FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions

Boscari, Federico; Galasso, Silvia; Facchinetti, Andrea; Marescotti, Maria Cristina; Vallone, Valeria Beatriz Fernández; Amato, Anna Maria Letizia; Avogaro, Angelo; Bruttomesso, Daniela

doi:10.1016/j.numecd.2017.10.023

Cited by 54 publications

(47 citation statements)

References 18 publications

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“…In contrast, the median ARD was optimal during hyperglycemia. The present study findings are in line with the recently published accuracy of FSL CGMS [14][15][16][17] . The MARD between FSL and Dexcom G4 Platinum (Dexcom Inc., San Diego, CA, USA) CGMS was higher in hypoglycemia than in either euglycemia or hyperglycemia 15,17 .…”

Section: Discussionsupporting

confidence: 93%

“…The present study findings are in line with the recently published accuracy of FSL CGMS [14][15][16][17] . The MARD between FSL and Dexcom G4 Platinum (Dexcom Inc., San Diego, CA, USA) CGMS was higher in hypoglycemia than in either euglycemia or hyperglycemia 15,17 . The MARD of several devices, including the FSL, compared with venous or capillary BG are also higher in hypoglycemia than in euglycemia or hyperglycemia 14,16,17 .…”

Section: Discussionsupporting

confidence: 93%

“…One report has described that SMBG can serve as the primary comparator for FGMS performance evaluation 13 . Many studies have used the MARD to determine the accuracy of FGMS and CGMS [13][14][15][16][17][18] . However, we applied median ARD instead of MARD, because the distribution of the glucose values measured in the present study was not normal.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus

Kumagai

Muramatsu

Fujii

et al. 2018

J of Diabetes Invest

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Aims/Introduction Flash and continuous glucose monitoring systems are becoming prevalent in clinical practice. We directly compared a flash glucose monitoring system (FreeStyle Libre Pro [FSL ‐Pro]) with a continuous glucose monitoring system ( iP ro2) in patients with diabetes mellitus. Materials and Methods Glucose concentrations were simultaneously measured using the FSL ‐Pro, iP ro2 and self‐monitoring blood glucose in 10 patients with diabetes mellitus, and agreement among them was assessed. Results Parkes error grid analysis showed that the 92.9 and 7.1% of glucose values measured using the FSL ‐Pro fell into areas A and B, respectively, and that 96.3, 2.8 and 0.9% of those determined using iP ro2 fell into areas A, B and C, respectively. The median absolute relative differences compared with self‐monitoring blood glucose were 8.1% (3.9–12.7%) and 5.0% (2.6–9.1%) for the FSL ‐Pro and iP ro2, respectively. Analysis of 5,555 paired values showed a close correlation between FSL ‐Pro and iP ro2 glucose values (ρ = 0.96, P < 0.01). Notably, 65.3% of all glucose values were lower for the FSL ‐Pro than the iP ro2. Median glucose values also decreased by 3.3% for the FSL ‐Pro compared with the iP ro2 (177.0 [133.0–228.0] vs 183.0 [145.0–230.0] mg/dL, P < 0.01). The difference in glucose values between the two systems was more pronounced in hypoglycemia. The median absolute relative difference between FSL ‐Pro and iP ro2 during hypoglycemia was much larger than that during euglycemia and hyperglycemia. Conclusions Both the FSL ‐Pro and iP ro2 systems are clinically acceptable, but glucose values tended to be lower when measured using the FSL ‐Pro than the iP ro2. Agreement was not close between these systems during hypoglycemia.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus

Kumagai

Muramatsu

Fujii

et al. 2018

J of Diabetes Invest

View full text Add to dashboard Cite

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“…1), which were connected to the leads of a CHI 1440 potentiostat (CH Instruments) to provide 1 Hz measurements of sensor current. The Dexcom G4 is designed for 7 days of use but is often used for up to 14 days (21). Therefore, in vivo experiments were performed 7-13 days after sensor implantation to reflect clinically relevant conditions.…”

Section: Sensorsmentioning

confidence: 99%

Fibrotic Encapsulation Is the Dominant Source of Continuous Glucose Monitor Delays

et al. 2019

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Continuous glucose monitor (CGM) readings are delayed relative to blood glucose, and this delay is usually attributed to the latency of interstitial glucose levels. However, CGM-independent data suggest rapid equilibration of interstitial glucose. This study sought to determine the loci of CGM delays. Electrical current was measured directly from CGM electrodes to define sensor kinetics in the absence of smoothing algorithms. CGMs were implanted in mice, and sensor versus blood glucose responses were measured after an intravenous glucose challenge. Dispersion of a fluorescent glucose analog (2-NBDG) into the CGM microenvironment was observed in vivo using intravital microscopy. Tissue deposited on the sensor and nonimplanted subcutaneous adipose tissue was then collected for histological analysis. The time to half-maximum CGM response in vitro was 35 ± 2 s. In vivo, CGMs took 24 ± 7 min to reach maximum current versus 2 ± 1 min to maximum blood glucose ( P = 0.0017). 2-NBDG took 21 ± 7 min to reach maximum fluorescence at the sensor versus 6 ± 6 min in adipose tissue ( P = 0.0011). Collagen content was closely correlated with 2-NBDG latency ( R = 0.96, P = 0.0004). Diffusion of glucose into the tissue deposited on a CGM is substantially delayed relative to interstitial fluid. A CGM that resists fibrous encapsulation would better approximate real-time deviations in blood glucose.

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“…Direct accuracy comparisons between different CGM systems are uncommon and typically require patients to wear two [9][10][11][12][13] or three [14][15][16] sensors simultaneously and submit to frequent blood sampling. Because most clinical trials evaluating outcomes associated with CGM use blinded CGM or SMBG regimens as the control group, direct comparisons of outcomes associated with different CGM systems are even less common.…”

Section: Introductionmentioning

confidence: 99%

Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems

Welsh

Gao

Derdzinski

et al. 2019

Diabetes Technology & Therapeutics

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Background: Accuracy and feature sets of continuous glucose monitoring (CGM) systems may influence device utilization and outcomes. We compared clinical trial accuracy and real-world utilization and effectiveness of two different CGM systems. Materials and Methods: Separately conducted accuracy studies of a fifth-generation and a sixth-generation CGM system involved 50 and 159 adults, respectively. For between-system performance comparisons, propensity score methods were utilized to balance cohort characteristics. Real-world outcomes were assessed in 10,000 anonymized patients who had switched from the fifth-generation to the sixth-generation system and had used connected mobile devices to upload data from both systems, allowing pairwise comparisons of device utilization and glucose concentration distributions. Results: Propensity score-adjusted mean absolute relative differences for the fifth-and sixth-generation systems were 9.0% and 9.9%, and the percentages of values within-20%/20 mg/dL were 93.1% and 92.5%, respectively. The sixth-generation system, but not the fifth-generation system, met accuracy criteria for interoperable CGM systems. Both systems had high real-world utilization rates (93.8% and 95.3% in the fifth-and sixthgeneration systems, respectively). Use of the sixth-generation system was associated with fewer glucose values <55 mg/dL (<3.1 mmol/L) (0.7% vs. 1.1%, P < 0.001) and more values 70-180 mg/dL (3.9-10.0 mmol/L) (57.3% vs. 56.0%, P < 0.001) than the fifth-generation system. Conclusions: CGM performance outcomes can be compared through the propensity score analysis of clinical trial data and pairwise comparisons of real-world data. The systems compared here had nearly equivalent accuracy and utilization rates. Longer term biochemical and psychosocial benefits observed with the fifthgeneration system are also expected with the sixth-generation system.

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FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions

Cited by 54 publications

References 18 publications

Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus

Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus

Fibrotic Encapsulation Is the Dominant Source of Continuous Glucose Monitor Delays

Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems

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