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This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMD data collection | Experimental | Subjects will intensively collect spectral raman data in a home-based setting for 5 days using WM3.4NR and comparators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WM3.4NR | Device | The investigational medical device will collect spectral raman data from tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generation and validation of predictive calibration models | The collected data will generate individual calibration models capable of predicting tissue glucose concentrations. An evaluation of the models by the consensus error grid will be performed. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of the intervention by the paucity of adverse events | The number of subjects experiencing device-related adverse events will be recorded. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Erik Henriksen, MD | University Hospital Odense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology M, Odense University Hospital | Odense | 5000 | Denmark |
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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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