabetes, single gene mutation diabetes, secondary diabetes caused by pancreatic damage, Cushing's syndrome, thyroid dysfunction, or acromegaly; * Subjects from other medical institutes are diabetes, non-diabetic patients and healthy participants who are invited to participate in the study. Exclusion Criteria: * Those who have a history of drug abuse; * Sexually transmitted diseases such as AIDS and syphilis, and infectious diseases such as viral hepatitis and tuberculosis which are at active phase; * Any condition that the investigator think that the subject is not suitable for participating in the study. For detailed In-/Ex-clusion criteria please see the study protocol.
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
- Shanghai Jiao-Tong University School of Medicine — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Guang Ning, MD,PHD — Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
- Study coordinator: Guang Ning, MD,PHD
- Email: guangning@medmail.com.cn
- Phone: 8621-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Retinopathy