Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

  1. Minor Study First Submitted
This observational study aims to validate whether a novel wearable sensor can non-invasively and remotely assess the renal health status of patients with diabetes by detecting the concentration of ammonia (NH₃) in exhaled breath, thereby facilitating the early detection and diagnosis of diabetic kidney disease (DKD). The study will enroll approximately 2,000 patients with type 2 diabetes mellitus, employing a single breath sample collection combined with conventional renal function tests to establish a predictive model linking exhaled ammonia concentration with kidney disease stage, and to validate its diagnostic accuracy.
Trial Details
NCT Number NCT07875010
Lead Sponsor Shanghai Pudong Hospital
Conditions
(from sponsor)
Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2, Kidney Diseases
Related terms Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Diseases
Enrollment 380 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov