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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-24 | Experimental | Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype 0.5 | Device | Investigational Medical Device collecting Raman data from tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| Determination of number of calibration days | The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid. | 2 years |
| Safety evaluation of the Investigational Medical Device by reporting of adverse events | Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Device function | Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries | 2 years |
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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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