Back to resultsAnalysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser (VAARABreath)
Primary Purpose
Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Device: Sokru device
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus focused on measuring Volatile Organic Compounds, Hypoglycaemia
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.
Sites / Locations
- University of Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Arm
Arm Description
Participants in the study arm will undergo the study procedure which are different induced glycaemic states.
Outcomes
Primary Outcome Measures
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.
Changes VOC Patterns over time as boxplots
Difference in box plots from selected VOC peaks over time.
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.
Secondary Outcome Measures
Time lag
The time lag between hypoglycaemia onset and change in VOCs will be calculated-
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.
Full Information
NCT ID
NCT05933616
First Posted
June 26, 2023
Last Updated
July 26, 2023
Sponsor
University of Bern
Collaborators
DCB Research AG, Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05933616
Brief Title
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Acronym
VAARABreath
Official Title
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
DCB Research AG, Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases
Keywords
Volatile Organic Compounds, Hypoglycaemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Participants in the study arm will undergo the study procedure which are different induced glycaemic states.
Intervention Type
Device
Intervention Name(s)
Device: Sokru device
Intervention Description
Different induced glycaemic states in people living with diabetes (PwD).
Primary Outcome Measure Information:
Title
Changes VOC Patterns over time as gallery plots
Description
Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
Time Frame
During the study procedure (approximately 5 hours)
Title
Changes VOC Patterns over time as boxplots
Description
Difference in box plots from selected VOC peaks over time.
Time Frame
During the study procedure (approximately 5 hours)
Title
Correlation between blood glucose and patterns
Description
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.
Time Frame
During the study procedure (approximately 5 hours)
Secondary Outcome Measure Information:
Title
Time lag
Description
The time lag between hypoglycaemia onset and change in VOCs will be calculated-
Time Frame
During the study procedure (approximately 5 hours)
Title
Association between the onset of change in glucose, vital signs and VOC spectra
Description
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.
Time Frame
During the study procedure (approximately 5 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Witthauer Lilian, Prof.Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
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