Intended Use and Regulatory Information

About

LibreView, version 3.7
(including LibreLinkUp, version 4.1)

(01) 05021791002993

(10) 3.7 07 MAY 2021

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.

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.

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.

Regulatory Representatives

Newyu is an affiliate of Abbott Laboratories.


Medical Device


Manufacturer

Abbott Diabetes Care Ltd., Range Road, Witney, Oxon, OX29 OYL, UK


Europe

EU Importer:

Abbott B.V., Wegalaan 9, 2132 JD Hoofddorp, The Netherlands


EU Authorized Representative:

Abbott B.V., Wegalaan 9, 2132 JD Hoofddorp, The Netherlands

Expected Clinical Benefits

Complications of diabetes mellitus (including, but not limited to: diabetic retinopathy, diabetic nephropathy) are well documented 1. Reviewing glucose monitoring device data patients with diabetes, caregivers and healthcare professionals can work to achieve and maintain specific glycaemic goals. Given the results of the Diabetes Control and Complications Trial (DCCT) 2 and other studies, there is broad consensus on the health benefits of normal or near-normal blood glucose levels and on the importance, especially in insulin-treated patients, of glucose monitoring devices in treatment efforts designed to achieve these glycaemic goals. Based principally on the DCCT results, experts recommend that most individuals with diabetes should attempt to achieve and maintain glucose levels as close to normal as is safely possible. In addition, there is prevailing agreement that dense glucose data collection using continuous glucose monitoring (CGM) devices supports informed treatment and therapy decisions as it allows assessment of glucose variability and hyper- and/or hypoglycaemic risk 3. This data is more actionable for HCPs than solely using A1c (glycated haemoglobin) information for patient care decisions. CGM and its associated dense glucose data is useful in supporting HCPs in the identification of dysglycaemia in other patient groups without diabetes (for example, pre-diabetes 4).


1 Textbook of Diabetes, Volumes 1 & 2; Pickup and Williams, 1999.

2 Diabetes Control and Complications Trial Research Group (DCCT): The effect of intensive treatment of diabetes on the development and progression of long term complications in insulin dependent diabetes mellitus. New Engl J Med, 329: 977-86; 1993.

3 International Consensus Report - Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care 2019 Aug; 42(8): 1593-1603.

4 Continuous glucose monitoring is more sensitive than HbA1c and fasting glucose in detecting dysglycaemia in a Spanish population without diabetes. Diabetes Practice 142 (2018) 100-109.