Clinical trial NCT05933616: Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Official title: Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Metabolic Disease
Glucose Metabolism Disorders
Endocrine System Diseases
Keywords: Volatile Organic Compounds
Hypoglycaemia
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: DCB Research AG
name: Insel Gruppe AG, University Hospital Bern
First posted: 2023-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: (as in VAARA study, NCT05771090)

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Pregnancy or lactation period
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* 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.
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.

Primary outcomes:
measure: Changes VOC Patterns over time as gallery plots
timeFrame: During the study procedure (approximately 5 hours)
measure: Changes VOC Patterns over time as boxplots
timeFrame: During the study procedure (approximately 5 hours)
measure: Correlation between blood glucose and patterns
timeFrame: During the study procedure (approximately 5 hours)
Secondary outcomes:
measure: Time lag
timeFrame: During the study procedure (approximately 5 hours)
measure: Association between the onset of change in glucose, vital signs and VOC spectra
timeFrame: During the study procedure (approximately 5 hours)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Witthauer Lilian, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: