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NCT Number: NCT06821399

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

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Type 2 Diabetes Mellitus (T2DM) Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hosptial of lanzhou university, Lanzhou, China

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Triglycerides

    Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

  3. Glycated Hemoglobin

    Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

  4. Insulin levels

    Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

  5. Total Cholesterol

    Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

Study contacts

Contact information is provided by the study sponsor or research team.

Liping Gu Liping Gu

CONTACT

[email protected]

86-13564720656

Sponsors and collaborators

Lead sponsor

Yufan Wang

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Feb 12, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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