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Accuracy Assessment of the GlucoMen(®) Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen(®) Day CGM systems worn simultaneously by eight participants...

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Detalles Bibliográficos
Autores principales: Hochfellner, Daniel A., Simic, Amra, Taucher, Marlene T., Sailer, Lea S., Kopanz, Julia, Pöttler, Tina, Mader, Julia K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8869704/
https://www.ncbi.nlm.nih.gov/pubmed/35200366
http://dx.doi.org/10.3390/bios12020106
Descripción
Sumario:The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen(®) Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6–14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5–18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen(®) Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.