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The Value of Integrated Continuous Glucose Monitoring, Heart Rate Variability Monitoring, and Periodic OCTA Assessments in the Comprehensive Prevention and Management of Diabetic Retinopathy

The Value of Integrated Continuous Glucose Monitoring, Heart Rate Variability Monitoring, and Periodic OCTA Assessments in the Comprehensive Prevention and Management of Diabetic Retinopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128130
Enrollment
Unknown
Registered
2026-07-14
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Type 2 Diabetes Mellitus,Diabetic Retinopathy

Interventions

Proliferative Diabetic Retinopathy Group:None
Severe Non-Proliferative Diabetic Retinopathy Group:None
Moderate Non-Proliferative Diabetic Retinopathy Group:None
Mild Non-Proliferative Diabetic Retinopathy Group:None
No Apparent Diabetic Retinopathy Group:None

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years; 2.A confirmed diagnosis of type 2 diabetes mellitus (T2DM); 3.Continuous residence in the local area for at least 6 months; 4.Ability and willingness to comply with the required examinations and long-term follow-up;

Exclusion criteria

Exclusion criteria: 1.Presence of atrial fibrillation, severe cardiac arrhythmias, or implantation of a cardiac pacemaker; 2.Recent acute myocardial infarction or severe heart failure; 3.Current use of medications that may affect heart rate variability (HRV), such as ß-blockers, antiarrhythmic drugs, or related agents; 4.Presence of other ocular diseases that may interfere with fundus examination results, including age-related macular degeneration, retinal vein occlusion, uveitis, or advanced glaucoma; 5.High myopia or an axial length greater than 26.5 mm; 6.Gestational diabetes mellitus (GDM); 7.History of retinal laser photocoagulation, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy, or pars plana vitrectomy; 8.Presence of severe systemic diseases, including advanced renal insufficiency, malignant tumors, or acute infections; 9.Fundus images that are not interpretable due to severe cataract, corneal opacity, or other media opacities; 10.Inability to comply with the follow-up schedule;

Design outcomes

Primary

MeasureTime frame
Continuous glucose monitoring parameters;Heart rate variability parameters;Fundus photography and diabetic retinopathy grading;OCT and OCTA parameters;

Secondary

MeasureTime frame
Intraocular pressure;Vital signs;Peripheral nerve function;Axial length;Demographic and clinical characteristics;Electrocardiogram findings;Laboratory parameters;Slit-lamp and fundus examination findings;Visual acuity;Eye movement parameters;Physical examination;Visual field parameters;Cognitive function;

Countries

China

Contacts

Public ContactYunhai Tu

Eye Hospital, Wenzhou Medical University

tyh5@21cn.com+86 577 88068861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026