Performance of a 15-Day Continuous Glucose Monitoring System in Children and Adolescents With Diabetes.
6 affiliations
- 1Institut für Diabetes-Technologie Ulm GmbH, Germany.
- 2Division of Pediatric Endocrinology and Diabetology, Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm, Germany.
- 3Partner Site Ulm, German Center for Child and Adolescent Health (DZKJ), Germany.
- 4Diabetes-Center for Children and Adolescents, AUF DER BULT, Hannover, Germany.
- 5Department of Pediatric and Adolescent Medicine, University Hospital Tuebingen, Germany.
- 6Section of Pediatric Endocrinology and Diabetology, Department of Pediatrics and Adolescent Medicine, University Hospital Augsburg, Germany.
Abstract
Background
The CareSens Air (CSAir) continuous glucose monitoring system is approved for use in adults in South Korea and received adults-only CE marking in early 2024. The aim of this prospective, multicenter, pivotal study in children and adolescents with insulin-dependent diabetes mellitus was to determine if the performance and safety of CSAir in these populations are comparable to those observed in adults.Method
Sensors were worn for 15 days on the upper arm in children and adolescents aged 7 to 17 years and on the upper arm and/or upper buttock in children aged 2 to 6 years. Frequent capillary comparator measurements were performed during in-clinic sessions at the beginning, middle, and end of the sensor-wearing period. Point accuracy was assessed via agreement rates (AR) and mean absolute relative difference (MARD). Additional assessments included clinical point accuracy, technical reliability, and safety.Results
For subjects aged 7 to 17 years, %20/20 AR was 90.8%, and MARD was 8.9%. A total of 99.9% of values fell within Zones A and B of the Diabetes Technology Society error grid. Sensor survival probability reached 75.2%. In children aged 2 to 6 years, %20/20 ARs were 86.6% and 98.4%, and MARDs were 10.3% and 7.8% for arm- and buttock-worn sensors, respectively. No serious adverse events were reported. Mild and moderate adverse device effects comprised skin issues such as itching or erythema at the sensor application or insertion site.Conclusions
The observed performance and safety of CSAir in children and adolescents are similar to those in adults. These data may support an extension of regulatory approval of CSAir for children aged 2 years and older.
Related
- Glycaemic outcomes of three months of continuous glucose monitoring in children, adolescents and young adults with type 1 diabetes at a Kenyan tertiary hospital: a single-arm prospective study.
- Usability, acceptability and feasibility of continuous glucose monitoring among children and adolescents with type 1 diabetes in Kenya
- Performance and Safety of a Continuous Glucose Monitoring System in Pregnant Women With Gestational Diabetes Mellitus: A Multicenter, Open-Label Trial
- Real-world accuracy, extended-wear performance, and user satisfaction with a novel 21-day continuous glucose monitoring system in pediatric type 1 diabetes.
- Continuous glucose monitoring, automated insulin delivery, and remote care in adolescents with type 1 diabetes: advances toward integrated digital management
BibTeX
@article{link2026performance,
title = {{Performance of a 15-Day Continuous Glucose Monitoring System in Children and Adolescents With Diabetes.}},
author = {Manuela Link and Christian Denzer and Torben Biester and Jantje Weiskorn and Julian Ziegler and Franziska Liebrich and Désirée Dunstheimer and Jakob Krämer and Manuel Eichenlaub and Anne Beltzer and Martin Wabitsch and Guido Freckmann},
journal = {Journal of diabetes science and technology},
year = {2026},
month = oct,
doi = {10.1177/19322968261493981},
url = {https://europepmc.org/article/MED/42872793},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Performance of a 15-Day Continuous Glucose Monitoring System in Children and Adolescents With Diabetes.
AU - Manuela Link
AU - Christian Denzer
AU - Torben Biester
AU - Jantje Weiskorn
AU - Julian Ziegler
AU - Franziska Liebrich
AU - Désirée Dunstheimer
AU - Jakob Krämer
AU - Manuel Eichenlaub
AU - Anne Beltzer
AU - Martin Wabitsch
AU - Guido Freckmann
PY - 2026
DA - 2026/10/14
JO - Journal of diabetes science and technology
DO - 10.1177/19322968261493981
UR - https://europepmc.org/article/MED/42872793
AB - Background The CareSens Air (CSAir) continuous glucose monitoring system is approved for use in adults in South Korea and received adults-only CE marking in early 2024. The aim of this prospective, multicenter, pivotal study in children and adolescents with insulin-dependent diabetes mellitus was to determine if the performance and safety of CSAir in these populations are comparable to those observed in adults.Method Sensors were worn for 15 days on the upper arm in children and adolescents aged 7 to 17 years and on the upper arm and/or upper buttock in children aged 2 to 6 years. Frequent capillary comparator measurements were performed during in-clinic sessions at the beginning, middle, and end of the sensor-wearing period. Point accuracy was assessed via agreement rates (AR) and mean absolute relative difference (MARD). Additional assessments included clinical point accuracy, technical reliability, and safety.Results For subjects aged 7 to 17 years, %20/20 AR was 90.8%, and MARD was 8.9%. A total of 99.9% of values fell within Zones A and B of the Diabetes Technology Society error grid. Sensor survival probability reached 75.2%. In children aged 2 to 6 years, %20/20 ARs were 86.6% and 98.4%, and MARDs were 10.3% and 7.8% for arm- and buttock-worn sensors, respectively. No serious adverse events were reported. Mild and moderate adverse device effects comprised skin issues such as itching or erythema at the sensor application or insertion site.Conclusions The observed performance and safety of CSAir in children and adolescents are similar to those in adults. These data may support an extension of regulatory approval of CSAir for children aged 2 years and older.
SN - 1932-2968
ER -