CompletedNot Applicable

Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes

Switzerland20 participantsStarted 2024-10-01

Plain-language summary

The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.

Who can participate

Age range

45 Years – 70 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: * Signed written informed consent * T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP) * \< 10 years since T2D diagnosis * HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days) * Willingness to undergo study procedures * Age 45 -70 years (inclusive) Exclusion Criteria: * Pregnancy and/or lactation period * Currently on chronic or occasional treatment with pulmonary drugs * Insulin dependency * Smoking (last cigarette within the last six months) * BMI above 30 kg/m² * Lp(a) above 125 nmol/l * LDL not in the individual target range of an earlier cholesterol goal according ESC guideline 2021 (LDL based on last measurement by treating physician but not older than 30 days) * Irregular 12-lead ECG or increased carotid plaque burden based on a three-point sonography. Both examinations are performed and evaluated according to the investigator's judgment. * History of, or manifested, cardiovascular diseases * Medical history of epilepsy or other neurological disease associated with seizure events * Known sensitivity to medical grade adhesives * Comorbidities that are suspected to alter the VOC spectra * Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation * Not able to understand, write or read German

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

VOC spectra

Timeframe: 6-8 hour study visit

Trial details

NCT IDNCT07147010

SponsorDCB Research AG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More Type 2 Diabetes trials