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| Name | Class |
|---|---|
| DCB Research AG | OTHER |
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The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Induction of different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab Demo 1.0 | Device | Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia. During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels | The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states. | The data is collected during the study procedure (6 to 8 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels | The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states. | The data is collected during the study procedure (6 to 8 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien Rebeaud, PhD | Liom Health AG | Study Director |
| Markus Laimer, Prof Dr med | University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markus Laimer | Bern | Canton of Bern | 3010 | Switzerland |
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| Spectral fingerprints measured by the Lab Demo 1.0 | This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose) | The data is collected during the study procedure (6 to 8 hours) |
| Blood glucose levels | Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) |
| Heart rate | Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) |
| Oxygen saturation | Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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