User Guide

LibreLinkUp is a free mobile app that enables you to receive glucose readings from family and friends who use a FreeStyle Libre app. You can remotely monitor glucose readings and trends, stay connected, and manage diabetes together.

Not all mobile apps, products, or features are available in all regions.

DOC43870 Rev. F

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 device data to support effective diabetes management.

In addition:

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. This device is not intended to replace self-monitoring practices as advised by a physician.

Any problems with the mobile device, NFC, Bluetooth, 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.

Glossary

  1. LibreLinkUp – The mobile app for family, friends, and caregivers to remotely monitor and support the person with diabetes using a FreeStyle Libre glucose sensor.

  2. FreeStyle Libre Sensor – The glucose monitoring sensor for the person with diabetes. In this user guide, this term can refer to the FreeStyle Libre, FreeStyle Libre 10-day, FreeStyle Libre 14-day, FreeStyle Libre 2, or FreeStyle Libre 3 sensor.
  3. FreeStyle Libre app – The mobile app compatible for use with a FreeStyle Libre sensor. In this user guide, this term can refer to the FreeStyle LibreLink app, FreeStyle Libre 2 app, and the FreeStyle Libre 3 app.

  4. Connection – The person with diabetes using a FreeStyle Libre sensor who shares their glucose data with a LibreLinkUp user.

Smartphone Requirements

The LibreLinkUp app is compatible with many popular Android and iOS smartphones.

Recommended operating systems:

  1. Android 8.0, 8.1, 9.0, 10, 11

  2. iOS 13.1.3, 13.2, 13.3, 13.3.1, 13.4.1, 13.7, 14.0, 14.4.2

The phone must meet the following requirements:

  1. Wi-Fi or a cellular data plan

The LibreLinkUp app is not compatible with the FreeStyle LibreLink special edition app or FreeStyle Libre 2 special edition app.

How FreeStyle Libre apps and LibreLinkUp work with LibreView

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

  1. Glucose readings are uploaded from FreeStyle Libre Sensor to a FreeStyle Libre app.

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

  3. A family member or friend can install the LibreLinkUp app on their own phone and accept the sharing invitation. The FreeStyle Libre app user is now a Connection in the LibreLinkUp app.

  4. The family member or friend can view the Connection’s glucose readings in the LibreLinkUp app.

Getting Started With LibreLinkUp

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

FreeStyle Libre apps
The person wearing the FreeStyle Libre Sensor uses a FreeStyle Libre app on their mobile phone to send a sharing invitation email to their family member or friend.
LibreLinkUp
The family member or friend receives the invitation email and follows the instructions to install the LibreLinkUp app on their own mobile phone.

The LibreLinkUp app is not compatible with the FreeStyle LibreLink special edition app or FreeStyle Libre 2 special edition app.

After the sharing invitation is accepted, the family member or friend will receive glucose data and glucose notifications through LibreLinkUp.

Below are instructions for each app:

Understanding Glucose Readings

For LibreLinkUp App Versions 4.0 or Later

When you open LibreLinkUp, you will see the latest glucose reading from your connections, an arrow indicating which direction their glucose is trending, and a glucose graph.

1

Navigation Menu

Tap to open the navigation menu.

2

Notification Settings

Tap to go to the connection’s notification settings.

3

Glucose reading card

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

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

  2. Orange indicates a high glucose reading (>250 mg/dL or 13.3 mmol/L) for FreeStyle Libre 3 users, (>240 mg/dL or 13.3 mmol/L) for all other users.

  3. Green indicates readings in your connection’s target range.

  4. 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.”

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

  2. "HI" indicates a glucose reading higher than 22.2 mmol/L (400 mg/dL) for United States and Canada FreeStyle Libre 2, 27.8mmol/L (500 mg/dL) for all other users

If either of these readings is seen, the App User Manual that corresponds to the FreeStyle Libre app 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 Libre app user should contact their healthcare professional immediately.

In other cases, instead of a bold number and timestamp, you may see --- and “No Recent Data”. This appears because no data from your connection has been received in the LibreLinkUp app in the last 5 minutes.

You may see --- and “No Recent Data” for the following reasons:

  1. If your connection is using a FreeStyle Libre sensor:

    • Your connection has not scanned their sensor in the last 5 minutes

    • Your connection does not have an active FreeStyle Libre sensor

    • There is a service interruption that is preventing the uploading of glucose data from the FreeStyle Libre app to LibreView services

  2. If your connection is using a FreeStyle Libre 2 sensor:

    • Your connection has not scanned their sensor in the last 5 minutes

    • Your connection does not have an active FreeStyle Libre 2 sensor

    • Your connection is experiencing signal loss with their FreeStyle Libre 2 sensor

    • There is a service interruption that is preventing the uploading of glucose data from the FreeStyle Libre app to LibreView services

  3. If your connection is using a FreeStyle Libre 3 sensor:

    • Either your device or your connection’s device has no Internet connectivity

    • Your connection does not have an active FreeStyle Libre 3 sensor

    • Your connection is experiencing signal loss with their FreeStyle Libre 3 sensor

    • There is a service interruption that is preventing the uploading of glucose data from the FreeStyle Libre app to LibreView services

4

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

Between0.06 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

5

Glucose graph

The glucose graph displays up to the last 12 hours of your connection’s available glucose history, high and low glucose alarm thresholds (if the connection is using a FreeStyle Libre sensor that supports glucose alarms and the glucose alarm setting is enabled in the LibreLinkUp app), and the connection’s target glucose range.

The glucose graph is interactive: tap anywhere in the glucose graph area and the glucose reading card will be updated with the glucose value and timestamp for that point on the glucose trace. The glucose graph is updated each time the app is opened to the glucose graph screen if your device has internet connectivity. Gaps may appear in the glucose trace if this glucose data is not available in the connection’s glucose history. If the connection’s glucose reading exceeds 21 mmol/L (350 mg/dL), the glucose trace will display at 21 mmol/L (350 mg/dL) but the glucose reading card will accurately display the connection’s glucose reading for that time.

For the high and low glucose alarm thresholds on the glucose graph:

  1. If your connection is using a FreeStyle Libre 2 sensor:

    • The high and low glucose alarm thresholds will appear at the alarm threshold glucose value set by your connection in their FreeStyle Libre app.

  2. If your connection is using a FreeStyle Libre 3 sensor:

    • The high and low glucose alarm thresholds will appear at the alarm threshold glucose value set by you in the LibreLinkUp app.

The target glucose range is the green shaded area in the glucose graph, and the values are set by the connection in their FreeStyle Libre app.

6

Logbook

Tap to go to the Logbook screen.

The logbook displays the last 2 weeks of glucose events.

  1. If your connection is using a FreeStyle Libre sensor:

    • The glucose events include glucose readings when the connection scanned their sensor.

  2. If your connection is using a FreeStyle Libre 2 sensor:

    • The glucose events include glucose readings when the connection scanned their sensor and shared glucose alarms.

  3. If your connection is using a FreeStyle Libre 3 sensor:

    • The glucose events include customized glucose alarms you received based on your connection’s glucose readings.

Tap on a glucose event in the list to view event details.

Notifications

For LibreLinkUp App Versions 4.0 or Later

The notification types available in LibreLinkUp depend on the sensor your connection is using. You do not need to have the app open or running in the background to receive notifications.

The notification types are:

  1. If your connection is using a FreeStyle Libre sensor:

    • Glucose reading - when your connection scans their sensor

    • New sensor started – when your connection starts a new sensor

  2. If your connection is using a FreeStyle Libre 2 sensor:

    • Glucose reading - when your connection scans their sensor

    • Shared glucose alarms – receive the same glucose alarms your connection receives in their FreeStyle Libre app

    • Dismissed glucose alarm – when your connection acknowledges their glucose alarm in their FreeStyle Libre app

    • New sensor started – when your connection starts a new sensor

  3. If your connection is using a FreeStyle Libre 3 sensor:

    • LibreLinkUp-set glucose alarms – receive glucose alarms based on your connection’s glucose reading.

    • No Recent Data – when the LibreLinkUp app has not received a glucose reading from a connection in over 5 minutes

    • New sensor started – when your connection starts a new sensor

    • Sensor ended – when your connection’s sensor has ended

Notification settings can be changed by connection and depend on the sensor your connection is using. To change the connection’s notifications settings:

  1. Go to the connection’s main screen

  2. Tap the gear icon

  3. Change the notification settings

  1. If your connection is using a FreeStyle Libre sensor:

    • Toggle glucose readings on or off

  2. If your connection is using a FreeStyle Libre 2 sensor and LibreView account is registered outside of the United States:

    • Toggle glucose readings on or off

    • Set the low glucose alarm settings

    • Toggle low glucose alarm on or off (Note - You can only enable the low glucose alarm in the LibreLinkUp app for your connection if they first enable the low glucose alarm in their FreeStyle Libre app)

    • Your connection’s low glucose alarm threshold value will appear only if your connection first enables the low glucose alarm in their FreeStyle Libre app and you enable the low glucose alarm in the LibreLinkUp app. This low glucose alarm threshold value can only be changed in your connection’s FreeStyle Libre app.

    • Set the high glucose alarm settings

    • Toggle high glucose alarm on or off (Note - You can only enable the high glucose alarm in the LibreLinkUp app for your connection if they first enable the high glucose alarm in their FreeStyle Libre app)

    • Your connection’s high glucose alarm threshold value will appear only if your connection first enables the high glucose alarm in their FreeStyle Libre app and you enable the high glucose alarm in the LibreLinkUp app. This high glucose alarm threshold value can only be changed in your connection’s FreeStyle Libre app.

  3. If your connection is using a FreeStyle Libre 2 sensor and LibreView account is registered in the United States:

    • Toggle glucose readings on or off

    • Set the low glucose alarm settings

    • Toggle low glucose alarm on or off (Note - You can only enable the low glucose alarm in the LibreLinkUp app for your connection if they first enable the low glucose alarm in their FreeStyle Libre app)

    • Your connection’s low glucose alarm threshold value will appear only if your connection first enables the low glucose alarm in their FreeStyle Libre app and you enable the low glucose alarm in the LibreLinkUp app. This low glucose alarm threshold value can only be changed in your connection’s FreeStyle Libre app.

    • Set the high glucose alarm settings

    • Toggle high glucose alarm on or off (Note - You can only enable the high glucose alarm in the LibreLinkUp app for your connection if they first enable the high glucose alarm in their FreeStyle Libre app)

    • Your connection’s high glucose alarm threshold value will appear only if your connection first enables the high glucose alarm in their FreeStyle Libre app and you enable the high glucose alarm in the LibreLinkUp app. This high glucose alarm threshold value can only be changed in your connection’s FreeStyle Libre app.

    • Set the urgent low glucose alarm settings

    • Toggle urgent low glucose alarm on or off

    • Your connection’s urgent low glucose alarm threshold value is fixed at 55 mg/dL (3.1 mmol/L) and cannot be changed.

  4. If your connection is using a FreeStyle Libre 3 sensor:

    • Set the low glucose alarm notification settings

    • Toggle low glucose alarm on or off

    • If the low glucose alarm is toggled on, set the low glucose alarm threshold value and tap Save. You will receive a notification when your connection’s glucose readings fall below this threshold value.

    • Set the high glucose alarm notification settings

    • Toggle high glucose alarm on or off

    • If the high glucose alarm is toggled on, set the high glucose alarm threshold value and tap Save. You will receive a notification when your connection’s glucose readings rise above this threshold value.

    • Set the No Recent Data notification settings

    • Toggle No Recent Data on or off

    • Set the No Recent Data time period and tap Save. If No Recent Data is toggled on, you will receive a notification if you have not received any glucose readings within this time period.

Having trouble receiving notifications?

  1. Make sure your phone has an active Internet connection (Wi‐Fi or cellular).

  2. Turn off Airplane Mode.

  3. Turn off Do Not Disturb.

  4. Make sure your phone is sufficiently charged.

  5. Make sure your phone has at least 66MB of available memory.

Note: If you have not enabled notifications permissions for the LibreLinkUp app on your smartphone’s operating system, you will not be able to view the notification settings for your connections. To view the notification settings for your connections, go to the notification settings on your smartphone’s operating system and enable notifications for the LibreLinkUp app.

Removing a Connection

To permanently stop receiving notifications from a FreeStyle Libre app 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 Libre app user will need to send a new invitation from their FreeStyle Libre 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 3.9
(including LibreLinkUp, version 4.2)

catalogue

(01) 00860000502016

(10) 3.9 31 MAR 2022

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.

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 is a subsidiary of Abbott Laboratories.

Newyu maintains a 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 / region 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.

Medical Device

Medical Device

Manufacturer
Manufacturer

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

ARGENTINA

Argentina Representative ABBOTT LABORATORIES ARGENTINA

PM number: 39-703

Australia

Australian Sponsor:

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

ARTG ID: 343435

BRAZIL

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

Colombia Importer of Record: Impomed S.A.S.

INVIMA registration number: INVIMA 2018DM-008191

Israel

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

New Zealand Sponsor: CLINICAL & REGULATORY SERVICES LIMITED (CARSL)

WAND Reference: 171216-WAND-6PFS9Z