Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

Klonoff, David C.; Lias, Courtney; Beck, Stayce E.; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubín, Guillermo; Burk, Robert D.; Kowalski, Aaron J.; Little, Randie R.; Nichols, James H.; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric J.; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert J.; Vesper, Hubert W.

doi:10.1177/1932296815614587

Cited by 21 publications

(28 citation statements)

References 7 publications

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“…This was because its context related to the recent paper by Klonoff et al, describing a blood glucose monitor system surveillance protocol. 5 Their protocol suggests use of deep lancing techniques to obtain capillary samples for plasma glucose measurement on comparative glucose instruments. 5 Our initial correspondence commented on the paucity of published information on hemolysis, specifically within this context.…”

Section: Letter To the Editormentioning

confidence: 99%

Capillary Samples and Hemolysis: Further Considerations

Heenan¹,

Lunt

Chan³

et al. 2017

J Diabetes Sci Technol

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Section: Letter To the Editormentioning

confidence: 99%

Capillary Samples and Hemolysis: Further Considerations

Heenan¹,

Lunt

Chan³

et al. 2017

J Diabetes Sci Technol

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“…More pressure has come from professional organizations and diabetes advocate groups for post-market surveillance of SMBG systems [206,207]. Considerable discussion is ongoing on how to implement as post-market surveillance program with regard to funding, oversight, and reporting of the results of evaluations [200,208,209]. Challenges for manufacturers accompany tighter requirements on SMBG systems.…”

Section: Calls For Improved Performance and Postlaunch Monitoringmentioning

confidence: 98%

“…In 2013, the Diabetes Technology Society held a one-day public meeting of diabetes experts, presided over by its president, David Klonoff, to discuss several questions around SBGM systems and their ability to meet current regulatory standards. Protocols for testing SBGM systems postlaunch are currently being developed [200]. Publications where SMBG systems are evaluated according to ISO15197:2003, ISO15197:2013, FDA draft guidance, and so-called "10/10" and "5/5" criteria are becoming more common [195,[201][202][203][204].…”

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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“…Even though the ISO 15197:2013 guideline describes the performance criteria that BG systems need to fulfill for market approval, postsurveillance programs with alternative test protocols have been demanded in the light of unexpected low performance of marketed systems in daily practice. 12 The advantage of the presented glucose clamp approach is that it allows a simultaneous quantitative and reproducible evaluation of measurement accuracy, precision and bias of BG systems over the clinically relevant glucose range with a relatively small number of volunteers. In Table 5 we listed these and further advantages as well as limitations of the presented clamp approach for evaluating the performance of a BG system.…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

Zijlstra

Heinemann

Fischer

et al. 2016

J Diabetes Sci Technol

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The performance of blood glucose (BG) measurement systems (BG meters plus test strips) is a much debated and researched topic. Reliable BG measurements are needed to ensure that patients with diabetes make the same clinical decisions (eg, select appropriate insulin dose) as they would do if the glucose measurements were made with a laboratory or even better with a reference method. 1 BG systems are considered accurate if they show high precision and high trueness, that is, both the random error (measurement imprecision or variability) and the systematic error (measurement bias) are low. 2 The evaluation of BG systems should be performed in accordance with standard guidelines like the International Organization for Standardization (ISO) (ISO 15197:2013 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus). Such guidelines describe in detail test procedures to be followed. They also specify the allowed measurement deviation of the measurement results from the laboratory measurements and the maximum number of inaccurate results or outliers acceptable. The analytical goals defined by the ISO guidelines are now widely adopted by manufacturers of BG systems and regulatory agencies.Despite the prerequisite of demonstrating compliance with ISO 15197 before market approval of a new BG system, the performance of currently available BG systems (= after market approval) has been fiercely debated after reports Abstract Background: The objective was to evaluate the performance (in terms of accuracy, precision, and trueness) of 5 CE-certified and commercially available blood glucose (BG) systems (meters plus test strips) using an innovative clinical-experimental study design with a 3-step glucose clamp approach and frequent capillary BG measurements. Methods:Sixteen subjects with type 1 diabetes participated in this open label, single center trial. BG was clamped at 3 levels for 60 minutes each: 60-100-200 mg/dL. Medical staff performed regular finger pricks (up to 10 per BG level) to obtain capillary blood samples for paired BG measurements with the 5 BG systems and a laboratory method as comparison. Conclusions: This 3 range glucose clamp approach enables a systematic performance evaluation of BG systems under controlled and reproducible conditions. The random error of the tested BG systems was comparable, but some showed a lower systematic error than others. These BG systems allow an accurate glucose measurement at low, normal and high BG levels. Results

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Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

Cited by 21 publications

References 7 publications

Capillary Samples and Hemolysis: Further Considerations

Capillary Samples and Hemolysis: Further Considerations

Electrochemical Glucose Biosensors for Diabetes Care

A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

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