title: The accuracy and efficacy of real-time continuous glucose monitoring sensor in Chinese diabetes patients: a multicenter study.
abstract: BACKGROUND
  The purpose of this multicenter study was to investigate the accuracy of a real-time continuous glucose monitoring sensor in Chinese diabetes patients.
  
  
  METHODS
  In total, 48 patients with type 1 or 2 diabetes from three centers in China were included in the study. The MiniMed Paradigm(®) 722 insulin pump (Medtronic, Northridge, CA) was used to monitor the real-time continuous changes of blood glucose levels for three successive days. Venous blood of the subjects was randomly collected every 15 min for seven consecutive hours on the day when the subjects were wearing the sensor. Reference values were provided by the YSI(®) 2300 STAT PLUS™ glucose and lactate analyzer (YSI Life Sciences, Yellow Springs, OH).
  
  
  RESULTS
  In total, 1,317 paired YSI-sensor values were collected from the 48 patients. Of the sensor readings, 88.3% (95% confidence interval, 0.84-0.92) were within±20% of the YSI values, and 95.7% were within±30% of the YSI values. Clarke and consensus error grid analyses showed that the ratios of the YSI-sensor values in Zone A to the values in Zone B were 99.1% and 99.9%, respectively. Continuous error grid analysis showed that the ratios of the YSI-sensor values in the region of accurate reading, benign errors, and erroneous reading were 96.4%, 1.8%, and 1.8%, respectively. The mean absolute relative difference (ARD) for all subjects was 10.4%, and the median ARD was 7.8%. Bland-Altman analysis detected a mean blood glucose level of 3.84 mg/dL. Trend analysis revealed that 86.1% of the difference of the rates of change between the YSI values and the sensor readings occurred within the range of 1 mg/dL/min.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Endocrinology and Metabolism and Shanghai Clinical Center for Diabetes, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Diabetes Institute, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhou
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Lv
authors.forename: Yiming
authors.initials: Y
authors.lastname: Mu
authors.forename: Xianling
authors.initials: X
authors.lastname: Wang
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.forename: Xingguang
authors.initials: X
authors.lastname: Zhang
authors.forename: Jinxiao
authors.initials: J
authors.lastname: Wu
authors.forename: Yuqian
authors.initials: Y
authors.lastname: Bao
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods*; D002681:China / Q000453:epidemiology; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D004867:Equipment Design; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood* / Q000188:drug therapy / Q000453:epidemiology; D007003:Hypoglycemia / Q000097:blood* / Q000453:epidemiology; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation*; D011446:Prospective Studies; D012016:Reference Values; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose