Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies

Diabetes Technology & Therapeutics
Lori Laffel

Abstract

This study was designed to evaluate accuracy, performance, and safety of the Dexcom (San Diego, CA) G4(®) Platinum continuous glucose monitoring (CGM) system (G4P) compared with the Dexcom G4 Platinum with Software 505 algorithm (SW505) when used as adjunctive management to blood glucose (BG) monitoring over a 7-day period in youth, 2-17 years of age, with diabetes. Youth wore either one or two sensors placed on the abdomen or upper buttocks for 7 days, calibrating the device twice daily with a uniform BG meter. Participants had one in-clinic session on Day 1, 4, or 7, during which fingerstick BG measurements (self-monitoring of blood glucose [SMBG]) were obtained every 30 ± 5 min for comparison with CGM, and in youth 6-17 years of age, reference YSI glucose measurements were obtained from arterialized venous blood collected every 15 ± 5 min for comparison with CGM. The sensor was removed by the participant/family after 7 days. In comparison of 2,922 temporally paired points of CGM with the reference YSI measurement for G4P and 2,262 paired points for SW505, the mean absolute relative difference (MARD) was 17% for G4P versus 10% for SW505 (P < 0.0001). In comparison of 16,318 temporally paired points of CGM with SMBG for G4P an...Continue Reading

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Software Mentioned

STAR
Dexcom G5 CGM
Dexcom G4 Platinum
G4 Platinum
Dexcom G4 Platinum RT - CGM
SAS
G4P Platinum
G4P

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