Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders (RESPYR-SBA)

Early Identification of Metabolic Function Derangements Such as Diabetes, Liver, Renal Issues by Respyr Smart Breath Analyzer and Its Validation as a Screening Tool Among Diseased and Healthy Controls

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Metabolic Diseases; Lung Diseases; Kidney Diseases; Diabetes Mellitus, Type 2; Healthy Volunteers

Detailed Description

The smart breath analyzer, Respyr is an IoT and deep-tech enabled portable device developed by Humors Tech Pvt Ltd, Bangalore, India. The device measures volatile organic compounds (VOCs) and gases at parts-per-million and parts-per-billion levels in exhaled breath using AI and ML-based algorithms to identify metabolic derangements non-invasively.

Registration Details:

The study is registered with CTRI (CTRI/2022/09/045983) and ethics approval has been obtained from the Institutional Ethics Committee of JSS Medical College, Mysore (Ref: JSSMC/IEC/260822/07/CT Final Approval/2022-23, dated 19.12.2022). Protocol number: HTB-PROTOCOL-01, Version 1, dated 07 March 2022.

Testing Procedure:

Participants will provide an exhaled breath sample under fasting conditions, or with a minimum gap of 1 hour after consuming water and 3-4 hours after consuming food. The breath analyzer readings will be compared against standard laboratory diagnostic values including FBS/RBS, RFT, LFT, spirometry, and lipid profile, all tested within 15 days of participation.

Regulatory Compliance:

The study follows ICH-GCP guidelines, CDSCO-DCGI and New Drugs and Clinical Trial Rules 2019, and ICMR Ethical Guidelines for Biomedical Research on Human Participants.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Mysore, Karnataka, India, 570015
      • Dept. of Community Medicine, JSS Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Measured in mg/dl. Normal range: <150 mg/dl. Compared with smart breath analyzer readings.	baseline
HDL	Measured in mg/dl. Normal range: 40-60 mg/dl. Compared with smart breath analyzer readings.	baseline
VLDL	Measured in mg/dl. Normal range: 2-30 mg/dl. Compared with smart breath analyzer readings.	Baseline
LDL	Measured in mg/dl. Normal range: 100-129 mg/dl. Compared with smart breath analyzer readings.	Baseline
Cholesterol/ HDL Ratio	Ratio with no unit. Normal range: <4.5. Compared with smart breath analyzer readings.	Baseline
LDL/HDL Ratio	Ratio with no unit. Normal range: <3. Compared with smart breath analyzer readings.	Baseline
Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT)	Measured in g/dl. Normal ranges: Total Protein 6.4-8.3 g/dl, Albumin 3.4-4.8 g/dl, Globulin 2-3.5 g/dl. Compared with smart breath analyzer readings.	Baseline
Serum Creatinine Level assessed by Renal Function Test (RFT)	Measured in mg/dl. Normal range: 0.7-1.3 mg/dl. Compared with smart breath analyzer readings.	Baseline
Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS)	Measured in mg/dl. Normal range: 75-110 mg/dl. Compared with smart breath analyzer readings.	Baseline
HBA1C (4.0-5.6)	HbA1c Level assessed by Glycated Hemoglobin Test	Baseline
Post Prandial (<140)	Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS)	Baseline
Total/Direct/Indirect Bilirubin	Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT)	Baseline
SGOT/AST (<37 U/L)	SGOT/AST Level assessed by Liver Function Test (LFT	Baseline
ALP (30-90 U/L)	Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT)	Baseline
Total Protein, Albumin, Globulin, A/G ratio	Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT)	Baseline
Serum urea (13-43 mg/dl)	Serum Urea Level assessed by Renal Function Test (RFT)	Baseline
Uric acid (3.5-7.2 mg/dl)	Serum Uric Acid Level assessed by Renal Function Test (RFT)	Baseline
Calcium, Phosphorus	Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT)	Baseline
Sodium, Potassium, Chloride	Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT)	Baseline

Collaborators and Investigators

• Sponsor: Respyr
• Collaborators: JSS Medical College Hospital
• Investigators: Principal Investigator: Nayanabai Shabadi, M.D, JSS Medical College, Mysore

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Metabolic disorders; Kidney function; Liver function; Machine learning; Volatile organic compounds; Exhaled breath analysis; Point-of-care diagnostics; Breath analyzer; Non-invasive screening; IoT health device
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Lung Diseases; Diabetes Mellitus, Type 2; Liver Diseases; Kidney Diseases; Metabolic Diseases
• Other Study ID Numbers: HUMORS-CTRI-2022-045983; CTRI/2022/09/045983 (Registry Identifier: Clinical Trials Registry India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data contains proprietary device output from a commercially sensitive medical technology. Data sharing is restricted due to intellectual property considerations and patient confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No