Freestyle Libre approved in the US

No More Routine Finger Sticks(1) for Americans with Diabetes: Abbott′s FreeStyle® Libre Approved in the U.S.

  • REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION
  • EASY-TO-USE(2), LONGER LASTING AND LESS BULKY(3) THAN OTHER CONTINUOUS GLUCOSE MONITORS AVAILABLE IN U.S.
  • STUDIES SHOW THAT PEOPLE WHO USE THE FREESTYLE LIBRE SYSTEM TEST THEIR GLUCOSE LEVELS MORE FREQUENTLY AND SPEND LESS TIME IN HYPOGLYCEMIA(4,5)
  • LOW GLOBAL PRICING STRUCTURE AIMS TO MAKE TECHNOLOGY BROADLY ACCESSIBLE

ABBOTT PARK, Ill., Sept. 27, 2017 /PRNewswire/ – Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre Flash Glucose Monitoring System as a replacement1 for blood glucose monitoring (BGM) for adults with diabetes in the U.S. This revolutionary new glucose sensing technology eliminates the need for routine finger sticks1 and is the only personal continuous glucose monitor (CGM) that does not require finger stick calibration. Designed to be approachable, accessible and affordable for the 30 million people with diabetes in America6, the FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days, making it the longest lasting personal glucose sensor available in the U.S.

The BGM replacement indication means that people with diabetes and their physicians can now make treatment decisions based on information from the FreeStyle Libre system, without the need for painful routine finger sticks1—and at a fraction of the cost of other CGM systems currently available7.

“Today, we are celebrating a breakthrough moment for people with diabetes in the U.S.—an end to the worry and hassles associated with routine finger sticks which have been the standard of glucose testing for more than 40 years,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “At Abbott, we believe that FreeStyle Libre will transform diabetes management and we’re proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives.”

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This is good news. We’ve been waiting for this for a while now.

the FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days

If memory serves me, this sensor in Europe is rated to wear for 14 days. I wonder why that got reduced for the US and I also wonder if the user can choose to extend the weartime.

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Always great to have another option!

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This IMO is HUGE!!! news for PWDs but not for Dexcom which is down big after hours. I am a BIG Libre fan and have been telling many on this forum to go to ebay and get them from the UK and Germany until they were approved. Thank you FDA as that will no longer be needed.

You can get several free android apps including LibreView. Libre is a NFC device and does not talk bluetooth so it does not talk to the Iphone.

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Terry - I did not see the 10 day approval. I sure hope they did not change the EU sensor. I would be surprised if they did. For some it would fall off after about 12 days maybe thats why they approved for 10 days, not sure but I will look into it.

10 day sensor life

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm

September 27, 2017

The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).

The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days.

Yes its approval is 10 days but the EU approval is 14 days. Is the sensor the same? Is there a US version and an EU version? If so ebay may be back in business.

I understand the Libre gives readings when you scan it. Does it provide a continuous graph like Dexcom? The size and shape appear slightly more convenient than the G5, but I really like getting the G5 readings on my iPhone and especially my Apple Watch, which allows me to check my level at a glance. What other features differentiate the two products?

Happy dance, oh, happy dance! I’ve been waiting for this. I’m not happy that the approval is only for ten days, though. That makes it more expensive. Even as it is, I don’t feel I could afford to use it all the time, but I think that I could learn enough from it during the time I use it that even if I only use it half or one-fourth the time, I’d have learned enough to improve my control the whole month.

I rarely have hypos at night, so I really don’t feel I have that much need for an alarm. And I don’t want to give up real estate on my abdomen for a CGM, which is the only approved location for the Dexcom, as I understand it. I’m relatively thin, and I need the limited territory I have there with enough fat for my MDI.

It would be wonderful if Medicare would eventually approve the device, but I have no intention to wait for that to happen.

I don’t know that much about the actual hardware, but I believe that a handheld is used to trigger and record a reading and that it also can backfill many hours with no interrogation, like sleeping.

I also think there is some retrospective analysis software that includes an ambulatory glucose profile (AGP) that is quite useful.

I have seen it mentioned that there are phone apps for reader. There is info on diatribe, for LibreLink.

Also many discussions on forum.fudiabetes.org .

From what I’ve seen, yes, it does provide a continuous graph - it just only provides it when you scan the sensor.

I also know that there are third-party apps out there to (along with the addition of an NFC-capable smartwatch, like the Sony Smartwatch3) than can provide alarms…

I believe it keeps 8 hours of data in the sensor, so as long as you scan it at least that often, you will capture a continuous graph of data.

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Perhaps with third-party apps like xDrip, but not with the Libre reader.

Glimp (3rd party android app) can scan the sensor beyond the 14 days, in Europe. It also allows blood calibration which increases the accuracy significantly. If not calibrated, using the original reader/LibreLink app, one should expect approx 15-20 mg/dl discrepancy.

With Blucon nightrider and xdrip+ it is also possible to turn Libre into a CGM, much cheaper than Dex & co.

Terry - its an NFC device. It works like Apple Pay. Touch your phone or the reader to the sensor. There is an existing NFC to bluetooth device which you can turn it into a real CGM but it has some limitations.
http://www.ambrosiasys.com/

It only holds 8hrs of data so if you don’t touch a tleast every 8 hours you have gaps in the downloadable data.
The 14 day limitation is the power. I don’t know why this is only a 10day approval, maybe a smaller battery?? I will find out.

It woz the FDA wot dunnit. Purely down to the regulatory regime. CE mark for Europe just has to show that it does what it says it will do. Unlike FDA, no potential safety concerns to be addressed. I also understand that the warm up/soak in period which is 1 hour in Europe is going to be 12 hours in the USA. The sensors are basically the same, I guess it is just the software in the chip.

What this does do is make the Dexcom G4/G5 the cheaper option if users re-start their sensors and get the typical 2-3 weeks out of each. The G5 still requires 2 calibrations per day, but is now approved (in Europe anyway) for bolusing decisions which reduces the need for fingersticks

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As someone who used Libre pods sent by a friend in Europe, I am SO VERY excited about this! I do however want to find out how much it will cost and how exactly it will be covered by my insurance. I fear that if a patient opts out for a Freestyle Libre, they will have to either give up their CGM coverage and/or have fewer test strips allowed. Which might be fine after a while, but it will be an adjustment for me personally anyway…

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I’m looking forward to seeing how much this is, and how it all goes. I need some trending info and am not considering the Dex (I also use tylenol a lot and Dex doesn’t like it). Anyone know if this can take a hot tub???

@Laura_S - As FYI, the Dexcom G6 which is scheduled for a 2018 release will not be impacted by Tylenol (Acetaminophen).

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