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

NCT07875010 | Active Not Recruiting

• 1 other identifier: 2025-IIT-027
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathies MeSH:D003928; Diabetes Mellitus, Type 2; Kidney Diseases

Keywords

breath ammonia; noninvasive monitoring; wearable sensor; diabetic kidney disease

Outcome Measures

Primary Outcomes (2)

• 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%).

  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.

  At the time of laboratory device testing (single assessment)

Secondary Outcomes (2)

• Three-Tier Kidney Health Risk Stratification

  Baseline（week 0）

• Correlation Between Breath Ammonia and Renal Function

  Baseline（week 0）

Other Outcomes (1)

• Health Economic Evaluation

  Through study completion, an average of 2 years

Study Arms (2)

Diabetic Kidney Disease Group

Diabetic Kidney Disease Group

Diabetic Non-DKD Group

Diabetic Non-DKD Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Department of Pharmacy

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 15, 2026
• Study Start: October 9, 2025
• Primary Completion: January 7, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months after the primary results publication, for a period as specified in the data sharing agreement.

Locations

CN (1)