This is a single-centre, multiple cohort, open study.
The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
80
During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid)
Profil for Stoffwechselforschung GmbH
Neuss, Nordrhein-Westfallen, Germany
RECRUITINGGlucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia
Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia
Time frame: The data is collected during the study procedure (up to 5 hours)
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