FDA Clears Medtronic Diabetes Management Mobile Device

Dublin, Ireland-based Medtronic plc has received 510(k) clearance from the U.S. Food and Drug Administration for its Minimed Connect technology. The product is designed to provide a mobile connection to critical information for managing diabetes. MiniMed allows patients to view their insulin pump and continuous glucose monitor (CGM) data on a smartphone and provides remote monitoring and text message notifications for their loved ones. It also gives healthcare teams more convenient access to more comprehensive patient data so they can adjust their patients’ care plans.

Minimed Connect consists of a small device that easily fits on a keychain or in a pocket, a smartphone app for the person with diabetes, and a web display on desktop or mobile devices for their care partners. The Minimed Connect device transmits pump and sensor glucose data from the patient’s Minimed insulin pump to the app and web display, which shows real-time sensor glucose and insulin information on the phone or any Internet-enabled device. The system also delivers preset text notifications to loved ones when the person with diabetes’ glucose values go too high or too low, or when an alarm on the pump isn’t cleared, hoped to provide greater peace of mind for care partners. In addition, Minimed Connect provides healthcare teams with more comprehensive data, and with more convenient access to their patients’ diabetes data so they can adjust care plans.

“Engagement from people with diabetes, loved ones and healthcare providers is key to living well with diabetes. With Minimed Connect, the entire care team can have access to critical diabetes data to inform the decisions that help people have better outcomes,” said Annette Brüls, vice president and general manager, Diabetes Services and Solutions at Medtronic. “MiniMed Connect is another step in our broader strategy to be a holistic diabetes management company. The Connect platform represents how we will use leadership technologies, data and informatics to enable better therapy decision-making and care for people with diabetes. Our hope is that this will make it easier for more people to manage their disease and optimize their therapy so they can achieve greater freedom and better health.”

The MiniMed Connect remote web display will be available with iOS, Android, or any other Internet enabled devices. The related smartphone app will initially be available with iOS devices. Samsung is working with Medtronic to also develop an app for Android and optimized experiences on Samsung mobile devices.