The Diabetic Retinopathy Screening, Prevention and Control Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500,000
- 试验地点
- 2
- 主要终点
- Diabetic macular edema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diabetic macular edema
时间窗: through study completion, up to 20 years
Diabetic macular edema
Referable diabetic retinopathy
时间窗: through study completion, up to 20 years
Referable diabetic retinopathy
Diabetic retinopathy
时间窗: through study completion, up to 20 years
diabetic retinopathy
Vision threatening diabetic retinopathy
时间窗: through study completion, up to 20 years
Vision threatening diabetic retinopathy
次要结局
- Physical activity(through study completion, up to 20 years)
- Blood pressures (mmHg)(through study completion, up to 20 years)
- Visceral fat (cm^2)(through study completion, up to 20 years)
- Fasting serum C peptide (ug/L)(through study completion, up to 20 years)
- Postprandial serum C peptide (ug/L)(through study completion, up to 20 years)
- Postprandial serum insuline (μIU/mL)(through study completion, up to 20 years)
- Postprandial glucose (mmol/L)(through study completion, up to 20 years)
- Cardiolvascular diseases(through study completion, up to 20 years)
- HbA1c (%)(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)
- Lipids (mg/dl)(through study completion, up to 20 years)
- Diastolic blood pressure(through study completion, up to 20 years)
- Fasting serum insuline (μIU/mL)(through study completion, up to 20 years)
- Intimal medial thikness (mm)(through study completion, up to 20 years)
- Pulse wave velocity (cm/s)(through study completion, up to 20 years)
- Albumin-creatinine-ratio (mg/mmol)(through study completion, up to 20 years)
- Smoking history(through study completion, up to 20 years)
- Vegetable and fruits intake(through study completion, up to 20 years)
- Systolic blood pressure(through study completion, up to 20 years)
- Body mass index (BMI)(through study completion, up to 20 years)
- Fasting glucose (mmol/L)(through study completion, up to 20 years)
研究者
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine