An Evaluation of the Accuracy of a Flash Glucose Monitoring System in Children with Diabetes in comparison with Venous Blood Glucose

Abstract

Aims. To evaluate the performance of a factory-calibrated flash glucose monitoring system in children with diabetes compared to venous blood glucose (BG). Methods. A total of 13 hospitalized participants newly diagnosed with type 1 diabetes, aged 1~14 years old, were involved in the study. Sensor glucose measurements on days 2, 3, 6, 7, 12, and 13 of wear were compared with venous BG. During these days, the venous BG results were obtained either 4 or 7 times per day. Results. The accuracy was evaluated against venous BG, with 469 of 469 (100.0%) sensor and venous BG pairs within consensus error grid zones A and B, including 94.7% in zone A. The overall mean absolute relative difference (MARD) was 11.67%. The MARD of blood glucose lower than 4.0 mmol/L (MARD=16.89%) was higher than blood glucose between 4 and 10 mmol/L (MARD=11.58%) and blood glucose higher than 10 mmol/L (MARD=7.79%). Compared to venous BG, the MARDs of wear days 2, 3, 6, 7, 12, and 13 were 11.53%, 9.66%, 11.79%, 10.89%, 13.18%, and 13.92%, respectively, with no statistically significant difference (P=0.25). The median ARD was highest when the glucose decreased >0.11 mmol/L/min (20.27%) and lower than 10.00% when the glucose changed between 0.06 and 0.11 mmol/L/min, changed <0.06 mmol/L/min, and increased >0.11 mmol/L/min. Conclusions. The accuracy of the system is good and remains stable over 14 days of wear; however, the accuracy depends on the glucose level and rates of glucose concentration changes.

Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis

“…The accuracy of FGM may play a role in this setting, even though a higher mean absolute relative difference has generally been reported during hypoglycemia rather than hyperglycemia. [27][28][29] It is worth noting that the definition of hypoglycemia differed among the included studies. According to current guidelines, it should be defined as any measurable glucose concentration <70 mg/dL, either symptomatic or asymptomatic.…”

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

“…The senor values were mostly lower than those of the capillary BG, and the difference gradually increased with the increase of BG levels. Different studies have debated whether there is a lag effect between the FreeStyle ® Libre System values and capillary BG values 5,16 ; therefore, we performed a detailed difference analysis at different time points (0, 5, 10, and 15 min) and different BG levels. Our results showed a gradual increase in the MARD over time, suggesting the lag time was short.…”

“…Recent studies [5][6][7][8][9][10] have demonstrated the benefits of the FreeStyle ® Libre Glucose Monitoring System, which includes helping reduce hemoglobin A1c (HbA1c) levels and hypoglycemic episodes and increase the target range time in children and adult populations. However, most of the trials were conducted on children aged >4 years, and there is limited data on children aged <4 years, including infants, with diabetes mellitus.…”

Performance of intermittently scanned continuous glucose monitoring systems in people with type 1 diabetes: A pooled analysis

“…Although most studies have shown that isCGM systems are within a safe clinical range [10][11][12] conclusive large-scale assessments of isCGM performance and the impact of the rate of change in glucose are currently lacking. Therefore, the aim of this pooled analysis was to assess isCGM (FreeStyle Libre 1; Abbott Diabetes Care, Alameda, California) performance and the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes.…”