GlobeNewswire05.22.20
Medtronic plc 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 percent of low excursions, a 44 percent 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 percent 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.
References
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 app vs. without Sugar.IQ app, TIR with/without Sugar.IQ app: 63.4 percent/59.3 percent; avoidance of low with/without predictive alerts: 65 percent/36 percent; avoidance of high with/without predictive alerts: 44 percent/11 percent.
2 Guardian Connect SSED, page 20, table 6: Glucose Missed Detection Alert Performance Calibrating Every 12 Hours
“An analysis of real-world data has shown patients using low predictive alerts avoided 65 percent of low excursions, a 44 percent 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 percent 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.
References
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 app vs. without Sugar.IQ app, TIR with/without Sugar.IQ app: 63.4 percent/59.3 percent; avoidance of low with/without predictive alerts: 65 percent/36 percent; avoidance of high with/without predictive alerts: 44 percent/11 percent.
2 Guardian Connect SSED, page 20, table 6: Glucose Missed Detection Alert Performance Calibrating Every 12 Hours