Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
1 other identifier
observational
2,920
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2025
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
ExpectedApril 23, 2026
May 1, 2025
7 months
January 2, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Fundus examination
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.
Conduct examinations at enrollment and twelve months after enrollment.
Secondary Outcomes (5)
Metabolomics analysis
at enrollment
Triglycerides
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Glycated Hemoglobin
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.
Total Cholesterol
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Study Arms (4)
DR High-Risk Population Cohort
An annual follow - up fundus examination is conducted. Metabolic differences are analyzed between the population with progressed diabetic retinopathy (DR) and those without progression. A predictive model for early warning of DR in type 2 diabetes is constructed to forecast the onset of DR one year later.
Diabetic Retinopathy Early-Stage Population Cohort
Seeking specific metabolites that can reflect diabetic retinopathy and its severity in early - onset and late - onset type 2 diabetes mellitus (T2DM).
Moderate-Stage Diabetic Retinopathy (DR) Population Cohort
Exploring a multidisciplinary model of chronic disease management for patients in the middle stage of diabetic retinopathy (DR), with both the endocrinology department and the ophthalmology department jointly developing standardized standard operating procedures for systemic and ocular examinations of metabolic diseases.
Advanced-Stage Diabetic Retinopathy (DR) Population Cohort
The establishment of an integrated ward for diabetic eye diseases. For patients with severe diabetic eye diseases who urgently need ophthalmic surgery in the short term but have poor blood glucose control, the ophthalmology and endocrinology departments jointly manage and treat the patients. Endocrinologists adjust the blood glucose - lowering treatment plan. After the blood glucose stabilizes, ophthalmic surgery is performed. Continuous glucose monitoring is used to closely observe blood glucose fluctuations during the hospital stay, including intraoperative blood glucose. After the surgery, both ophthalmologists and endocrinologists jointly follow up with the patients.
Interventions
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Conduct metabolomics testing at enrollment.
Eligibility Criteria
Type 2 Diabetes Mellitus Patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yufan Wanglead
Study Sites (3)
The first hosptial of lanzhou university
Lanzhou, China
Shanghai general hosptial
Shanghai, China
The forth people's hosptial of shenyang
Shenyang, China
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
January 2, 2025
First Posted
February 12, 2025
Study Start
February 1, 2025
Primary Completion
August 31, 2025
Study Completion (Estimated)
July 31, 2028
Last Updated
April 23, 2026
Record last verified: 2025-05