CLINICAL STUDY FOR EVALUATION OF POTENTIAL INTERFERENTS ON THE NON-INVASIVE MODULE OF THE TENSORTIP COMBINED INVASIVE AND NON-INVASIVE GLUCOSE METER

Session Name
GLUCOSE SENSORS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:30 - 09:30
Presenter
  • Andreas Pfützner, Germany
Authors
  • Andreas Pfützner, Germany
  • Filiz Demircik, Germany
  • Julia Jantz, Germany
  • Anke H. Pfützner, Germany
  • Mina Hanna, Germany
  • Alexander Lier, Germany

Abstract

Background and Aims

Nutritional substances, over-the-counter drugs, and popular nutritional supplements can influence blood flow. This study was performed to evaluate possible interferences for the non-invasive module of the TensorTip Combo glucose meter (CoG, CNOGA Medical, Cesarea, Israel).

Methods

Ten healthy subjects were included in this trial (6 male, 4 female, age: 41±14 yrs). They arrived after an overnight fast and ingested the test substance (ten visits/patient). Six glucose assessment were performed at time-points related to the anticipated pharmacokinetic profiles. YSI Stat2300 plus and COBAS served as reference methods. Mean absolute relative bias for each concentration was calculated and plotted against the plasma substance concentration. Interference was assumed when the slope of the regression line was >10% or <-10%.

Results

No interference was seen with any of the tested substances (acetaminophen, acetyl salicylic acid, ascorbic acid, caffeine, diclofenac, ethyl alcohol, ibuprofen, mannose, xylose, 3Ω-fatty acids). Uptake of ethyl alcohol (0.2 g/kg) caused interference with the YSI results (-11 % vs. COBAS) and the invasive device module results (-11 % vs COBAS, non-invasive module: 0.6 % vs. COBAS). Overall MARD vs. YSI (n = 600) in the observed glucose range (71 to 158 mg/dL) was 8.8 % and 7.4 % for the non-invasive and the invasive modules, respectively.

Conclusions

The non-invasive CoG module was not influenced by any of the tested substances. Operating the invasive CoG module after alcohol uptake may result in too low results (e.g. plasma alcohol levels of 2.0 o/oo result in a 20 % underestimation by the invasive CoG module).

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