ArticleJournal of diabetes science and technology2024
Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.
Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Use of an insulin titration protocol based on continuous glucose monitoring in postoperative cardiac surgery patients with type 2 diabetes and prediabetes: a randomized controlled trial.Cardiovascular diabetology · 2025Trial
- Updated Calibration Algorithm Improves Analytical Accuracy of a Continuous Glucose Monitoring System.Journal of diabetes science and technology · 2026Article
- International clinical opinion on transparency, standardisation, and calibration alignment in the performance evaluation of systems for continuous glucose monitoring.Diabetes, obesity & metabolism · 2026Review
- Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Review
- And the Dog Was Barking: Transforming Quality of Life in Diabetes Through Innovative Hypoglycemia Detection.Journal of diabetes · 2025Article
- The Promise of Hypoglycemia Risk Prediction.Journal of diabetes science and technology · 2024Article
- Concept and Implementation of a Novel Continuous Glucose Monitoring Solution With Glucose Predictions on Board.Journal of diabetes science and technology · 2024Article
- Predicting Glucose Values: A New Era for Continuous Glucose Monitoring.Journal of diabetes science and technology · 2024Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated.
methodsAdult 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.
resultsData 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.
conclusionsThe 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.
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