UPDATE: Updated to include comments from Ascensia
Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application.
Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin.
The newly launched system includes a body-attached sensor to track glucose levels under the skin, a worn insulin pump and an infusion patch connected to the pump with a catheter to deliver insulin. The device is designed to automatically adjust insulin levels, but requires manual entry of carbohydrates consumed and approval for bolus correction recommendations.
“The response from the diabetes community has been tremendously positive and we are proud to be leading this remarkable period in diabetes history in partnership with the clinical and advocacy communities. We’ve essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting. We are very excited to see that real-world insights from our Customer Training Phase reinforce the positive outcomes demonstrated through our pivotal trial of the system,” intensive insulin management division prez Alejandro Galindo said in a prepared statement.
The hybrid closed loop system features Medtronic’s SmartGuard algorithm, which the company says is the 1st step on its phased approach towards developing a fully automated, closed loop system. The MiniMed 670G also includes the company’s Guardian Sensor, a glucose sensor with a 7-day lifespan and baked in diagnostic technology to constantly monitor the sensor’s health. The system is designed to “learn” an individual’s insulin needs and take action to minimize both high and low glucose levels.
“This technology is a significant breakthrough for the diabetes community and as a practicing endocrinologist, I have been awaiting this moment on behalf of my patients for a very long time. The data demonstrating the benefits of this system are compelling and I’m confident it will simplify diabetes care for both patients and clinicians alike,” Diabetes group chief medical officer Dr. Francine Kaufman said in a press release.
Medtronic said that after it won early approval for the system last September, it has been working on obtaining payer coverage and market and manufacturing readiness, alongside appropriate training and education for device use. The initial launch will be for members of the company’s Priority Access Program, with shipments beginning next week to be fulfilled over the coming months into the fall of 2017. Other orders will be filled after the initial launch, the company said.
“The MiniMed 670G system has proven to be life-changing for many patients who participated in the Customer Training Phase and we are truly excited to be able to introduce it to many more who stand to benefit. We’ve seen this system positively impact not only patients like Claire, but also their caregivers who are experiencing a new sense of security. The constant vigilance that this chronic medical condition imposes on both patients and their families is now relaxed and caregivers have a new level of independence and freedom. As someone who lives with type 1 diabetes, it’s exciting to see this innovation alleviate much of the burden of managing this chronic disease,” Dr. Jennifer Sherr of the Yale School of Medicine said in prepared remarks.
The system features Asensia Diabetes Care‘s Contour Next Link 2.4 blood glucose monitoring system, Medtronic said.
Ascensia claims the Contour Next Link 2.4 is the only blood glucose monitoring system FDA approved as part of the hybrid closed loop MiniMed 670G system.
“We believe the MiniMed 670G system offers significant advantages to current insulin pump products available in the U.S., and marks an important milestone towards the goal of developing a fully automated, closed loop system. The speed of the approval of the MiniMed 670G system by the FDA is a testament to its importance and the difference it can make for people with diabetes. We are proud that our meters are an integral part of this system and are excited about the scientific advances it demonstrates,” Ascensia managing director Robert Schumm said in a press release.
San Diego, Calif.-based Dexcom said it won FDA approval for its G5 mobile app for Android devices, allowing users to view and monitor their glucose levels on their Android devices in real time.
The company touted the approval as the 1st and only continuous glucose monitoring platform available for Android in the US, joining its application for Apple (NSDQ:AAPL) iOS devices which won approval in 2015.
The company’s G5 Mobile is a compact CGM system which displays real-time glucose activity on approved displays, and the Android application allows users to view and share glucose data on their personal devices.
“Providing Android users with access to the Dexcom G5 Mobile CGM System has been a priority for Dexcom. The new Android app has been thoughtfully designed with customer needs and feedback in mind. It focuses on delivering technology that empowers users by putting critical glucose information on their phones and is compatible with the most popular Android devices currently in the market,” prez & CEO Kevin Sayer said in a prepared release.
The Dexcom G5 Mobile application will be initially available on select devices from Samsung, Motorola and LG, as well as Android Wear watches, the company said.
