Evaluation of 12 Blood Glucose Monitoring Systems for Self-Testing: System Accuracy and Measurement Reproducibility

Freckmann, Guido; Baumstark, Annette; Schmid, Christina; Pleus, Stefan; Link, Manuela; Haug, Cornelia

doi:10.1089/dia.2013.0208

Cited by 69 publications

(70 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…6,7,18 Noteworthy comparative studies reported good performance of CXT-BGMS when ISO 15197:2013 accuracy limits were applied. 16,17,19 In a recent multicenter study conducted in 21 hospitals under routine conditions using 2100 leftover blood samples, 20 CXT-BGMS results were remarkably congruent with the present data. The ISO accuracy limits and CEG results similarities corroborate the generalizability of the performance data of the CXT-BGMS in different hospital environments.…”

Section: Discussionsupporting

confidence: 88%

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Ottiger

Gygli

Huber

et al. 2016

J Diabetes Sci Technol

View full text Add to dashboard Cite

This study assesses and demonstrates that CONTOUR® XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBÄK) and Swiss (QUALAB) quality control guidelines for point-of-care testing (POCT) and fulfills the ISO15197:2013 accuracy limits criteria under the routine conditions of a hospital point-of care setting. This single-center study was conducted in Switzerland using 105 venous blood samples from hospitalized patients. Each sample was tested in comparison to the hexokinase reference method. Compliance with POCT guidelines was assessed by daily BGMS measurements using control solutions. Accuracy of CXT-BGMS according to ISO limits was 98.41%. All control measurements were within the limits defined by RiliBÄK (within ± 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within ± 10% of target values).

show abstract

Section: Discussionsupporting

confidence: 88%

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Ottiger

Gygli

Huber

et al. 2016

J Diabetes Sci Technol

View full text Add to dashboard Cite

show abstract

“…This was one factor that led to a surge in the number and types of "generic" BGM meters. In some cases, when meters sourced from retail distribution channels were tested, the generic testing systems meters demonstrated dramatically inferior accuracy and precision compared to systems from major branded manufacturers (56)(57)(58)(59). These generic meters showed sufficient performance data to obtain initial FDA clearance; however, they may not have maintained adequate performance over time, in part due to poor quality control leading to large between-lot variability in test strips.…”

Section: Randomized Controlled Trialsmentioning

confidence: 99%

“…Several published studies have compared BGM brands and models by name during headto-head testing (56,57,136,(145)(146)(147)(148). For clinicians and consumers, MARD provides an excellent measure of accuracy and precision when evaluating a BGM (134).…”

Section: Iso Standardsmentioning

confidence: 99%

“…A commonly used stability standard is ≤4 mg/ dL difference between measurements at BG concentrations ≤100 mg/dL or ≤4% at BG concentrations >100 mg/dL. Most current CGM devices require periodic recalibration to ensure accuracy over the life of the device (56,57,142,158).…”

Section: How Much Accuracy Is Needed?mentioning

confidence: 99%

“…Contaminants on the skin from food sources (fruits, juices, sodas, milk) and even hand lotions can artificially raise capillary blood glucose levels and potentially lead to an overdose of insulin with subsequent hypoglycemia. Acetaminophen is well-known to result in spurious values in CGM systems (15,44,56,164,165). Physical compression of the CGM sensor during sleep can result in seriously low glucose readings.…”

Section: What Impacts Accuracy?mentioning

confidence: 99%

See 2 more Smart Citations

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

View full text Add to dashboard Cite

Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards

Wang,

Zhang,

Gong

et al. 2024

iLABMED

View full text Add to dashboard Cite

ObjectiveThis study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.MethodsThe glucose measurement values obtained from four types of BGMSs (Roche Accu‐Chek® Performa, Bayer Contour™ TS, Sinomedisite Glupad® H1 Plus, and Sinocare® Gold‐Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12‐A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.ResultsFrom 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient r was 0.995 for Roche Accu‐Chek® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad® H1 Plus, and 0.997 for Sinocare® Gold‐Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu‐Chek® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad® H1 Plus, and 100.00% (35/35) of Sinocare® Gold‐Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu‐Chek® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad® H1 Plus, and 91.43% (32/35) of Sinocare® Gold‐Accu.ConclusionsAmong the four types of BGMSs evaluated, the glucose meters of Roche Accu‐Chek® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.

show abstract

Evaluation of 12 Blood Glucose Monitoring Systems for Self-Testing: System Accuracy and Measurement Reproducibility

Cited by 69 publications

References 15 publications

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards

Contact Info

Product

Resources

About