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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 either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements. |
|
| Medium term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. |
|
| Long term collection of IMD data | Experimental | Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements. |
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| Medium term collection of IMD data, increased # of sessions | Experimental | Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P0.2 | Device | Investigational Medical Device collecting spectral raman data from tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generation of predictive algorithms for determining blood glucose levels | Collected spectral raman data will found the development of predictive algorithms for glucose determination. | 3 years |
| Validation of predictive algorithms for determining blood glucose levels | Performance of predictive models will be evaluated using the consensus error grid. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Ovesen Banke, MSc | Contact | +45 71 99 79 77 | stefan@rspsystems.com |
| Name | Affiliation | Role |
|---|---|---|
| Jan Erik Henriksen, MD | Odense University Hospital, Dpt. of Endocrinology M | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology M | Recruiting | 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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