NCT05933616Completed
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Source: ClinicalTrials.gov · Last updated 16 Aug 2024
Brief summary (registry, in English)
The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 26 Jun 2023
- Start date
- 20 Apr 2023
- Primary completion date
- 16 Jun 2023
- Lead sponsor
- University of Bern
- Diseases
- Type 1 diabetes
- NCT number
- NCT05933616
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 20 Apr 2023 to the primary completion date, 16 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.
Other illness
- History of cardiovascular diseases
- Diabetes-related comorbidities
- Epilepsy
Lab values
- HbA1c \>9 %
Other
- Pregnancy or lactation period
- Smoking (last cigarette within past 6 months)
- Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.
- Known sensitivity to Latex.
Who the study is looking for
- Written informed consent.
- Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) \>1 year
- Age 18 - 50 (inclusive)
- Caucasian ethnicity
- BMI between 18.5 and 24.9 kg/m2 (inclusive)
- Usage of a continuous glucose monitoring (CGM)
Criteria the registry did not label
- (as in VAARA study, NCT05771090)
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.