Earlier this year, at the request of Dexcom, The USA FDA expanded iCGM use to back of arm with “Approval” for insulin dose calculations.
In a recent podcast [I only read the written transcript], the president of Dexcom talked about this fact.
No and my apologies. I misinformed and I’m wrong. Then I insisted. Truly bad form on my part. I’m sorry. That site is European. Also apologies to @wadawabbit and @WearsHats earlier in the thread.
Thanks @joe and no problem. At one point Dexcom told me the arm was okay as long as I had approval from my doctor to use it although I would definitely advise checking for yourself on that. It will be nice when the US gives its blessed authorization - the more workable options the better as far as I’m concerned!
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Thanks for the update/clarification. With so many things to keep track of, it’s easy to get wires crossed. So Medtronic Guardian sensors are approved for arms in the US. Dexcom are approved for arms overseas. But they’re not FDA approved for arms. Good to know and have that straight.
Nice thing is that I get a lot less skin irritation from the Dexcom, personally. Guardian sensors used to give me a rash after a day or two, and it would just get worse over the course of the week. And then I couldn’t use the skin anywhere near the site for at least a week. Dexcom sensors last longer and the adhesive doesn’t irritate my skin. So, so far at least, I’m able to just move around the abdomen.
I have been using g6 sensors on my arms for about 10 months. It was a collaboration between my Dr and Dexcom rep because I am a heavy equipment mechanic and I could not keep a sensor in place for 10 days on my abdomen do to movement and abrasion. I have had 5 or 6 replaced on my arm for excessive bleeding, I am a bleeder so that is no reflection on dexcom sensors at all . I have experienced great accuracy and life expectancy from sensors rotated around my upper arms. The first time I called about warranty on a sensor I did have to explain that Dr recommended arm placement, never questioned since then.
keep in mind that the only glucose measurement device to receive “FDA Approval” is the "iCGM". The lower case letter “i” is key. Up to last month, thlease be e only device with iCGM rating is the Dexcom G6. Please show care with terminology.
That said, there are many glucose devices marketed with “FDA Certification” meaning they appear to be safe to use; this includes BGM, CGM, and the newer smart pens. Also, earlier this year, The FDA included a section in its regulation acknowledging the uniqueness of T1D management and stated decisions such s sensor placement should be made by PWD in consultation with care provider.
@Hen51 the popular links box contains information for GREAT BRITAIN, not the USA!!!
Is the correct site for the USA users. It is important to look in the upper right hand corner of the website for the country’s flag to know you are in the proper site.