Evaluating the Accuracy, Reliability, and Clinical Applicability of Continuous Glucose Monitoring (CGM): Is CGM Ready for Real Time?

Mazze, Roger S.; Strock, Ellie S.; Borgman, Sarah; Wesley, David; Stout, Philip J.; Racchini, Joel R.

doi:10.1089/dia.2008.0041

Cited by 99 publications

(63 citation statements)

References 14 publications

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“…1 Continuous glucose monitoring is actually recognized as the only technique with the ability to provide complete diurnal/nocturnal glucose patterns and supply trend information. 1,2 Several clinical studies have indicated that utilization of CGM data, both retrospectively and in real time, can help adjust insulin therapies, prevent (or minimize the occurrence of) extreme glycemic excursions, 3,4 reduce glycated hemoglobin values, 5,6,7 and achieve a tight glycemic control in both intensive care 8,9 and surgical units. 10 Despite these clear advantages, utilization of CGM techniques is still limited in the current clinical practice, mainly because of concerns about their accuracy, reliability, robustness, and patient tolerability.…”

Section: Introductionmentioning

confidence: 99%

Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor

Valgimigli

Lucarelli

Scuffi

et al. 2010

J Diabetes Sci Technol

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Background: The objective of this work was to determine the clinical accuracy of GlucoMen®Day, a new microdialysis-based continuous glucose monitoring system (CGMS) from A. Menarini Diagnostics (Florence, Italy). Accuracy evaluation was performed using continuous glucose-error grid analysis (CG-EGA), as recommended by the Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A). Methods: Two independent clinical trials were carried out on patients with types 1 and 2 diabetes mellitus, the glycemic levels of whom were monitored in an in-home setting for 100-hour periods. A new multiparametric algorithm was developed and used to compensate in real-time the GlucoMen®Day signal. The time lag between continuous glucose monitoring (CGM) and reference data was first estimated using the Poincaré plot method. The entire set of CGM/reference data pairs was then evaluated following the CG-EGA criteria, which allowed an estimation of the combined point and rate accuracy stratified by glycemic ranges. Results: With an estimated time lag of 11 minutes, the linear regression analysis of the CGM/reference glucose values yielded r = 0.92. The mean absolute error (MAE) was 11.4 mg/dl. The calculated mean absolute rate deviation (MARD) was 0.63 mg/dl/min. The data points falling within the A+B zones of CG-EGA were 100% in hypoglycemia, 95.7% in euglycemia, and 95.2% in hyperglycemia. Conclusions: The GlucoMen®Day system provided reliable, real-time measurement of subcutaneous glucose levels in patients with diabetes for up to 100 hours. The device showed the ability to follow rapid glycemic excursions and detect severe hypoglycemic events accurately. Its accuracy parameters fitted the criteria of the state-of-the-art consensus guideline for CGMS, with highly consistent results from two independent studies.

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Section: Introductionmentioning

confidence: 99%

Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor

Valgimigli

Lucarelli

Scuffi

et al. 2010

J Diabetes Sci Technol

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“…Studies have shown that these agents, when used in combination with basal insulin and metformin, can flatten the postprandial glucose profile without increasing the risks of hypoglycemia and weight gain often associated with prandial insulin treatment (26)(27)(28)(29). In addition, improved devices for continuous glucose monitoring (CGM) allow for more complete assessment of 24-h glycemic patterns (30)(31)(32)(33).…”

mentioning

confidence: 99%

Design of FLAT-SUGAR: Randomized Trial of Prandial Insulin Versus Prandial GLP-1 Receptor Agonist Together With Basal Insulin and Metformin for High-Risk Type 2 Diabetes

Investigators¹,

Probstfield²,

Hirsch³

et al. 2015

Diabetes Care

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OBJECTIVEGlycemic variability may contribute to adverse medical outcomes of type 2 diabetes, but prior therapies have had limited success in controlling glycemic fluctuations, and the hypothesis has not been adequately tested. RESEARCH DESIGN AND METHODSPeople with insulin-requiring type 2 diabetes and high cardiovascular risk were enrolled during a run-in period on basal-bolus insulin (BBI), and 102 were randomized to continued BBI or to basal insulin with a prandial GLP-1 receptor agonist (GLIPULIN) group, each seeking to maintain HbA 1c levels between 6.7% and 7.3% (50-56 mmol/mol) for 6 months. The primary outcome measure was glycemic variability assessed by continuous glucose monitoring; other measures were HbA 1c , weight, circulating markers of inflammation and cardiovascular risk, albuminuria, and electrocardiographic patterns assessed by Holter monitoring. RESULTSAt randomization, the mean age of the population was 62 years, median duration of diabetes 15 years, mean BMI 34 kg/m 2 , and mean HbA 1c 7.9% (63 mmol/mol). Thirty-three percent had a prior cardiovascular event, 18% had microalbuminuria, and 3% had macroalbuminuria. At baseline, the continuous glucose monitoring coefficient of variation for glucose levels was similar in both groups. CONCLUSIONSFLAT-SUGAR is a proof-of-concept study testing whether, in a population of individuals with type 2 diabetes and high cardiovascular risk, the GLIPULIN regimen can limit glycemic variability more effectively than BBI, reduce levels of cardiovascular risk markers, and favorably alter albuminuria and electrocardiographic patterns. We successfully randomized a population that has sufficient power to answer the primary question, address several secondary ones, and complete the protocol as designed.

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“…So why do patients, who are otherwise accustomed to wearing chronically semi-invasive devices, not want to use CGM on a regular basis? Apart from some general reasons such as discomfort, high cost, and low reliability, 8 the main cause is probably related to the primary reason for undergoing CGM, which is to allow patients to make better decisions. This aim, however, is something that seems to have been forgotten by manufacturers.…”

Section: Clinical Evidence On Efficacy and Reasons For Continuous Glumentioning

confidence: 99%

Smart Telemedicine Support for Continuous Glucose Monitoring: The Embryo of a Future Global Agent for Diabetes Care

Rigla

2011

J Diabetes Sci Technol

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Although current systems for continuous glucose monitoring (CGM) are the result of progressive technological improvement, and although a beneficial effect on glucose control has been demonstrated, few patients are using them. Something similar has happened to telemedicine (TM); in spite of the long-term experience, which began in the early 1980s, no TM system has been widely adopted, and presential visits are still almost the only way diabetologists and patients communicate. The hypothesis developed in this article is that neither CGM nor TM will ever be routinely implemented separately, and their consideration as essential elements for standard diabetes care will one day come from their integration as parts of a telemedical monitoring platform. This platform, which should include artificial intelligence for giving decision support to patients and physicians, will represent the core of a more complex global agent for diabetes care, which will provide control algorithms and risk analysis among other essential functions.

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Evaluating the Accuracy, Reliability, and Clinical Applicability of Continuous Glucose Monitoring (CGM): Is CGM Ready for Real Time?

Cited by 99 publications

References 14 publications

Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor

Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor

Design of FLAT-SUGAR: Randomized Trial of Prandial Insulin Versus Prandial GLP-1 Receptor Agonist Together With Basal Insulin and Metformin for High-Risk Type 2 Diabetes

Smart Telemedicine Support for Continuous Glucose Monitoring: The Embryo of a Future Global Agent for Diabetes Care

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