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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06821399
Enrollment
2920
Registered
2025-02-12
Start date
2025-02-01
Completion date
2028-07-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetic Retinopathy, Type 2 Diabetes Mellitus (T2DM)

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.

Interventions

DIAGNOSTIC_TESTFundus Examination

Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).

DIAGNOSTIC_TESTMetabolomics analysis

Conduct metabolomics testing at enrollment.

Sponsors

Yufan Wang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fundus examinationConduct 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

MeasureTime frameDescription
Metabolomics analysisat enrollmentBy 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.
TriglyceridesConduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Glycated HemoglobinConduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Insulin levelsConduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Total CholesterolConduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.

Countries

China

Contacts

Primary ContactLiping Gu Liping Gu
guliping1980@126.com86-13564720656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026