Evaluation of the Performance of a Novel System for Continuous Glucose Monitoring

Zschornack, Eva; Schmid, Christina; Pleus, Stefan; Link, Manuela; Klötzer, Hans-Martin; Obermaier, Karin; Schoemaker, Michael; Strasser, Monika; Frisch, Gerhard; Schmelzeisen-Redeker, Günther; Haug, Cornelia; Freckmann, Guido

doi:10.1177/193229681300700403

Cited by 52 publications

(51 citation statements)

References 22 publications

(42 reference statements)

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“…Since it is only recently that any devices have even approached such performance, regulatory criteria for device approval have been more pragmatic, focusing on the hazards of incorrect readings (e.g., suboptimal treatment decisions, including improper adjustments in medication dosage, potentially increasing the frequency of both hypoglycemia and hyperglycemia) (58). Accuracy, ergonomics, and ease of use of blood glucose meters have improved dramatically over time (124)(125)(126), and the accuracy of CGM is beginning to approach that of BGM devices (113,114,(127)(128)(129)(130). However, a clinically significant variation in accuracy and precision persists among currently marketed GM devices.…”

Section: Gm Accuracy Precision and Data Display Metricsmentioning

confidence: 99%

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

et al. 2016

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Section: Gm Accuracy Precision and Data Display Metricsmentioning

confidence: 99%

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

et al. 2016

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“…8,20 In total, there were 30 subjects who wore system B sensors; 20 10 of these subjects also wore system A sensors. 8 Detailed information about the study procedure and participants can be found in the respective publications.…”

Section: Study Design and Populationmentioning

confidence: 99%

“…8 Detailed information about the study procedure and participants can be found in the respective publications. 8,20 The analysis presented here is based on data of the 10 subjects who wore both systems in parallel. Each of these subjects wore 2 sensors of each system type simultaneously.…”

Section: Study Design and Populationmentioning

confidence: 99%

“…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.…”

mentioning

confidence: 99%

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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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“…Unlike the consistent results observed with the Roche prototype sensor, the other systems tested either showed modest overall performances or lacked sufficient accuracy at clinically relevant times, namely, critical periods of hypoglycemia or when the BG level is changing rapidly. 15 Looking into the future, Schoemaker predicted that, one day, CGM technology will become a routine part of personalized diabetes management, and he is convinced of the expanding role and clinical significance of CGM systems. Enhanced accuracy and generation of clinically actionable CGM data are key features to ensure future success of CGM technology, Schoemaker contended.…”

Section: An Accurate Sensor In the Makingmentioning

confidence: 99%

6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

Alzaid

Schlaeger²,

Hinzmann³

2013

Diabetes Technology & Therapeutics

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International experts in the fields of diabetes, diabetes technology, endocrinology, and pediatrics gathered for the 6 th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and beyond. The aim of this meeting was to continue setting up a global network of experts in this field and provide an international platform for exchange of ideas to improve life for people with diabetes. The 2013 meeting comprised a comprehensive scientific program, parallel interactive workshops, and two keynote lectures. All these discussions were intended to help identify gaps and areas where further scientific work and clinical studies are warranted. Opening Lecture: News from the World of DiabetesSatish Garg, University of Colorado Denver, Aurora, Colorado Drugs can't do it alone, we need technology too S atish Garg, in his opening lecture, gave insights into the status of diabetes care in general, described the direction of the ongoing diabetes research, and unveiled exciting technological advances coming our way in the near future. He argued that diabetes technology has a major contribution to make on the quality of life and the day-to-day interaction between patient and disease. He put forward a poignant question, saying that we are almost spoiled for choice by the number of antidiabetes agents currently available to treat diabetes, but has that changed patient outcome?Garg advocated that drugs cannot do it alone and that there is a clear gap in the management of diabetes that may be filled in by diabetes-related technologies. Diabetes: uncontrollable costGarg presented recently published data that show the cost of diabetes alone amounts to a staggering $245 billion per year in the United States.1 This figure is expected to rise in the future. Almost one-third of people with diabetes belong to the elderly age group (above 65 years of age), meaning that most individuals have been systematically excluded from research trials and clinical studies. Garg made a timely and passionate plea that elderly people with diabetes must not be left out of the diabetes research agenda.A closer examination of the cost of diabetes expenditure reveals that 80% of the money is used to pay for services and late complications. Eight percent of the total expenditure is used for diabetes technology. Garg suggested that people with diabetes should be cared for from the outset to reduce the expense incurred due to late complications. Glycated hemoglobin and hypoglycemia as measures of healthcare outcomeRecent clinical data of 25,000 people with type 1 diabetes attending 67 leading diabetes centers across the United States were presented by Garg. The T1D Exchange Study 2 is an observational study that showed several interesting findings. First, despite all existing efforts, the pursuit of the target glycated hemoglobin (HbA1c) level remains elusive for many people with diabetes across the United States. Second, the incidence of hypoglycemia remains a major concern for many people with diabetes, especially the elderly. Another and...

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Evaluation of the Performance of a Novel System for Continuous Glucose Monitoring

Abstract: Abbreviations: (BG)

Cited by 52 publications

References 22 publications

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

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

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

6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

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Evaluation of the Performance of a Novel System for Continuous Glucose Monitoring

Abstract: Abbreviations: (BG)

Cited by 52 publications

References 22 publications

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

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

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

6thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia

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6^thAnnual Symposium on Self-Monitoring of Blood Glucose (SMBG) Applications and Beyond, April 25–27, 2013, Riga, Latvia