Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders

NCT07646015 | Completed

• 2 other identifiers: HUMORS-CTRI-2022-045983CTRI/2022/09/045983
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath. The study will be conducted with healthy participants and participants with known cases of diabetes, kidney related issues, liver related issues, and lung related issues as confirmed by pathology reports. In phase 1, 500 apparently healthy individuals with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test will be recruited. In phase 2, 500 patients of type 2 diabetes, liver function, renal function, and lung function derangements each diagnosed by 10% increment above normal values will be enrolled. In phase 3, validation of the breath analyzer as a screening tool for early identification of type 2 diabetes, liver, renal, lung and other metabolic function derangements will be done by randomly assigning healthy and diseased participants for exhaled breath sample analysis. The study is based on the principle of exhaled breath analysis where parts per million and parts per billion level of volatile organic compounds and gases in human breath will be measured. AI based algorithms will be generated to effectively screen unhealthy biomarker levels, enabling timely preventive action.

Conditions

Diabetes Mellitus, Type 2; Liver Diseases; Kidney Diseases; Lung Diseases; Metabolic Diseases; Healthy Volunteers

Keywords

Breath analyzer; Exhaled breath analysis; Volatile organic compounds; Non-invasive screening; Metabolic disorders; Machine learning; Liver function; Kidney function; IoT health device; Point-of-care diagnostics

Outcome Measures

Primary Outcomes (1)

• Validation of Smart Breath Analyzer for Screening of Metabolic Disorders

  Development and validation of an IoT and deep-tech enabled smart breath analyzer for accurate and early screening of metabolic derangements including diabetes, kidney disease, liver disease, lung disease, AI and ML-based algorithms will be generated to provide an affordable, non-invasive screening option enabling timely preventive healthcare action

  Baseline

Secondary Outcomes (19)

• Triglycerides

  baseline

• HDL

  baseline

• VLDL

  Baseline

• LDL

  Baseline

• Cholesterol/ HDL Ratio

  Baseline

Study Arms (2)

Healthy Volunteers

Apparently healthy individuals aged 18-75 years with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test, as confirmed by blood examination conducted within 15 days of participation. Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.

Patients with Metabolic Disorders

Patients aged 18-75 years with confirmed diagnosis of one or more metabolic disorders including type 2 diabetes (confirmed by FBS/RBS), kidney disease (confirmed by RFT), liver disease (confirmed by LFT), and lung disease (confirmed by spirometry), with relevant diagnostic reports tested within 15 days of participation. Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with confirmed metabolic disorders including type 2 diabetes, liver disease, kidney disease, and lung disease recruited from JSS Hospital and Medical College, Mysore, India.

You may qualify if:

• Participant must either be a completely healthy individual as confirmed by blood examination, or a known case of diabetes, kidney disease, liver disease, and lung disease with relevant diagnostic reports tested within 15 days of participation
• All genders and ethnicities
• Age 18 to 75 years
• Participant who has given informed consent
• Participant must be fully vaccinated for COVID-19
• Participant must use the smart breath analyzer at fasting condition; if not fasting, minimum gap of 1 hour after water and 3-4 hours after food

You may not qualify if:

• Individual less than 18 or above 75 years of age
• Pregnant and lactating females
• Known case of ongoing illness such as Cancer, AIDS, COVID-19, Cough, Fever, TB, Chickenpox, Influenza, Mumps, or Tonsillitis
• Individual who has not given informed consent

Sponsors & Collaborators

• Respyr: lead
• JSS Medical College Hospital: collaborator

Study Sites (1)

Dept. of Community Medicine, JSS Medical College

Mysore, Karnataka, 570015, India

Location

Related Links

• A multicentric observational study in India to validate Humors' Smart Breath Analyzer for non-invasive screening of diabetes, liver, kidney, and lung using ML based exhaled breath analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Liver Diseases; Kidney Diseases; Lung Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Nayanabai Shabadi, M.D

  JSS Medical College, Mysore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start: October 3, 2022
• Primary Completion: October 3, 2023
• Study Completion: October 5, 2023
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)