It's an exciting time for people with diabetes in the United States, as we now join the rest of the world in having access to the Abbott FreeStyle Libre Flash Glucose Monitoring technology.
Abbott Diabetes Care announced late Wednesday it had received FDA approval of this new device, which has been available overseas for several years already, but stuck in regulatory purgatory for a full year and two months here in the U.S.
This is the first device of its kind, different than a traditional continuous glucose monitor (CGM) with a sensor that beams data directly to a separate device or mobile app and has glucose alerts. Instead, the Libre consists of a small round sensor worn on the upper arm that users handheld scanner over to obtain glucose readings, as often or as little as one may want.
Unlike any other diabetes device currently available in the USA, the Libre does not require a fingerstick blood sugar check to confirm the data's accuracy. This no-calibration device has been called a game-changer by patients using it around the world.
WHAT IS THE ABBOTT FREESTYLE LIBRE?
Here's the skinny on the FreeStyle Libre (you can also watch a slick 22-second marketing video from Abbott). Note that there are some key differences between what's approved now for the U.S. versus what's available globally:
Scannable Sensor: As opposed to existing rectangular or shell-shaped CGM sensors that constantly beam glucose data onto a receiver or smartphone app, the Libre has a little disc sensor about the size and thickness of two stacked quarters, and users just hold the handheld reader device over the it (from 1-4 cm) to scan it for data. It's approved for use only on the upper arm at this time, attached to the skin using an easy-push inserter device. It measures interstitial fluid every minute.
Wear Time: The sensor's approved for 10 days of wear in America, rather than 14 as it is worldwide, and with the FreeStyle Libre Pro (physicians version) here in the U.S. The assumption is that this was an extra safety precaution from the FDA, prompted by their lingering uncertainty about no calibrations.
Handheld Reader: Much like the OmniPod PDM, this unit looks a lot like one of Abbott's traditional glucose meters, but it's smaller than a newer iPhone. It uses a micro-USB for recharging, and scans the sensor within a few seconds -- even through clothing, including thick winter coats and leather jackets. It has a back-lit touchscreen color display and stores up to 90 days of readings, but the sensor itself can only store 8 hours worth of data, so you have to scan it at least once in that period of time. That means if you leave the reader at home before a long day out, or sleep more than eight hours, Libre won't be able to capture all the glucose data during that time. Still, this is an eye-catching device with an easy-to-read screen (even in the sunlight, we're told!) and it certainly gets points for style.
No 'Routine' Fingersticks: This is huge, and marks a turning point in the D-Device world here in the States, as no other device is currently OK'd by FDA for zero calibrations. Both Dexcom and Medtronic require fingerstick calibrations at least twice a day, though the Dexcom G5 Mobile system has obtained an FDA "non-adjunctive claim," meaning it's approved for patients to make treatment and insulin dosing decisions based on that system. The Libre now has that designation, too, with the FDA specifically stating, "fingerstick testing is not needed to inform appropriate care choices or to calibrate glucose levels with this system." However, it's still recommended that users do a fingerstick test if the system displays a "Check Blood Glucose" symbol, if the data appears inaccurate, or generally if the patient's having symptoms or illness is at play.
Built-in Meter: Even though it's a no-calibration device, that doesn't mean there still isn't a need at times for fingersticks (as noted above). So the Libre has a built-in glucose meter that uses Freestyle strips. So no need for "routine" fingersticks, but users still may be poking fingers for blood drops every so often.
Flash, Not Continuous: To be clear, despite the FDA categorizing this under the umbrella of CGM, instead of creating a whole new category of device, this new Flash Glucose Monitoring FGM) system is not the same as continuous glucose monitoring as we know it. As noted, you must scan the mobile device over the sensor to get readings. It does not include alarms for real-time low or high blood sugars, and the data is not currently streamed to mobile devices like smartphones (more on connectivity functions below). The mobile hand-held device displays trends data including lows, stable, and high readings with a directional arrow and the ability to review 8 hours of glucose history.
Warmup Period: Once you insert the sensor and start it up, there's a 12-hour warmup period before you can start seeing actual glucose data. This a drawback, as it's quite a bit longer than the 1-hour warmup period allowed in other countries, and it's reminiscent of the Abbott FreeStyle Navigator CGM that years ago had a full 10-hour warmup period before data displayed. This was not mandated by FDA, we're told, but apparently implemented by Abbott itself to address performance -- i.e. from what we hear from users in the global DOC, Libre data becomes more accurate over time, especially after the first 24 hours of starting a sensor.
Not for Kids: The FDA approval is for ages 18 and older, meaning it's not officially allowed for children. Of course, as many in the D-Community know, physicians may be willing to write an "off label" prescription. Your Doctor's Opinion May Vary on that. We weren't able to get any more detail from Abbott on their plans or timeline for pediatric approval.
Water Resistant: Official marketing materials say the Libre sensor can be worn during bathing, showering, swimming as long as it's not deeper than 3 feet or kept underwater for more than 30 minutes at a time.
Tylenol OK: Abbott's initial news release urged users to avoid acetaminophen (ingredient in Tylenol and hundreds of other medications), but now it appears that warning has been removed. The FDA says this is no longer an issue, after the Libre Pro version recently had its label changed reflecting the same.
Accuracy: UK study data on the Libre shows that it has an accuracy standard pretty much on par with the two existing CGMs here in the U.S. TBD on how it compares to both the Dexcom's G5 and Medtronic's latest Guardian sensor, once those are tested side-by-side in real life.
Better Outcomes: For more than a year now, Abbott Diabetes Care has been presenting clinical data at conferences on how much better PWDs do using this Libre -- mostly because of its ease of use. Clinical studies and real-world evidence published over the past year or so show that PWDs are able to lower the amount of hypoglycemia they experience without raising A1Cs, and that they generally do better than those using traditional fingersticks. Bottom line: the more Libre scans, the better the D-management
SHOW ME THE DATA...
With all the craze for improved data sharing and viewing in U.S., the Libre is taking a unique approach on two fronts:
- No Initial Connectivity: At the time of launch, Abbott is not offering any connectivity for the Libre with a mobile device or smartphone, although that is availabe outside the U.S. with the LibreLink mobile app, allowing people to even leave their handheld reader at home and simply use their smartphone to scan the sensor directly. That's a "future iteration" for the States, we're told, but Abbott hasn't yet named a timeline.
- A New Standard for Data Viewing: The Libre offers a visual snapshot of a person's glucose fluctuations during a typical day called the Ambulatory Glucose Profile (AGP). This reveals hypoglycemic and hyperglycemic trends in a new style of view, and is being discussed across the industry as a potential way to standardize diabetes data displays; the American Association of Clinical Endocrinologists (AACE) has recently recommended that the healthcare industry standardize on the AGP report across all glucose monitoring devices for patients and physicians.
AVAILABILITY AND COST
Abbott tells us the Libre will be available with a prescription in U.S. pharmacies, starting in December 2017.
Of course Abbott is pursuing Medicare and private insurance coverage, but we're still waiting to hear whether the company will also sidestep payors' Durable Medical Equipment (DME) hurdles to allow pharmacies to sell the Libre directly to PWDs.
Costs: These are the details on what the Libre pricing looks like –
- The suggested retail cost for the sensors is $36 each -- less than Dexcom sensors at $88 each and Medtronic’s CGM sensors that ring in $94 for the Enlites, and $108 each for the new Guardian 3. Prices may vary depending on the pharmacy.
- The handheld receiver is only $70, practically free compared to the four-digit price tag of a Dexcom system and the even higher cost of a Medtronic pump-CGM system.
- Even though it takes away the need for "routine" fingersticks and calibrations, you'll still need test strips. Those costs vary by brand and other factors, of course.
Medicare Coverage: On Jan. 4, 2018, Abbott announced that the Libre would be covered by Medicare, as it doesn't require calibrations and meets the "therapeutic CGM" classification for coverage (as long as eligibility criteria's met).
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. In Australia, the units are sold for about $95 each out-of-pocket without coverage.
“We intentionally designed the product to make it as affordable as possible,” Abbott Diabetes Care's senior VP Jared Watkin told the Chicago Tribune.
At the company's Libre website, which has some positive messaging of "'You Can Do This' without fingersticks," there's an option to sign up for alerts on the latest news and access updates on Libre availability.
ABBOTT'S ROCKY ROAD
This launch marks a much-anticipated comeback for Abbott in innovative diabetes tech here in the States, after the company has been largely focused on basic glucose meters and strips since it stopped selling the FreeStyle Navigator CGM back in 2010. It's been a rocky road over the years, particularly with big product recalls that have shaken the Diabetes Community's faith in the company.
Abbott submitted the Libre to FDA in mid 2016, a full two year after it became available in Europe in 2014. This consumer version follows the professional, blinded-version available to physicians that was approved for the U.S. in September 2016, and it comes after Health Canada's approval of the consumer Libre for that country in June and the recent NHS announcement that it would soon begin covering this device. In total, more than 400,000 people worldwide are using the Libre in 40 countries.
The FDA actually issued its own
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said the FDA's Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the agency's Center for Devices and Radiological Health. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes -- with a wave of the mobile reader.”
THE FUTURE WITH LIBRE
This a big development, that paves the way for next-generation technology. It's already having an impact on the existing D-device market, with competitor Dexcom taking a significant stock price hit after early news of Libre's approval. Not surprisingly, Abbott's stock price rose 4% on Wednesday following the announcement.
Whether Libre will have long-lasting impact on main competitors Dexcom and Medtronic is anyone's guess at this point since Libre doesn't offer any continuous data stream or alarms -- huge factors for many current CGM users. Dexcom has a lot going for it, as does Medtronic with the new Minimed 670G Hybrid Closed Loop System, though challenges on sensor manufacturing have meant a delayed product launch and frustration in the D-Community.
Dexcom is already planning to submit its future sensor, the G6, in the coming months with plans to launch sometime in 2018. While that has an expected 10-day wear with better accuracy, at this time it's still expected to have a single daily calibration requirement. The generations beyond that go toward Dexcom's overall goal of no calibrations, and this Libre approval helps make that more possible.
Sure, this current iteration of Libre requires a handheld device to scan for data. But we understand the next-generation in development won't require scanning by hand, but will have direct data communication capabilities (much like Dexcom's G5 currently has via a mobile app). There's no ETA on that next-gen product yet.
Startup Bigfoot Biomedical, which made the bold decision to use Abbott's next-gen system with their future automated insulin delivery system before the Libre even snagged FDA approval, sees this new approval as a game-changing step forward. Founder and D-Dad Jeffrey Brewer uses words like "breakthrough" and "dramatic advance" in describing the Libre.
"All the technology I've seen in the last decade only provided more power, but at the sacrifice of quality of life," he says, noting that the Libre provides a QOL boost even with the variations in versions marketed globally. "Importantly, Abbott was able to keep the product indicated as a replacement for fingersticks in dosing insulin – so no fingerstick calibration needed over the full 10-day period."
Brewer says he's thrilled with the Abbott collaboration, and this regulatory clearance keeps everything on track for a 2018 pivotal trial start for the Bigfoot system.
We echo that excitement, and send our congrats to Abbott for finally making it to this milestone. We can't wait to see how PWDs here in the U.S. feel about the new Libre system!
** UPDATE: On July 27, 2018, the FDA approved a new 14-day version of the Abbott FreeStyle Libre system, with improved accuracy and only a 1-hour warmup period (compared to the initial 10-hour warmup waiting period)! Abbott expects that to launch in the US in the coming months by Fall 2018.