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The Diabetic Retinopathy Screening, Prevention and Control Program

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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

Tracking Information
First Submitted Date January 22, 2020
First Posted Date January 27, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date June 5, 2018
Estimated Primary Completion Date June 5, 2038   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2020)
  • Diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    diabetic retinopathy
  • Referable diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    Referable diabetic retinopathy
  • Vision threatening diabetic retinopathy [ Time Frame: through study completion, up to 20 years ]
    Vision threatening diabetic retinopathy
  • Diabetic macular edema [ Time Frame: through study completion, up to 20 years ]
    Diabetic macular edema
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2020)
  • HbA1c (%) [ Time Frame: through study completion, up to 20 years ]
  • Smoking history [ Time Frame: through study completion, up to 20 years ]
  • Alcohol intake [ Time Frame: through study completion, up to 20 years ]
  • Salt intake [ Time Frame: through study completion, up to 20 years ]
  • Vegetable and fruits intake [ Time Frame: through study completion, up to 20 years ]
  • Physical activity [ Time Frame: through study completion, up to 20 years ]
  • Blood pressures (mmHg) [ Time Frame: through study completion, up to 20 years ]
  • Lipids (mg/dl) [ Time Frame: through study completion, up to 20 years ]
  • Cardiolvascular diseases [ Time Frame: 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
  • Systolic blood pressure [ Time Frame: through study completion, up to 20 years ]
  • Diastolic blood pressure [ Time Frame: through study completion, up to 20 years ]
  • Visceral fat (cm^2) [ Time Frame: through study completion, up to 20 years ]
  • Fasting glucose (mmol/L) [ Time Frame: through study completion, up to 20 years ]
  • Postprandial glucose (mmol/L) [ Time Frame: through study completion, up to 20 years ]
  • Fasting serum C peptide (ug/L) [ Time Frame: through study completion, up to 20 years ]
  • Postprandial serum C peptide (ug/L) [ Time Frame: through study completion, up to 20 years ]
  • Fasting serum insuline (μIU/mL) [ Time Frame: through study completion, up to 20 years ]
  • Postprandial serum insuline (μIU/mL) [ Time Frame: through study completion, up to 20 years ]
  • Intimal medial thikness (mm) [ Time Frame: through study completion, up to 20 years ]
  • Pulse wave velocity (cm/s) [ Time Frame: through study completion, up to 20 years ]
  • Albumin-creatinine-ratio (mg/mmol) [ Time Frame: through study completion, up to 20 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Diabetic Retinopathy Screening, Prevention and Control Program
Official Title The Diabetic Retinopathy Screening, Prevention and Control Program
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Retention:   Samples With DNA
Description:
DNA, Serum and plasma are retained
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.
Condition Diabetic Retinopathy
Intervention Not Provided
Study Groups/Cohorts Subjects with fundus photography
Subjects diagnosed with diabetes or not who have fundus images from MMCs and other medical institutes.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 22, 2020)
500000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 5, 2040
Estimated Primary Completion Date June 5, 2038   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Guang Ning, MD,PHD 8621-64370045 ext 665344 guangning@medmail.com.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240652
Other Study ID Numbers Ruijin-20191231
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Guang Ning, Shanghai Jiao Tong University School of Medicine
Study Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Guang Ning, MD,PHD Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date February 2020