This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
173
Investigational Medical Device collecting Raman data from tissue
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany
Determination of number of calibration days
The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.
Time frame: 2 years
Safety evaluation of the Investigational Medical Device by reporting of adverse events
Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation
Time frame: 2 years
Device function
Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries
Time frame: 2 years
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