Status:
COMPLETED
Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
Lead Sponsor:
DCB Research AG
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
BOYDSENSE
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief 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...
Detailed Description
The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better underst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07147010
Start Date
October 1 2024
End Date
November 27 2025
Last Update
December 9 2025
Active Locations (1)
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1
Inselspital Bern
Bern, Switzerland, 3010