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The Diabetic Retinopathy Screening, Prevention and Control Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240652
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: The Diabetic Retinopathy Screening, Prevention and Control Program
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : June 5, 2038
Estimated Study Completion Date : June 5, 2040

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    diabetic retinopathy

  2. Referable diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    Referable diabetic retinopathy

  3. Vision threatening diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    Vision threatening diabetic retinopathy

  4. Diabetic macular edema [ Time Frame: through study completion, up to 20 years ]
    Diabetic macular edema


Secondary Outcome Measures :
  1. HbA1c (%) [ Time Frame: through study completion, up to 20 years ]
  2. Smoking history [ Time Frame: through study completion, up to 20 years ]
  3. Alcohol intake [ Time Frame: through study completion, up to 20 years ]
  4. Salt intake [ Time Frame: through study completion, up to 20 years ]
  5. Vegetable and fruits intake [ Time Frame: through study completion, up to 20 years ]
  6. Physical activity [ Time Frame: through study completion, up to 20 years ]
  7. Blood pressures (mmHg) [ Time Frame: through study completion, up to 20 years ]
  8. Lipids (mg/dl) [ Time Frame: through study completion, up to 20 years ]
  9. Cardiolvascular diseases [ Time Frame: through study completion, up to 20 years ]
  10. 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

  11. Systolic blood pressure [ Time Frame: through study completion, up to 20 years ]
  12. Diastolic blood pressure [ Time Frame: through study completion, up to 20 years ]
  13. Visceral fat (cm^2) [ Time Frame: through study completion, up to 20 years ]
  14. Fasting glucose (mmol/L) [ Time Frame: through study completion, up to 20 years ]
  15. Postprandial glucose (mmol/L) [ Time Frame: through study completion, up to 20 years ]
  16. Fasting serum C peptide (ug/L) [ Time Frame: through study completion, up to 20 years ]
  17. Postprandial serum C peptide (ug/L) [ Time Frame: through study completion, up to 20 years ]
  18. Fasting serum insuline (μIU/mL) [ Time Frame: through study completion, up to 20 years ]
  19. Postprandial serum insuline (μIU/mL) [ Time Frame: through study completion, up to 20 years ]
  20. Intimal medial thikness (mm) [ Time Frame: through study completion, up to 20 years ]
  21. Pulse wave velocity (cm/s) [ Time Frame: through study completion, up to 20 years ]
  22. Albumin-creatinine-ratio (mg/mmol) [ Time Frame: through study completion, up to 20 years ]

Biospecimen Retention:   Samples With DNA
DNA, Serum and plasma are retained


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240652


Contacts
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Contact: Guang Ning, MD,PHD 8621-64370045 ext 665344 guangning@medmail.com.cn

Locations
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China, Shanghai
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, Professor    8621-64370045 ext 671817    feifei1116@hotmail.com   
Principal Investigator: Guang Ning, Professor         
China
Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Guang Ning, MD,PHD    008621 64370045 ext 671817    guangning@medmail.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guang Ning, MD,PHD Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04240652    
Other Study ID Numbers: Ruijin-20191231
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases