ArticleJournal of diabetes science and technology2025
Comparative Performance Analysis of Manual and Updated Optional Calibration Algorithms for the CareSens Air CGM System.
Article in Journal of diabetes science and technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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Who cites it
4 citing papers in PubMed.
- International clinical opinion on transparency, standardisation, and calibration alignment in the performance evaluation of systems for continuous glucose monitoring.Diabetes, obesity & metabolism · 2026Review
- Metrics in pregnancy: is it the time for new glycaemic goals for pregnant women with type 1 diabetes? An experience with advanced hybrid closed loop.Acta diabetologica · 2026Article
- 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
- Towards Standardization of CGM Performance Studies: The QUSS-CGM Questionnaire for Assessing User Satisfaction.Patient related outcome measures · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe CE-marked CareSens Air continuous glucose monitoring (CGM) system (CSAir) features a 15-day sensor lifetime, a 2-hour warm-up period and mandatory manual calibrations. During subsequent product development, the algorithm was updated to reduce the warm-up period to 30 minutes and make user-entered calibrations optional. This study compared the CSAir's performance between the manual and updated algorithms.
methodsThirty adults with diabetes wore three CSAir sensors on their upper arms for 15 days. The study included three in-clinic sessions with capillary comparator measurements at 15-minute intervals over seven hours and glucose manipulation in the hypo- or hyperglycemic range. Point accuracy was assessed via mean absolute relative difference (MARD), 20/20 agreement rates (AR) stratified by BG range, and sensor wear time. Further evaluations included clinical point accuracy, alert reliability, technical reliability, safety and user satisfaction.
resultsThe CSAir's updated algorithm exhibited improved accuracy compared with the manual calibration algorithm, with a total 20/20 AR of 93.9% (vs 90.1%) and an MARD of 8.7% (vs 9.9%). Accuracy remained stable across measurement ranges and sensor lifetime. Diabetes Technology Society Error Grid analysis revealed high clinical accuracy, with 88.0% and 92.4% of data pairs in zone A for the manual and updated algorithms, respectively. The estimated survival probability was 88.8%. Participants reported positive user satisfaction. No safety concerns were identified.
conclusionsBoth algorithms of CSAir demonstrated robust performance and reliability with improved accuracy with the updated version. The study results of the CSAir suggest its suitability for nonadjunctive use.
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