Venous, Arterialized-Venous, or Capillary Glucose Reference Measurements for the Accuracy Assessment of a Continuous Glucose Monitoring System

Kropff, Jort; Steen, Sigrid C. van; deGraaff, Peter; Chan, Man Wai; Amstel, Rombout B E van; DeVries, J. Hans

doi:10.1089/dia.2017.0189

Cited by 10 publications

(5 citation statements)

References 25 publications

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“…Comparison of the MARD and MRD results shows the impact of choice of the reference sample. 22 In general, MRD during dynamic phases was approximately 5% higher when compared to venous samples because postprandial glucose concentrations are higher in capillary blood than in venous blood. 23 Consequently, RCGM which had the largest negative bias of the three systems compared to SMBG in the hyperglycemic range, showed the smallest absolute bias compared to venous samples.…”

Section: Discussionmentioning

confidence: 97%

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison

Freckmann

Link

Kamecke

et al. 2019

J Diabetes Sci Technol

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Background: To be able to compare continuous glucose monitoring (CGM) systems, they have to be worn in parallel by the same subjects. This study evaluated the performance and usability of three different CGM systems in direct comparison. Method: In this open, prospective study at two sites, 54 patients with diabetes wore three CGM systems each (Dexcom G5™ Mobile CGM system [DG5], Guardian™ Connect system [GC], and a Roche CGM system [RCGM]) in parallel for 6 or 7 days in a mixed inpatient and outpatient setting. Capillary comparison measurements were performed using a self-monitoring of blood glucose (SMBG) system. During study site visits, glucose excursions were induced. Performance of the systems was evaluated by calculating mean absolute relative differences (MARD, calculated as absolute differences for glucose concentrations <100 mg/dL and as relative differences for glucose concentrations ≥100 mg/dL), and mean relative differences (MRD, bias) between CGM and SMBG results. In addition, usability of the systems was assessed. Results: Overall MARD was 10.1 ± 2.1 for DG5, 11.5 ± 4.2 for GC, and 11.9 ± 5.6 for RCGM. Performance improved in all systems after the first day of use. All systems showed >99% of values within zones A and B of the consensus error grid. Overall, all CGM systems showed a small negative bias compared to SMBG. Usability of the systems differed regarding patch adhesion rate, failure rate, and patient rating. Most patients preferred GC, but in general all systems were rated positively. Conclusion: All three CGM systems showed similar overall accuracy in this direct comparison, but small differences were observed with regard to specific glucose ranges and usability aspects.

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Section: Discussionmentioning

confidence: 97%

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison

Freckmann

Link

Kamecke

et al. 2019

J Diabetes Sci Technol

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“…Venous blood, from which PG was measured as a reference, was collected; this offers more accurate data than those based on capillary glucose used in previous studies. Arterialized-venous samples were previously used as reference measurements, showing no significant impact on CGM accuracy (Kropff et al, 2017); therefore, this reference seems preferable because of its ease of operation.…”

Section: Discussionmentioning

confidence: 99%

Accuracy of Flash Glucose Monitoring During Postprandial Rest and Different Walking Conditions in Overweight or Obese Young Adults

Zhang

Sun²,

Wongpipit

et al. 2021

Front. Physiol.

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Aims: To investigate the accuracy of FreeStyle LibreTM flash glucose monitoring (FGM) relevant to plasma glucose (PG) measurements during postprandial rest and different walking conditions in overweight/obese young adults.Methods: Data of 40 overweight/obese participants from two randomized crossover studies were pooled into four trials: (1) sitting (SIT, n = 40); (2) walking continuously for 30 min initiated 20 min before individual postprandial glucose peak (PPGP) (20iP + CONT, n = 40); (3) walking continuously for 30 min initiated at PPGP (iP + CONT, n = 20); and (4) accumulated walking for 30 min initiated 20 min before PPGP (20iP + ACCU, n = 20). Paired FGM and PG were measured 4 h following breakfast.Results: The overall mean absolute relative difference (MARD) between PG and FGM readings was 16.4 ± 8.6% for SIT, 16.2 ± 4.7% for 20iP + CONT, 16.7 ± 12.2% for iP + CONT, and 19.1 ± 6.8% for 20iP + ACCU. The Bland–Altman analysis showed a bias of −1.03 mmol⋅L–1 in SIT, −0.89 mmol⋅L–1 in 20iP + CONT, −0.82 mmol⋅L–1 in iP + CONT, and −1.23 mmol⋅L–1 in 20iP + ACCU. The Clarke error grid analysis showed that 99.6–100% of the values in all trials fell within zones A and B.Conclusion: Although FGM readings underestimated PG, the FGM accuracy was overall clinically acceptable during postprandial rest and walking in overweight/obese young adults.

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“…If BGM or CGM systems are calibrated with capillary blood samples, using samples other than capillary blood for comparison measurements may introduce additional bias. [31][32][33] Because laboratory analyzers typically require larger blood volumes than BGM systems, obtaining capillary blood samples with sufficient volume may be an issue. If a measurement bias exists between instruments used for calibration and for comparison measurements, this bias will affect all comparison measurements.…”

Section: Comparing Accuracy Of Bgm Systems and Cgm Systemsmentioning

confidence: 99%

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices

Freckmann

Pleus

Grady

et al. 2018

J Diabetes Sci Technol

101

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Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.

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Venous, Arterialized-Venous, or Capillary Glucose Reference Measurements for the Accuracy Assessment of a Continuous Glucose Monitoring System

Abstract: The use of venous, arterialized-venous, or capillary reference measurements did not significantly impact CGM accuracy. Venous reference seems preferable due to its ease of operation.

Cited by 10 publications

References 25 publications

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison

Accuracy of Flash Glucose Monitoring During Postprandial Rest and Different Walking Conditions in Overweight or Obese Young Adults

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices

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