Accuracy and Reliability of Continuous Glucose Monitoring Systems: A Head-to-Head Comparison

Luijf, Yoeri M.; Mader, Julia K.; Doll, W.; Pieber, Thomas R.; Farret, Anne; Place, Jérôme; Renard, Éric; Bruttomesso, Daniela; Filippi, Alessio; Avogaro, Angelo; Arnolds, Sabine; Benesch, Carsten; Heinemann, Lutz; DeVries, J. Hans

doi:10.1089/dia.2013.0049

Cited by 76 publications

(71 citation statements)

References 9 publications

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“…The current system was accurate, with an overall MARD of 11.1% for samples .4.2 mmol/L (75 mg/dL). CGM performance was less in the hypoglycemic range, as is also seen with other CGM products (7,8,11,12). A limited but statistically significant reduction of CGM measurement accuracy occurred in the last month of use, possibly due to long-term degradation of the glucoseindicating gel before end of sensor life was reached.…”

Section: Discussionmentioning

confidence: 54%

Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial

et al. 2016

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OBJECTIVEIt is known that continuous glucose monitoring (CGM) systems can lower mean glucose compared with episodic self-monitoring of blood glucose. Implantable CGM systems may provide additional benefits. RESEARCH DESIGN AND METHODSWe studied the Eversense (Senseonics Inc.) implantable CGM sensor in 71 participants aged 18 years and older with type 1 and type 2 diabetes in a 180-day multinational, multicenter pivotal trial. Participants used the CGM system at home and in the clinic. CGM accuracy was assessed during eight in-clinic visits with the mean absolute relative difference (MARD) for venous reference glucose values >4.2 mmol/L as the primary end point. Secondary end points included Clarke Error Grid Analysis and alarm performance. The primary safety outcome was device-related serious adverse events. This trial is registered with ClinicalTrials .gov, number NCT02154126. RESULTSThe MARD value against reference glucose values >4.2 mmol/L was 11.1% (95% CI 10.5, 11.7). Clarke Error Grid Analysis showed 99.2% of samples in the clinically acceptable error zones A and B. Eighty-one percent of hypoglycemic events were detected by the CGM system within 30 min. No device-related serious adverse events occurred during the study. CONCLUSIONSOur results indicate the safety and accuracy of this new type of implantable CGM system and support it as an alternative for transcutaneous CGM.People with diabetes frequently use fingerstick capillary glucose measurements to guide their dosing decisions (1). Continuous glucose monitoring (CGM) systems can provide glucose data in real time and reduce the need for fingerstick testing (2). Additionally, people with diabetes can receive temporal information, trend information, and alarms for impending hypoglycemic and hyperglycemic events (2). When used regularly, CGM can effectively lower mean glucose compared with fingerstick glucose measurements only (3). Unfortunately, wear time of current transcutaneous CGM is low in some populations, which might partially be explained

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Section: Discussionmentioning

confidence: 54%

Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial

et al. 2016

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“…16 There are many publications which present accuracy data for CGM systems, but only a few of these provide information about phases of rapidly changing glucose concentrations. 4,6,8,[17][18][19][20] Detailed information about accuracy at specific BG rates of change are even scarcer. 3,4,18 For the results presented here, data obtained in a clinical study 8,20 were analyzed in a post hoc evaluation to investigate the rate-of-change dependence of 2 CGM systems.…”

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confidence: 99%

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Pleus

Schoemaker

Morgenstern

et al. 2015

J Diabetes Sci Technol

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Introduction: The accuracy of continuous glucose monitoring (CGM) systems is often assessed with respect to blood glucose (BG) readings. CGM readings are affected by a physiological and a technical time delay when compared to BG readings. In this analysis, the dependence of CGM performance parameters on the BG rate of change was investigated for 2 CGM systems. Methods: Data from a previously published study were retrospectively analyzed. An established CGM system (Dexcom G4, Dexcom, San Diego, CA; system A) and a prototype system (Roche Diagnostics GmbH, Mannheim, Germany; system B) with 2 sensors each were worn by 10 subjects in parallel. Glucose swings were induced to achieve rapidly changing BG concentrations. Mean absolute relative differences (MARD) were calculated in different BG rate-of-change categories. In addition, sensor-to-sensor precision was assessed. Results: At BG rates of change of –1 mg/dl/min to 0 mg/dl/min and 0 mg/dl/min to +1 mg/dl/min, MARD results were 12.6% and 11.3% for system A and 8.2% and 10.0% for system B. At rapidly changing BG concentrations (<–3 mg/dl/min and ≥+3 mg/dl/min), higher MARD results were found for both systems, but system B was less affected (system A: 24.9% and 29.6%, system B: 10.6% and 16.3%). The impact of rate of change on sensor-to-sensor precision was less pronounced. Conclusions: Both systems were affected by rapidly changing BG concentrations to some degree, although system B was mostly unaffected by decreasing BG concentrations. It would seem that technological advancements in CGM systems might allow for a more precise tracking of BG concentrations even at rapidly changing BG concentrations.

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“…same time using a reference system (see, eg, Bailey et al, 3 Damiano et al, 4 Freckmann et al, 5 Garg et al, 6 Kovatchev et al, 7 Kropff et al, 8 Leelarathna et al, 9 Luijf et al, 10 Luijf et al, 11 Weinstein et al, 12 and Zschornack et al 13 )…”

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confidence: 99%

Performance Comparison of CGM Systems

Kirchsteiger

Heinemann

Freckmann

et al. 2015

J Diabetes Sci Technol

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Currently three manufacturers from the United States have needle-type systems for real-time continuous glucose monitoring (CGM) on the market. Each of these manufacturers has introduced new generations of its respective CGM system to the market over the past decade; each new generation has shown substantial improvements in analytical performance, size, handling, and so on (Dexcom G4® Platinum, Abbott FreeStyle® Navigator II [currently not available in the US market], Medtronic Enlite®).1 As well, one manufacturer from the European Union (EU) has announced a new product. 2While the rapid development and subsequent improvement are quite positive for clinical usage, they hamper the evaluation of the safety and efficacy of such systems in the classic evaluation setting, that is, the performance of clinical head-tohead studies, which typically require years for completion.One parameter often used to characterize the analytical performance of CGM systems is MARD, the mean (sometimes also the median value is used) absolute relative difference between the CGM readings and the values measured at the The ongoing progress of continuous glucose monitoring (CGM) systems results in an increasing interest in comparing their performance, in particular in terms of accuracy, that is, matching CGM readings with reference values measured at the same time. Most often accuracy is evaluated by the mean absolute relative difference (MARD). It is frequently overseen that MARD does not only reflect accuracy, but also the study protocol and evaluation procedure, making a crossstudy comparison problematic.

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Accuracy and Reliability of Continuous Glucose Monitoring Systems: A Head-to-Head Comparison

Cited by 76 publications

References 9 publications

Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial

Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Performance Comparison of CGM Systems

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