Application Submitted to FDA for Integrated Insulet OmniPod Insulin Pump and DexCom Continuous Glucose Monitor

We were very excited to hear recently that DexCom has filed an application with FDA for an integrated glucose management system, combining Insulet’s tubeless disposable pump, the OmniPod (see Test Drive from diaTribe #4), with DexCom’s continuous glucose monitor (see our Test Drive from diaTribe #15). Notably, the integrated system will combine the pump controller, CGM handheld, and blood glucose meter all into the OmniPod personal diabetes manager (PDM), eliminating the need for carrying three different devices; continuous glucose readings from the DexCom sensor will be sent wirelessly to the OmniPod PDM. Like the Medtronic Paradigm system, users of the system will still need two separate skin punctures at two sites, one for insulin delivery and the other for the CGM sensor. The OmniPod disposable pump and the DexCom CGM are two products that have both advanced diabetes technology significantly, so the new combination is certainly one we are very interested in trying. It seems that both companies have done a good job of keeping the integration user-friendly, without adding any extra barriers for FDA approval. That said, FDA has new guidelines for insulin pumps, so we are not sure how long we’ll have to wait – we hope for a product launch in the next year. --AB