Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Me… (NCT07646015) | Clinical Trial Compass
CompletedNot Applicable
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
India3,000 participantsStarted 2022-10-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a breath analyzer to screen for conditions like type 2 diabetes, liver disease, and kidney disease — how does a breath-based test actually detect these conditions, and is this kind of testing anywhere close to being used in real clinical care?
2Since this trial has already been completed, do you know if the results have been published, and what did they show about how accurate this breath analyzer was compared to standard blood or urine tests?
3Given that this was a Phase N/A validation study — meaning it was testing a device rather than a treatment — does participating or having participated in something like this have any direct benefit for someone with my diagnosis, or was it purely about developing a screening tool?
4If this breath analyzer technology eventually becomes validated and available, do you think it could play a role in how my condition is monitored going forward, or are the standard tests we already use considered more reliable?
5Since this trial enrolled both patients with metabolic conditions and healthy volunteers, what would it mean for me specifically if a tool like this showed it could reliably tell the difference between someone with my condition and someone without it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validation of Smart Breath Analyzer for Screening of Metabolic Disorders