NCT04240652

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
170mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jun 2018Jun 2040

Study Start

First participant enrolled

June 5, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2038

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2040

Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

20 years

First QC Date

January 22, 2020

Last Update Submit

February 2, 2020

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (4)

  • Diabetic retinopathy

    diabetic retinopathy

    through study completion, up to 20 years

  • Referable diabetic retinopathy

    Referable diabetic retinopathy

    through study completion, up to 20 years

  • Vision threatening diabetic retinopathy

    Vision threatening diabetic retinopathy

    through study completion, up to 20 years

  • Diabetic macular edema

    Diabetic macular edema

    through study completion, up to 20 years

Secondary Outcomes (22)

  • HbA1c (%)

    through study completion, up to 20 years

  • Smoking history

    through study completion, up to 20 years

  • Alcohol intake

    through study completion, up to 20 years

  • Salt intake

    through study completion, up to 20 years

  • Vegetable and fruits intake

    through study completion, up to 20 years

  • +17 more secondary outcomes

Study Arms (1)

Subjects with fundus photography

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Jiao-Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33087340DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, Serum and plasma are retained

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Guang Ning, MD,PHD

    Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD,PHD

CONTACT

8621-64370045guangning@medmail.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

June 5, 2018

Primary Completion (Estimated)

June 5, 2038

Study Completion (Estimated)

June 5, 2040

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(2)