The Diabetic Retinopathy Screening, Prevention and Control Program

Diabetic Retinopathy Clinical Trial

Official title:

The Diabetic Retinopathy Screening, Prevention and Control Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240652
• Other study ID #: Ruijin-20191231
• Status: Recruiting
• Start date: June 5, 2018
• Est. completion date: June 5, 2040

Study information

• Verified date: February 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Guang Ning, MD,PHD
• Phone: 8621-64370045
• Email: guangning[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The greatest harm of diabetes is various acute and chronic complications, especially diabetic retinopathy(DR), leading to extremely high rates of disability and blindness. Early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate. To change this situation, deep learning(DL), a form of artificial intelligence (AI), might be a potential effective method to solve this dilemma.

Description:

The greatest harm of diabetes is various acute and chronic complications, especially DR, leading to extremely high rates of disability and blindness. However, if the fundus examination is carried out regularly in the early stages of onset, the risk of blindness can be significantly reduced. Therefore, early screening, early diagnosis, and early treatment are the keys to maintaining vision in patients with DR. However, compared with the high prevalence of diabetes in China, the DR screening ability is relatively inadequate.

The Diabetic Retinopathy Screening and Prevention Program is a branch project of MMC. Its purpose is to carry out an efficient workflow for early detecting, timely managing of DR, and to establish a referral system for implementing treatment and the long-term follow-up of DR by means of DL. First, In order to improve its sensitivity and specificity, more participants are involved in other medical institutes besides MMCs, then we can effectively explore the prevalance of DR in China and helps to early screening, prevention, treatment and referal process of DR. Secend, we collect participants' serum, plasma,DNA, several medical stastistics and life styles to explore genetics, new biomarkers, risk factors of DR.

Objective:

1. To validate the methodology and feasibility of DR screening using a DL based automated DR grading system in clinical practice.

2. To explore the prevalence of DR and subgroup identification, and fundus images analysis, etc.

3. To explore the genetics, new biomarkers, risk factors of DR.

4. To explore the methods of early screening, prevention, treatment and referal process of DR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500000
• Est. completion date: June 5, 2040
• Est. primary completion date: June 5, 2038
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiao-Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Jiao-Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic retinopathy	diabetic retinopathy	through study completion, up to 20 years
Primary	Referable diabetic retinopathy	Referable diabetic retinopathy	through study completion, up to 20 years
Primary	Vision threatening diabetic retinopathy	Vision threatening diabetic retinopathy	through study completion, up to 20 years
Primary	Diabetic macular edema	Diabetic macular edema	through study completion, up to 20 years
Secondary	HbA1c (%)		through study completion, up to 20 years
Secondary	Smoking history		through study completion, up to 20 years
Secondary	Alcohol intake		through study completion, up to 20 years
Secondary	Salt intake		through study completion, up to 20 years
Secondary	Vegetable and fruits intake		through study completion, up to 20 years
Secondary	Physical activity		through study completion, up to 20 years
Secondary	Blood pressures (mmHg)		through study completion, up to 20 years
Secondary	Lipids (mg/dl)		through study completion, up to 20 years
Secondary	Cardiolvascular diseases		through study completion, up to 20 years
Secondary	Body mass index (BMI)	Body weight (kg) and height (m) will be combined to report BMI in kg/m^2	through study completion, up to 20 years
Secondary	Systolic blood pressure		through study completion, up to 20 years
Secondary	Diastolic blood pressure		through study completion, up to 20 years
Secondary	Visceral fat (cm^2)		through study completion, up to 20 years
Secondary	Fasting glucose (mmol/L)		through study completion, up to 20 years
Secondary	Postprandial glucose (mmol/L)		through study completion, up to 20 years
Secondary	Fasting serum C peptide (ug/L)		through study completion, up to 20 years
Secondary	Postprandial serum C peptide (ug/L)		through study completion, up to 20 years
Secondary	Fasting serum insuline (µIU/mL)		through study completion, up to 20 years
Secondary	Postprandial serum insuline (µIU/mL)		through study completion, up to 20 years
Secondary	Intimal medial thikness (mm)		through study completion, up to 20 years
Secondary	Pulse wave velocity (cm/s)		through study completion, up to 20 years
Secondary	Albumin-creatinine-ratio (mg/mmol)		through study completion, up to 20 years