FreeStyle LibreLink – BE

By Abbott SA/NV

The FreeStyle LibreLink app is approved for use with the FreeStyle Libre Sensor. Now you can monitor your glucose on your phone without routine finger pricks! [1] Check your glucose by holding your phone near your Sensor.

Level 1

I am a CE-certified medical device

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General description
Additional info
Media

General description

Main purpose

The FreeStyle LibreLink app is approved for use with the FreeStyle Libre Sensor. Now you can monitor your glucose on your phone without routine finger pricks! [1] Check your glucose by holding your phone near your Sensor.

You can use the app to:

* View your current glucose reading, trend arrow, and glucose history
* Add notes to track your food, insulin use, and exercise
* See glucose reports, including your Ambulatory Glucose Profile
* Connect to health care professionals and carers with LibreView and LibreLinkUp [2]

Why prick when you can scan?[1]

[1] If you are using the FreeStyle LibreLink app, you must also have access to a blood glucose monitoring system, as the App does not provide one. A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels, when interstitial fluid glucose levels may not accurately reflect blood glucose levels, or if hypoglycaemia or impending hypoglycaemia is reported by the Sensor, or when symptoms do not match the Sensor readings.

[2] Use of the FreeStyle LibreLink and LibreLinkUp apps requires registration with the LibreView system, which is provided by Abbott and Newyu, Inc.

Target audience

FreeStyle LibreLink is intended for measuring glucose levels in people with diabetes when used with a Sensor.

Approach

Newyu is committed to ensuring patient privacy and data security. LibreView provides a robust data infrastructure and secure encryption measures to support patient privacy and data security:
Robust data system security:
LibreView is hosted in world-class data centers that feature biometric security, data back-ups, redundant power supplies and continuous surveillance systems. All data transferred to LibreView is encrypted using industry-standard SSL/TLS to ensure that it remains private from malicious parties.

Privacy and HIPAA compliance
LibreView meets or exceeds all HIPAA requirements and complies with state and federal regulations.

Account security
Access to your LibreView account is possible only through password protected user accounts.

LibreView runs on Fortune 500 SaaS infrastructure to not only ensure your security, but also the continuous uptime of your account. Your data will be both secure from intrusion and constantly backed up to prevent the loss of crucial information or access to your records.

Connectivity to sensors and platforms

The app is designed to work with iPhones and Android phones that meet the following minimum criteria. You can also consult our compatibility guide for additional information.

iOS: iPhone Models: iPhone 7 or higher iOS 11 Operating System or higher

Android: Operating System: Android 5.0 (Lollipop) or higher Near Field Communication: Your phone must be protected from NFC and NFC must be managed.

Financing and pricing model

The App is free

Pathology

Diabetes

Functions

Diagnostics

Users

Everyone

Additional info

Compliance to M1 criteria

Data privacy (More info)

Company declares to be compliant with GDPR rulesCompany declares that the data are stored in EU only

Class type of medical device (More info): 2B

ISO Standards

ISO 13485 Quality Management Systems for Medical Devices (on company level)

FAMHP registration number: 00001

FAMHP product identification code: BE/CA01/1-00001-MDD-0007

Reference publication

Newyu (“Newyu”, “us” or “we”) is a software and services company that operates primarily in the healthcare industry. This privacy notice is intended to cover the informational website that Newyu provides at www.newyu.com (“Site” or “website”) for marketing purposes.

User instructions

To learn more about the FreeStyle LibreLink app, visit http://FreeStyleLibre.com
You can read the user instructions from the App under the Help section of the Menu.

Components of the application

Native appWeb applicationWearable / SensorClient-server

Complaints handling

Via e-mail: Support_be@librelink.cust-serv.comVia telephone: 080082106

Media

Screenshot1 Screenshot2 Screenshot3

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