Integrated Device to Feature Next-Generation Insulet OmniPod in Combination with DexCom Continuous Glucose Monitor
As we wrote in New Now Next in diaTribe #24, Insulet and DexCom submitted their combined insulin pump-continuous glucose monitor (CGM) device for FDA approval during an especially difficult time for device regulation. Sure enough, the FDA responded with a formal written response requesting substantial additional information including additional human clinical trial data concerning the safety of insulin delivery by the system. But the setback is a positive in some respects because it means the combination product will now feature the second-generation version of the OmniPod, which we believe will be approved in 2011. The new pod will be a third smaller and 25% lighter: great news for those who will ultimately use the combination product. The original plan was for the first-generation OmniPod to be paired with DexCom’s current CGM sensor, the SEVEN PLUS; however, at the time of this writing, it is not known version of the DexCom CGM will be incorporated into the Insulet insulin pump. Unfortunately, based on recent FDA activities and the public statements of the companies, it is highly unlikely that we will see a combined Insulet/DexCom product in 2011. Here's hoping that 2011 nonetheless sees progress on this integrated device, and that the picture looks better at the end of the coming year.