An observational study in Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2 and Kidney Diseases, sponsored by Shanghai Pudong Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Shanghai Pudong Hospital · Observational
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 380 is above the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Shanghai Pudong Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
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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.
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Exclusion Criteria:
Diabetic Kidney Disease Group
Diabetic Non-DKD Group
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%).
Time frame: 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.
Time frame: At the time of laboratory device testing (single assessment)
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%.
Time frame: 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).
Time frame: Baseline（week 0）
Health Economic Evaluation
Estimated reduction in end-stage renal disease incidence and annual medical cost savings (target ≥5 million RMB/year), combined with market penetration analysis (target ≥30%).
Time frame: Through study completion, an average of 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 12 months after the primary results publication, for a period as specified in the data sharing agreement.
Ran from Oct 2025 to primary completion in Jan 2026, 2 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Pudong Hospital