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

Yufan Wang

Status: Enrolling

Conditions: Diabetes; Type 2 Diabetes Mellitus (T2DM); Diabetic Retinopathy

Treatments: Diagnostic Test: Fundus Examination; Diagnostic Test: Metabolomics analysis

Study type: Observational

Funder types: Other

Identifiers

NCT06821399

2023ZD0508104

Details and patient eligibility

About

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.

Enrollment: 2,920 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,920 participants in 4 patient groups

DR High-Risk Population Cohort

Description:

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.

Treatment:

Diagnostic Test: Metabolomics analysis

Diagnostic Test: Fundus Examination

Diabetic Retinopathy Early-Stage Population Cohort

Description:

Seeking specific metabolites that can reflect diabetic retinopathy and its severity in early - onset and late - onset type 2 diabetes mellitus (T2DM).

Treatment:

Diagnostic Test: Metabolomics analysis

Diagnostic Test: Fundus Examination

Moderate-Stage Diabetic Retinopathy (DR) Population Cohort

Description:

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.

Treatment:

Diagnostic Test: Metabolomics analysis

Diagnostic Test: Fundus Examination

Advanced-Stage Diabetic Retinopathy (DR) Population Cohort

Description:

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.

Treatment:

Diagnostic Test: Metabolomics analysis

Diagnostic Test: Fundus Examination