Importance of Blood Glucose Meter and Carbohydrate Estimation Accuracy

Virdi, Naunihal; Mahoney, John J.

doi:10.1177/193229681200600425

Cited by 27 publications

(22 citation statements)

References 12 publications

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“…To see how the SEG's "slight, higher risk" category translates into CEG's "little to no effect on clinical action" warrants further investigation. Interestingly, the bolus insulin dosing error-the difference of hypothetical insulin doses calculated based on BGMS and reference method results 8 -was lowest for the CNU and highest for the OT BGMS. Both, the FIL and OT BGMS showed an insulin dosing error indicating a tendency toward underdosing (ie, resulting in potential hyperglycemia), while the confidence range for the CNU was equally distributed around -1.5 to 1.5 insulin units ( Figure 5).…”

Section: Discussionmentioning

confidence: 99%

“…11 Post hoc analyses were performed to assess the hypothetical bolus insulin dosing error resulting from erroneous BGMS measurements. 8 The bolus dose calculation consisted of 2 terms:…”

Section: Assessment and Analysesmentioning

confidence: 99%

“…However, modeling analyses suggest that errors in insulin dosing may occur even when using BGMS that fulfill these ISO accuracy criteria. 8 Importantly, standards should specify 100% of the data, and not only define a percentage of correct measurements, 9 which is why continuous measures are preferable.…”

mentioning

confidence: 99%

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Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

Bedini¹,

Wallace

Pardo

et al. 2015

J Diabetes Sci Technol

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The accuracy of blood glucose (BG) self-monitoring is an important prerequisite for the sustained success of diabetes management. Accurate BG monitoring allows for adequate bolus insulin dosing decisions and the detection of hypoand hyperglycemic episodes. 1-3 Self-monitoring of BG is often a central element of a diabetes management plan aiming to reduce glycemic variability, the risk of hypo-and hyperglycemia, and associated complications. 4,5 The impact 609368D STXXX10.

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Section: Discussionmentioning

confidence: 99%

“…11 Post hoc analyses were performed to assess the hypothetical bolus insulin dosing error resulting from erroneous BGMS measurements. 8 The bolus dose calculation consisted of 2 terms:…”

Section: Assessment and Analysesmentioning

confidence: 99%

See 1 more Smart Citation

Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

Bedini¹,

Wallace

Pardo

et al. 2015

J Diabetes Sci Technol

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“…In contrast, the simulation models for total error of 15% predicted that large insulin dosing errors would occur "very infrequently," with reduced total error of 10% reducing the frequency even more. However, there is more study needed to understand the frequency of dosing errors and the actual clinical impact of such dosing errors [210][211][212][213][214].…”

Section: Calls For Improved Performance and Postlaunch Monitoringmentioning

confidence: 99%

Electrochemical Glucose Biosensors for Diabetes Care

Ocvirk¹,

Buck²,

DuVall³

2016

Trends in Bioelectroanalysis

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Blood glucose monitoring (BGM) is the most successful application of electrochemical biosensor technology and has motivated tremendous improvements in biology, chemistry, measurement, and fabrication methods of biosensors. The performance of electrochemical biosensors used for BGM has improved greatly over the last four decades. Technological advance has allowed to measure blood glucose (BG) over a wide range of glucose concentration, a wide temperature and hematocrit range in the presence of an abundance of interfering substances with ever-increasing accuracy, and precision in minute sample volumes. The use of optimized enzymes, mediators, and electrochemical measurement methods enables this tremendous progress in performance. Continuous glucose monitoring (CGM) systems based on minimally invasive amperometric sensors, inserted into the subcutaneous tissue, have significantly improved over initial offerings over the last 15 years with regard to time of use, accuracy, reliability, and convenience due to a multitude of parallel advances: materials needed for enzyme immobilization, polymeric cover membranes, and biocompatible coatings needed to tackle the response by the complex body interface have been developed; wireless transfer and processing of unprecedented data volume have been established; effortless and painless insertion schemes of ever smaller sensors have been realized in order to overcome the concerns of persons with diabetes (PwDs) to use a minimally invasive sensor; and scalable manufacturing technologies of miniaturized minimally invasive sensors have allowed for ever improved reproducibility and increased production volume. Looking ahead, the demands on blood glucose system performance G. Ocvirk (*) Roche Diabetes Care GmbH, Mannheim, Germany e-mail: gregor.ocvirk@roche.com H. Buck and S.H. DuVall Roche Diabetes Care, Inc., Indianapolis, IN, USA e-mail: harvey.buck@roche.com; stacy.duvall@roche.com are expected to grow even as the pressures to lower the cost of systems increase. The drive for the future is to continue to push the limits on system performance under real-life conditions while lowering cost, all while finding ways to provide the best medical value to PwDs and healthcare providers. Technical issues of commercially available CGM sensors remain to be solved which currently impede reliable hypo-and hyperglycemic alarms, safe insulin dosing recommendations, or insulin pump control at any time of use. It is realistic to assume that continuous glucose monitoring (CGM) systems will be adopted in the future by a larger population of PwDs. Yet it is also clear that BGM systems will remain a major choice of the great majority of PwDs on a global scale. This review offers a technical overview about user, system, and major regulatory requirements and available suitable sensor technology and demonstrated performance of electrochemical BGM and CGM systems from an industrial R&D perspective.

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“…The analytical performance of blood glucose monitoring systems (BGMSs) is critical because their accuracy can affect decisions regarding glycaemic control, such as insulin dosage [5].…”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose

Jeon¹,

Shin²

2016

J Lab Med Qual Assur

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Diabetes is a major worldwide health epidemic that Background: We evaluated the accuracy of the B. Braun Omnitest 5 blood glucose monitoring system (BGMS; Infopia Co. Ltd., Korea), which was recently developed for selfmonitoring of blood glucose. Methods: Precision was assessed according to Clinical and Laboratory Standards Institute guideline EP5-A3 with control materials containing low, normal, and high levels of glucose. Linearity was evaluated over the range of 52.5-548.0 mg/dL prepared from patient samples. For system accuracy, 100 capillary blood samples measured by the B. Braun Omnitest 5 BGMS were compared to plasma-equivalent blood glucose values of the fingertip blood samples measured by the YSI 2300 STAT PLUS glucose analyser (YSI Life Sciences, USA). Accuracy was evaluated according to the International Organization for Standardization (ISO) 15197: 2013 criteria. Results: The range for the total coefficient of variation (%) was 1.5%-4.9% for three lots of strips. Both within-run precision and within-laboratory precision fulfilled the manufacturer's claim. ISO 15197: 2013 states that more than 95% of blood glucose measurement values must be within ±15 mg/dL for ranges below 100 mg/dL and ±15% for ranges above 100 mg/

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Importance of Blood Glucose Meter and Carbohydrate Estimation Accuracy

Cited by 27 publications

References 12 publications

Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197

Electrochemical Glucose Biosensors for Diabetes Care

Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose

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