User Guide

LibreLinkUp is a free mobile app that enables you to receive glucose readings from family and friends whenever they scan their FreeStyle Libre sensor with their FreeStyle LibreLink app. Every scan is automatically sent to the LibreLinkUp app on your mobile phone as a notification. You can remotely monitor glucose readings and trends, stay connected and help loved ones better manage their diabetes.

LibreLinkUp is compatible with Android phones running Android OS 6.0 and higher and iPhones running iOS 11 and higher.

Foreword

Safety and efficacy are key cornerstones in the design and support of the LibreView system. Newyu takes its responsibilities as a medical device manufacturer seriously.

LibreView includes the LibreView website and LibreLinkUp mobile app.

Intended Use

LibreView is intended for use by patients, caregivers and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management.

In other words:

LibreView is a secondary viewer and is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

LibreView is not intended to be used for immediate clinical decision making, and is not intended to replace self-monitoring practices as advised by a physician.

Home users should consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software.

Healthcare professionals should use information in the software in conjunction with other clinical information available to them.

When using the LibreLinkUp mobile app:

LibreLinkUp is not intended to be used by clinicians.

Patients should not rely on caregivers to notify them about low or high glucose.

Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.

Any problems with the mobile device, NFC, wireless internet connection, mobile data connection, FreeStyle LibreLink, LibreLinkUp or LibreView could cause data to not be shared with caregivers, or delay transmission to caregivers.

LibreView (and thus LibreLinkUp) should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose information.

Minimum App Version and Smartphone Requirements

To provide the best experience, LibreLinkUp users will be required to update their LibreLinkUp app to at least v3.0.0 by April 2020. App versions v2.6 and earlier will no longer be supported after April 2020.

The LibreLinkUp app is compatible with many popular Android and iOS smartphones. The phone must meet the following requirements:

  • LibreLinkUp v3.0
    • Android OS 6.0 or higher
    • iOS 11 or higher
    • Wi-Fi or a cellular data plan
  • LibreLinkUp v2.6 or earlier
    • Android OS 4.4 or higher
    • iOS 10 or higher
    • Wi-Fi or a cellular data plan

How FreeStyle LibreLink and LibreLinkUp Work With LibreView

For FreeStyle LibreLink users that choose to share their glucose data with a LibreLinkUp user:

  1. Glucose readings are uploaded from a FreeStyle Libre sensor to the FreeStyle LibreLink app.

  2. The FreeStyle LibreLink app transmits the glucose readings to the LibreView cloud for storage using WiFi or a cellular data plan.

  3. The FreeStyle LibreLink app allows a user to invite family members or friends to view glucose readings stored in LibreView.

  4. A family member or friend can install the LibreLinkUp app on their own phone, accept the sharing invitation and then view glucose readings from the FreeStyle LibreLink app user.

Getting Started With LibreLinkUp

Sharing data from a person wearing a FreeStyle Libre sensor with a family or friend involves two apps:

The person wearing the FreeStyle Libre sensor uses the FreeStyle LibreLink app on their mobile phone to send a sharing invitation email to their family member or friend.

The family member or friend receives the invitation email and follows the instructions to install the LibreLinkUp app on their mobile phone.

After the sharing invitation is accepted, the family member or friend will receive notifications through LibreLinkUp every time the person using FreeStyle LibreLink scans their sensor.

Below are instructions for each app:

FreeStyle LibreLink app instructions

For the person wearing a FreeStyle Libre sensor that wants to share their glucose readings.

To invite someone to see your glucose readings, open your FreeStyle LibreLink app, then:

  1. Open the Navigation Menu. From any screen, tap the “three lines” icon in the upper left corner.
  2. Tap Share.
  3. Tap LibreLinkUp.
  4. Tap Create Connection.
  5. Enter Connection information. Enter name and e-mail address of the person you want to share your glucose readings with.
  6. Tap Invite.

You can share your glucose readings from FreeStyle LibreLink with up to 20 family members and friends.

LibreLinkUp app instructions

For the family member or friend who wants to view glucose readings.

After you receive a connection invitation email from a FreeStyle LibreLink user, click on the link in the email to download the LibreLinkUp app from the app store (if you don’t already have the app installed).

After installing LibreLinkUp app, follow the prompts to create an account and connect:

  1. Tap Get Started on the Welcome screen.
  2. Review and accept the End User License Agreement and Privacy Notice.
  3. Create an account. Enter your country of residence, name, email address and preferred password.
  4. Go to your email inbox to verify your account and complete setup.
  5. After you have set up your account, you will see a notification telling you that a FreeStyle LibreLink user would like to share their glucose readings with you. Press Accept.

You will now receive a notification each time the FreeStyle LibreLink user scans their FreeStyle Libre sensor with their FreeStyle LibreLink app. You will not receive information about unsuccessful scans or scan errors. You do not need to have the LibreLinkUp app running to receive notifications from your connections.

You can connect with up to 20 FreeStyle LibreLink users to see their glucose readings.

Having Trouble?

If you successfully installed LibreLinkUp and set up your account, but do not see a notification from the FreeStyle LibreLink user make sure your phone has an active Internet connection (Wi-Fi or cellular) and your phone settings allow you to receive notifications.

If you still do not see an invitation and you know that the invitation was sent, ask the FreeStyle LibreLink user who invited you to send a new invitation to the email address you used when you installed LibreLinkUp.

Understanding Glucose Readings (For LibreLinkUp App Versions 3.0 or Later)

When you open LibreLinkUp, you will see the latest glucose reading from your connections, the time the reading was taken, and an arrow indicating which direction their glucose was trending. If you are following a FreeStyle Libre 2 user, you will also see your connection’s glucose alarm events.

1. Current glucose

The bold number indicates your connection’s latest glucose reading in what’s called a reading card. The color band on the reading card indicates whether your connection’s glucose is high, low, in target, or out of target.

Red indicates a low glucose reading (<70 mg/dL or 3.9 mmol/L).

Orange indicates a high glucose reading (>240mg/dL or 13.3 mmol/L).

Green indicates readings in your connection’s target range.

Yellow indicates readings between your connection’s target range and their high and low thresholds.

In some cases, instead of a bold number, you may see a glucose reading of “LO” or “HI.”

“LO” indicates a glucose reading lower than 2.2 mmol/L (40 mg/dL).

“HI” indicates a glucose reading higher than 22.2 mmol/L (400 mg/dL).

If either of these readings is seen, the FreeStyle LibreLink User Guide states that the user should check their blood glucose with a test strip. If they get a “LO” or “HI” result from a blood glucose meter, the FreeStyle LibreLink user should contact their healthcare professional immediately.

2. Trend arrow

This arrow shows which way your connection’s glucose was heading at the time of the scan. There are five possible trends:

Glucose is rising quickly

More than 0.1 mmol/L (2 mg/dL) per minute

Glucose is rising

Between 0.06 mmol/L - 0.1 mmol/L (1-2 mg/dL) per minute

Glucose is changing slowly

Less than 0.06 mmol/L (1 mg/dL) per minute

Glucose is falling

Between 0.06 mmol/L - 0.1 mmol/L (1-2 mg/dL) per minute

Glucose is falling quickly

More than 0.1 mmol/L (2 mg/dL) per minute



The trend arrow may not always appear with your reading if there is insufficient data. Also, the arrow will not display in the notifications you receive on your phone. Instead, you will see text describing the glucose rate of change (e.g., glucose is falling).

3. Scan history

The last 100 scans are listed below the latest reading card. The list starts with second most recent reading.

Understanding Glucose Readings (For LibreLinkUp App Versions 2.6 or Earlier)

When you open LibreLinkUp, you will see the latest glucose reading from your connections, the time the reading was taken, and an arrow indicating which direction their glucose was trending.

1. Current glucose

The bold number indicates your connection’s latest glucose reading in what’s called a reading card. The color band on the reading card indicates whether your connection’s glucose is high, low, in target, or out of target.

Red indicates a low glucose reading (<70 mg/dL or 3.9 mmol/L).

Orange indicates a high glucose reading (>240mg/dL or 13.3 mmol/L).

Green indicates readings in your connection’s target range.

Yellow indicates readings between your connection’s target range and their high and low thresholds.

In some cases, instead of a bold number, you may see a glucose reading of “LOW” or “HIGH.”

“LOW” indicates a glucose reading lower than 2.2 mmol/L (40 mg/dL).

“HIGH” indicates a glucose reading higher than 22.2 mmol/L (400 mg/dL).

If either of these readings is seen, the FreeStyle LibreLink User Guide states that the user should check their blood glucose with a test strip. If they get a “LO” or “HI” result from a blood glucose meter, the FreeStyle LibreLink user should contact their healthcare professional immediately.

2. Trend arrow

This arrow shows which way your connection’s glucose was heading at the time of the scan. There are five possible trends:

Glucose is rising quickly

More than 0.1 mmol/L (2 mg/dL) per minute

Glucose is rising

Between 0.06 mmol/L - 0.1 mmol/L (1-2 mg/dL) per minute

Glucose is changing slowly

Less than 0.06 mmol/L (1 mg/dL) per minute

Glucose is falling

Between 0.06 mmol/L - 0.1 mmol/L (1-2 mg/dL) per minute

Glucose is falling quickly

More than 0.1 mmol/L (2 mg/dL) per minute



The trend arrow may not always appear with your reading if there is insufficient data. Also, the arrow will not display in the notifications you receive on your phone. Instead, you will see text describing the glucose rate of change (e.g., glucose is falling).

3. Scan history

The last 100 scans are listed below the latest reading card. The list starts with second most recent reading.

Notifications (For LibreLinkUp App Versions 3.0 or Later)

Notifications are defaulted to On and can be changed by connection. You do not need to have the app open or running in the background to receive notifications.

To change the connection’s notifications settings:

  1. Go to the connection’s main screen.
  2. Tap the bell icon.
  3. Toggle notifications on or off.
Having trouble receiving notifications?
  • Make sure your phone has an active Internet connection (Wi-Fi or cellular).
  • Turn off Airplane Mode.
  • Turn off Do Not Disturb.
  • Make sure your phone is sufficiently charged.
  • Make sure your phone has at least 66MB of available memory.

Note: If you have enabled notifications for your Connections in the notification settings and you still are not receiving notifications, go to the notifications settings on your smartphone’s operating system and enable notifications for the LibreLinkUp app.

Turning Notifications On and Off (For LibreLinkUp App Versions 2.6 or Earlier)

Notifications are defaulted to On when you first set up LibreLinkUp. You do not need to have the app open or running in the background to receive notifications.

To turn notifications Off, go to the main screen of the app and tap the bell icon. Then follow the instructions on the screen to turn notifications off.

The bell icon will then display with a line through it, indicating that notifications for the app are turned off.

To turn them on again, click on the bell icon and follow the instructions to turn notifications back on.

Having trouble receiving notifications?

  • Make sure your phone has an active Internet connection (Wi-Fi or cellular).
  • Make sure the bell icon on the main screen of the app is enabled (no line through the bell).
  • Turn off Airplane Mode.
  • Turn off Do Not Disturb.
  • Make sure your phone is sufficiently charged.
  • Make sure your phone has at least 25MB of available memory.

Note: If you tap on the bell icon with a line through it and see a message that notifications are turned off on your phone, you will need to go into the Settings for your phone’s operating system to allow notifications for LibreLinkUp. Each phone’s operating system is different, so if you are having difficulty, try “Googling” the phone model and operating system version to determine how to enable notifications.

After turning notifications on for LibreLinkUp in your phone settings, return to the LibreLinkUp main screen and confirm that notifications are now on (bell icon should no longer have a line through it).

Removing a connection

To permanently stop receiving notifications from a FreeStyle LibreLink user, remove them from your list of Connections.

  1. Open the Navigation Menu. From the main screen in your LibreLinkUp app, tap the “three lines” icon in the upper left corner to open the main menu.
  2. Tap Connections.
  3. Tap X. A window will open asking you to confirm you want to remove this Connection.
  4. Tap Remove. This removes the person from your list of Connections. You will no longer receive glucose readings from this person.

If you remove a connection by mistake, the FreeStyle LibreLink user will need to send a new invitation from their FreeStyle LibreLink app.

LibreLinkUp Privacy

LibreLinkUp users must accept the Newyu End User License Agreement before installing the app, and the Abbott Diabetes Care Inc. Privacy Notice and Terms of Use before signing in and using the LibreLinkUp and LibreView services.

After installation and registration, these documents are accessible from within the app for your convenience.

LibreView Regulatory

About

LibreView, version 3.1
(including LibreLinkUp, version 3.0)

catalogue

(01) 00860000502016

(10) 3.1 08 FEB 2020

LibreView Website

LVWebsite

LibreLinkUp Mobile App

LLUMobileApp

Quality Management

ISO (International Organization for Standardization) 13485

Newyu services are considered a medical device in many global countries and regions. Alongside our security program, Newyu has achieved ISO (International Organization for Standardization) 13485 certification for our Quality Management Systems (QMS), covering our medical devices and related activities. ISO 13485 is a globally recognized quality standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our certification encompasses our product life-cycle, including design and development, production, storage and distribution, and support.

21 Code of Federal Regulations (CFR) Part 820

The United States maintains one of the world’s most robust set of legislation and guidance concerning medical devices. There are similarities to ISO 13485 but also many differences. As a US-based device manufacturer, Newyu maintains compliance with the US Quality System Regulations (QSR) and registers our establishment with the FDA annually.

Vigilance

Any serious injury or death that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Global Regulatory Representatives

Newyu maintains our Quality Management System for our global product in support of regional registrations or approvals as required to place the device on the market.

Shown below are in-country representatives for regulatory affairs issues and incident reporting, including Newyu partners, sponsors or representatives where applicable.

If a country is available from the product as a country for registration, but is not listed below, most likely it is not a medical device or does not require registration in that country. Please contact LibreView support with any questions.

Manufacturer
Manufacturer

Newyu, Inc., 3452 Lake Lynda Dr. Suite 352, Orlando, FL 32817 USA

ARGENTINA

Class 1 device, Argentina Representative ABBOTT LABORATORIES ARGENTINA

PM number: 39-703

Australia

Class 1 device, Australian Sponsor:

EMERGO AUSTRALIA, Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney, NSW 2000, Australia

ARTG ID: 296121

BRAZIL

Class II device, Brazil Importer of Record: Emergo Brazil Import Imp Distr de Prod Méd Hosp Ltda., CNPJ: 04.967.408/0001-98

Av. Francisco Matarazzo, 1.752, Salas 502/503, Água Branca, São Paulo-SP, CEP – 05001-200

BRAZILVIGILANCE@UL.COM

Resp Téc: Luiz Levy CRF-SP: 42415

ANVISA: 80117580705

COLOMBIA

Class IIa device, Colombia Importer of Record: Impomed S.A.S.

INVIMA registration number: IMVIMA 2018DM-008191

Europe
Europe

Class 1 device, EU Authorized Representative:

EMERGO EUROPE, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

Israel

Class 1 device, Israeli Registration Holder:

I.L.Emergo Israel Ltd., Tel: 02-6731634, 9 Andrei Sakharov St., Matam, P.O.B. 15401, Haifa 3190501

AMAR registration number: 24820088

NEW ZEALAND

Class 1 device, New Zealand Sponsor: CLINICAL & REGULATORY SERVICES LIMITED (CARSL)

WAND Reference: 171216-WAND-6PFS9Z

Saudi Arabia

Class 1 device, Saudi Authorized Representative:

MEDICAL SUPPLIES & SERVICE CO. LTD MEDISERV

Singapore

Class A Exempt device, contact Manufacturer as above, imported by ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Turkey

Class 1 Exempt device, contact Manufacturer as above

United Arab Emirates

Class 1 device, UAE Authorized Representative: PHARMAWORLD STORE

UAE Registration DR/C/15481/2018