Health Canada has approved an upgrade to the FreeStyle Libre Continuous Glucose Monitoring System. The FreeStyle Libre 2 system continuously measures glucose data every minute with customizable, optional real-time alarms1 to alert users when their glucose is high or low without scanning.
Approved to for children (ages 4 and older) and adults with diabetes, this latest technology sustains excellent performance for up to 14 days, providing trends, insights and actionable data on a reader or with the FreeStyle LibreLink mobile app – all at the same price as the current FreeStyle Libre system.
Latest sensor-based glucose monitoring technology will be available in the coming months to more than 3.7 million Canadians with diabetes2.
New Features Added to the FreeStyle Libre 2 include:
- Improved accuracy – the Freestyle Libre is the only CGM that measures glucose every minute, meeting the highest level of accuracy standards – taking 1440 readings per day. This is the highest number of daily readings in any CGM currently on the market. That’s five times more glucose readings than competitor brands.
- Optional, real-time alarms1 that measure glucose levels every minute, FreeStyle Libre 2 gives users the option to be alerted in real-time of critical events such as hypoglycemia (low glucose levels3) or hyperglycemia (high glucose levels4).
- The new system will be priced at the same cost as the current FreeStyle Libre system.
- Improved accuracy right from day 1. Studies by Abbott have shown a 9.1% mean absolute relative difference (MARD)
What was approved?
Unlike Libre 14 day where the sensor was approved in mid-2017, and the App for iOS and Android made available almost 18 months later, Health Canada has approved the entire suite of Libre 2 products.
The approved devices include:
|Device name||Identifier first issue date||Device identifier|
|FREESTYLE LIBRE 2 (IOS)||2020-11-30||72086-01|
|FREESTYLE LIBRE 2 APP (ANDROID)||2020-11-30||72085-01|
|FREESTYLE LIBRE 2 READER KIT||2020-11-30||71970-01|
|FREESTYLE LIBRE 2 SENSOR KIT||2020-11-30||71993-01|
|FREESTYLE LIBRE SOFTWARE||2020-11-30||VERSION 1.0|
You can read a copy of the Health Canada Medical License webpage in the attached PDF here.
How FreeStyle Libre 2 Works
Using Bluetooth technology, when activated, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor.
Similar to Libre 1, the FreeStyle Libre 2 sensor is worn on the back of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. With a one-second scan using FreeStyle LibreLink, a smartphone app, or handheld reader, users can see their glucose reading, trend arrow and eight-hour history. Users can also share data with their physicians or family members via the LibreLinkUp mobile app.
Abbott′s FreeStyle Libre 2 system utilizes the same proprietary wired enzyme technology as the FreeStyle Libre system.
What is a CGM and what are the benefits of using Libre 1 or Libre 2?
CGM allows you to monitor your glucose day and night without the need for traditional blood glucose finger tests. A CGM also allows you to see the trends and patterns in your glucose to help you and your diabetes team make more informed treatment decisions.
A real-world study published in the British Medical Journal shows that the use of FreeStyle Libre system over one year is often associated with improved quality of life and that work absenteeism rate and diabetes-related hospital admissions decreased by two thirds.
Read more about the benefits of using a CGM in our previous post on WHAT ARE THE BENEFITS OF USING A DEXCOM G6 OR FREESTYLE LIBRE CONTINUOUS GLUCOSE MONITOR (CGM) FOR DIABETES CONTROL?
1 Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.
2 Diabetes Canada. https://diabetes.ca/DiabetesCanadaWebsite/media/Advocacy-and-Policy/Backgrounder/2020_Backgrounder_Canada_English_FINAL.pdf. accessed November 24, 2020.
3 FreeStyle Libre 2 User Manual. Based on low glucose alarms set at 70 mg/dl.
4 FreeStyle Libre 2 User Manual. Based on high glucose alarms set at 180 mg/dl.