This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days. The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Investigational Medical Device collecting spectral Raman data non-invasively from tissue
Steno Diabetes Center Copenhagen (SDCC)
Gentofte Municipality, Denmark
Steno Diabetes Center Odense (SDCO)
Odense C, Denmark
Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
Ulm, Germany
Sahlgrenske University Hospital (SUH)
Gothenburg, Sweden
Measurement accuracy
Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).
Time frame: 6 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: 6 months
Device deficiencies
Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.
Time frame: Up to 6 months
Device usability
The use of the device will be evaluated by means of questionnaires. The subjects are asked if they encountered any problems during measurements, and if so, to elaborate the problems encountered.
Time frame: 6 months
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Department of Medicine, Uddevalla Hospital (UVH)
Uddevalla, Sweden
University Hospitals Birmingham (UHB)
Birmingham, United Kingdom