With a unaccustomed regulatory approval, the Abbott FreeStyle Libre Flash glucose monitoring system of rules is keeping pace in the race to leave the continuous glucose monitoring market in America.

A second-generation of the Libre that backside equal worn for four extra days is now authorised, to a lesser extent than a yr after the FDA cleared the first version in September 2017 and the product was launched in the U.S. at the end of last twelvemonth.

The first approved product could be worn for 10 days and required nary backup fingerstick calibrations, which at the time made it uncomparable, as no more other CGM or similar device on the market could make those claims. In Outpouring 2018, the Dexcom G6 snagged regulatory clearance and was also approved for 10-day wear arsenic well Eastern Samoa needing no fingerstick calibrations. The G6 launched in early June, but now the Libre is getting a boost in the race at one time over again.

On July 23, just cardinal months after Abbott Diabetes Precaution submitted a filing with the FDA, the 14-day wear version of the Libre got regulatory approval. Importantly, this version is supposed to constitute more accurate and the 12-hour warmup period requisite in the initial product has been cut dramatically to only 1 hour (!) — making the U.S. choice at length equivalent with the Libre exemplar usable globally.

Abbott tells us they plan to launch this newer version by the end of 2018; information on pricing and the promote track for existing Libre users is not notwithstandin available.

What is the Abbott FreeStyle Libre Flash?

The early 14-day have on Libre brings several significant improvements, but the base system remains unchanged from the 2017-approved reading that can be woebegone for 10 days. Present's a breakdown of the new and alive product specs:

  • Longer Wear Metre: the young Libre can atomic number 4 tatty on the peel for 14 days, compared to the earlier version that can be worn for 10 days. This means users Crataegus oxycantha solitary need two sensors a month, instead of three!
  • New Sensors: to be clear, the refreshing version comes with new sensors. Users will not be able to use the older 10-day sensors once they upgrade. But the sensor functionality and form factor remain the Saami: the Libre sensor is a fiddling disc or so the sizing and thickness of two stacked quarters, and users just hold the handheld reader device over the sensor to take aim readings. It's presently approved for wear only on the speed arm, related to to the skin using an prosperous-agitate inserter device, and information technology measures interstitial fluid all minute.
  • New Reader: the new system also includes a untried handheld receiver, we're told — though it will also look and function the same equally the current model (which is smaller than a newer iPhone and has a improved-in BG meter for FreeStyle strip fingersticks). It's still rechargeable with a miniskirt-USB telegraph.
  • Shorter Warmup: as noted, the warmup time is now down to just 1 hour before users can first scanning for glucose data, compared to the whopping 12 hours on the originally variant. That's even less warmup time than required for the Dexcom G5 and G6 CGMs. Righteous like the first Libre version, this new one is authorized for making insulin dosing and treatment decisions — though interestingly, the FDA lul says that this newest version shouldn't be used for dosing in the forward 11 hours subsequently the warmup period.
  • Built accuracy: The new 14-Clarence Day Libre has a 9.4% MARD (golden standard measure of CGM truth, vs. the 9.7% MARD on the first interlingual rendition.
  • Still No Alerts: Same as before, there are No alerts on the Libre for Low or Flooding glucose readings as is the case with traditional CGMs like Dexcom, Medtronic, and the freshly-approved implantable 90-day wear Eversense CGM past Senseonics.
  • Adults Only: The FDA still hasn't cleared the Libre for anyone younger than long time 18, though with some of the recent clinical trial data we've seen, it may not be too such longer there. Of track, doctors put up ever choose to go "off-tag" and prescribe it for teens or kids, despite the official FDA labeling.
  • Mobile App: Abbott says they've already filed for FDA approval of the companion mobile app known as the LibreLink, which is lendable over the sea and allows for data show as well as smartphone scanning instead of exploitation the handheld reader. Keeping in mind how quickly regulators have authorised past Libre updates, we wouldn't personify dumbfounded to see this mobile app approved and ready aside the time the 14-sidereal day Libre launches late this yr. We also promise that includes the remote monitoring tool called LibreLinkUp too.
  • Future Pipeline: a very breathless emerging generation promises to eliminate the pauperization for a handheld reader/smartphone scan entirely. That's what Bigfoot Biomedical has agreed to use in its development closed-loop system system and they're already functioning information technology into clinical trials, we pick up. With that future Libre having continous Bluetooth data-streaming, and hopefully alerts for those who wishing them, this Abbott product could become a "true CGM" and literal game-changer.

For intersection comparisons, you crapper check over details on the competitive products here: the Dexcom G6 CGM launched in June, the new 90-solar day implantable Eversense CGM approved in June, and Medtronic's Guardian Connect complete CGM approved in March and launched in mid-June. On that point are other CGMs in development, but we don't bear to get word those anytime before long.

New Libre Accession and Affordability

Abbott says pricing and upgrade details will be disclosed late in the year closer to launch. Here's what we do now, supported the current Libre scheme:

  • The recommended retail cost for the 10-day sensors is $36 each; prices may vary depending connected the pharmacy.
  • The handheld receiver is only $70, practically free compared to what traditional CGMs cost.
  • Level though it takes away the need for "routine" fingersticks and calibrations, users volition all the same postulate some test strips. Those costs depart past stigmatize and other factors, of course.

Since Abbott is specifically promoting the affordability of the Libre compared to handed-down CGMs, we hope to see the keep company keep the same pricetag with this latest version. Summation with the extra 4 superfluous years of wear, users may involve just TWO sensors for a full month rather than three — nice!

Importantly, we urge Abbott to come in up with a easy upgrade or trade-in policy — especially given the short time it's been since the 10-day Libre launched and many PWDs likely still have those sensors connected hand.

Everyone's coverage varies, as e'er, and that'll embody true with this 14-day Libre overly. We also expect that Medicare coverage will follow shortly, given the Centers for Medicare and Medicaid Services (CMS) already covers the 10-day Libre as of archaeozoic 2017.

Product Popularity Growing

In just the freshman year that Libre has been available in the U.S., we've detected multitudes of testimonials about how people are finding IT a much handier and helpful D-tech option than even traditional CGMs. Sure, IT's non for everyone. Merely umpteen are seeing IT as more low-cost and less burdensome alternative than a time-honoured CGM. Some others are turning to that for special niche purposes like scuba diving underwater! And the always-progressive Do-Information technology-Yourself community has certainly been finding their own #WeAreNotWaiting ways to make the Libre fit best into their own lives.

We're excited to insure this modish Libre version ready to go, likely openhanded the traditional and heavenward-and-coming CGM companies a run for their money.