Diabetes Mellitus, Type 2, Healthy Volunteers, Kidney Diseases, Liver Diseases, Lung Diseases, Metabolic Diseases
Conditions
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
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.
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.
Interventions
None listed
Sponsors
Respyr
JSS Medical College Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Smart Breath Analyzer for Screening of Metabolic Disorders | 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
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | baseline | Measured in mg/dl. Normal range: \<150 mg/dl. Compared with smart breath analyzer readings. |
| HDL | baseline | Measured in mg/dl. Normal range: 40-60 mg/dl. Compared with smart breath analyzer readings. |
| VLDL | Baseline | Measured in mg/dl. Normal range: 2-30 mg/dl. Compared with smart breath analyzer readings. |
| LDL | Baseline | Measured in mg/dl. Normal range: 100-129 mg/dl. Compared with smart breath analyzer readings. |
| Cholesterol/ HDL Ratio | Baseline | Ratio with no unit. Normal range: \<4.5. Compared with smart breath analyzer readings. |
| LDL/HDL Ratio | Baseline | Ratio with no unit. Normal range: \<3. Compared with smart breath analyzer readings. |
| Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT) | 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. |
| Serum Creatinine Level assessed by Renal Function Test (RFT) | Baseline | Measured in mg/dl. Normal range: 0.7-1.3 mg/dl. Compared with smart breath analyzer readings. |
| Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS) | Baseline | Measured in mg/dl. Normal range: 75-110 mg/dl. Compared with smart breath analyzer readings. |
| HBA1C (4.0-5.6) | Baseline | HbA1c Level assessed by Glycated Hemoglobin Test |
| Post Prandial (<140) | Baseline | Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS) |
| Total/Direct/Indirect Bilirubin | Baseline | Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT) |
| SGOT/AST (<37 U/L) | Baseline | SGOT/AST Level assessed by Liver Function Test (LFT |
| ALP (30-90 U/L) | Baseline | Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT) |
| Total Protein, Albumin, Globulin, A/G ratio | Baseline | Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT) |
| Serum urea (13-43 mg/dl) | Baseline | Serum Urea Level assessed by Renal Function Test (RFT) |
| Uric acid (3.5-7.2 mg/dl) | Baseline | Serum Uric Acid Level assessed by Renal Function Test (RFT) |
| Calcium, Phosphorus | Baseline | Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT) |
| Sodium, Potassium, Chloride | Baseline | Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT) |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORNayanabai Shabadi, M.D
JSS Medical College, Mysore
Outcome results
None listed