Senseonics Reports Topline Accuracy Results from US Pivotal Study of Eversense CGM System

Senseonics Holdings announced topline results of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Clinical Investigation.

Results from the 90 adults with diabetes generated over 16,000 comparative glucose data points and demonstrated strong accuracy for the 90-day continuous wear period with a mean absolute relative difference (MARD) of 8.8% across the 40-400 mg/dL range when compared to YSI blood reference values.

According to the Principle Investigator, Dr. Mark Christiansen of Diablo Clinical Research, “The accuracy result is quite significant with the device. This was an important study and we are thankful to all the patients and clinics who participated. The early result shows that this system can be an important treatment option for our patients. Having a long lasting, 90-day CGM sensor that is safe and accurate will be a welcome addition to the diabetes community, as it will offer greater freedom of choice.”



The PRECISE II U.S. investigational device exemption trial enrolled 90 participants at eight clinical centers. The objective of the study was to determine the safety and effectiveness of the Eversense® CGM system over 90 days of continuous glucose sensor wear.

Participants in the study underwent unilateral (n=75) or bilateral sensor (n=15) insertions in the clinic and used the system’s smart transmitter and mobile app at home for the next 90 days. Sensor glucose readings were calculated prospectively. Calibration with a standard home blood glucose meter was performed twice a day but real-time glucose readings and trends were not made available to participants. Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.

“The promising results and compelling accuracy data shown in the PRECISE II study represent a major milestone for the company,” said Tim Goodnow, PhD., CEO and President of Senseonics. “We are quite excited to complete the full analysis and report on other outcomes in the coming months. Pending FDA review and approval, we look forward to bringing this exciting technology to the U.S. market and to people with diabetes.”

Senseonics expects to submit its Pre-Marketing Approval (PMA) package to the U.S. Food and Drug Administration in the next few months. Subject to receiving FDA regulatory approval, Senseonics plans to initiate sales in the United States. The company currently markets the system under the brand name Eversense in select European countries.

Eversense CGM System is an Investigational Device and is limited by United States law to investigational use.

A press release can be found from Senseonics website.

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.

Medtronic and Qualcomm collaborate develop continuous glucose monitoring (CGM) systems

Medtronic and Qualcomm through its wholly-owned subsidiary, Qualcomm Life, Inc., announced a global, multi-year collaboration to jointly develop future generation continuous glucose monitoring (CGM) systems that aim to improve health outcomes for people with diabetes. By giving insights to doctors and people with type 2 diabetes concerning glucose levels, the companies intend to enable more informed care, especially for those who do not have control of their diabetes today. The collaboration seeks to leverage Medtronic's market-leadership in diabetes management and Qualcomm Life's expertise in developing reference designs for wireless, single-use and small integrated modules to create more affordable, easier-to-use CGM systems, including a new sensor and smaller design that can provide near real-time and retrospective glucose data.

The initial focus of the collaboration will be to develop a single-use CGM system designed for broader practice by general practitioners who manage care for the vast majority of the 400 million people worldwide with type 2 diabetes. This collaboration supports Medtronic's strategy to develop comprehensive CGM solutions that not only measure glucose but enable the delivery of actionable insights to both patients and providers.

Leveraging Qualcomm Life's deep wireless expertise and technologies, 2net(TM) Design is a platform for designing the communications components of connected medical devices, including disposable drug delivery devices and disposable diagnostic devices for condition specific connected therapies.

"We believe that glucose should be a vital sign of diabetes health. Professional CGM is an increasingly used diagnostic tool that empowers physicians and patients with meaningful glucose data to tackle glucose control. Our solutions go beyond delivering data and provide automated observations and clinical decision support to help create a personalized care plan," said Laura Stoltenberg, vice president and general manager, Non-Intensive Diabetes Therapies at Medtronic. "Our vision is to transform diabetes care so people with diabetes can enjoy greater freedom and better health. We are thrilled to be collaborating with Qualcomm Life - a best-in-class leader in wireless technologies that is ahead of the curve in a rapidly changing connected world - to develop innovative and affordable CGM systems that will fundamentally change type 2 diabetes management."

"Qualcomm Life's connected health expertise along with our enabling 2net Connectivity Platform and 2net Design capabilities fit naturally with Medtronic's diabetes leadership in bringing future generation CGM systems to market," said Rick Valencia, president and general manager, Qualcomm Life, Inc. "This collaboration furthers our commitment of enabling new connected care models that liberate vital data and unlock insights to deliver intelligent care wherever the patient may be."

Advanced CGM solutions are a critical element of an integrated care model. By building an ecosystem of industry leading partners, Medtronic aims to deliver more than just devices and provide intelligent solutions that improve outcomes, while lowering the overall cost of care.

Senseonics receives CE approval to continuous glucose monitoring (CGM) system

Senseonics Holdings, Inc announced it has received CE Mark approval for the Eversense Continuous Glucose Monitoring (CGM) System.



“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” said Dr. Tim Goodnow, CEO and President of Senseonics. “The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes.”

The Eversense System includes an implanted glucose sensor that lasts up to 90 days, a wearable and removable smart transmitter to calculate glucose levels, and a mobile app for display of real-time glucose readings. The Eversense System is now the world’s first long-term wear sensor, which eliminates the weekly sensor insertion required by currently marketed CGM systems. The previously presented multi-center European PRECISE pivotal trial showed strong accuracy and safety results throughout the 90 day use of the Eversense CGM System.

Product details can be found from Senseonics website by clicking this link.