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

Sponsor
Yufan Wang
Study ID
NCT06821399
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Fundus Examination — DIAGNOSTIC_TEST
    Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
  • Metabolomics analysis — DIAGNOSTIC_TEST
    Conduct metabolomics testing at enrollment.

Study Details

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.

Key Dates

First listed
Feb 12, 2025
Start date
Feb 1, 2025
Status verified
May 2025
Primary completion
Aug 31, 2025
Completion
Jul 31, 2028

Study Design

Enrollment
2,920 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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).
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Fundus examination [ Time Frame: Conduct examinations at enrollment and twelve months after enrollment. ]

Central Contacts

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