The popular next-gen "flash" glucose monitoring device FreeStyle Libre from Abbott Diabetes Care has received FDA approval for a new mobile app allowing users to scan the sensor directly from their smartphone, with no need to use the separate handheld receiver.

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This direct-to-phone functionality is a big deal for PWDs (people with diabetes) of course, because it eliminates the need to carry around and charge yet another gadget, and allows for Libre sensor-scanning with just the phone app.

News of FDA approval for this long-awaited app came on Nov. 1, just in time to make headlines at the start of Diabetes Awareness Month. Abbott had submitted the app to FDA regulators earlier in the summer, and obtained agency approval at the end of October.

This follows the other big Libre tech news for Abbott Diabetes Care recently:

  • The mid-October launch of its 14-day sensor, which added an additional four days onto the Libre sensor wear-time and also dramatically slashed the warmup period from the whopping 12 hours to only 1 hour before glucose data begins appearing.
  • Medicare approval in October for the Libre 14-day sensor (which came at the same time as Medicare coverage for the Dexcom G6 system).
  • CE Mark approval on Oct. 1 of a next-generation product dubbed Libre 2, which builds in Bluetooth Low Energy to allow for optional real-time alerts for high and low glucose levels -- an important missing component of the original Libre Flash, which neither streams continuous data or offers alerts like other CGM products on the market from Dexcom, Medtronic Minimed, and Senseonics' Eversense.

We in the U.S. will still have to wait for regulatory review of the next-gen Libre 2. But having access to the new LibreLink mobile app is a milestone for this technology, in terms of convenience and value for users.

 

FreeStyle Libre: What You Should Know

Here's a reminder of what the FreeStyle Libre glucose monitoring system is all about:

Scannable Sensor: The sensor is a little disc about the size and thickness of two stacked quarters that sticks onto your arm. Users just wave the handheld reader over the sensor to scan it and get 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. Note that it's only approved for adults and the pediatric market is a work in progress for Abbott.

Wear and Warmup: While the initial U.S. version could only be worn for 10 days and had a crazy-long warmup period of 12 hours, the latest version is good to wear for an additional four days and it now takes just 1 hour before the system starts generating data.

Cost: It's also impressive that Abbott isn't raising the price-tag for the new 14-day sensor, pricing it at the same suggested retail cost of $36 per sensor as the initial shorter-wear version.

Medicare? It's also worth reiterating that the FreeStyle Libre, both the 10-day and 14-day sensors, are approved for Medicare coverage, in keeping with the agency's policy decision earlier in 2018 that smartphone app use is allowed for CGM-using Medicare beneficiaries.

No More 'Routine' Fingersticks: Thanks to the calibration-free capability, users no longer have to do one or two extra blood sugar fingersticks to confirm results on the Libre. The new 14-day Libre sensor is more accurate with a 9.4% MARD (gold standard measure of CGM accuracy), versus the 9.7% MARD on the first version (lower scores are better).

Handheld Receiver: This is the device that users have had to carry to scan the Libre sensor to get glucose readings, according to FDA mandate. But it's now no longer required! The latest FDA approval allows use of the new mobile app to collect readings.

LibreView Platform: U.S. users have had access to this online platform for viewing their Libre-generated data, but to date have not had a mobile option of any kind.  

 

New Abbott LibreLink Phone App (!)

The LibreLink app utilizes the iPhone's near-field communication (NFC) capabilities to enable users to just hold their phone near the Libre sensor to instantly capture and view real-time results. Notably, it can scan data directly from both the 10-day and 14-day Libre models.

It displays an 8-hour glucose history, plus a directional arrow showing how glucose levels are changing.

It currently works only with iPhone models 7s and beyond, using iOS 11 or later, but Abbott says they're working on the Android version and hope to bring that to market ASAP with regulatory approval.

Abbott spokes-folks tell us LibreLink will also include text-to-speak glucose readings, the ability to log "smaller" insulin doses (?), and will support 26 languages.

We're told the iPhone app should be available for download in the coming week or so, which likely means we'll see that by mid-November 2018. Of course, you can use the receiver and phone app interchangeably as you prefer.

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It's Free! Abbott tells us point-blank that the app won't cost anything, but will be available for free on the iOS store (and eventually, the Google Play store for Android once that's available).

Data Sharing: Yes, you can! In this app, there’s a reports section offering the Ambulatory Glucose Profile (AGP), standardized single-page reports with glucose and insulin info in a colorful, easy-to-read format. There's a share function that allows users to easily send these reports via text, email, etc. to anyone, similar to photo-sharing buttons that allow you to send pictures to contacts in your phone.

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More Libre Overseas

Overseas, there's also a separate app known as LibreLinkUp that has more remote-sharing connectivity, but we're told that's not ready for the States yet.

And the new Libre 2 is only available outside the U.S. currently, as it just recently got CE Mark approval and is launching in Europe. This official second-generation Libre product adds in optional High and Low glucose alerts, and it also bumps up accuracy on the sensor. Abbott isn't revealing its timeline U.S. launch, but given their current progress, it shouldn't be too much longer. Following the initial three-year stretch it took for FreeStyle Libre to make it to the USA in late 2017, things have moved pretty quickly from there.

 

Doing Diabetes from Your iPhone

No doubt that for many of us, being able to manage our diabetes tasks directly from our mobile phones is a life-changer. No more need for separate medical devices! The phone is always with us anyway! And the easy-scroll operation requires no special training.

Abbott Diabetes Care Senior VP Jared Watkin officially stated: "The FreeStyle LibreLink app is a digital health tool that integrates glucose data directly on a compatible smartphone so all of the mobile apps that people use every day are in one convenient place. This is another step forward in making glucose monitoring seamlessly fit into a patient's daily lifestyle -- helping them live a fuller, healthier life... We're committed to liberating people from the many hassles of diabetes management through our life-changing technology and tools."

Having a mobile app that can scan directly from the sensor is a huge step forward, and we look forward to the next big leap with the availability of alerts.

After that, we're eager to see future generations of the FreeStyle Libre -- especially a future iteration that automated insulin delivery startup Bigfoot Biomedical has signed on to use, providing continuous beaming of glucose data with no more need to scan the sensor manually. That's going to be a quantum lead forward, taking the Libre from "Flash Glucose Monitor" category into a true CGM on par with the other competing devices on the market.

Amen to that!

Here's to the FreeStyle Libre's march forward!