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Diabetic RetinopathyNCT04240652

The Diabetic Retinopathy Screening, Prevention and Control Program

An observational study of Diabetic Retinopathy, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Retinopathy
How many people
500,000 participants
Where
2 sitesChina
Study dates
5 Jun 2018to 5 Jun 2040
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Guang Ning, MD,PHD contact

8621-64370045 ext. 665344

guangning@medmail.com.cn

China2 sites, 2 recruiting

  • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Guang Ning, Professor, 8621-64370045 ext. 671817, feifei1116@hotmail.com

    Guang Ning, Professor

    Recruiting

  • Shanghai Jiao-Tong University School of Medicine

    Shanghai, 200025

    Guang Ning, MD,PHD, 008621 64370045 ext. 671817, guangning@medmail.com.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04240652
Study groupRoleWhat they receive
Subjects with fundus photographySubjects diagnosed with diabetes or not who have fundus images from MMCs and other medical institutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetic retinopathy

    diabetic retinopathy

    Measured: through study completion, up to 20 years

  2. Referable diabetic retinopathy

    Referable diabetic retinopathy

    Measured: through study completion, up to 20 years

  3. Vision threatening diabetic retinopathy

    Vision threatening diabetic retinopathy

    Measured: through study completion, up to 20 years

  4. Diabetic macular edema

    Diabetic macular edema

    Measured: through study completion, up to 20 years

Secondary outcomes (22)

  1. HbA1c (%)

    Measured: through study completion, up to 20 years

  2. Smoking history

    Measured: through study completion, up to 20 years

  3. Alcohol intake

    Measured: through study completion, up to 20 years

  4. Salt intake

    Measured: through study completion, up to 20 years

  5. Vegetable and fruits intake

    Measured: through study completion, up to 20 years

  6. Physical activity

    Measured: through study completion, up to 20 years

  7. Blood pressures (mmHg)

    Measured: through study completion, up to 20 years

  8. Lipids (mg/dl)

    Measured: through study completion, up to 20 years

  9. Cardiolvascular diseases

    Measured: through study completion, up to 20 years

  10. Body mass index (BMI)

    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2

    Measured: through study completion, up to 20 years

  11. Systolic blood pressure

    Measured: through study completion, up to 20 years

  12. Diastolic blood pressure

    Measured: through study completion, up to 20 years

  13. Visceral fat (cm^2)

    Measured: through study completion, up to 20 years

  14. Fasting glucose (mmol/L)

    Measured: through study completion, up to 20 years

  15. Postprandial glucose (mmol/L)

    Measured: through study completion, up to 20 years

  16. Fasting serum C peptide (ug/L)

    Measured: through study completion, up to 20 years

  17. Postprandial serum C peptide (ug/L)

    Measured: through study completion, up to 20 years

  18. Fasting serum insuline (μIU/mL)

    Measured: through study completion, up to 20 years

  19. Postprandial serum insuline (μIU/mL)

    Measured: through study completion, up to 20 years

  20. Intimal medial thikness (mm)

    Measured: through study completion, up to 20 years

  21. Pulse wave velocity (cm/s)

    Measured: through study completion, up to 20 years

  22. Albumin-creatinine-ratio (mg/mmol)

    Measured: through study completion, up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start5 Jun 2018
  3. Primary completion5 Jun 2038 (estimated)
  4. Study completion5 Jun 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500,000 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04240652
Sponsor's protocol ID
Ruijin-20191231
Status last verified
Feb 2020
First submitted
22 Jan 2020
Last updated
5 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 33087340

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Retinopathy, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guang Ning, MD,PHD (8621-64370045 ext. 665344, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetic retinopathy (time frame: through study completion, up to 20 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04240652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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Clinical Trial NCT04240652 | AzTrials