With a new regulatory approval, the Abbott FreeStyle Libre Flash glucose monitoring system is keeping pace in the race to lead the continuous glucose monitoring market in America.
A second-generation of the Libre that can be worn for four extra days is now approved, less than a year after the FDA cleared the first version in September 2017 and the product was launched in the U.S. at the end of last year.
The first approved product could be worn for 10 days and required no backup fingerstick calibrations, which at the time made it unique, as no other CGM or similar device on the market could make those claims. In Spring 2018, the Dexcom G6 snagged regulatory clearance and was also approved for 10-day wear as well as needing no fingerstick calibrations. The G6 launched in early June, but now the Libre is getting a boost in the race once again.
On July 23, just three months after Abbott Diabetes Care submitted a filing with the FDA, the 14-day wear version of the Libre got regulatory approval. Importantly, this version is supposed to be more accurate and the 12-hour warmup period required in the initial product has been cut dramatically to only 1 hour (!) -- making the U.S. option finally equivalent with the Libre model available globally.
Abbott tells us they plan to launch this newer version by the end of 2018; information on pricing and the upgrade path for existing Libre users is not yet available.
What is the Abbott FreeStyle Libre Flash?
The new 14-day wear Libre brings several significant improvements, but the base system remains unchanged from the 2017-approved version that can be worn for 10 days. Here's a breakdown of the new and existing product specs:
- Longer Wear Time: the new Libre can be worn on the skin for 14 days, compared to the earlier version that can be worn for 10 days. This means users may only need two sensors a month, instead of three!
- New Sensors: to be clear, the new 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 same: the Libre sensor is a little disc about the size and thickness of two stacked quarters, and users just hold the handheld reader device over the sensor to take readings. It's currently approved for wear only on the upper arm, attached to the skin using an easy-push inserter device, and it measures interstitial fluid every minute.
- New Reader: the new system also includes a new handheld receiver, we're told -- though it will also look and function the same as the current model (which is smaller than a newer iPhone and has a built-in BG meter for FreeStyle strip fingersticks). It's still rechargeable with a mini-USB cable.
- Shorter Warmup: as noted, the warmup time is now down to just 1 hour before users can start scanning for glucose data, compared to the whopping 12 hours on the earlier version. That's even less warmup time than required for the Dexcom G5 and G6 CGMs. Just like the first Libre version, this new one is approved for making insulin dosing and treatment decisions -- though interestingly, the FDA still says that this newest version shouldn't be used for dosing in the first 11 hours after the warmup period.
- Improved accuracy: The new 14-day Libre has a 9.4% MARD (gold standard measure of CGM accuracy, vs. the 9.7% MARD on the first version.
- Still No Alerts: Same as before, there are no alerts on the Libre for Low or High glucose readings as is the case with traditional CGMs like Dexcom, Medtronic, and the newly-approved implantable 90-day wear Eversense CGM by Senseonics.
- Adults Only: The FDA still hasn't cleared the Libre for anyone younger than age 18, though with some of the recent clinical trial data we've seen, it may not be too much longer there. Of course, doctors can always choose to go "off-label" 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 available overseas and allows for data display as well as smartphone scanning instead of using the handheld reader. Keeping in mind how quickly regulators have approved other Libre updates, we wouldn't be surprised to see this mobile app approved and ready by the time the 14-day Libre launches late this year. We also hope that includes the remote monitoring tool called LibreLinkUp too.
- Future Pipeline: a very exciting future generation promises to eliminate the need for a handheld reader/smartphone scan entirely. That's what Bigfoot Biomedical has agreed to use in its developing closed loop system and they're already working it into clinical trials, we hear. With that future Libre having continous Bluetooth data-streaming, and hopefully alerts for those who want them, this Abbott product could become a "true CGM" and real game-changer.
For product comparisons, you can check out details on the competing products here: the Dexcom G6 CGM launched in June, the new 90-day implantable Eversense CGM approved in June, and Medtronic's Guardian Connect stand-alone CGM approved in March and launched in mid-June. There are other CGMs in development, but we don't expect to see those anytime soon.
New Libre Access and Affordability
Abbott says pricing and upgrade details will be disclosed later in the year closer to launch. Here's what we do now, based on the current Libre system:
- The suggested retail cost for the 10-day sensors is $36 each; prices may vary depending on the pharmacy.
- The handheld receiver is only $70, practically free compared to what traditional CGMs cost.
- Even though it takes away the need for "routine" fingersticks and calibrations, users will still need some test strips. Those costs vary by brand and other factors, of course.
Since Abbott is specifically promoting the affordability of the Libre compared to traditional CGMs, we hope to see the company keep the same pricetag with this latest version. Plus with the additional 4 extra days of wear, users may need just TWO sensors for a full month rather than three -- nice!
Importantly, we urge Abbott to come up with a user-friendly 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 on hand.
Everyone's insurance coverage varies, as always, and that'll be true with this 14-day Libre too. We also expect that Medicare coverage will follow soon, given the Centers for Medicare and Medicaid Services (CMS) already covers the 10-day Libre as of early 2017.
Product Popularity Growing
In just the first year that Libre has been available in the U.S., we've heard multitudes of testimonials about how people are finding it a much handier and helpful D-tech option than even traditional CGMs. Sure, it's not for everyone. But many are seeing it as more affordable and less burdensome option than a traditional CGM. Some others are turning to it for special niche purposes like scuba diving underwater! And the always-innovative Do-It-Yourself community has certainly been finding their own #WeAreNotWaiting ways to make the Libre fit best into their own lives.
We're excited to see this latest Libre version ready to go, likely giving the traditional and up-and-coming CGM companies a run for their money.