This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form). The clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)
Study Type
OBSERVATIONAL
Enrollment
36
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, Germany
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
The accuracy of glucose values determined by D-Base 2.0 Prototype B in comparison with Contour Next (CNXT) values (non-invasive vs invasive glucose measurement) is determined by the following specific analysis: * Number and percentage of D-Base 2.0 Prototype B results within ±15 mg/dl or ±15% as well as ±20 mg/dl or ±20% and ±30 mg/dl or ±30% of mean CNXT results for mean CNXT results \<100 mg/dl or ≥100 mg/dl, respectively
Time frame: 3-13 days per subject
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