Medtronic wins CE Mark for Guardian Connect mobile CGM

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European union for its Guardian Connect mobile continuous glucose monitoring system.

The Fridley, Minn.-based medical giant said it is the 1st smartphone-enabled CGM system to win CE Mark approval for the company, and expects to launch the device on a country-by-country basis in the 2nd quarter of its fiscal year 2017.

“Having continuous, real-time access to glucose values and being alerted to important trends and events is key for people with diabetes. With our new Guardian Connect system, we’ve continued to innovate so we can deliver these insights for people with diabetes on insulin injection therapy. Guardian Connect is also compatible with our CareLink diabetes therapy management platform and arms healthcare providers, their patients and care partners with actionable data to help improve day-to-day diabetes management and make long-term therapy adjustments. Expanding our solutions to help more people with diabetes no matter where they are on the care continuum is central to our goal of transforming diabetes care for greater freedom and better health,” diabetes services and solutions prez Annette Brüls said in a press release.

The Guardian Connect allows diabetes patients to check their current glucose level on their mobile device at any time, and the system can be set to alert the user of high and low glucose levels through their smartphone device.

The company touted the system as the 1st and only mobile CGM system with customizable SMS text alerts, and said the system features automatic upload of data to the CareLink therapy management software.

The device consists of a wearable CGM device designed to take glucose readings every 5 minutes, with data sent directly to the smartphone app. Initial launch will only be available on Apple (NSDQ:AAPL) iOS devices, with a Google (NSDQ:GOOG) Android version currently in development.

In June, Medtronic touted a pivotal trial of a device on its quest for an “artificial pancreas” which showed that its hybrid “closed-loop” insulin management system proved safe and effective.

The HCL system is designed to automatically control blood glucose levels with minimal input or supervision from patients or caregivers. The system, using Medtronic’s MiniMed 670G insulin pump, 4th-generation sensors and a control algorithm, was used in a 3-month study of 124 patients with Type I diabetes; 99 subjects opted for a continued-access program after the initial trial ended.

The HCL system logged a glucose reading every 5 minutes during the trial, but patients still had to occasionally calibrate the sensors and take mealtime or corrective insulin doses.

After some 12,400 patient-days, the study showed, there were no incidents of diabetic ketoacidosis, severe hypoglycemia or serious device-related adverse events. Patients showed lower percentages of low blood sugar at night while using the HCL system, and mean HBA1c levels fell.

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