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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Metabolic Disease
• Intervention / Treatment: Device: Device: Sokru device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

(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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm; Participants in the study arm will undergo the study procedure which are different induced glycaemic states.	Device: Device: Sokru device; Different induced glycaemic states in people living with diabetes (PwD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Changes VOC Patterns over time as boxplots	Difference in box plots from selected VOC peaks over time.	During the study procedure (approximately 5 hours)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time lag	The time lag between hypoglycaemia onset and change in VOCs will be calculated-	During the study procedure (approximately 5 hours)
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)

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: DCB Research AG; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Witthauer Lilian, Prof.Dr., University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Volatile Organic Compounds; Hypoglycaemia
• Additional Relevant MeSH Terms: Diabetes Mellitus; Hypoglycemia; Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: VAARABreath

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No