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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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This is a single-centre, multiple cohort, open study.
The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Induction of hyperglycaemia and hypoglcemia states and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values measured by Super GL and Freestyle Libre 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Demo 2.0 | Device | 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 |
|---|---|---|
| Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia | Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia | The data is collected during the study procedure (up to 5 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Banu Eyueboglu Seitz, PhD | Contact | 0041 41 552 00 59 | bes@liom.com | |
| Fabien Rebeaud, PhD | Contact | 0041 41 552 00 59 | fr@liom.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc Stoffel, MD | Profil for Stoffwechselforschung GmbH, Neuss, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil for Stoffwechselforschung GmbH | Recruiting | Neuss | Nordrhein-Westfallen | 41460 | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |