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| Name | Class |
|---|---|
| DCB Research AG | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Participants in the study arm will undergo the study procedure which are different induced glycaemic states. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: Sokru device | Device | Different induced glycaemic states in people living with diabetes (PwD). |
|
| 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) |
| 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 |
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(as in VAARA study, NCT05771090)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Witthauer Lilian, Prof.Dr. | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Bern | 3010 | Switzerland |
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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) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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