Flash Glucose Measurements in Children with Type 1 Diabetes in Real-Life Settings: To Trust or Not to Trust?

Szadkowska, Agnieszka; Gawrecki, Andrzej; Michalak, Arkadiusz; Zozulińska‐Ziółkiewicz, Dorota; Fendler, Wojciech; Młynarski, Wojciech

doi:10.1089/dia.2017.0287

Cited by 34 publications

(58 citation statements)

References 26 publications

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“…Interestingly, Szadkowska et al [27] using the Contour Plus One glucometer also reported an overestimation of the glycaemia by the sensor of 7.35 mg/dL. This fact stresses the importance of the quality of the capillary BG meter used as reference.…”

Section: Discussionmentioning

confidence: 98%

“…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. 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.…”

Section: Discussionmentioning

confidence: 99%

“…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. Fokkert et al [35] compared the SG values with the StatStrip POC glucose measurement systems.…”

Section: Discussionmentioning

confidence: 99%

“…This figure is, however, less well than reported in previous studies in children as well as in adults. In children, Edge et al [25] reported a MARD of 13.9% and Szadkowska et al [27] observed a MARD of 13.5%. In adults, MARDs of 11.4% (12% compared with the YSI reference) [20], of 13.2% [37], and of 10–17% [35] have been reported.…”

Section: Discussionmentioning

confidence: 99%

“…Experience about the accuracy and usability in children, however, is still limited. So far, only 4 studies in children have been published [24-27]. The primary aim of the present study was to evaluate the accuracy of the FGM for estimating BG levels in children and adolescents with type 1 DM by comparing the scanned glucose result with the capillary BG value obtained by the BG meter the patients were actually using.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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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.

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Section: Discussionmentioning

confidence: 98%