# Abbott Freestyle Libre now approved in the US

**URL:** <https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181>\
**Category:** C/GM\
**Tags:** freestyle-libre\
**Created:** [September 27, 2017, 11:41pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181 "2017-09-27T23:41:38Z")\
**Posts on this page:** 20\
**Page:** 1

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**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\
**Post date:** [September 27, 2017, 11:41pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/1 "2017-09-27T23:41:38Z")

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> [@How to use the Freestyle Libre anywhere, without a reader](https://forum.fudiabetes.org/t/how-to-use-the-freestyle-libre-anywhere-without-a-reader/2120/1):
>
> I am really interested in the Freestyle Libre, which is not available yet in the US.

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](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.

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 1:17am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/2 "2017-09-28T01:17:27Z")

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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.

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**Author:** ![Sam](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/sam/32/10595_2.png) [@Sam](https://forum.fudiabetes.org/u/Sam)\
**Post date:** [September 28, 2017, 1:21am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/3 "2017-09-28T01:21:47Z")

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> [@Michel](#):
>
> 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.

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**Author:** ![Pianoplayer7008](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/pianoplayer7008/32/1507_2.png) [@Pianoplayer7008](https://forum.fudiabetes.org/u/Pianoplayer7008)\
**Post date:** [September 28, 2017, 1:25am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/4 "2017-09-28T01:25:50Z")

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> [@Michel](#):
>
> Now I am curious as to how it will be priced on the US market

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).

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 2:21am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/5 "2017-09-28T02:21:50Z")

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24 posts were split to a new topic: [Insurance bounced my CGM prescription](https://forum.fudiabetes.org/t/insurance-bounced-my-cgm-prescription/2189)

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 2:25am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/13 "2017-09-28T02:25:21Z")

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A post was merged into an existing topic: [Insurance bounced my CGM prescription](https://forum.fudiabetes.org/t/insurance-bounced-my-cgm-prescription/2189)

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 2:26am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/14 "2017-09-28T02:26:33Z")

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A post was merged into an existing topic: [Insurance bounced my CGM prescription](https://forum.fudiabetes.org/t/insurance-bounced-my-cgm-prescription/2189)

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**Author:** ![kenrick](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/kenrick/32/113_2.png) [@kenrick](https://forum.fudiabetes.org/u/kenrick)\
**Post date:** [September 28, 2017, 4:10am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/15 "2017-09-28T04:10:57Z")

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Wow! Really interesting it is 10 days instead of 14 like everywhere else.

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**Author:** ![Sam](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/sam/32/10595_2.png) [@Sam](https://forum.fudiabetes.org/u/Sam)\
**Post date:** [September 28, 2017, 4:13am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/16 "2017-09-28T04:13:51Z")

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> [@kenrick](#):
>
> interesting it is 10 days instead of 14 like everywhere else.

Are they restartable?

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 4:16am UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/17 "2017-09-28T04:16:00Z")

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> [@Sam](#):
>
> Are they restartable?

No. They die by software btw, they keep on peeping for a while if you use an opensource reader, it looks like:

> [@How to use the Freestyle Libre anywhere, without a reader](https://forum.fudiabetes.org/t/how-to-use-the-freestyle-libre-anywhere-without-a-reader/2120):
>
> I am really interested in the Freestyle Libre, which is not available yet in the US. I have looked into what it would take to use it. Many forum threads discuss it, so finding info is easy. Finding good info is harder. Some things I figured out: You can mix and match readers and sensors from any country. Readers are locked into mg/dl or mmol/L, so, if you decide to purchase a reader, it is best to purchase one in a country which uses the unit you use. It is possible to use the FreeStyle…

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**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 2:20pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/18 "2017-09-28T14:20:48Z")

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> [@kenrick](#):
>
> Really interesting it is 10 days instead of 14 like everywhere else.

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.

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**Author:** ![Boerenkool](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/boerenkool/32/6307_2.png) [@Boerenkool](https://forum.fudiabetes.org/u/Boerenkool)\
**Post date:** [September 28, 2017, 3:32pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/19 "2017-09-28T15:32:57Z")

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> [@Michel](#):
>
> 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.

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**Author:** ![mikep](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/mikep/32/149_2.png) [@mikep](https://forum.fudiabetes.org/u/mikep)\
**Post date:** [September 28, 2017, 4:14pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/20 "2017-09-28T16:14:57Z")

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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?

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<div class="post-metadata">

**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 4:18pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/21 "2017-09-28T16:18:17Z")

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> [@mikep](#):
>
> sensor dies with the software? That’s a major drawback in my opinion.

I agree.

> [@mikep](#):
>
> Also, do you need the receiver or can you use an iPhone?

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?

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**Author:** ![mikep](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/mikep/32/149_2.png) [@mikep](https://forum.fudiabetes.org/u/mikep)\
**Post date:** [September 28, 2017, 4:20pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/22 "2017-09-28T16:20:08Z")

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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.

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**Author:** ![kenrick](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/kenrick/32/113_2.png) [@kenrick](https://forum.fudiabetes.org/u/kenrick)\
**Post date:** [September 28, 2017, 6:16pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/23 "2017-09-28T18:16:06Z")

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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.

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**Author:** ![kenrick](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/kenrick/32/113_2.png) [@kenrick](https://forum.fudiabetes.org/u/kenrick)\
**Post date:** [September 28, 2017, 6:32pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/24 "2017-09-28T18:32:39Z")

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This article has more info, suggesting the 10 day limit and long warmup period is a FDA thing.

> **[NEWS: FDA OKs FreeStyle Libre for United States!](https://www.healthline.com/diabetesmine/newsflash-fda-oks-freestyle-libre-united-states)**
>
> DiabetesMine shares the breaking news that Abbott Diabetes Care's much-anticipated Flash Glucose Monitoring system is finally approved in the U.S.

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**Author:** ![Bradford](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/bradford/32/30_2.png) [@Bradford](https://forum.fudiabetes.org/u/Bradford)\
**Post date:** [September 28, 2017, 7:49pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/25 "2017-09-28T19:49:50Z")

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Unfortunate casualty of Libre release… Down almost 33% as of now…

 ![image](https://canada1.discourse-cdn.com/flex030/uploads/fudiabetes/original/2X/5/5413470fb8ae0d9b543fbe5412992b9ed79d90df.png)

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<div class="post-metadata">

**Author:** ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)\
**Post date:** [September 28, 2017, 8:03pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/26 "2017-09-28T20:03:25Z")

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> [@kenrick](#):
>
> This article has more info,

(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.

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<div class="post-metadata">

**Author:** ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)\
**Post date:** [September 28, 2017, 8:05pm UTC](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181/27 "2017-09-28T20:05:20Z")

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> [@Thomas](#):
>
> available with a prescription in U.S. pharmacies

rats 🙂

[Next page](https://forum.fudiabetes.org/t/abbott-freestyle-libre-now-approved-in-the-us/2181.md?page=2)
