OmniPod & Navigator: When's the Wedding?

Amy Tenderich Health Guide
  • Reprinted with permission of Amy Tenderich of www.diabetesmine.com.

     

    How sweet would it be to have a tubeless insulin pump that also "talks" to a state-of-the-art CGM (continuous glucose monitor)? It may be coming sooner than we think...

     

    Obviously, Insulet Corp. and Abbott Diabetes Care are in bed together: the integration of Abbott's FreeStyle glucose meter into the OmniPod wireless insulin pump was a stroke of genius, as far as I'm concerned. Many of you also noticed that Insulet made mention of Abbott's new Navigator continuous glucose monitor in a recent SEC filing:

     

    "We have partnered with Abbott Diabetes Care Inc., a global healthcare company that develops continuous glucose monitoring technology, to develop a product that will integrate the receiver portion of Abbott's continuous glucose monitor, the FreeStyle Navigator, with the OmniPod System PDM."

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    Oh, how I tried to get details on this, but both companies are mandatorily tight-lipped.

     

    Here's what I do know:

     

    The companies have "an active R&D cooperation" to integrate continuous glucose monitoring into the OmniPod.

     

    Once complete, the new product will consist of a single handheld device with all the same functionality of the current OmniPod PDM -- including integrated FreeStyle fingerstick monitor -- plus the capability to pick up and display data from the Navigator CGM.

     

    The patient will wear two separate insertions, i.e. the Pod and the Navigator sensor will NOT be combined. But the built-in FreeStyle will serve to calibrate the CGM, so the controller unit at least is a real all-in-one deal.

     

    Looks like Abbott's strategy with the Navigator is to become the 'Intel Inside' of insulin delivery products.

     

    The company couldn't share any details on timing, in large part because the Navigator is still awaiting FDA approval. Part of the hold-up is its PMA (pre-market approval) status, he says. This is reserved for new technologies/therapies hitting the market for the first time, and thus requires a higher level of scrutiny than for "predicate devices" that are already mass-marketed, such as insulin pumps. Still makes me wonder how the DexCom managed its lightening-fast FDA approval?

     

    Anyway, it's pretty clear that the OmniPod/Navigator wedding won't be this year. But the participants are optimistic that the engagement won't drag on too long. I, for one, am excited to dance at that wedding.

Published On: July 20, 2007