Application of the FreeStyle®Libre Glucose Monitoring System in type 1 diabetes mellitus patients aged 1-4 years.

Abstract

To investigate the analytical accuracy, safety performance, and user satisfaction (guardians of study participants) of the FreeStyle®Libre Glucose Monitoring System in the treatment of type 1 diabetes mellitus (T1DM), in children aged <4 years. Sixteen hospitalized children with new onset T1DM, aged 4 months to 4 years, were enrolled in this study. Patients wore the sensor for 14 days; sensor scans were performed immediately and at 5, 10, and 15 min after capillary blood glucose (BG) measurements to evaluate the effectiveness of the device and the lag effect. The consensus error grid showed that 96.40% of values fell within zone A (no clinical impact) and 3.60% within zone B (little/no clinical impact). Overall, the mean absolute relative difference (MARD) was 9.34%, and was higher in the capillary BG <4.0 mmol/L group (15.18%) than in the 4-10 mmol/L (9.63%) and >10 mmol/L (7.17%) groups. The MARD increased gradually with scanning time extension, indicating a short lag effect. Regression analysis showed that a higher BG level was associated with a greater difference in FreeStyle®Libre System measurements. The use of the FreeStyle®Libre System in children aged 1-4 years is accurate and safe, and may be accurate down to 4 months, independent of patient characteristics.