Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-79
SponsorYufan Wang
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Type 2 Diabetes Mellitus Patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fundus Examination
Diagnostic testPerforming fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Metabolomics analysis
Diagnostic testConduct metabolomics testing at enrollment.
Treatment groups
2,920 Participants
are divided into 4 treatment groupsGroup A: DR High-Risk Population Cohort2 interventions
Group B: Diabetic Retinopathy Early-Stage Population Cohort2 interventions
Group C: Moderate-Stage Diabetic Retinopathy (DR) Population Cohort2 interventions
Group D: Advanced-Stage Diabetic Retinopathy (DR) Population Cohort2 interventions
Trial outcomes
Primary outcomes
1
Fundus examination
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.
Time frame
Conduct examinations at enrollment and twelve months after enrollment.Secondary outcomes
1
Metabolomics analysis
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.
Time frame
at enrollment2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yufan Wang
Lead sponsor
Shanghai General Hospital, China
Sponsor institution
Source ClinicalTrials.gov