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NCT Number: NCT04240652

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, Shanghai Municipality, China

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About this study

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:

  • To validate the methodology and feasibility of DR screening using a DL based automated DR grading system in clinical practice.
  • To explore the prevalence of DR and subgroup identification, and fundus images analysis, etc.
  • To explore the genetics, new biomarkers, risk factors of DR.
  • To explore the methods of early screening, prevention, treatment and referal process of DR.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Guang Ning, MD,PHD

CONTACT

[email protected]

8621-64370045 ext. 665344

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2038
Study completion
2040
First posted
Jan 27, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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