Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser

Diabetes Mellitus Clinical Trial

— VAARABreath  

Official title:

Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05933616
• Other study ID #: VAARABreath
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

(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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Hypoglycemia
• Metabolic Disease
• Metabolic Diseases

Intervention

Device:
• Device: Sokru device
Different induced glycaemic states in people living with diabetes (PwD).

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University of Bern	DCB Research AG, Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes VOC Patterns over time as gallery plots	Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.	During the study procedure (approximately 5 hours)
Primary	Changes VOC Patterns over time as boxplots	Difference in box plots from selected VOC peaks over time.	During the study procedure (approximately 5 hours)
Primary	Correlation between blood glucose and patterns	Signals will be classified into euglycemic (between 4 and 10 mmol/l), hypoglycaemic (smaller than 4 mmol/l) and hyperglycaemic (above 10 mmol/l) phases or stable and changing phases. A principal component analysis (PCA) of the data will be performed to identify which VOCs are characteristic for certain glucose levels. A partial least squares discriminant analysis (PLS-DA) will be used to further identify important features of the VOC fingerprints.	During the study procedure (approximately 5 hours)
Secondary	Time lag	The time lag between hypoglycaemia onset and change in VOCs will be calculated-	During the study procedure (approximately 5 hours)
Secondary	Association between the onset of change in glucose, vital signs and VOC spectra	Associations between changes in VOCs and perceived hypoglycaemic symptoms, heart rate, ECG, and oxygen saturation will be evaluated using correlation coefficients and mixed effects models.	During the study procedure (approximately 5 hours)