The Diabetic Retinopathy Screening, Prevention and Control Program

February 2, 2020 updated by: Guang Ning, Shanghai Jiao Tong University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Shanghai Jiao-Tong University School of Medicine
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
        • Principal Investigator:
          • Guang Ning, Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetic retinopathy
Time Frame: through study completion, up to 20 years
diabetic retinopathy
through study completion, up to 20 years
Referable diabetic retinopathy
Time Frame: through study completion, up to 20 years
Referable diabetic retinopathy
through study completion, up to 20 years
Vision threatening diabetic retinopathy
Time Frame: through study completion, up to 20 years
Vision threatening diabetic retinopathy
through study completion, up to 20 years
Diabetic macular edema
Time Frame: through study completion, up to 20 years
Diabetic macular edema
through study completion, up to 20 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c (%)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Smoking history
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Alcohol intake
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Salt intake
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Vegetable and fruits intake
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Physical activity
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Blood pressures (mmHg)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Lipids (mg/dl)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Cardiolvascular diseases
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Body mass index (BMI)
Time Frame: through study completion, up to 20 years
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
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Diastolic blood pressure
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Visceral fat (cm^2)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Fasting glucose (mmol/L)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Postprandial glucose (mmol/L)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Fasting serum C peptide (ug/L)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Postprandial serum C peptide (ug/L)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Fasting serum insuline (μIU/mL)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Postprandial serum insuline (μIU/mL)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Intimal medial thikness (mm)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Pulse wave velocity (cm/s)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years
Albumin-creatinine-ratio (mg/mmol)
Time Frame: through study completion, up to 20 years
through study completion, up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2038

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Retinopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings