Performance of a 15-Day Continuous Glucose Monitoring System in Children and Adolescents With Diabetes.

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.