Quick Start Guide

for Professionals

To use LibreView you will need:

A computer with a compatible Windows or Mac operating system
The corresponding data cable for the device, if applicable
A compatible glucose monitoring device

Welcome to LibreView - the all-in-one, web-based data management platform for FreeStyle Libre, FreeStyle Libre 2, FreeStyle Libre Pro* and most major blood glucose meters. Connect your patients’ devices to upload patient data into your LibreView account. Your patients’ information will be encrypted and secure. Because LibreView is a web-based platform, you’ll be able to access your patients' glucose information from anywhere with an internet connection, even outside the office. LibreView supports most Abbott glucose monitoring devices and other compatible blood glucose meters to create standardized, easy-to-read reports.

Not all devices, mobile apps, and reports are available in all regions. Units of measurement are for purposes of illustration and will be available as applicable per region. Note that only FreeStyle Libre and related products can be uploaded to Mac computers.

Newyu Record 814 v20. © 2020 Newyu, Inc. All rights reserved.

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 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, 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.

Minimum System Requirements

LibreView can be used just to view data, or to also upload data. The minimum system configuration required to use LibreView as a data viewer is:

Windows 7 SP1, Windows 8.1 or Windows 10 Anniversary update (and higher)

  • Display resolution of 1024 x 768 pixels or greater.

  • The latest version of Internet Explorer, Google Chrome and Mozilla Firefox

  • 1 Ghz processor (dual/multi-core recommended)

  • 2 GB RAM

  • Internet connection with 0.5 Mbps download speed

  • We recommend using the most up-to-date version of your browser. Please note, at this time, Microsoft Edge is not a supported browser.

Mac OS X Yosemite (10.10) or higher

  • Display resolution of 1024 x 768 pixels or greater

  • The latest version of Safari (Mac OS X Yosemite 10.10 or higher) and Google Chrome

  • 1 Ghz processor (dual/multi-core recommended)

  • 2 GB RAM

  • Internet connection with 0.5 Mbps download speed

In order to upload data, you must install the LibreView Device Drivers (LDD) when prompted. Uploading data requires the following additional system specifications:

Windows LDD 3.2.0 and higher

  • Windows 7 SP1, Windows 8.1 or Windows 10 April 2018 update (and higher)

  • Will install if not present .Net Framework 4.7.2 and Microsoft Visual C++ 2017 Redistributable (x86)

  • 8 GB+ RAM and 200 MB free disk space

  • Internet connection with 1 Mbps upload speed

  • Local Administrator account

Mac LDD 1.2.0 and higher

  • Mac OS X Yosemite (10.10) or higher

  • 8 GB+ RAM and 200 MB free disk space

  • Internet connection with 1 Mbps upload speed

  • Local Administrator account

Creating a LibreView Account

You can create a professional account from an email invitation or directly on the LibreView website.

  1. Go to www.libreview.com and click Sign Up

  2. Select LibreView Professional Account

  3. Select your country of residence

  4. Agree to the Terms of Use

  5. Agree to the Privacy Notice

  6. Fill out your information

  7. Go to your email inbox, find the verification email from LibreView and click on the Verify Email button

  8. Select Next on the sign up screen in LibreView to complete your account setup

Your email address will be your username.

You can use the same email address to log into multiple practices.

Setting Up Your Practice

When you first sign up for LibreView, you are creating a private account. To access more advanced LibreView features, you will need to create a LibreView Practice. This will allow you to add Care Team members, securely share patient information with your staff, and invite patients to upload remotely.

  1. When creating a Practice, you will become the default Practice Administrator. Review the information about this and click Continue.

  2. Enter the information about your Practice including name, address and phone number. It is important to ensure this information is correct since patients will use it to identify your Practice when you invite them to share remotely.

  3. Click Create Practice to finish setting up your Practice.

Note: When setting up a new Practice, you can customize your Practice ID to make it easier for patients to connect to your account.

Invite and Manage Your Care Team

You can include other members of your team in your LibreView Practice. Care Team members in your LibreView Practice will have access to all the patient data in that Practice.

If you are a Practice Administrator, you can edit Practice Info such as the Practice name and address, or customize your unique Practice ID. The Practice ID is how patients can connect their LibreView account to your Practice.

  1. Go to Settings Menu, click on My Practices, and select your practice name.

  2. Select Care Team

  3. Add the user's name and email address, decide if the user should have Admin privileges, and click Save.

  4. The invitee will receive an email invitation to join your LibreView Practice. If they already have a LibreView account, they can simply sign in and accept the invitation to your Practice.

  5. If you are a Practice Administrator, you can remove Care Team members from your Practice

Installing Device Drivers

LibreView requires a one-time download and installation of a device drivers file that recognizes the glucose monitoring device when it is plugged in to the computer. Make sure you are using the most up-to-date version of your internet browser when starting the download.

  1. Click the Create 1-Time Report button

  2. In the window that appears, click on the Download button specific to your computer's operating system

  3. Wait for the file to download onto your computer

  4. Open the downloaded file by clicking on it and allowing it to run

  5. Follow the prompts to complete the installation

Note: You may need your IT Administrator to grant permission for the download and installation.

Links to the latest LibreView Device Drivers are also available on the LibreView Support website. Search for the "Install LibreView Device Drivers" topic and follow the instructions to download and install the drivers.

Best Practices

  • Make sure you are logged in as the Local Administrator or have your administrator's username and password available when you are installing the device drivers.

  • Have a compatible glucose device on hand to test the device drivers once they are installed.

  • If you are part of a practice or hospital system, you may need to contact your IT team for assistance.

Uploading from Apps

LibreView Device Drivers are not required to upload data from FreeStyle LibreLink apps into LibreView. If you only upload data with the FreeStyle LibreLink app, you do not need to install the drivers.

Uploading a USB Device

Once the device drivers are downloaded and installed, you can plug in a compatible device using the corresponding cable and start uploading data.

Go to the upload screen and choose the appropriate option:

For a one-time report:

  1. Select Create 1-Time Report to create a report that is accessible in LibreView for 24 hours, contains no patient-identifying information, and is not saved in the LibreView database.

  2. Once the data is uploaded, the reports will automatically open

For a saved report:

  1. Select Create Report Linked to Patient to save the report to a patient's profile

  2. If this is the first time you are uploading this device, search for an existing patient or create a new patient. Once you associate a device to a patient, all data from that device will be automatically linked to that patient.

  3. Once the data is uploaded, the patient's reports will automatically open.

  4. Once the data is associated with a patient, it can be viewed anytime from the patient's Profile by going to Glucose History and clicking Glucose Reports.

Note: When you upload a device, you may need to allow your browser to access the Device Drivers file. Save time by ticking the box so your browser will remember your selection before selecting “Allow” or “Launch application”.

Viewing Reports

  1. In a patient's profile under Glucose History, click the Glucose Reports button to see their data.

  2. Use the menu to navigate between the different available reports

These are the reports you’ll see, depending on the primary device selected:

  • Glucose Only reports (for compatible FreeStyle blood glucose devices): Snapshot, Daily Log, Modal Day

  • Meal and insulin reports (for FreeStyle Insulinx only): Snapshot, Daily Log, Mealtime Patterns, Modal Day, Weekly Summary, Reader Details

  • FreeStyle Libre reports: Snapshot, AGP, Glucose Pattern Insights, Daily Patterns, Daily Log, Weekly Summary, Monthly Summary, Mealtime Patterns, Reader Details

Note: Not all devices, mobile apps, or reports are available in all regions.

See the Report Tours at pro.libreview.io for more information on specific reports.

Refer to the Compatible Devices article on the LibreView Support site for a list of supported devices.

Understanding Reports

Use the report labels and legends to understand the reports. LibreView provides a standard set of information and graphs relating to diabetes management and is only one part of understanding glucose patterns. Additional Information is provided below:

  • Glucose Management Indicator (GMI) uses average Sensor glucose data. GMI can provide an indication of the current state of a person's glucose management when used in conjunction with the entire glucose management program. Laboratory A1C may be different then GMI, and it is important to use the A1C in conjunction with GMI and other reported metrics in diabetes management.

  • In reports other than those with specific fixed standards, the glucose values are labeled as high when higher than 250 mg/dL (13.9 mmol/L) and low when lower than 70 mg/dL (3.9 mmol/L) by default. The default target range is set for 70-180 mg/dL (3.9-8.0 mmol/L). These ranges can be adjusted for certain reports, other than the standard reports, which have specifically selected target ranges.

  • The target glucose range is displayed on some glucose graphs and is used to calculate Time in Target and Time in Range, except where standard ranges are applied.

  • Sensor data captured is the percentage of possible Sensor data the device recorded from scanning the Sensor. To maximize this percentage, have the patient wear their Sensor for the entire timeframe and scan as per Sensor instructions.

  • Sometimes information may be missing from reports if:

    • The patient did not wear the Sensor for the entire timeframe.

    • The patient did not scan at least once every 8 hours.

    • The patient did not enter food and/or insulin information in their device.

    • The time on the device was changed.

    • There was an excess of information to include in the report.

Changing Report Settings

While viewing reports you can change the settings you'd like to use. You can also set default preferences for the reports by patient or Care Team member.

When you're viewing reports, use the buttons on the bottom of the screen to adjust your settings.

  1. You can change the report dates by clicking on the blue button that says Change Report End Date. The default setting will show data from the date of the most recent upload. Click Save to generate reports using the new settings.

  2. You can select or unselect the devices that are used in the report set by clicking the blue button that says Data Sources. The default setting will show data from all devices that have data in the reporting period and can be included in the report set. Click Save to generate reports using the new settings.

  3. You can select the reports, adjust target ranges, change report parameters and more by clicking the blue Report Settings button. Click Save to generate reports using the new settings.

To set new default report preferences, go to your Settings menu.

  1. Click the Settings Menu icon and go to Report Preferences

  2. Set your target ranges, glucose thresholds, and report display order for all reports. Not all reports have adjustable target ranges.

  3. Deselect any reports you don't need to view

  4. Your settings will be saved as you make changes

Note: Click Restore Defaults to return to the default report settings.

Using Your Patient Dashboard

Use your Patient Dashboard to quickly view patient status and access their saved data.

Click the Patients icon to see the Dashboard. From the Patient Dashboard, click on a patient's name to access additional data associated with that patient.

Customize your Patient Dashboard to view additional information about the patients in your Practice. This allows you to view multiple patients at one time and identify patients that may be at-risk.

Views

Views are made up of groups of rows and columns. There are some pre-set Views - like Recent Uploads or Starred Patients.

You can edit the pre-set Views or create and save Custom Views with the parameters you find most important. Select the columns, filters, and settings for your Custom View and Save it so you can use it in the future.

Flags

Add or edit "flags" to highlight data that meets defined conditions like a specific average glucose value or a certain number of low glucose events

Starring a Patient

Click the "star" next to a patient's name on their patient page to add them to your Starred Patients - you can use this to view a subset of patients.

Export patients in your current view

Export the Patient Dashboard to a CSV file by clicking Export View in the bottom corner of the Dashboard.

Invite Patients to Upload Remotely

You can invite patients to create their own LibreView accounts and upload their devices from home. This may reduce uploading time in the office and provide earlier insight into their glucose data. Data uploaded by patients in your Practice is automatically added to their Profile and visible to all Care Team members in your Practice.

  1. From any screen, click the Invite Patient icon (shown above) at the top of the screen, next to the search bar.

  2. Enter the patient's name, birth date, email, and the Practice you'd like them to share with, then click Next.

  3. In the Patient Profile and Patient Dashboard you can view the status of your invitation.

Note: You can also invite an existing patient by going to their Profile and got the Invite Patient to Upload from Home tile. Select Invite Patient and an email address for the patient to receive the invitation.

Patient Page

In the Patient Profile section you will see information about the patient and any additional details associated with their account.

You can invite the patient to upload from home from this page, and you will see the list of your Practices that the patient is in.

Glucose History

In the Glucose History section you will see historical glucose information associated with that patient. Click Glucose Reports to view the Report Set for that patient.

Practices

In the Pratices section you will see all Practices you are a part of that include this patient. From this section you can view Practice Records, Patient Notes, and edit Practice Settings.

Manage Account Information

Click the Settings Menu icon and select Account Settings to change your account information

  • In Account Settings, you can edit your own information such as name, email, and password.

  • Preferences: Set your date format and language preferences

Helpful Resources

LibreView offers several resources to help you set up and use your LibreView account.

For Customer Support, contact the Abbott Diabetes Care Customer Support line for your country of residence


Argentina +0800-800-6334

Australia +61 1800 801 478

Austria 0800 222 775

Bahrain 800 19722

Belgium 0800 82106

Brazil 0800 703 0128

Canada 754-210-8584 ext. 3; 855-450-3563

Chile 800 802 226 / 22 3683080

Colombia 01800 5181895

Czech Republic 800 143688

Croatia 0800 989097

Denmark 80 83 10 42

Finland +358 0800 772 355

France +33 800947909

Germany +49 8006365500

Greece 211 198 5892 / 00800 123393

Hong Kong +852-5808-4196

Ireland +353 1800719995

Israel +972773645506

Italy +39 800693000

Japan 0120-37-8055

Jordan 962798555525

Korea 080-014-5757

Kuwait 220 62972

Lebanon +961 1387 815

Luxembourg 800 72 106

Mexico 55244175 / 018007112208

Netherlands 0800 242 4400

New Zealand 0800 106 100

Norway 800-117006

Oman 800 74396

Philippines +63 2 8702 8577

Poland 800 388 700

Portugal 800860207

Qatar 00800 100869

Saudi Arabia 92000 3788

Singapore +65 1800 272 2881

Slovenia 0800 82028

South Africa 0800 222 688

Spain +34 900800726

Sweden +46 200439522

Switzerland 0800 102 102

Turkey 0 850 2034323

United Arab Emirates 800 0178174

United Kingdom 08006123006

United States 1-754-210-8584 ext. 3

Intended Use and Regulatory Information

About

LibreView, version 3.3
(including LibreLinkUp, version 3.2)

catalogue

(01) 00860000502016

(10) 3.3 11 JUL 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.

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: 325903

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: IMVIMA 2018DM-008191

Europe
EUROPE

EU Authorized Representative:

EUROPE EU Authorized Representative: EMERGO EUROPE, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

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

SAUDI ARABIA

Saudi Authorized Representative:

MEDICAL SUPPLIES & SERVICE CO. LTD MEDISERV

SINGAPORE

Contact Manufacturer as above, imported by ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

TURKEY

Contact Manufacturer as above

UNITED ARAB EMIRATES

UAE Authorized Representative: PHARMAWORLD STORE

UAE Registration DR/C/15481/2018