This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Investigational Medical Device collecting spectral Raman data from tissue
Steno Diabetes Center Aarhus
Aarhus, Denmark
Measurement accuracy of IMD
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)
Time frame: 4 months
Safety evaluation: paucity of adverse events
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study
Time frame: 4 months
Device deficiency
Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.
Time frame: 4 months
Device usability
The use of the device by the subjects will be evaluated by means of questionnaires
Time frame: 4 months
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