September 27, 2017
The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System [clip…]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm
Note. This version just now approved for direct use by consumers is for a 10-day sensor. The “pro” version already approved (to be applied by a professional in a doctor’s office) is for a 14-day sensor. Somewhat confusing.
Wow. That is an amazing set of news. I did not expect it anytime soon.
Now I am curious as to how it will be priced on the US market, and if it will be available without a prescription.
My guess is prescription will be required as it’s an injectible device… they’ll want a doctor making the decision if the benefits outweigh risks… though I could be wrong.
The receivers will continue to be available on eBay.
I’m curious about that, too, since I got a call today that my insurance once again refuses to pay for my Dexcom…I’m in “I give up on it” mode right now (hopefully that mood won’t last long).
24 posts were split to a new topic: Insurance bounced my CGM prescription
A post was merged into an existing topic: Insurance bounced my CGM prescription
A post was merged into an existing topic: Insurance bounced my CGM prescription
Wow! Really interesting it is 10 days instead of 14 like everywhere else.
No. They die by software btw, they keep on peeping for a while if you use an opensource reader, it looks like:
I had missed that when I read it. That is weird, also probably not a good thing for us. It probably means 30% higher prices.
I have a suspicion it comes from Abbott rather than the FDA. Since we have the only established market for CGMs, they feel that they can afford to make the system more expensive for us. If that is true (I wonder how this can be checked), it makes me really angry at Abbott.
I hope that isn’t true and I think that would be a strange business model. Besides cost, there aren’t many advantages to their system compared to a CGM, so they have to be cheaper. Taking into account that FSL sensors can’t be restarted, unlike Dexcom sensors, I don’t think they can afford to raise the price of their product.
The US version will have a 12-hour warming up period instead of a 1-hour period. That won’t help their sales either.
Ok who’s gonna be the first guinea pig here to get it?
@michel - sensor dies with the software? That’s a major drawback in my opinion. Also, do you need the receiver or can you use an iPhone?
I agree.
It is not a CGM, really. It does not broadcast, you have to scan it by hand with a reader. You can buy a third party addon that you glue on the top and which bluetooths to the cellphone. @Kenrick and @MaryPat may be able to discuss it at greater length?
Sounds cumbersome, definitely love having my CGM on my iPhone so I don’t have to carry and extra device. Also, with Dex being able to talk directly to Apple Watch (hopefully soon) I don’t see myself switching.
No iPhone app, the sensor uses NFC. I read Apple is opening up NFC to third parties so it could be coming.
The software-defined 10 (or 14) day lifetime limit has always bothered me. It is almost an ethical thing if the device can reasonably operate longer, which seems to be the case from the 3rd party apps.
I don’t think most CGM users would switch, except perhaps due to cost. It’s pretty small too. The main benefit is for someone who has never used a CGM to see the effect of food, exercise, etc.! I read you need a prescription in the USA but even if insurance doesn’t cover it, for a couple hundred bucks you could try it for a few weeks and learn some patterns.
This article has more info, suggesting the 10 day limit and long warmup period is a FDA thing.
(from same article)
Abbott tells us the Libre will be available with a prescription in U.S. pharmacies, starting in December 2017.
The company also is not disclosing final pricing information until it gets closer to launch at year’s end, but Abbott spokeswoman Vicky Assardo says the pricing will be “very similar” to the price in Europe – where the reader costs about $69, and each sensor costs about $70 out-of-pocket without insurance.
rats 
