Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Mader, JK; Waldenmaier, D; Mueller-Hoffmann, W; Mueller, K; Angstmann, M; Vogt, G; Rieger, CC; Eichenlaub, M; Forst, T; Freckmann, G.
Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.
J Diabetes Sci Technol. 2024; 18(5):1044-1051
Doi: 10.1177/19322968241267774
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- Mader Julia
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- Abstract:
- BACKGROUND: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated. METHODS: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days. During four in-clinic visits, frequent comparison measurements with capillary blood glucose (BG) samples were performed. The primary endpoint was the 20/20 agreement rate (AR): the percentage of CGM readings within ±20 mg/dL (at BG values <100 mg/dL) or ±20% (at BG values ≥100 mg/dL) of the comparator. Further evaluations included mean absolute relative difference (MARD) and 20/20 AR in different BG ranges and across the wear time. RESULTS: Data from 48 participants and 139 sensors were analyzed. During in-clinic sessions the 20/20 AR was 90.5% and the MARD was 9.2%. For BG ranges <70, 70-180, and >180 mg/dL, 20/20 AR was 94.3%, 89.0%, and 92.5%, respectively. At the beginning, middle, and end of sensor wear time, 20/20 AR was 92.8%, 91.5%, and 85.9%, respectively. The 14-day survival probability was 82.4%. Pain and bleeding after sensor insertion were within the expected range. Based on the study outcome, the use of the device is regarded as safe. CONCLUSIONS: The system showed a good performance compared to capillary BG measurements. This level of accuracy could be shown over the entire measurement range, especially in the low glycemic range, and the whole wear time of the sensors. The results of this study are supporting a non-adjunctive use of the device.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Blood Glucose Self-Monitoring - instrumentation
- Female - administration & dosage
- Middle Aged - administration & dosage
- Male - administration & dosage
- Blood Glucose - analysis
- Adult - administration & dosage
- Aged - administration & dosage
- Diabetes Mellitus - blood
- Reproducibility of Results - administration & dosage
- Continuous Glucose Monitoring - administration & dosage
- Find related publications in this database (Keywords)
- accuracy
- continuous glucose monitoring
- MARD
- performance