T1D Exchange recently published the results of a major study that confirms the use of Continuous Glucose Monitoring (CGM) without regular use of confirmatory Blood Glucose Measurements (BGM) is as safe and effective as use of CGM with confirmatory BGM.
This multi-center study enrolled 226 adults with type 1 diabetes (T1D). All study participants were provided with a Dexcom G4 Continuous Glucose Monitoring System with an enhanced algorithm, which was used for the 6-month duration of the study. Participants were split into two study arms: 149 participants dosed their insulin based on the CGM reading alone without first confirming with a blood glucose meter measurement and 77 were required to confirm the CGM reading with a blood glucose measurement before dosing insulin. Among the major findings of the study is the confirmation there was no difference in outcomes for those using only CGM and those using both CGM and BGM.
Previously, the FDA has not recommended making insulin-based decisions from CGM devices. However, CGM technology is rapidly improving in accuracy of monitoring. In December 2016, the FDA expanded the indications for the Dexcom G5 sensor, now allowing for replacement of fingerstick blood glucose testing for diabetes treatment decisions. T1D Exchange REPLACE BG study results are consistent with this FDA decision.