Diabetic Nephropathies MeSH:D003928NCT07875010
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
An observational study of Diabetic Nephropathies MeSH:D003928 and Diabetes Mellitus, Type 2, run by Shanghai Pudong Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2, Kidney Diseases
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older) with type 2 diabetes mellitus recruited from Shanghai Pudong Hospital and its medical alliance network. Participants are classified into two groups based on the presence of diabetic kidney disease (DKD) according to KDIGO 2023 criteria: those with DKD (UACR ≥30 mg/g and eGFR 25-75 mL/min/1.73m²) and those without DKD. The target population represents patients with type 2 diabetes across various stages of renal involvement in real-world clinical settings.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This study employed a design combining a cross-sectional observational study (model construction) with a prospective cohort study (external validation). A total of 1,500-2,000 patients with type 2 diabetes mellitus were enrolled and, according to the KDIGO 2023 criteria, were stratified into a diabetic kidney disease (DKD) group (600-800 cases) and a non-renal disease in diabetes group (900-1,400 cases). After an 8-hour fasting period, subjects used disposable sterile sampling tubes to collect end-tidal gas, from which the NH₃ concentration (expressed in ppb) was measured; simultaneously, fasting blood glucose, glycated hemoglobin (HbA1c), lipid profile, serum creatinine, eGFR, and urinary albumin-to-creatinine ratio (UACR) were recorded. Logistic regression analysis was used to construct diagnostic models for DKD using NH₃ alone and in combination with UACR/eGFR. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were calculated using ROC curves, while the optimal cutoff value was determined using the Youden index. The stability of the models was further assessed via 10-fold cross-validation and external cohort validation. Additionally, a three-tiered renal health risk stratification system based on exhaled NH₃ concentration was established.
- Keywords
- breath ammonia, noninvasive monitoring, wearable sensor, diabetic kidney disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Kidney Disease Group | Diabetic Kidney Disease Group | |
| Diabetic Non-DKD Group | Diabetic Non-DKD Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of Breath Ammonia Concentration for Diabetic Kidney Disease Staging
Area under the receiver operating characteristic curve (AUC) ≥0.92, sensitivity ≥90%, specificity ≥85%, with optimal cutoff determined by the Youden index, validated in an external cohort (data completeness ≥95%).
Measured: Baseline（week 0）
Performance of the Wearable NH₃ Sensor
Detection limit ≤0.5 ppb, response time ≤10 seconds, humidity and temperature interference <5%, power consumption ≤10 mW, meeting ISO 13485 requirements.
Measured: At the time of laboratory device testing (single assessment)
Secondary outcomes (2)
Three-Tier Kidney Health Risk Stratification
Development of low/intermediate/high risk categories based on breath ammonia concentration and renal function, with associated management pathways; DKD screening coverage ≥80% and early diagnosis rate ≥95%.
Measured: Baseline（week 0）
Correlation Between Breath Ammonia and Renal Function
Pearson or Spearman correlation coefficients between breath ammonia concentration and eGFR (negative) and UACR (positive).
Measured: Baseline（week 0）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start9 Oct 2025
- Primary completion7 Jan 2026
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathies MeSH:D003928Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingru Gong, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875010
- Sponsor's protocol ID
- 2025-IIT-027
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07875010
- Acronym / sponsor ID
- 2025-IIT-027
- Keywords
- breath ammonia, noninvasive monitoring, wearable sensor, diabetic kidney disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study employed a design combining a cross-sectional observational study (model construction) with a prospective cohort study (external validation). A total of 1,500-2,000 patients with type 2 diabetes mellitus were enrolled and, according to the KDIGO 2023 criteria, were stratified into a diabetic kidney disease (DKD) group (600-800 cases) and a non-renal disease in diabetes group (900-1,400 cases). After an 8-hour fasting period, subjects used disposable sterile sampling tubes to collect end-tidal gas, from which the NH₃ concentration (expressed in ppb) was measured; simultaneously, fasting blood glucose, glycated hemoglobin (HbA1c), lipid profile, serum creatinine, eGFR, and urinary albumin-to-creatinine ratio (UACR) were recorded. Logistic regression analysis was used to construct diagnostic models for DKD using NH₃ alone and in combination with UACR/eGFR. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were calculated using ROC curves, while the optimal cutoff value was determined using the Youden index. The stability of the models was further assessed via 10-fold cross-validation and external cohort validation. Additionally, a three-tiered renal health risk stratification system based on exhaled NH₃ concentration was established.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Kidney Disease Group | – | –Diabetic Kidney Disease Group |
| Diabetic Non-DKD Group | – | –Diabetic Non-DKD Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) with type 2 diabetes mellitus recruited from Shanghai Pudong Hospital and its medical alliance network. Participants are classified into two groups based on the presence of diabetic kidney disease (DKD) according to KDIGO 2023 criteria: those with DKD (UACR ≥30 mg/g and eGFR 25-75 mL/min/1.73m²) and those without DKD. The target population represents patients with type 2 diabetes across various stages of renal involvement in real-world clinical settings.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of Breath Ammonia Concentration for Diabetic Kidney Disease Staging
Time frame: Baseline（week 0）
Area under the receiver operating characteristic curve (AUC) ≥0.92, sensitivity ≥90%, specificity ≥85%, with optimal cutoff determined by the Youden index, validated in an external cohort (data completeness ≥95%).
Performance of the Wearable NH₃ Sensor
Time frame: At the time of laboratory device testing (single assessment)
Detection limit ≤0.5 ppb, response time ≤10 seconds, humidity and temperature interference <5%, power consumption ≤10 mW, meeting ISO 13485 requirements.
2 secondary outcomes
Three-Tier Kidney Health Risk Stratification
Time frame: Baseline（week 0）
Correlation Between Breath Ammonia and Renal Function
Time frame: Baseline（week 0）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies MeSH:D003928 and Diabetes Mellitus, Type 2, run by Shanghai Pudong Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Breath Ammonia Concentration for Diabetic Kidney Disease Staging (time frame: Baseline（week 0）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.