The Diabetic Retinopathy Screening, Prevention and Control Program

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500000

Contacts and Locations

• Study Contact: Name: Guang Ning, MD,PHD; Phone Number: 665344 8621-64370045; Email: guangning@medmail.com.cn

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Shanghai Jiao-Tong University School of Medicine
    • Contact: Guang Ning, MD,PHD; Phone Number: 671817 008621 64370045; Email: guangning@medmail.com.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
      • Principal Investigator: Guang Ning, Professor
      • Contact: Guang Ning, Professor; Phone Number: 671817 8621-64370045; Email: feifei1116@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetes patients under the management of MMC, and diabetes, non-diabetic, and healthy participants from other medical institutes who meet the In-/Ex-clusion Criteria will be included in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with fundus photography; Subjects diagnosed with diabetes or not who have fundus images from MMCs and other medical institutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic retinopathy	diabetic retinopathy	through study completion, up to 20 years
Referable diabetic retinopathy	Referable diabetic retinopathy	through study completion, up to 20 years
Vision threatening diabetic retinopathy	Vision threatening diabetic retinopathy	through study completion, up to 20 years
Diabetic macular edema	Diabetic macular edema	through study completion, up to 20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%)		through study completion, up to 20 years
Smoking history		through study completion, up to 20 years
Alcohol intake		through study completion, up to 20 years
Salt intake		through study completion, up to 20 years
Vegetable and fruits intake		through study completion, up to 20 years
Physical activity		through study completion, up to 20 years
Blood pressures (mmHg)		through study completion, up to 20 years
Lipids (mg/dl)		through study completion, up to 20 years
Cardiolvascular diseases		through study completion, up to 20 years
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
Systolic blood pressure		through study completion, up to 20 years
Diastolic blood pressure		through study completion, up to 20 years
Visceral fat (cm^2)		through study completion, up to 20 years
Fasting glucose (mmol/L)		through study completion, up to 20 years
Postprandial glucose (mmol/L)		through study completion, up to 20 years
Fasting serum C peptide (ug/L)		through study completion, up to 20 years
Postprandial serum C peptide (ug/L)		through study completion, up to 20 years
Fasting serum insuline (μIU/mL)		through study completion, up to 20 years
Postprandial serum insuline (μIU/mL)		through study completion, up to 20 years
Intimal medial thikness (mm)		through study completion, up to 20 years
Pulse wave velocity (cm/s)		through study completion, up to 20 years
Albumin-creatinine-ratio (mg/mmol)		through study completion, up to 20 years

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China

Publications and helpful links

General Publications

• Zhang Y, Shi J, Peng Y, Zhao Z, Zheng Q, Wang Z, Liu K, Jiao S, Qiu K, Zhou Z, Yan L, Zhao D, Jiang H, Dai Y, Su B, Gu P, Su H, Wan Q, Peng Y, Liu J, Hu L, Ke T, Chen L, Xu F, Dong Q, Terzopoulos D, Ning G, Xu X, Ding X, Wang W. Artificial intelligence-enabled screening for diabetic retinopathy: a real-world, multicenter and prospective study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001596. doi: 10.1136/bmjdrc-2020-001596.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Anticipated): June 5, 2038
• Study Completion (Anticipated): June 5, 2040

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: Ruijin-20191231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No