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

Daniel A. Hochfellner,Marlene T. Taucher,Amra Simic,Julia K. Mader,Tina Pöttler,Julia Kopanz,Lea S. Sailer

doi:10.3390/bios12020106

Daniel A. Hochfellner, Marlene T. Taucher + Show 5 more

Open Access

https://doi.org/10.3390/bios12020106

Copy DOI

Journal: Biosensors	Publication Date: Feb 9, 2022
Citations: 6	License type: CC BY 4.0

Affiliation: Medical University of Graz

Abstract

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.

Highlights

The introduction of continuous glucose monitoring (CGM) represents one of the most important advancements within diabetes treatment and self-management over the last decades
CGM provides easy access to current glucose levels, glucose trends, and the retrospective analysis of glucose excursions, facilitating easier and better diabetes management for both people living with diabetes (PLWD) and health care professionals
PLWD using CGM technology show improvement in HbA1c, glucose variability, hypoglycemia prevalence, overall well-being, and treatment satisfaction and have less fear of hypoglycemia compared to Self-monitoring of blood glucose (SMBG) [1,2,3]

Summary

Introduction

The introduction of continuous glucose monitoring (CGM) represents one of the most important advancements within diabetes treatment and self-management over the last decades. PLWD using CGM technology show improvement in HbA1c, glucose variability, hypoglycemia prevalence, overall well-being, and treatment satisfaction and have less fear of hypoglycemia compared to SMBG [1,2,3]. Most current CGM have already reached accuracy levels of SMBG and are, labeled for nonadjunctive use by regulators, meaning that CGM can be utilized for treatment decisions without the subsequent SMBG confirmation [8,9,10,11]. As CGM enables easy assessment of the time spent in target range (TIR), which has been shown to be a valid marker of glycemic control alongside HbA1c, there has been an evolution of individual treatment guidelines for CGM use with a focus on TIR [12]

Objectives

Methods

Results