ArticleJournal of diabetes science and technology2026
Performance, Safety and Usability of a Third-Generation Continuous Glucose Monitoring System in a Pediatric Population: Results From a Prospective, Multicenter Study.
Article in Journal of diabetes science and technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
backgroundA 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.
methodThis 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.
resultsThe 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.
conclusionsIn a pediatric population, the novel CGM system demonstrated accurate and stable performance across its 15-day wear life and showed high usability.
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