BRAMPTON, ONTARIO, CANADA - May 23, 2018 - Medtronic of Canada Ltd., a subsidiary of Medtronic plc (NYSE:MDT) today announced it has received a licence from Health Canada for Guardian™ Connect...
Standalone CGM System Helps People Using Insulin Injections to Know More and Guess Less
BRAMPTON, ONTARIO, CANADA - May 23, 2018 -
Medtronic of Canada Ltd., a subsidiary of Medtronic plc (NYSE:MDT) today announced it has received a licence from Health Canada for Guardian™ Connect — a stand-alone continuous glucose monitoring system, designed for people using insulin injections who want to know more about their glucose levels and guess less when managing their diabetes.
With the Guardian Connect system, people using insulin to manage their diabetes will be able to check their current glucose level anytime on their mobile device, as easily as checking other information sources such as email, the weather, or social media. They can also be alerted about high or low glucose levels on their mobile device, helping them to avoid or address high or low glucose situations. The Guardian Connect system is a mobile CGM system with customizable text message alerts enabling care partners to receive high or low glucose alerts on any connected mobile device. The system also features the option to automatically upload the data daily into CareLink™ management software, which reduces the burden of data upload for both people living with diabetes and their healthcare providers.
The Guardian Connect system consists of a small wearable CGM device that takes glucose readings every five minutes (288 times a day) and sends these glucose values directly to a smartphone app. People living with diabetes can use the system to check glucose levels on their mobile phones, enabling them to see highs and lows in real-time, understand the trends, and help improve their daily management of diabetes. Alerts can also be set up if glucose levels go above or below preset levels, helping patients prevent or address potentially dangerous high or low glucose events.
“With Guardian Connect, I’m able to better manage my diabetes which leaves me free to focus on the positive and live my life the way I want to live it. I have become more aware of how emotions, moods, exercise, food, etc. affect blood sugar. The biggest difference is that it warns before a low.” – Sara, living with Type 1 diabetes in Sweden, and using the Guardian Connect System since February 2017.
The Guardian Connect smartphone app will initially be available with Apple (iOS) mobile devices. Medtronic is currently developing an Android version of the Guardian Connect app that will be available at a later date.
“Health Canada’s licence of the Guardian Connect System will provide Canadians with a tool to fill a gap that exists today with diabetes management: the ability to predict potentially dangerous glucose highs or lows so they can take action sooner,“ said Laura Cameron, senior director of Diabetes at Medtronic Canada. “These predictive alerts will help people to proactively manage their diabetes, letting them worry less about their glucose levels, and focus more on living their life.”
The Guardian Connect system will be available in Canada in early fall of 2018. Additional information can be found at www.medtronicdiabetes.ca/guardianconnect
About Continuous Glucose Monitoring (CGM)
A CGM system provides continuous, real-time trend information about glucose levels for people with diabetes. It allows for appropriate intervention (after verifying with a blood fingerstick test) to mitigate hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar), maximizing the patient’s time in the optimal glucose target range. To use a CGM system, the person with diabetes inserts a tiny sensor beneath the skin, typically in the abdomen. The sensor, which measures glucose levels from the fluid under the skin, is attached to a transmitter that sends readings to a wearable monitor or the insulin pump every five minutes. Alerts and alarms can be customized to notify patients up to 60 minutes before they reach personal preset low or high sensor glucose limits. CGM provides a more complete picture because it reveals high and low glucose levels that periodic blood fingerstick testing might miss.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.ca)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
About Medtronic Canada
Proud to celebrate 50 years in Canada in 2018, Medtronic Canada (www.medtronic.ca), headquartered in Brampton, Ontario, is a subsidiary of Medtronic plc, which is one of the world’s largest medical technology, services and solutions companies — alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 1,100 people in Canada, serving physicians, hospitals and patients across the country. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
a) Do not use the Guardian Connect System for pediatric patients until you have thoroughly reviewed (with your Healthcare Professional) the system alert performance in the Guardian Connect Application User Guide and the sensor accuracy performance in the Guardian Sensor (3) Performance document. Discuss with your Healthcare Professional how to best set up your Guardian Connect System alerts to reduce the risk of missing low blood glucose or high blood glucose events.
b) In the pediatric clinical study (3-18 years of age), larger differences were observed between the Guardian Connect System and actual blood glucose values compared to those differences observed in the adolescent/adult clinical study (14-75 years of age), particularly at low glucose levels.
c) In the pediatric clinical study, a significant percentage of low glucose events were not detected by the Guardian Connect System. Do not rely solely on the Guardian Connect System alerts to detect low glucose.
d) In the pediatric clinical study, the Guardian Connect System triggered a high percentage of false low glucose and false high glucose alerts. The Guardian Connect System is not intended to make therapy adjustments: always check your capillary blood glucose before making therapy adjustments.
e) In the pediatric clinical study, enabling the ‘Alert Before Low’ and ‘Alert Before High’ predicted alerts significantly reduced the percentage of missed low blood glucose and missed high blood glucose events, but also significantly increased the percentage of false low glucose and false high glucose alerts. Do not ignore alerts from your Guardian Connect System. Always follow your treatment instructions from your Healthcare Professional when responding to an alert from your Guardian Connect System.