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Completed

NCT Number: NCT07646015

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Healthy Volunteers Kidney Diseases Liver Diseases Lung Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Community Medicine, JSS Medical College

Mysore, Karnataka, 570015, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validation of Smart Breath Analyzer for Screening of Metabolic Disorders

    Time frame: Baseline

    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

Secondary outcomes

  1. Triglycerides

    Time frame: baseline

    Measured in mg/dl. Normal range: <150 mg/dl. Compared with smart breath analyzer readings.

  2. HDL

    Time frame: baseline

    Measured in mg/dl. Normal range: 40-60 mg/dl. Compared with smart breath analyzer readings.

  3. VLDL

    Time frame: Baseline

    Measured in mg/dl. Normal range: 2-30 mg/dl. Compared with smart breath analyzer readings.

  4. LDL

    Time frame: Baseline

    Measured in mg/dl. Normal range: 100-129 mg/dl. Compared with smart breath analyzer readings.

  5. Cholesterol/ HDL Ratio

    Time frame: Baseline

    Ratio with no unit. Normal range: <4.5. Compared with smart breath analyzer readings.

  6. LDL/HDL Ratio

    Time frame: Baseline

    Ratio with no unit. Normal range: <3. Compared with smart breath analyzer readings.

  7. Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT)

    Time frame: Baseline

    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.

  8. Serum Creatinine Level assessed by Renal Function Test (RFT)

    Time frame: Baseline

    Measured in mg/dl. Normal range: 0.7-1.3 mg/dl. Compared with smart breath analyzer readings.

  9. Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS)

    Time frame: Baseline

    Measured in mg/dl. Normal range: 75-110 mg/dl. Compared with smart breath analyzer readings.

  10. HBA1C (4.0-5.6)

    Time frame: Baseline

    HbA1c Level assessed by Glycated Hemoglobin Test

  11. Post Prandial (<140)

    Time frame: Baseline

    Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS)

  12. Total/Direct/Indirect Bilirubin

    Time frame: Baseline

    Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT)

  13. SGOT/AST (<37 U/L)

    Time frame: Baseline

    SGOT/AST Level assessed by Liver Function Test (LFT

  14. ALP (30-90 U/L)

    Time frame: Baseline

    Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT)

  15. Total Protein, Albumin, Globulin, A/G ratio

    Time frame: Baseline

    Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT)

  16. Serum urea (13-43 mg/dl)

    Time frame: Baseline

    Serum Urea Level assessed by Renal Function Test (RFT)

  17. Uric acid (3.5-7.2 mg/dl)

    Time frame: Baseline

    Serum Uric Acid Level assessed by Renal Function Test (RFT)

  18. Calcium, Phosphorus

    Time frame: Baseline

    Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT)

  19. Sodium, Potassium, Chloride

    Time frame: Baseline

    Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT)

Sponsors and collaborators

Lead sponsor

Respyr

Industry

Collaborators

  • JSS Medical College Hospital

Registry information

Official study title

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

Acronym: RESPYR-SBA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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