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

Abstract

Background/Aims: The FreeStyle® Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years in January 2016. Experience in children is still limited. We evaluated the accuracy and usability of the FGM in children with type 1 diabetes mellitus (DM). Methods: 67 children with type 1 DM (35 girls), aged 4–18 years, were included. Subjects wore a sensor on the back of their upper arm. For the first 14 days, they regularly measured capillary blood glucose (BG) with their usual BG meter (Accu-Chek® Mobile [ACM], Roche [n = 24]; Contour® Next Link [CNL], Bayer [n = 26]; OneTouch® Verio® IQ [OTV], LifeScan [n = 17]) followed by a sensor glucose (SG) scanning. SG readings were compared to BG measurements by consensus error grid (CEG) analysis; the mean difference (MD), the mean relative difference (MRD), the mean absolute difference (MAD), and the mean absolute relative difference (MARD) were calculated. After 14 days, subjects were asked to fill in a questionnaire on the usability of the FGM. Results: 2,626 SG readings were paired with BG results. FGM readings were highly correlated with BG (r = 0.926, p < 0.001). 80.3% of the data pairs were in zone A (= no effect on clinical action) and 18.4% were in zone B (= altered clinical action with little or no effect on the clinical outcome) of the CEG. Overall MD was +7.5 mg/dL; MD varied with the BG meter: ACM +10.4 mg/dL, CNL +14.2 mg/dL, OTV –3.6 mg/dL (p < 0.001). Overall, MARD was 16.7%. We observed a large interindividual variability in the accuracy parameters. MD and MRD were inversely related to BMI (r = –0.261 [p < 0.05]; r = –0.266 [p < 0.05], respectively). MARD was inversely related to age (r = –0.266 [p < 0.05]). Twenty-nine patients (43.3%) reported sensor problems, mainly early detachment of the sensor. Nonetheless, the usability questionnaire indicated high levels of satisfaction. Conclusions: Our results showed a reasonable agreement between the FGM SG readings and capillary BG measurements in children. There was, however, a large interindividual variability. The wearing of the sensor requires special attention. Further studies in children are imperative in order to document the accuracy and safety of the FGM in the paediatric population.

Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study

“…Comparison of regression results from this study to the previous one conducted in children and adolescents confirmed a good agreement between isCGM and BG results . The comparison of CEG analysis with 95.2% of results in zones A + B is slightly lower compared to data reported previously in larger population of pediatric and adults patients . The percentage of results with no effect on clinical action according CEG analysis was comparable to that early reported in children (82.2% vs 83.8%); furthermore, although comparisons between devices not tested “head to head” in the same trial should be considered with caution, it is noteworthy that the zone A percentage described in this study was greater than the percentage reported for another frequently used rtCGM system .…”

“…Comparison of regression results from this study to the previous one conducted in children and adolescents confirmed a good agreement between isCGM and BG results . The comparison of CEG analysis with 95.2% of results in zones A + B is slightly lower compared to data reported previously in larger population of pediatric and adults patients .…”

“…In addition to previous reports, this is to our knowledge the first randomized controlled trial to evaluate the non‐adjunctive use of isCGM in the pediatric population with T1D. Two previous randomized controlled trials in adult patients with diabetes demonstrated safety and efficacy of isCGM to replace SMBG .…”

“…The sensor‐based flash glucose monitoring system (FreeStyle Libre, Abbott Diabetes Care), an isCGM device can be scanned as often as needed with the reader displaying current sensor glucose level, glucose trend arrow and graphs of the glucose readings over the previous 8 hours; furthermore, it does not require finger‐stick calibration, as it is calibrated in the factory, and has a wear period of 14 days (10 days and a 12‐hour warm‐up period in the United States) . Recently published data have demonstrated safety and efficacy of isCGM technology to replace SMBG in adult patients with diabetes and good accuracy results in pediatric and adolescent population with T1D, with little data on benefit in glycemic control in this population . The aim of the present study was to evaluate efficiency and safety of isCGM as a replacement for standard SMBG‐based glucose control in children with type 1 diabetes (T1D) during a summer camp.…”

Persistent heterogeneity in diabetes technology reimbursement for children with type 1 diabetes: The SWEET perspective

“…This strategy of the regulatory authorities is understandable but unacceptable. Although Massa et al showed a reasonable agreement between the FGM readings and capillary blood glucose measurements in children, they observed a large interindividual variability in accuracy and concluded that the wearing of the sensor requires special attention. Therefore, FGM users still need test strips for confirmation, especially during hypoglycemic periods, to avoid overtreatment or discrepancies between the clinical perception and FGM.…”