Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,920
- 试验地点
- 3
- 主要终点
- Fundus examination
研究概览
简要总结
This study aims to integrate clinical indicators and features of fundus images, combined with metabolomics, to construct an early warning model for diabetic retinopathy (DR) in type 2 diabetes. By combining clinical indicators with metabolomics, the investigators aim to establish a precise DR typing model based on the age of diabetes onset (early-onset diabetes, late-onset diabetes) and based on the coexistence with two types of diabetic macrovascular complications. A multidisciplinary collaboration will be conducted for comprehensive management of DR to control the progression of moderate-stage DR. Cloud-based patient rooms combined with continuous glucose monitoring (CGM) will further explore the role of integrated diabetes retinopathy ward management models in the management of patients undergoing diabetes retinopathy surgery, pioneering a new model for the management of advanced 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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for type 2 diabetes in the "China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)";
- •Aged between 20 and 79 years old, without other severe underlying diseases; ③ Possesses full cognitive and literacy abilities; ④ Volunteers to participate in this study and are willing to sign an informed consent form.
排除标准
- •Those who have been diagnosed with type 1 or other types of diabetes;
- •Those with severe cardiac, pulmonary, hepatic, or renal insufficiency;
- •Those with mental confusion, speech disorders, or dementia, etc.;
- •Those who are unable to take care of themselves, bedridden, or have mobility impairments; ⑤ Women who are breastfeeding or pregnant;
- •Those with a recent history of surgery, trauma, acute major vascular complications, or infectious diseases.
结局指标
主要结局
Fundus examination
时间窗: Conduct examinations at enrollment and twelve months after enrollment.
Assess the severity of diabetic retinopathy (DR), and group accordingly. The high - risk DR cohort and the early - stage DR cohort have a fundus examination once a year; the mid - stage DR cohort has a fundus examination every six months; the late - stage DR cohort has a fundus examination every three months.
次要结局
- Metabolomics analysis(at enrollment)
- Glycated Hemoglobin(Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.)
- Total Cholesterol(Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.)
- Triglycerides(Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.)
- Insulin levels(Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.)
研究者
Yufan Wang
Chief Physician
Shanghai General Hospital, China