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

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Bingyan Cao ◽  
Rui Wang ◽  
Chunxiu Gong ◽  
Di Wu ◽  
Chang Su ◽  
...  

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.

2021 ◽  
pp. 193229682110379
Author(s):  
Ligong Ji ◽  
Lixin Guo ◽  
Junqing Zhang ◽  
Yufeng Li ◽  
Zhiyan Chen

This study reports a clinical evaluation of AiDEX CGM system featuring a 14-day sensor, real-time glucose monitoring and factory-calibration. A multicenter, prospective, masked clinical study was conducted at with a total of 120 participants. Each participant wore 4 studied sensors and had one in-clinic visit for venous blood reference tests. 40 out of the 120 participants wore additional Abbott Libre sensors and performed at least 7 capillary BG tests daily for additional reference and comparison. Continuous glucose error grid analysis (CG-EGA) showed that AiDEX and Abbott Libre had good agreement with venous blood glucose, with 98.69% and 98.96% accurate readings, respectively. Overall MARD of AiDEX CGM systems was 9.08% when compared to venous blood reference and 10.1% when compared to finger capillary BG reference.


2018 ◽  
Vol 89 (3) ◽  
pp. 189-199 ◽  
Author(s):  
Guy G. Massa ◽  
Inge Gys ◽  
Anniek Op ‘t Eyndt ◽  
Esmiralda Bevilacqua ◽  
Anne Wijnands ◽  
...  

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.


2018 ◽  
Author(s):  
Muhammad Fahad Arshad ◽  
Ahmed Iqbal ◽  
Jonathan Bury ◽  
Jonathan Wadsley ◽  
Alia Munir

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 966-P
Author(s):  
ATSUSHI FUJIYA ◽  
TOSHIKI KIYOSE ◽  
TAIGA SHIBATA ◽  
HIROSHI SOBAJIMA

Animals ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 408
Author(s):  
Francesca Del Baldo ◽  
Alessia Diana ◽  
Claudia Canton ◽  
Nikolina Linta ◽  
Roberto Chiocchetti ◽  
...  

A flash glucose monitoring system (FGMS) has been validated for use in diabetic dogs. However, it is unknown whether skin thickness affects FGMS measurements. The aim of this study was to evaluate whether FGMS accuracy is affected by skin thickness. Fourteen client-owned diabetic dogs on insulin treatment were prospectively enrolled in the study. The dogs were divided into two groups according to their ultrasound-measured skin thickness: dogs with skin thickness < 5 mm (Group 1) and dogs with skin thickness > 5 mm (Group 2). On days 1, 7 and 14, glucose curves were obtained simultaneously using the FGMS and a validated portable blood glucose meter. Paired measurements were used to calculate the mean bias and to determine accuracy according to ISO 15197:2013 criteria. The mean bias was significantly inversely correlated (p = 0.02; r = −0.6) with the mean skin thickness. Clinical accuracy was observed only in Group 2, with 99% of the results in zone A + B of the Parkes consensus error grid analysis. In conclusion, skin thickness seems to affect FGMS measurements, and the device is accurate in dogs with thicker skin (>5 mm); in dogs with thin skin (<5 mm), the clinical accuracy is low, and the results should be interpreted with caution.


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