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

NCT05933616 | Completed

• 1 other identifier: VAARABreath
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Metabolic Disease; Glucose Metabolism Disorders; Endocrine System Diseases

Keywords

Volatile Organic Compounds; Hypoglycaemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Time lag

  During the study procedure (approximately 5 hours)

• Association between the onset of change in glucose, vital signs and VOC spectra

  During the study procedure (approximately 5 hours)

Study Arms (1)

Study Arm

EXPERIMENTAL

Participants in the study arm will undergo the study procedure which are different induced glycaemic states.

Device: Device: Sokru device

Interventions

Device: Sokru device DEVICE

Different induced glycaemic states in people living with diabetes (PwD).

Study Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• DCB Research AG: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Hypoglycemia

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Witthauer Lilian, Prof.Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 6, 2023
• Study Start: April 20, 2023
• Primary Completion: June 16, 2023
• Study Completion: July 31, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)