DiabetesNCT06821399
Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetic Retinopathy, run by Yufan Wang at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetes, Diabetic Retinopathy, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Fundus Examination and Metabolomics analysis
- How many people
- 2,920 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2025to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Adult, Older adult
Study population: Type 2 Diabetes Mellitus Patients
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The first hosptial of lanzhou university
Lanzhou
Jie Han Jie Han, 13893633986, 540441755@qq.com
- Recruiting
Shanghai general hosptial
Shanghai
Liping Gu Liping Gu, 13564720656, guliping1980@126.com
- Recruiting
The forth people's hosptial of shenyang
Shenyang
Jinsong Kuang Jinsong Kuang, 024-86203666, Kjs_1965@163.com
About this study
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.
- Being tested
- Fundus Examination, Metabolomics analysis
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus ExaminationDiagnostic test
Performing fundus photography on patients to assess the progression of diabetic retinopathy (DR).
Metabolomics analysisDiagnostic test
Conduct metabolomics testing at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| DR High-Risk Population Cohort | 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. Receives: Diagnostic Test: Fundus Examination; Diagnostic Test: Metabolomics analysis | |
| Diabetic Retinopathy Early-Stage Population Cohort | Seeking specific metabolites that can reflect diabetic retinopathy and its severity in early - onset and late - onset type 2 diabetes mellitus (T2DM). Receives: Diagnostic Test: Fundus Examination; Diagnostic Test: Metabolomics analysis | |
| Moderate-Stage Diabetic Retinopathy (DR) Population Cohort | 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. Receives: Diagnostic Test: Fundus Examination; Diagnostic Test: Metabolomics analysis | |
| Advanced-Stage Diabetic Retinopathy (DR) Population Cohort | 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. Receives: Diagnostic Test: Fundus Examination; Diagnostic Test: Metabolomics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Conduct examinations at enrollment and twelve months after enrollment.
Secondary outcomes (5)
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.
Measured: at enrollment
Triglycerides
Measured: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Glycated Hemoglobin
Measured: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Insulin levels
Measured: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Total Cholesterol
Measured: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Feb 2025
- Primary completion31 Aug 2025
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yufan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yufan Wang, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821399
- Sponsor's protocol ID
- 2023ZD0508104
- Status last verified
- May 2025
- First submitted
- 2 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06821399
- Acronym / sponsor ID
- 2023ZD0508104
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,920 participants (estimated)
- Lead sponsor
- Yufan WangUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DR High-Risk Population Cohort | – | Diagnostic Test: Fundus Examination, Diagnostic Test: Metabolomics analysisAn 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. |
| Diabetic Retinopathy Early-Stage Population Cohort | – | Diagnostic Test: Fundus Examination, Diagnostic Test: Metabolomics analysisSeeking specific metabolites that can reflect diabetic retinopathy and its severity in early - onset and late - onset type 2 diabetes mellitus (T2DM). |
| Moderate-Stage Diabetic Retinopathy (DR) Population Cohort | – | Diagnostic Test: Fundus Examination, Diagnostic Test: Metabolomics analysisExploring 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. |
| Advanced-Stage Diabetic Retinopathy (DR) Population Cohort | – | Diagnostic Test: Fundus Examination, Diagnostic Test: Metabolomics analysisThe 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes Mellitus Patients
Key inclusion criteria (2 listed)
- Meets the diagnostic criteria for type 2 diabetes in the "China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)";
Key exclusion criteria (5 listed)
- Those who have been diagnosed with type 1 or other types of diabetes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundus ExaminationPerforming fundus photography on patients to assess the progression of diabetic retinopathy (DR). | Diagnostic test | Advanced-Stage Diabetic Retinopathy (DR) Population Cohort, DR High-Risk Population Cohort, Diabetic Retinopathy Early-Stage Population Cohort, Moderate-Stage Diabetic Retinopathy (DR) Population Cohort |
| Metabolomics analysisConduct metabolomics testing at enrollment. | Diagnostic test | Advanced-Stage Diabetic Retinopathy (DR) Population Cohort, DR High-Risk Population Cohort, Diabetic Retinopathy Early-Stage Population Cohort, Moderate-Stage Diabetic Retinopathy (DR) Population Cohort |
Primary outcome
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.
5 secondary outcomes
Metabolomics analysis
Time frame: at enrollment
Triglycerides
Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Glycated Hemoglobin
Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Insulin levels
Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Total Cholesterol
Time frame: Conduct examinations at enrollment, six months after enrollment, and twelve months after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Retinopathy, run by Yufan Wang at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liping Gu Liping Gu (86-13564720656, guliping1980@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundus examination (time frame: Conduct examinations at enrollment and twelve months after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.