DUBLIN, May 22, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval for the Android™ version of its Guardian™ Connect continuous glucose monitoring (CGM) system. The Guardian Connect system is a standalone CGM system that alerts patients of potential high or low sensor glucose events up to 60 minutes in advance and provides confidence to people living with diabetes who worry about fluctuating glucose levels and dangerous low glucose events. The Guardian Connect app will include several enhancements to further improve user experience. These include easier product setup through the in-app Startup Wizard, and personalized volume adjustments, including the ability to mute alerts when individuals do not want to be disturbed for a period of time.“An analysis of real-world data has shown patients using low predictive alerts avoided 65% of low excursions, a 44% improvement from patients not using low predictive alerts,¹” said Amit Bhargava, M.D., assistant professor of Medicine, Drexel University College of Medicine and division chief, Division of Endocrinology, Jefferson Hospital, Jefferson Hills, Pa. “This low detection is incredibly important for my patients that experience hypoglycemic unawareness, meaning they can go low without having any warning signs or symptoms. I am pleased to now be able to offer this technology to patients regardless of if they use an iOS or Android device.”The Guardian Connect system leverages the Guardian™ Sensor 3, the most advanced glucose sensor from Medtronic, to accurately alert users of lows more than 90% of the time,² so users can feel confident in the numbers they are seeing. Through the company’s latest predictive algorithms, the Guardian Connect system is also the only standalone CGM system that can alert patients of potential high or low sensor glucose events up to 60 minutes in advance, allowing individuals time to plan and take action if necessary.“Android compatibility for our Guardian Connect system allows even more users to check their glucose levels seamlessly and discreetly right on their smartphone and to take action if needed,” said Mike Hill, vice president and general manager of the Multiple Daily Injection Solutions team at Medtronic. “We’re committed to enhancing the user experience for our customers, so we’ve taken valuable feedback to make updates to the alert functions. Now users can adjust alert volume and mute alerts as needed in certain situations that would require this. Care partners can also continue to use the system to track glucose in real-time or receive text alerts for their loved ones with diabetes.”The updated Guardian Connect system with Android compatibility is expected to begin shipping in summer of this year. Existing Guardian Connect customers will also be contacted this summer about the update and how they can update their app to receive the latest functionality.About Continuous Glucose Monitoring (CGM)
A CGM system provides continuous, real-time glucose value and trend information about glucose levels for people with diabetes. In addition, a smart CGM system predicts future high and low glucose events and provides access to additional algorithms and insights that can inform users of clinically relevant glucose patterns. This allows for appropriate intervention (after verifying with a blood fingerstick test) to mitigate hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose), increasing 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, in the abdomen or upper arm. The sensor, which measures glucose levels from the interstitial fluid under the skin, is attached to a transmitter that sends readings to an app, wearable monitor or insulin pump every five minutes. Alerts 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.com)
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
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among 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 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. 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.Android is a trademark of Google LLC.-end-¹ Arunachalam S, et al. Poster presented at ADA 2019. 79th Scientific Sessions. June 7th-11th. San Francisco, California. #939-P; 802 matched subjects with alerts enabled in Sugar.IQ^TM app vs. without Sugar.IQ™ app, TIR with/without Sugar.IQ™ app: 63.4%/59.3%; avoidance of low with/without predictive alerts: 65%/36%; avoidance of high with/without predictive alerts: 44%/11%.
² Guardian Connect SSED, page 20, table 6: Glucose Missed Detection Alert Performance Calibrating Every 12 Hours Kendra Cassillo
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