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 wit...

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Bibliographic Details
Published in:Biosensors (Basel) 2022-02, Vol.12 (2), p.106
Main Authors: Hochfellner, Daniel A, Simic, Amra, Taucher, Marlene T, Sailer, Lea S, Kopanz, Julia, Pöttler, Tina, Mader, Julia K
Format: Article
Language:English
Subjects:
Accuracy
Blood Glucose - chemistry
Blood Glucose - metabolism
Blood Glucose Self-Monitoring - instrumentation
CGM
Diabetes
Diabetes mellitus
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - blood
diabetes technology
Environmental impact
Error analysis
Glucose
Glucose monitoring
Humans
Hypoglycemia
Insertion
Insulin
Medical equipment
Medical wastes
Monitoring
Pilot Projects
Questionnaires
Reproducibility of Results
Research facilities
Sensors
sustainability
Technology
Trends
type 1 diabetes
Usability
Values
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Summary: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.
ISSN:2079-6374
2079-6374
DOI:10.3390/bios12020106