A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System) and Enlite Sensor (Guardian REAL-Time System) Tested Simultaneously in Ambulatory Patients with Type 1 Diabetes

Matuleviciene, Viktorija; Joseph, Jeffrey I.; Andelin, Mervi; Hirsch, Irl B.; Attvall, Stig; Pivodic, Aldina; Dahlqvist, Sofia; Klonoff, David C.; Haraldsson, Börje; Lind, Marcus

doi:10.1089/dia.2014.0238

Cited by 80 publications

(84 citation statements)

References 20 publications

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“…Currently available CGM devices do not measure blood glucose levels <70 mg/dL (3.9 mmol/L) very accurately (112)(113)(114). Nevertheless, CGM can identify many episodes of hypo-and hyperglycemia that would go undetected by BGM (108,115).…”

Section: Pregnancy Complicated By Diabetesmentioning

confidence: 99%

“…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%

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

et al. 2016

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Section: Pregnancy Complicated By Diabetesmentioning

confidence: 99%

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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“…7 These performance improvements were confirmed in independent assessments. [8][9][10][11] Further improvements were thought needed to meet the stringent requirements of an artificial pancreas system. Accordingly, collaboration between an academic research group from University of Padova and Dexcom resulted in updated noise reduction and a modified calibration algorithm.…”

Section: Original Articlementioning

confidence: 99%

Clinical Accuracy of a Continuous Glucose Monitoring System With an Advanced Algorithm

Bailey

Chang

Christiansen

2014

J Diabetes Sci Technol

149

119

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Background : We assessed the performance of a modified Dexcom G4 Platinum system with an advanced algorithm, in comparison with frequent venous samples measured on a laboratory reference (YSI) during a clinic session and in comparison to self-monitored blood glucose (SMBG) during home use. Methods:Fifty-one subjects with diabetes were enrolled in a prospective multicenter study. Subjects wore 1 sensor for 7-day use and participated in one 12-hour in-clinic session on day 1, 4, or 7 to collect YSI reference venous glucose every 15 minutes and capillary SMBG test every 30 minutes. Carbohydrate consumption and insulin dosing and timing were manipulated to obtain data in low and high glucose ranges. Results:In comparison with the laboratory reference method (n = 2,263) the system provided a mean and median absolute relative differences (ARD) of 9.0% and 7.0%, respectively. The mean absolute difference for CGM was 6.4 mg/dL when the YSIs were within hypoglycemia ranges (≤ 70 mg/dL). The percentage in the clinically accurate Clarke error grid A zone was 92.4% and in the benign error B zone was 7.1%. Majority of the sensors (73%) had an aggregated MARD in reference to YSI ≤ 10%. The MARD of CGM-SMBG for home use was 11.3%. Conclusions:The study showed that the point and rate accuracy, clinical accuracy, reliability, and consistency over the duration of wear and across glycemic ranges were superior to current commercial real-time CGM systems. The performance of this CGM is reaching that of a self-monitoring blood glucose meter in real use environment.

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“…The Dexcom G4 sensor used in the current trial has shown higher accuracy in estimating blood glucose levels than other CGM sensors. [31][32][33] High accuracy is likely essential not only for making correct treatment decisions, but also for gaining patients' confidence in using the CGM system. 34 It may also influence the possibility of detecting hypoglycemia, and the Dexcom G4 has shown high accuracy in this glycemic range.…”

Section: Discussionmentioning

confidence: 99%

Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study)

Lind

Polonsky

Hirsch

et al. 2016

J Diabetes Sci Technol

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Background: The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI). Methods: Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase. Results: A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016. Conclusions: It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability.

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A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System) and Enlite Sensor (Guardian REAL-Time System) Tested Simultaneously in Ambulatory Patients with Type 1 Diabetes

Abstract: The Dexcom G4 sensor was associated with greater overall accuracy than the Enlite sensor during initial (Days 1-3) and later (Days 4-6) use and for glucose levels in the hypoglycemic range. Patients reported a significantly more positive experience using the Dexcom G4 than the Enlite.

Cited by 80 publications

References 20 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

Clinical Accuracy of a Continuous Glucose Monitoring System With an Advanced Algorithm

Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study)

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