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Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
Sponsor: Shanghai Pudong Hospital
Summary
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.
Official title: A Real-World Study of Remote, Continuous, Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease Based on a Wearable NH₃ Sensor With Two-Dimensional Heterostructures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
380
Start Date
2025-10-09
Completion Date
2028-08-31
Last Updated
2026-10-15
Healthy Volunteers
No
Locations (1)
Shanghai Pudong Hospital
Shanghai, China