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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
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The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
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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 |
|---|---|---|---|---|
| Sokru device | Device | Different induced glycaemic states in people living with diabetes (PwD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of volatile organic compound (VOC) signals measured by the Sokru device | The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L). | During the study procedure (approximately 5 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Volatile Organic Compound Signals | VOC signals measured by the Sokru device at different blood glucose levels | During the study procedure (approximately 5 hours) |
| Blood glucose concentration | Blood glucose levels are measured with the continuous glucose measurement system and in the venous blood at the time of the appearance of VOC signal peaks or drops |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Brandt | DCB Research AG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Sokru device, prototype
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| During the study procedure (approximately 5 hours) |
| Time of onset of subjective symptoms of hypoglycemia | Self-reported onset of subjective symptoms of hypoglycemia | During the study procedure (approximately 5 hours) |
| Heart rate | Heart rate is measured with a Mindray device | During the study procedure (approximately 5 hours) |
| Oxygen saturation | Oxygen saturation is measured with a Mindray device | During the study procedure (approximately 5 hours) |