Performance, Safety and Usability of a Third-Generation Continuous Glucose Monitoring System in a Pediatric Population: Results From a Prospective, Multicenter Study.

BACKGROUND

A proprietary continuous glucose monitoring (CGM) system that uses third-generation sensor technology has previously been shown to exhibit stable, single-digit mean absolute relative difference (MARD) and 15-day wear life in adults with diabetes.

METHOD: This was a prospective, single-arm study of pediatric participants aged 2 to 17 years that were enrolled at 3 clinical centers. Participants wore 2 sensors, one on each side of the abdomen, and were randomized to assessment of device performance on days 1 and 2, days 7 to 9 or days 15 and 16. Device performance across a range of metrics was assessed by comparison with venous blood glucose values obtained using a laboratory reference device. Per-protocol results are reported for the sensor with the inferior MARD.

RESULTS

The per-protocol set comprised 75 participants, of whom 16 were aged 2 to 5 years. The overall MARD was 8.89%, and MARDs at days 1 and 2, 7 to 9 and 15 and 16 were 8.65%, 8.70% and 9.30%, respectively. DTS error grid analyses showed that 100.0% of data pairs fell in clinically acceptable zones A+B. True alarm rates for hypoglycemia and hyperglycemia were high, at 98.6% and 98.8%, respectively. Mean sensor wear life was 14.4 days, and participant/guardian assessments of sensor usability revealed high satisfaction with respect to system assembly, sensor insertion and overall comfort. No device-related or skin-related adverse events were reported.

CONCLUSIONS

In a pediatric population, the novel CGM system demonstrated accurate and stable performance across its 15-day wear life and showed high usability.