FDA Approves New Diabetes Technology Allowing Data Sharing

Ann Bartlett Health Guide
  • Two things happened this week for Dexcom:  


    1) Apple computer fans, like me, now have the ability to upload our data from our devices to Dexcom’s Portrait on the Web.  This is a big step in the right direction as this opens more data sharing opportunities and I can finally see my own glucose trends and patterns online!


    Below is a picture of my own all over the place trends, and yes a little embarrassing as it may be it is a snapshot of 7 days.



    Along with the trend graph, you also have a pattern map that helps you to recognize whether your problem is a basal, or bolus deficiency, then below the pattern map is a content box, with insights and considerations, that offers pattern insights with some possible considerations. According to my chart, I’m 65% within target and I’ve been able to be much closer to 80%, so clearly I’m slacking off.

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    2) The FDA has approved Dexcom’s new Share Direct System. The press release from the FDA said, “The US Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using Apple mobile device such as an iPhone.”


    This is a big deal in so many ways! First it says that FDA is becoming more comfortable with data sharing technology, which has been a long road. And second, our diabetes technology is gaining more ground for wireless technology. A much needed resource for self monitoring and remote work with CDE's and docs.


    Starting in March, Dexcom will begin selling and shipping new receivers that have built-in Bluetooth that will allow real-time sharing through an iPhone or iPod touch. Dexcom may make their current Share device obsolete, but at least it is for a product that will have better, more flexilbe technology that can be built upon. 


    The share receiver will use a secure wireless connection via Bluetooth Low Energy (BLE) between the patient’s receiver and the app on a patient’s smartphone and then the app can transmit real-time data onto the mobile devices of up to 5 designated recipients (followers).  This new system bypasses the need for the docking station of the Dexcom Share.


    Here is the info for ordering the Dexcom G4 with Share:

    • The Share receiver is anticipated to ship to new patients in early March 2015.
    • All patients who purchased a Share cradle will receive a free upgrade to the Share receiver.
    • All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver.
    • There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver.

    The Share receiver will be compatible with future generation Dexcom sensor systems.


    Note to parents: this device will be available for children as young as 2, but Dexcom is getting ready to ask FDA for pediatric approval. So if parents feel desperate and your doctor can build a case, you might be able to get the upgraded algorithm. Otherwise patience is required.


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    And parents don’t be surprised if this latest Dexcom Share is a little like heaven and hell. Heaven if you kid is 5, hell if you kid is a college student! For people like me, age 50 but attitudinally still a college student, it’s not going to make or break my day.  But for my husband, he may want to have this connection, and if it makes him feel more secure, then I’m all in.


    A great week for diabetes technology.

Published On: January 29, 2015