Freestyle librelink app fda approved


#1

NOV 1 2018

People with diabetes living in the U.S. and using the FreeStyle Libre or FreeStyle Libre 14 Day systems are now able to monitor their glucose directly on their compatible iPhones*.

The FreeStyle LibreLink app, now approved by the FDA, enables users to hold their iPhone near their FreeStyle Libre or FreeStyle Libre 14 Day sensor to instantly capture and view their real-time glucose levels, assess their eight-hour glucose history, and see a directional arrow indicating how their glucose is changing. FreeStyle LibreLink app also includes a series of in-app reports that visualize trends and patterns that help people understand how well they are controlling their glucose.

“We’re committed to liberating people from the many hassles of diabetes management through our life-changing technology and tools,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “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.”

FreeStyle LibreLink app will be free to download through the Apple App Store in the coming weeks. Once available, people will be able to pair the FreeStyle Libre or FreeStyle Libre 14 day sensors with the app. The Android version of the app is currently under development.

*The FreeStyle LibreLink app is compatible with NFC enabled phones on Apple’s iPhone 7 and later, running iOS 11 and later.

Indications and Important Safety Information

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.

CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.


#2

500 million apple users
2 billion andriod users

and they do apple first? SMH!

thanks abbott


#3

There’s an Android app in Europe…but not on this side of the Atlantic for some reason. FDA/Health Canada approvals?


#4

The FDA delights in making things difficult


#5

Phones that have overpowered NFC can wipe out the sensor

if this app becomes available test it on a sensor you have just removed

Try it more then once to make sure

Not all android phones have NFC


#6

The app is out now and works great. I think everyone does IOS first because there are way less variables and is more secure so FDA will approve faster.


#7

Apple is also better at forcing your phone to run so slow you use it for a paperweight

And IOS is a tiny tiny tiny tiny bit more secure

WHY?
Bueller, anyone

It only has 25 percent of the users that android has

Android rules - fact


#8

Wow, just wow. I didn’t need all of that. I could really care less which operating system is “better” than the another.

Bottom line, I have an iPhone and the FDA approved app🤪


#9

I don’t have the Libre, but I am an Android user. I haven’t researched if anyone has made it available, but you should be able to just side load the apk file for the overseas version of the app. It’s a very common and easy process. There are lots of great apps not in the Play store that have to be installed this way. Just need someone who has it to upload the file to a public share domain, like github.

Only problem may br if the sensors are different, it might not be programmed to speak to the US/Canadian versions of the sensors. I don’t know. Only way to find out is for someone to try it.


#10

Hmm… I did just try to install the apk I found on apkpure, and got this message.

Now I’m curious… I’m sure there’s a way.

Edit:. Looks like you could accomplish that by making a new Google account and running the app through a VPN connection… But I assume you’d have to keep that VPN enabled all the time. Might make other reginal apps malfunction.

I’m not a programmer, but I bet there’s some hacktivist in our midst that could easily remove that safeguard.


#11

That is not the new one anyway

You could just use TOR until you get an EU IP - but they don’t last long