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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.
Protocol consists of two parts:
Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within 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.
Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSP-13-01 | Experimental | Experimental: IMD data collection Subjects will intensively collect spectral Raman data on P0.1 in a home-based setting for 5 days. Data will be paired with reference measurements. |
|
| RSP-13-02 | Experimental | Experimental: IMD data collection Subjects will collect spectral Raman data on P0.1 during four measuring sessions a day for 30 days distributed over a time period of 60 days. Each timepoint is conducted in duplicate. Spectral data will be compared to standard BG measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P0.1 | Device | Investigational Medical Device collecting spectral Raman data from tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generation and validation of predictive models by ISUP and MARD measures | Optical glucose data will be collected together with paired reference values (BGM and FGM, Protocol 1 and BGM, Subprotocol 2). For subprotocol 1, measurements will be collected every 15 minutes for 10 hours a day for 5 days distributed over a period of 10 days. For subprotocol 2, four daily measurements will be collected while subject is maintaining normal routines. Data will be collected for 30 days distributed over a period of 60 days. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using MARD and ISUP measures. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation: paucity of adverse events | Safety will be evaluated in a descriptive manner by the paucity of adverse events | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Erik Henriksen, MD, PhD | Steno Diabetes Center Odense, Denmark | Principal Investigator |
| Vibe Vestergaard, Nurse | Steno Diabetes Center Odense, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Odense | 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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Non-randomized interventional study comparing device and blood reference measurements in diabetic patients
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