F • Technical Information; Device Performance Summary - Dexcom ONE+ User Manual

F • Technical information

Device performance summary

The performance of the sensor* used in Dexcom ONE+ was assessed in a clinical study with 482 participants. The adult (18
years and older) and pediatric (2 to 17 years old) participants all had type 1 or type 2 diabetes.
Participants wore the sensor for up to 10.5 days on both their arm and abdomen. Pediatrics aged 2 to 6 may have worn a
device on their upper buttocks instead of their arm or abdomen.
Each participant attended up to three clinic sessions during the beginning, middle, or end of the 10.5 day wear period to have
their blood glucose measured every 15 minutes with a laboratory reference method, the Yellow Springs Instrument 2300 STAT
Plus™ Glucose Analyzer (or a blood glucose meter for pediatrics aged 2 to 6). The sensor performance was compared to the
laboratory reference method to evaluate accuracy in participants aged 7 years and older.
* Laffel LM, Bailey TS, Christiansen MP, Reid JL, Beck SE. Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in
Children and Adolescents With Type 1 Diabetes. Journal of Diabetes Science and Technology. 2022;0(0).
doi:10.1177/19322968221091816
Satish K. Garg, Mark Kipnes, Kristin Castorino, Timothy S. Bailey, Halis Kaan Akturk, John B. Welsh, Mark P. Christiansen, Andrew K. Balo,
Sue A. Brown, Jennifer L. Reid, and Stayce E. Beck. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with
Diabetes. Diabetes Technology & Therapeutics. Jun 2022. 373-380. http://doi.org/10.1089/dia.2022.0011
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