Medtronic Continuous Glucose Monitoring (CGM) System CE Approved

Medtronic announced it has received CE Mark for its new Guardian(TM) Connect mobile continuous glucose monitoring (CGM) system for people with diabetes using insulin injection therapy. Guardian Connect is the first smartphone-enabled CGM system from Medtronic to receive CE Mark and further demonstrates the company's intent to provide solutions for people across the diabetes care continuum. The system will be launched on a country-by-country basis in the second quarter of fiscal year 2017, beginning with select countries in Europe, Asia Pacific, and Latin America.


With Guardian Connect, people on insulin injections will be able to check their current glucose level anytime on their mobile device, as easily as checking other information sources such as email, the weather or social media. They can also be alerted of high and low glucose levels on their mobile device, helping them confidently avoid or address high and low glucose situations. Guardian Connect is the first and only mobile CGM system with customizable SMS text alerts enabling care partners to receive high and low glucose alerts on any connected mobile device. The system also features the option to automatically upload the data daily into CareLink(TM) therapy management software, which reduces the burden of data upload for both people on insulin injection therapy as well as their healthcare providers.

"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," said Annette Brüls, president, Diabetes Service and Solutions at Medtronic. "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."

The Guardian Connect system consists of a small wearable CGM device that takes glucose readings every five minutes (288 times a day) and sends these glucose values directly to a smartphone app. People on insulin injection therapy can use the system to check glucose levels on their mobile phones, enabling them to see highs and lows in real-time, understand the trends and help improve their daily management of diabetes. Alerts can also be set up if glucose levels go above or below preset levels, helping patients prevent or address potentially dangerous high and low glucose events. All of this information can be shared with care partners via SMS text messages and via access to the real-time CGM tracing from any web-enabled device. In addition, healthcare providers can leverage automatic daily data uploads via CareLink.

The Guardian Connect smartphone app will initially be available with iOS devices. Medtronic is currently developing an Android version of the Guardian Connect app for release at a later date. The Guardian Connect system is not yet available for sale in the United States.

A press release can be found from Medtronic website.

Non-invasive microwave device to monitor diabetes

A team of researchers from the School of Engineering at Cardiff University in Wales, UK have developed a wearable glucose monitor that does not require the extraction of blood.

Instead of taking measurements by pricking the skin, the device, which attaches to the body via sticky adhesives, uses microwaves to measure glucose levels, sending the resulting data to a computer or mobile app.

The team, led by Professor Adrian Porch and Dr Heungjae Choi, believe the device could make life easier for the millions of people suffering from diabetes around the world and, with the right investment, could reach the market within five years.

The project has received £1m in funding from the Wellcome Trust up to now, and has already been used in clinical trials in patients.

More information can be found by clicking this link.

FDA Approves Automatic Blood Glucose Monitoring System from Intuity Medical

Intuity Medical announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the POGO Automatic Blood Glucose Monitoring System. The POGO System is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one easy step. By combining all of the necessary blood glucose testing supplies into a convenient, selfcontained 10-test cartridge, POGO provides ease of use and discretion for millions of patients who need to regularly test their blood glucose in the management of their diabetes.

To perform a test, a patient simply presses the POGO test port, and POGO automatically lances the finger, collects

a blood sample and displays a result after a four-second countdown. The meter only requires a tiny blood sample of 0.25 microliters to analyze the glucose value. After all ten tests are complete, the patient disposes of the selfcontained cartridge, eliminating the need to handle used test strips or lancets since they remain inside the cartridge. This reduces the biohazards of used lancets and used test strips in public places.

“POGO brings new and unique features to home glucose monitoring,” commented Steve Edelman, MD, Clinical Professor of Medicine at the University of San Diego and Founding Director of Taking Control of Your Diabetes (TCOYD). “By reducing the number of steps and supplies needed to test, POGO addresses some of the common barriers to testing and gives patients a new way to test their glucose. As clinicians, making testing more convenient for the patient is essential to their diabetes care.”

When combined with Intuity Medical’s proprietary Patterns Diabetes Management application, a secure cloudbased system for managing glucose information, POGO provides both healthcare professionals and patients a comprehensive shared platform to detect and manage important patterns and trends that impact overall glucose control.

“POGO’s unique and patented technology has the potential to change the lives of millions of patients who see glucose testing as burdensome. More than half of the 287 patients in our pivotal clinical study reported that they would better adhere to their healthcare professional’s recommended testing schedule using POGO as compared to their current meter,” commented Emory V. Anderson, President and Chief Executive Officer, Intuity Medical. “With this FDA clearance milestone, the Intuity team will be focused on raising capital and building the company’s infrastructure for POGO’s commercial launch.”

Product information in details can be found from Intuity website.