Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management

List, Susan M; Starks, N.; Baum, John; Greene, Carmine; Pardo, Scott; Parkes, Joan Lee; Schachner, Holly C.; Cuddihy, Robert

doi:10.1177/193229681100500516

Cited by 5 publications

(2 citation statements)

References 12 publications

(14 reference statements)

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“…A study by List et al (2011) [17], which closely parallels our study protocol, evaluated the performance of CONTOUR ® USB BGMS that includes integrated diabetes management software with a USB port. The study tested the system's use by untrained lay users and healthcare professionals and compared results, as we did, with laboratory autoanalyzer blood glucose results.…”

Section: Discussionmentioning

confidence: 99%

Accuracy and precision assessment of a new blood glucose monitoring system

Guo²,

Liu

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Section: Discussionmentioning

confidence: 99%

Accuracy and precision assessment of a new blood glucose monitoring system

Guo²,

Liu

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…SMBG systems are often coupled to software packages or online tools produced by the manufacturer of the system to allow for more in-depth analysis of SMBG data collected by the user [66,146,147]. SMBG data is transferred from the meter to the software package.…”

Section: Monitoring Systemsmentioning

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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