NCT07875010Active, not recruiting
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 380 (actual)
- First submitted
- 30 Sept 2026
- Start date
- 9 Oct 2025
- Primary completion date
- 7 Jan 2026
- Lead sponsor
- Shanghai Pudong Hospital
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07875010
What you commit to
- Study type: Observational
- Participants enrolled: 380
- From 9 Oct 2025 to the primary completion date, 7 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pudong Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.