Clinical trial NCT06821399: Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
Official title: Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Diabetic Retinopathy
Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Shanghai General Hospital, China
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 2920
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 Diabetes Mellitus Patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fundus examination
timeFrame: Conduct examinations at enrollment and twelve months after enrollment.
Secondary outcomes:
measure: Metabolomics analysis
timeFrame: at enrollment
measure: Triglycerides
timeFrame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
measure: Glycated Hemoglobin
timeFrame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
measure: Insulin levels
timeFrame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
measure: Total Cholesterol
timeFrame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The first hosptial of lanzhou university
city: Shanghai
country: China
facility: Shanghai general hosptial
city: Shenyang
country: China
facility: The forth people's hosptial of shenyang
Study officials:
References: