Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 9 November 2021 / Approved: 12 November 2021 / Online: 12 November 2021 (11:58:57 CET)

How to cite: Hochfellner, D.A.; Simic, A.; Taucher, M.T.; Sailer, L.S.; Kopanz, J.; Pöttler, T.; Mader, J.K. Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study. Preprints 2021, 2021110217 (doi: 10.20944/preprints202111.0217.v1). Hochfellner, D.A.; Simic, A.; Taucher, M.T.; Sailer, L.S.; Kopanz, J.; Pöttler, T.; Mader, J.K. Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study. Preprints 2021, 2021110217 (doi: 10.20944/preprints202111.0217.v1).

Abstract

Aim of this study was to evaluate the accuracy and usability of a novel continuous glucose moni-toring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed sensor performance of two GlucoMen® Day CGM systems worn simultaneously in eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed reg-ularly over 14 days at home. Participants underwent two standardized 5-hour meal challenges with frequent plasma glucose (PG) measurements using a laboratory reference instrument at the research center. When comparing CGM to PG the overall mean absolute relative difference (MARD) was 9.7 [2.6-14.6]%. The overall MARD of CGM vs SMBG was 13.1 [3.5-18.6]%. In the consensus error grid (CEG) analysis, 98% of both CGM/PG and CGM/SMBG pairs were in the clinically acceptable zones A and B. The analysis confirms that GlucoMen® Day CGM meets the clinical requirements for state-of-the-art CGM. The needle-free insertion technology is well toler-ated by users and reduces medical waste compared to conventional CGM systems.

Keywords

Diabetes Technology; CGM; Accuracy; Type 1 Diabetes; Sustainability

Subject

MEDICINE & PHARMACOLOGY, Other

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