Improving diagnosis and treatment of diabetic retinopathy in type 2 diabetes
Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
This study is testing a new way to spot and treat diabetic eye disease in people with type 2 diabetes by using a mix of health data and advanced technology to improve care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2920 (estimated) |
| Ages | 20 Years to 79 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, China Academic / other |
| Locations | 3 sites (Lanzhou and 2 other locations) |
| Trial ID | NCT06821399 on ClinicalTrials.gov |
What this trial studies
This study integrates clinical indicators and fundus image features with metabolomics to create an early warning model for diabetic retinopathy (DR) in patients with type 2 diabetes. It aims to establish a precise DR typing model based on the age of diabetes onset and the presence of diabetic macrovascular complications. A multidisciplinary approach will be employed for comprehensive management of moderate-stage DR, utilizing cloud-based patient rooms and continuous glucose monitoring to enhance patient care. The goal is to pioneer a new management model for advanced DR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 79 with a diagnosis of type 2 diabetes who meet specific clinical criteria.
Not a fit: Patients with type 1 diabetes, severe underlying health conditions, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and more effective management of diabetic retinopathy, potentially preserving vision in patients with type 2 diabetes.
How similar studies have performed: While similar approaches have been explored, this study's integration of metabolomics with clinical indicators represents a novel approach in the management of diabetic retinopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Where this trial is running
Lanzhou and 2 other locations
- The first hosptial of lanzhou university — Lanzhou, China (Recruiting)
- Shanghai general hosptial — Shanghai, China (Recruiting)
- The forth people's hosptial of shenyang — Shenyang, China (Recruiting)
Study contacts
- Study coordinator: Liping Gu Liping Gu
- Email: guliping1980@126.com
- Phone: 86-13564720656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.