Medtronic has received FDA 510(k) clearance for its MiniMed Connect device, which allows users of Medtronic's continuous glucose monitor (CGM) and insulin pump to view data from those devices on their smartphone. At the same time, Medtronic announced a partnership with Samsung to optimize the viewing of this CGM and pump data.
The MiniMed Connect device is a keychain-sized device that users of the Medtronic MiniMed insulin pump will be able to purchase. It takes data from the pump and affiliated CGM and sends it to either a mobile app or a web platform where users, and their care providers, can access it. It also automatically sends a text alert to loved ones when glucose levels go too high or too low, or when an alarm on the pump isn't cleared.
"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," Annette Brüls, vice president and general manager, Diabetes Services and Solutions at Medtronic, said in a statement. "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 Samsung partnership will start with MiniMed -- the two companies are developing a special application that is optimized for Samsung devices -- but is broad-reaching in scope. According to a statement, the companies will work together to "develop a range of future solutions that will enhance the way people with diabetes live their lives, from remotely viewing diabetes data to ultimately integrating mobile and wearable devices into diabetes management systems." Samsung has recently expressed an interest in being more involved with the clinical side of mobile health, and this seems to be in that vein.
"Samsung is committed to applying its deep understanding of how people use technology to bring new innovations to healthcare," Dr. David Rhew, Chief Medical Officer and Head of Healthcare and Fitness for Samsung Electronics America, said in a statement. "Patients are seeking better ways not only to monitor their condition, but also to enjoy a greater quality of life. We are excited to partner with Medtronic to develop diabetes management solutions that produce positive change and greater autonomy for people living with diabetes."
Despite the Samsung partnership, the Medtronic app will be available for both iOS and Android devices, as well as any other internet-connected mobile device via a web app. It's due to launch this fall.
In a quarterly call recently, Medtronic Chief Financial Officer Gary Ellis also mentioned the MiniMed line, pointing out that in Europe the product already has additional functionality the company is working on bringing to the US: it can "automatically suspend insulin delivery when sensor glucose levels are predicted to approach a low limit and then resume insulin delivery once levels recover." This is a first-step toward a much-sought goal for the treatment of Type 1 diabetes: a pump and CGM that could work together to create an artificial pancreas.
In January, Medtronic's competitor Dexcom announced the FDA clearance of Dexcom Share, its own mobile-connected CGM offering, and the company has wasted no time deploying it, complete with an Apple Watch app. However, Dexcom's offering only connects a CGM, not an insulin pump as well. In addition, Glooko just recently announced that it's working with both Medtronic and Dexcom on offerings that will connect both companies' CGMs to Glooko's diabetes management data platform. Glooko notably has a prior relationship with Samsung as well.
It's unclear what the relationship is between this latest FDA clearance and Medtronic's Guardian Mobile, a smartphone-connected CGM that Medtronic announced at a conference last fall. That could be a separate technology, still forthcoming, or it could be part of the MiniMed Connect system.