The Accuracy and Efficacy of Real-Time Continuous Glucose Monitoring Sensor in Chinese Diabetes Patients: A Multicenter Study

Zhou, Jian; Lv, Xiaoyi; Mu, Yiming; Xl, Wang; Li, Jing; Zhang, Xingguang; Wu, Jing; Bao, Yuqian; Wang, Jia

doi:10.1089/dia.2012.0014

Cited by 16 publications

(11 citation statements)

References 21 publications

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“…Six studies or trials with FGM 53,54,56,59,60,62 and 13 studies or trials with CGM 26,31,32,34,36-38,44,45,47-49,52 provided sufficient information to calculate an overall incidence rate. From 1158 participants of these trials, we identified 1090 events of cutaneous complication over 138 to 158 accumulated years of wear time.…”

Section: Resultsmentioning

confidence: 99%

Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies

Asarani

Reynolds

Boucher

et al. 2019

J Diabetes Sci Technol

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Background: Continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use in diabetes management is increasing. Cutaneous complications associated with these devices were reported. We conducted a systematic review to provide an overview of cutaneous complications with CGM/FGM use. Methods: We identified observational studies and intervention trials that report on cutaneous complications with CGM/FGM use up to January 14, 2019. Studies were identified through Medline, Embase, and PubMed, or with hand searching of the previous publications. Screening was duplicated and data extracted to consider four main themes: incidence rate and severity, participant perspectives of cutaneous complications, potential solutions, and future directions in diabetic technology relevant to reducing cutaneous complications. Results: A total of 54 eligible studies were identified. The overall event rate of cutaneous complications reported from 19 trials was one event per eight weeks of sensor wear-time of which 1.5% were considered severe. The most common cutaneous complications were wear-related erythema, itching, and induration. Although skin irritations were the most common cause of CGM/FGM discontinuation, most users experienced less pain or discomfort with CGM/FGM than capillary blood glucose testing. Future technological advances may reduce, but not eliminate cutaneous complications. Conclusion: The incidence rate of reported cutaneous complications with CGM/FGM use from the available literature is low, with one event per eight weeks of sensor wear-time. Reported complication severity was also low, leading to low rates of CGM/FGM discontinuation. However, there appear to be discrepancies between reporting in trial and observational data. Greater constancy in reporting is necessary to understand the frequency of this issue.

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Section: Resultsmentioning

confidence: 99%

Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies

Asarani

Reynolds

Boucher

et al. 2019

J Diabetes Sci Technol

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show abstract

“…Both studies agreed with regard to not having any discernable effect of BMI on sensor performance, unlike prior studies of earlier versions of sensors. 17 A prior study by Zhou and colleagues 18 evaluated the performance a nonwired enzyme interstitial glucose sensor in a similar Chinese population of adults with diabetes (44 of 48 with type 2 diabetes). The study established the performance in the euglycemic and hyperglycemic ranges, but was unable to confirm clinically acceptable performance in the hypoglycemic range.…”

Section: Discussionmentioning

confidence: 99%

A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes

Guo

et al. 2016

J Diabetes Sci Technol

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“…The glucose concentration limit of 100 mg/dL was chosen according to the newest standard for in vitro blood glucose monitors, ISO 15197:2013. The statistically critical value for agreement at the deviation of ±20%/20 mg/dL was 85%, according to clinical results of the CGM system in China.…”

Section: Methodsmentioning

confidence: 99%

Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study

Zhou

Zhang

et al. 2017

J of Diabetes Invest

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Aims/IntroductionThe present study aimed to investigate the performance of a new real‐time continuous glucose monitoring system.Materials and MethodsInterstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare® CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values.ResultsAmong 1,678 paired sensor–reference values, 90.5% (95% confidence interval 89.1–91.9%) were within ±20%/20 mg/dL of the reference values, with a mean absolute relative difference of 9.1 ± 8.7% (95% CI: 8.9–9.2%). The percentages of paired sensor–reference values falling within zone A and B of the Clarke error grid analysis (EGA) and the type 1 diabetes consensus EGA were 99.1 and 99.8%. Continuous EGA showed that the percentages of accurate readings, benign errors, and erroneous readings were 89.9, 6.3 and 3.8%, respectively. Surveillance EGA showed that 90.6, 9.2, and 0.2% of sensor–reference values with no, slight and lower moderate risk, respectively. The mean absolute relative difference was 16.6, and 96.0% of the sensor values fell within zones A and B of the consensus EGA for hypoglycemia. More than 85% of sensor values were within ±20%/20 mg/dL of reference values, the mean absolute relative difference was <11, and >99.5% of the sensor values fell in zones A and B of the consensus EGA.ConclusionsThe Medtrum real‐time continuous glucose monitoring system was numerically and clinically accurate over a large glucose range across 7 days of wear.

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The Accuracy and Efficacy of Real-Time Continuous Glucose Monitoring Sensor in Chinese Diabetes Patients: A Multicenter Study

Abstract: The Paradigm insulin pump has high accuracy in both monitoring the real-time continuous changes and predicting the trend of changes in blood glucose level. However, actual clinical manifestations should be taken into account for diagnosis of hypoglycemia.

Cited by 16 publications

References 21 publications

Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies

Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies

A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes

Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study

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