Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus

April 21, 2026 updated by: Yufan Wang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2920

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Lanzhou, China
        • Recruiting
        • The first hosptial of lanzhou university
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai general hosptial
        • Contact:
      • Shenyang, China
        • Recruiting
        • The forth people's hosptial of shenyang
        • Contact:
          • Jinsong Kuang Jinsong Kuang
          • Phone Number: 024-86203666
          • Email: Kjs_1965@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Type 2 Diabetes Mellitus Patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Fundus Examination
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Diagnostic test: Metabolomics analysis
Conduct metabolomics testing at enrollment.
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).
Diagnostic test: Fundus Examination
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Diagnostic test: Metabolomics analysis
Conduct metabolomics testing at enrollment.
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.
Diagnostic test: Fundus Examination
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Diagnostic test: Metabolomics analysis
Conduct metabolomics testing at enrollment.
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.
Diagnostic test: Fundus Examination
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Diagnostic test: Metabolomics analysis
Conduct metabolomics testing at enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fundus examination
Time Frame: 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.
Conduct examinations at enrollment and twelve months after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolomics analysis
Time Frame: at enrollment
By metabolomics, we 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 so that we can better prevent and treat diabetic retinopathy.
at enrollment
Triglycerides
Time Frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Glycated Hemoglobin
Time Frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Insulin levels
Time Frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Total Cholesterol
Time Frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yufan Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023ZD0508104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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