An alternative sensor-based method for glucose monitoring in children and young people with diabetes

Abstract

ObjectiveTo determine accuracy, safety and acceptability of the FreeStyle Libre Flash Glucose Monitoring System in the paediatric population.Design, setting and patientsEighty-nine study participants, aged 4–17 years, with type 1 diabetes were enrolled across 9 diabetes centres in the UK. A factory calibrated sensor was inserted on the back of the upper arm and used for up to 14 days. Sensor glucose measurements were compared with capillary blood glucose (BG) measurements. Sensor results were masked to participants.ResultsClinical accuracy of sensor results versus BG results was demonstrated, with 83.8% of results in zone A and 99.4% of results in zones A and B of the consensus error grid. Overall mean absolute relative difference (MARD) was 13.9%. Sensor accuracy was unaffected by patient factors such as age, body weight, sex, method of insulin administration or time of use (day vs night). Participants were in the target glucose range (3.9–10.0 mmol/L) ∼50% of the time (mean 12.1 hours/day), with an average of 2.2 hours/day and 9.5 hours/day in hypoglycaemia and hyperglycaemia, respectively. Sensor application, wear/use of the device and comparison to self-monitoring of blood glucose were rated favourably by most participants/caregivers (84.3–100%). Five device related adverse events were reported across a range of participant ages.ConclusionsAccuracy, safety and user acceptability of the FreeStyle Libre System were demonstrated for the paediatric population. Accuracy of the system was unaffected by subject characteristics, making it suitable for a broad range of children and young people with diabetes.Trial registration numberNCT02388815.

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

“…In our study 76.2% of the hypoglycaemias and 93.8% of the hyperglycaemias were detected by the FGM. This is better than in the study of Edge et al [25] were 70% of the hypoglycaemias were detected and 85% of the hyperglycaemias.…”

“…In adults, Baily et al [20], found 99.7% and Fokkert et al [35] found 99.8% of the results in zone A and B. It is noteworthy to mention that Edge et al [25] and Baily et al [20] compared the scanned SG values with the capillary BG levels determined by the build-in meter using FreeStyle Optium test strips. Szadkowska et al [27] used the Contour Plus One glucometer.…”

“…Except for the OTV meter, our results are comparable with those reported in previous studies. Edge et al [25] evaluated the accuracy of the FGM in 89 children and reported that 99.4% of the results fell in zone A and B of the error grid. Szadkowska et al [27] studied the FGM in 78 children and found that 99.1% of the results fell in zone A and B.…”

Flash Glucose Monitoring: The Future Is Here

“…Several studies showed clinical benefits of flash glucose monitoring use in pediatric patients with T1D. [22][23][24] The clinical implications of CGM use to prevent hypoglycemia in children with T1D and other metabolic disorders were highlighted in this supplement by Lal et al 25 We hope that flash glucose monitoring (FreeStyle Libre personal) will be made available soon in the United States after approval by the FDA. We also hope that it is approved as ''nonadjunctive,'' since most providers and patients do not use current CGMs as adjunctive.…”

Freestyle Libre: available on the NHS?

“…Indeed, several studies have confirmed high levels of patient satisfaction with the FSL in adult and paediatric populations. [2][3][4] The IMPACT study, the major randomised controlled trial assessing the FSL, also described higher rates of treatment satisfaction. 5 …”