Diabetes Mellitus, Type 2RESPYR-SBANCT07646015
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
An observational study of Diabetes Mellitus, Type 2 and Liver Diseases, run by Respyr at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases
- How many people
- 3,000 participants
- Where
- 1 siteIndia
- Study dates
- 3 Oct 2022to 5 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Dept. of Community Medicine, JSS Medical College
Mysore, Karnataka, 570015
About this study
Official 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
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.
Read the 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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (19)
Triglycerides
Measured in mg/dl. Normal range: <150 mg/dl. Compared with smart breath analyzer readings.
Measured: baseline
HDL
Measured in mg/dl. Normal range: 40-60 mg/dl. Compared with smart breath analyzer readings.
Measured: baseline
VLDL
Measured in mg/dl. Normal range: 2-30 mg/dl. Compared with smart breath analyzer readings.
Measured: Baseline
LDL
Measured in mg/dl. Normal range: 100-129 mg/dl. Compared with smart breath analyzer readings.
Measured: Baseline
Cholesterol/ HDL Ratio
Ratio with no unit. Normal range: <4.5. Compared with smart breath analyzer readings.
Measured: Baseline
LDL/HDL Ratio
Ratio with no unit. Normal range: <3. Compared with smart breath analyzer readings.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
HBA1C (4.0-5.6)
HbA1c Level assessed by Glycated Hemoglobin Test
Measured: Baseline
Post Prandial (<140)
Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS)
Measured: Baseline
Total/Direct/Indirect Bilirubin
Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT)
Measured: Baseline
SGOT/AST (<37 U/L)
SGOT/AST Level assessed by Liver Function Test (LFT
Measured: Baseline
ALP (30-90 U/L)
Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT)
Measured: Baseline
Total Protein, Albumin, Globulin, A/G ratio
Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT)
Measured: Baseline
Serum urea (13-43 mg/dl)
Serum Urea Level assessed by Renal Function Test (RFT)
Measured: Baseline
Uric acid (3.5-7.2 mg/dl)
Serum Uric Acid Level assessed by Renal Function Test (RFT)
Measured: Baseline
Calcium, Phosphorus
Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT)
Measured: Baseline
Sodium, Potassium, Chloride
Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start3 Oct 2022
- Primary completion3 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respyr
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Nayanabai Shabadi, M.D, Principal investigator, JSS Medical College, Mysore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646015
- Sponsor's protocol ID
- HUMORS-CTRI-2022-045983
- Other IDs
- CTRI/2022/09/045983
- Acronym
- RESPYR-SBA
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07646015
- Acronym / sponsor ID
- RESPYR-SBA / HUMORS-CTRI-2022-045983
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- RespyrIndustry (pharma, biotech, devices)
- Collaborators
- JSS Medical College Hospital
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
19 secondary outcomes
Triglycerides
Time frame: baseline
HDL
Time frame: baseline
VLDL
Time frame: Baseline
LDL
Time frame: Baseline
Cholesterol/ HDL Ratio
Time frame: Baseline
LDL/HDL Ratio
Time frame: Baseline
Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT)
Time frame: Baseline
Serum Creatinine Level assessed by Renal Function Test (RFT)
Time frame: Baseline
Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS)
Time frame: Baseline
HBA1C (4.0-5.6)
Time frame: Baseline
Post Prandial (<140)
Time frame: Baseline
Total/Direct/Indirect Bilirubin
Time frame: Baseline
SGOT/AST (<37 U/L)
Time frame: Baseline
ALP (30-90 U/L)
Time frame: Baseline
Total Protein, Albumin, Globulin, A/G ratio
Time frame: Baseline
Serum urea (13-43 mg/dl)
Time frame: Baseline
Uric acid (3.5-7.2 mg/dl)
Time frame: Baseline
Calcium, Phosphorus
Time frame: Baseline
Sodium, Potassium, Chloride
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayanabai Shabadi, M.D principal investigator
JSS Medical College, Mysore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Liver Diseases, run by Respyr at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Smart Breath Analyzer for Screening of Metabolic Disorders (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.