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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Metabolic Disease, Glucose Metabolism Disorders, Endocrine System Diseases

Intervention / Treatment
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* Device: Device: Sokru device


Participation Criteria
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Eligibility Criteria
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(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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volatile Organic Compounds, Hypoglycaemia