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

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.

Inclusion Criteria: * Participants aged 18 years or older with type 2 diabetes mellitus, diagnosed according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition). * Participants who fully understand the project and can cooperate with the study procedures. * Participants (or their legally authorized representatives) who provide written informed consent. Exclusion Criteria: * Participants unable to live independently or with mental disorders who cannot cooperate with testing and follow-up. * Participants with a history of allergy or contraindication to the sensor materials or testing process.