title: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System.
abstract: BACKGROUND
  The purpose of this study was to evaluate the accuracy and efficacy of Dexcom G4 Platinum CGM System.
  
  
  METHODS
  Seventy-two subjects enrolled at 4 US centers; 61% were male; 83% had T1DM and17% had T2DM. Subjects wore at least 1 system for up to 7 days. Subjects participated in a total of 36 hours in the clinic to contribute YSI reference glucose measurements with venous blood draws every 15 minutes on study Day 1, Day 4, and Day 7.
  
  
  RESULTS
  The overall mean absolute relative difference (ARD) versus YSI was 13% with a median of 10%. Precision ARD was 9% ± 4% between 2 sensors with a 7% coefficient of variation. The mean ARD versus SMBG was 14% with a median of 11%. One hundred two (94%) sensors lasted 7 days and the systems displayed 97% of their expected glucose readings in average. The time spent in low CGM readings during nighttime hours decreased from the first night use to the 6th night (P < .001) with a small difference in average CGM glucose from 147 ± 40 mg/dL to 166 ± 62 mg/dL. There were no serious adverse events or infectious complications reported.
  
  
  CONCLUSIONS
  The study showed the Dexcom G4 Platinum CGM System is one of the most accurate CGMs. The significant reduction in nocturnal time spent in a hypoglycemic state observed during this study suggests that a longer term study of CGM use, especially nocturnal use, could be beneficial for patients with hypoglycemia unawareness.
authors: Dexcom, Inc, San Diego, CA, USA knakamura@dexcom.com.
authors: Katherine
authors: K
authors: Nakamura
authors: Dexcom, Inc, San Diego, CA, USA.
authors: Andrew
authors: A
authors: Balo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: accuracy; continuous glucose monitor; efficacy; hypoglycemia