San Diego-based Dexcom’s study, published in the Journal of Diabetes and Scientific Technology, evaluated the G7 CGM in children and adolescents with type 1 diabetes. G7, which last month won CE mark approval, remains under FDA 510(k) review.
Data from sensors, worn on the upper arm and abdomen, were available from 127 of 132 participants aged seven to 17 years old across 10.5 days of use, various glucose concentration ranges and various rates of glucose change for comparisons with temporally matched venous blood glucose measurements (YSI).
According to the published study, data was also available from 28 of 32 patients aged two to six for whom capillary (fingerstick) blood provided comparator glucose values.
Overall mean absolute relative difference (MARD) — a measure of accuracy — registered at 8.1% for arm-placed sensors, remaining in line with previous data that recorded MARD of 8.2% for adults and 8.1% MARD in pediatric patients. MARD registered at 9% for abdomen-placed sensors in the 7-17 group, while the 2-6 group provided an overall MARD of 9.3%.
Additionally, the study demonstrated that the 12-hour extended grace period for the G7 provides consistently reliable and accurate readings, while no clinically significant difference in accuracy when comparing arm-placed sensors and abdomen-placed sensors.
Dexcom CEO Kevin Sayer said on the company’s first-quarter earnings call yesterday that he expects the G7, currently available in Europe under CE mark, to still have a “meaningful” U.S. launch this year once it garners FDA approval.
Sayer noted that Dexcom’s teams are having preliminary discussions with payers to drive market access and preparing the addition of incremental G7 lines in advance of the loss to support the expected ramp in demand once the G7 wins approval. The company is also working with insulin delivery partners to ensure that connected pumps and pens are integrated with the new CGM.
