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This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.
Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.
Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSP-14 | Experimental | Comparative study of two Investigational Medical Devices (WM3.4NR and P0.1) Optical data will be obtained from T1D over a dynamic glycemic range. Data will be paired with references. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WM3.4NR | Device | The investigational medical device will collect spectral Raman data from tissue. |
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| Measure | Description | Time Frame |
|---|---|---|
| Generation and validation of prediction models | Two in-clinic visits each of a duration of 7-8 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM readings. In parallel, optical glucose data from two different prototypes of the investigational medical device will be collected. 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 from the two devices will be validated on independent data sets using MARD, ISUP and Consensus Error Grid endpoint measures. | 4 months |
| Performance evaluation | Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by paucity of adverse events | To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study. | 4 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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| P0.1 | Device | The investigational medical device will collect spectral Raman data from tissue. |
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