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This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSP-26-01 | Experimental |
| |
| RSP-26-02 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype 0.5 | Device | Investigational Medical Device collecting Raman data from tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance | Repeated measurements of blood sugar, to cover the diurnal variation, with the non-invasive examination device, and compare the result with blood drawn capillary and venous | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Frequency of adverse reactions related and non-related to the investigational device | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| 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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