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NCT07875010

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

Sponsor: Shanghai Pudong Hospital

View on ClinicalTrials.gov

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