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Effectiveness Study on Novel Technology for Intelligent Screening, Diagnosis, and Early Warning of Diabetic Complications

Effectiveness Study on Novel Technology for Intelligent Screening, Diagnosis, and Early Warning of Diabetic Complications

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115060
Enrollment
Unknown
Registered
2025-12-22
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Diabetes

Interventions

Gold Standard:1.New Technology in Intelligent Diagnosis This study uses centralized image reading, where specialists from tertiary hospitals interpret images of diabetes complications based on the "Ex
(2) Diabetic Nephropathy: Based on the "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2021 Edition)"
(3) Carotid Atherosclerosis: Assessed using carotid ultrasound to measure intima-media thickness and plaques, among other indicators
(4) Lower Limb Vascular Disease: Assessed using lower limb vascular ultrasound to examine blood vessels and plaques
(5) Diabetes-Related Cognitive Impairment: Assessed using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function in diabetic patients.
Index test:Novel Technology for Intelligent Screening, Diagnosis, and Early Warning of Diabetic Complications

Sponsors

Tianjin Medical University Chu Hsien-I Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. New Technology for Intelligent Diagnosis: (1) Patients diagnosed with type 1 or type 2 diabetes; (2) Age >= 18 years; (3) Participants fully understand the purpose, nature, and methods of the study, voluntarily agree to participate, and sign the informed consent form; (4) Availability of imaging data for chronic diabetic complications or comorbidities. 2.New Technology for Intelligent Screening and Early Warning: (1) Patients diagnosed with type 1 or type 2 diabetes; (2) Age >= 18 years; (3) Participants fully understand the purpose, nature, and methods of the study, voluntarily agree to participate, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. New Intelligent Diagnostic Technologies: (1) Individuals with severe mental illness or speech disorders; (2) Patients with malignant tumors; (3) Pregnant or breastfeeding women; (4) Suspected active infections (such as active tuberculosis, pneumonia, etc.); (5) Individuals with poor image quality. 2. New Technologies for Intelligent Screening and Early Warning (1) Individuals with severe mental illness or language disorders; (2) Patients with malignant tumors; (3) Pregnant or breastfeeding women; (4) Suspected active infections (such as active tuberculosis, pneumonia, etc.); (5) Severe liver or kidney dysfunction (alanine aminotransferase and/or aspartate aminotransferase > 3 times the upper limit of normal; estimated eGFR < 15 mL/min/1.73m^2).

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Area Under the Curve, AUC;Positive Predictive Value (PPV);Negative Predictive Value (NPV);

Countries

China

Contacts

Public ContactChen Liming

Tianjin Medical University Chu Hsien-I Memorial Hospital

xfx22081@vip.163.com+86 139 2097 9401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026