Posts Tagged ‘glucose monitor’

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

New Device for Diabetes Management is Most-Advanced CGM Available with up to 30% Improvement in Hypoglycemic Accuracy

SAN DIEGO–(BUSINESS WIRE)– Dexcom (NASDAQ: DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administration has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, Dexcom CEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.”

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose (blood sugar) measurement has been a finger stick meter. Although they remain an essential part of a comprehensive diabetes management program, finger stick meters are inherently limited by the fact that, like a photograph, it only provides data for the specific moment in which the measurement is completed; it doesn’t show whether glucose is going up or down — or how fast.

By contrast, CGM provides an in-motion picture that shows not only glucose levels, but also the speed and direction in which it is moving, and alerts the user to sudden changes so they can take action.

The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

Longest transmission range, enabling improved patient flexibility and convenience

A smaller, discrete profile that fits busy lifestyles

A first-of-its-kind color LCD display for easy viewing

Customizable alerts with specific tones

“Hypo alert” setting at 55 mg/dl that provides an increased level of safety — a feature that no other device has.

An ideal and convenient tool for diabetes management

The Dexcom G4 PLATINUM CGM system consists of just three parts: a sensor, transmitter, and monitor.

The tiny sensor – about the diameter of a human hair —is inserted by the user under the skin on the abdomen. A small transmitter sends data wirelessly to a sleek and small monitor, which easily fits in a purse or pocket. It provides data every 5 minutes for up to 7 consecutive days, quickly and easily showing the body’s response to medication, food and exercise. If users are outside their target zones, configurable alarms alert them so that they can take action.

The Dexcom G4 PLATINUM is prescribed by a physician and covered by most insurance plans for people taking insulin, and is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The company plans to begin taking orders for the Dexcom G4 PLATINUM immediately and expects to begin shipping to patients within the next several weeks. For more information, visit

About Dexcom, Inc.

DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients with diabetes and by healthcare providers in the hospital.

Cautionary Statement Regarding Forward Looking Statements

DexCom is a medical device company with a limited operating history. Successful commercialization of the company’s products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company’s development programs, the inability of patients to receive reimbursement from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company’s quarterly report on Form 10-Q for the period ended June 30, 2012, as filed with the Securities and Exchange Commission on August 6, 2012.

Amy Tenderich over at DiabetesMine is documenting her trial of the DexCom SEVEN, a continuous glucose monitor, that we initially covered back in 2005.

Dexcom (San Diego, CA) received FDA clearance for its G4 Platinum continuous glucose monitoring system. It includes an under-skin sensor, a wireless transmitter, and the interactive monitor that picks up readings from within 20 feet (6 meters).

This is a considerably improved device over their slightly older Seven Plus model, offering greater accuracy in trials, a significantly cooler look, and a new display that charts glucose levels and displays alerts.

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

dexcom transmitter Dexcom G4 Platinum Continuous Glucose Monitor Cleared in U.S. (video)The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

Longest transmission range, enabling improved patient flexibility and convenience

A smaller, discrete profile that fits busy lifestyles

A first-of-its-kind color LCD display for easy viewing

Customizable alerts with specific tones

“Hypo alert” setting at 55 mg/dl that provides an increased level of safety – a feature that no other device has.

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Bayer’s CONTOUR NEXT LINK Glucometer Now a Medtronic Standard

Bayer’s CONTOUR NEXT LINK Glucometer Now a Medtronic Standard

Bayer’s CONTOUR NEXT LINK Glucometer Now a Medtronic Standard

Medtronic, Inc. (NYSE: MDT) and Bayer HealthCare today announced that Bayer’s CONTOUR? NEXT LINK, a new blood glucose meter, is now available in the U.S. with Medtronic’s compatible integrated diabetes management systems.

Bayer’s new meter provides exceptional accuracy utilizing high-performance CONTOUR? NEXT test strips, helping optimize insulin delivery through wireless communication with the MiniMed? Paradigm™ REAL-Time Revel™ insulin pump and the MiniMed? Paradigm™ REAL-Time insulin pump. People with diabetes can have greater confidence that seamless integration with Medtronic’s Bolus Wizard? makes bolus calculations quick and easy, eliminating inaccuracies due to manual entry errors.

Bayer’s CONTOUR? NEXT LINK utilizes the new, high-accuracy CONTOUR? NEXT test strips that deliver exceptional accuracy for close-to-professional lab results that people with diabetes can count on, especially in the low glucose range (

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (December 31, 2011) and is represented in more than 100 countries. Find more information at

About the Diabetes Business at Medtronic

The Diabetes business at Medtronic ( is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.

About Medtronic

Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Bayer Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Medtronic Forward-Looking Statements

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Bayer is releasing in the U.S. its new high accuracy CONTOUR NEXT LINK, a wireless blood glucose meter designed to work with insulin pumps. As a matter of fact, the new glucometer will come standard with Medtronic‘s pumps, including the flagship MiniMed Paradigm REAL-Time Revel. The meter is also compatible with Medtronic’s stand-alone Guardian REAL-Time continuous glucose monitor.

Medtronic is planning on shifting all its insulin pump customers to the CONTOUR NEXT LINK, including shipping out the new glucometer to those using older devices.

Enables fast and easy bolus dosing and continuous glucose monitoring calibration

Pass-through feature allows for easy downloading to Medtronic’s convenient online CareLINK software, replacing the CareLINK USB device

Bayer’s No Coding™ technology makes testing easy by automatically setting the correct code each time a test strip is inserted

Easy-to-read display with large, clear numbers

Fast 5-second countdown and small 0.6 ?L blood sample

Optional pre- and post-meal markers with audible reminders

I promised details on the investigational Bayer Contour Next LINK Meter provided with my pump for the trial, so here you have it. A picture says a thousand words, so I’m going to take advantage of that. Forgive me, however, for the not-so-great picture quality. I had to use my phone camera today, as the other camera’s batteries were dead. FYI – If you click on an image, you can see it in a larger format. You also have the option of clicking through all the image up close.

Bayer Contour Meter has a USB connection for charging and downloading readings,

Results are displayed across the screen first in a big bold font, then it shoots to a smaller font as seen as it sends the results to the pump. Tough shot: Green bar says, “Results Sent.”

There is a useful “Notes” screen that includes this and the following image.

Notes also includes “Activity,” which isn’t pictured

The meter also includes a reminder to recheck your blood sugar. I haven’t used this yet, but this is a new feature, so I’m trying it out.

This is the Menu screen.

This is what you see when you select “Trends.”

The is an image of the Logbook. The text under this reading has a scrolling, “Sent, High Blood Sugar.”

Same scrolling text and amber color for a low. Font is white if reading is normal.

Easy on/off button, which seems like a silly thing to show you, but if you have the One Touch UltraLink, you understand. Just try turning the sucker off without throwing it out the window. Such an incredibly simple thing to make so hard.

Pretty cool! I didn’t give it enough credit in my first post, but I also hadn’t played with it much at that point. I don’t upload the meter into Carelink, all results are sent to the pump, so they are uploaded with the pump info. However, if you needed to upload the meter only, you could. Whatcha think?

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Ford Partners with Medtronic, Others for In-Car Health Management

Ford Partners with Medtronic, Others for In-Car Health Management

Ford Partners with Medtronic, Others for In-Car Health Management

Ford and Healthcare Experts Research SYNC Health and Wellness Connectivity Services Helping Manage Chronic Illness On the Go



Ford is researching ways for drivers to manage their health in the car, including voice-activating wellness smartphone apps such as Allergy Alert through the SYNC connectivity system.

Ford researchers demonstrate a series of possible in-car health and wellness connectivity services and apps aimed at helping people with chronic illnesses or medical disorders such as diabetes, asthma or allergies manage their condition while on the go

Leveraging Ford SYNC®, researchers developed glucose device connectivity and monitoring capability, location-based allergy and pollen reports and voice-controlled, cloud-based health management services

Ford is working with leading healthcare industry experts such as medical device maker Medtronic, mHealth pioneer WellDoc®, and SDI Health, developers of the informational allergy website, to develop its initial Health and Wellness connectivity portfolio

Health and Wellness Fact Sheets

DEARBORN, Mich., May 18, 2011 – As Americans take a more active role in managing their health and well-being, Ford researchers are taking a leading role in developing a series of health and wellness in-car connectivity solutions designed to empower people with self-help information while they drive.

Leveraging Ford SYNC® and its ability to connect devices via Bluetooth, access cloud-based Internet services and control smartphone apps, Ford is taking charge in this automotive whitespace area, developing industry-first voice-controlled in-car connections to an array of health aids from glucose monitoring devices, diabetes management services, asthma management tools and Web-based allergen alert solutions.

“Ford SYNC is well known in the industry and with consumers as a successful in-car infotainment system, but we want to broaden the paradigm, transforming SYNC into a tool that can help improve people’s lives as well as the driving experience,” said Paul Mascarenas, chief technology officer and vice president, Ford Research and Innovation.

Healthy statistics

Health of mind, body and spirit is a significant slice of a larger global health and wellness trend that is transcending multiple generations, spectrums and industries. So-called healthy homes, allergen-free cleaners and products, and the cosmetic and bariatric surgery boon, for example, are all converging to create an eclectic mash-up that is redefining health and wellness for today’s consumer.

An underlying consumer demand for being in the know about one’s health while on the go also continues to rise, fueling the growing number and breadth of mobile healthcare devices and health- and fitness-related software and smartphone applications hitting the market today.

According to a recent survey conducted by CTIA-The Wireless Association and Harris Interactive, for example, some 78 percent of U.S. consumers expressed interest in mobile health solutions. A recent study by digital messaging powerhouse MobileStorm further confirmed this phenomenon, indicating that medical and healthcare apps was the third fastest-growing category of smartphone applications in early 2010. The major app stores, such as the Apple App Store, are now housing upward of 17,000 available health apps for download, with nearly 60 percent of those aimed at consumers rather than healthcare professionals, reports mobile research specialist Research2Guidance.

“Wireless health provides an unprecedented ability for monitoring and promotion of health and wellness for all individuals,” said UCLA Electrical Engineering Professor William Kaiser, who has worked with NASA and the U.S. Department of Homeland Security’s Science and Technology Directorate to study how wireless health technologies can be used to track an individual’s fitness and health status and help identify potential risks and challenges. “Studies show wireless health empowers people with information and guidance that can directly address the most important health concerns.

“The new Ford health and wellness connectivity solutions represent a fundamental advancement for these individuals,” Kaiser added, “providing them additional support and functionality during time spent in the vehicle.”

Constant connections

Taking a smart, high-volume approach to bringing mobile health and wellness solutions inside the car, Ford researchers are first looking at two populations with the most need for a constant connection to potentially life-saving medical information – people with diabetes and those with asthma and/or allergies.

According to the American Diabetes Association, nearly 26 million adults and children are currently living with diabetes in the U.S., 3-plus million more than there were four years ago. Numbers grow even higher for those with asthma and allergies, with the Asthma and Allergy Foundation of America reporting some 60 million Americans have asthma and/or allergies.

To create relevant in-car features and services for those living with these ailments, Ford is working with experts in these fields, including medical device manufacturers, healthcare management service providers and Web-based medical alert services.

“Ford’s approach to health and wellness in the vehicle is not about trying to take on the role of a healthcare or medical provider, we’re a car company,” said Gary Strumolo, global manager, Interiors, Infotainment, Health & Wellness Research, Ford Research and Innovation. “Our goal is not to interpret the data offered by the experts, but to work with them to develop intelligent ways for Ford vehicles using the power of SYNC. In essence, creating a secondary alert system and alternate outlet for real-time patient coaching services if you will.”

For people with diabetes and their caregivers, constant knowledge and control of glucose levels is critical to avoiding hypoglycemia or low glucose, which can cause confusion, lightheadedness, blurry vision and a host of other symptoms that could be dangerous while driving. Many now depend on a portable continuous glucose monitoring device to track their levels.

Likewise, those with asthma and allergies need to have a clear understanding of their environment and potential symptom triggers – such as pollen levels in the air – that can quickly lead to an attack. Growing in popularity among this group are Web-based alert services and smartphone apps that can help flag dangerous pollen levels based on location.

Ford SYNC offers three unique ways to bring health and wellness connected services into the car:

Device connectivity via Bluetooth – Leveraging Bluetooth, medical devices can be connected to the car to share information through SYNC, just like a driver connects and accesses his or her cellphone and address book by voice control

Cloud-based services – Ford created an off-board network of location-based traffic, directions and information providers that drivers can simply access via their cellphone. Known as SYNC Services, new services such as medical services can be easily added through this plug-and-play voice-controlled capability

AppLink – Ford’s latest SYNC innovation allows smartphone apps to be accessed by drivers via voice control. The SYNC application programming interface (API) allows app developers to enable their apps to communicate through SYNC, delivering a smarter way for drivers to manage apps while driving

The ongoing Ford health and wellness research projects encompassing these needs include:

Glucose monitoring: Working with Medtronic, a leading manufacturer of glucose monitoring devices, Ford researchers have developed a prototype system that allows Ford SYNC to connect via Bluetooth to a Medtronic continuous glucose monitoring device and share glucose levels and trends through audio and a center stack display and provide secondary alerts if levels are too low.

“To address the growing challenge of chronic diseases, Medtronic is collaborating with companies like Ford to develop innovative solutions,” said James Dallas, senior vice president, Medtronic. “Diabetes in particular is a chronic disease where frequent monitoring of blood glucose levels throughout the day is critical. As medical and consumer technologies converge, Medtronic is uniquely positioned to provide patients, caregivers and physicians with actionable insight from the data our devices can gather from the human body. By utilizing information technology and consumer electronic devices, we can help patients actively manage their health via access to real-time data on phones, hand-held devices or even in their cars.”

Allergy alerts: Ford is working with SDI Health and to SYNC-enable its smartphone Allergy Alert app through AppLink, giving users voice-controlled access to the app that provides location-based day-by-day index levels for pollen; asthma, cold and cough and ultraviolet sensitivity; as well as four-day forecasts.

“Our developers initially created the iPhone app to provide users with greater access to the information they’ve come to rely on from,” said Jody Fisher, vice president of Marketing for SDI. “Having instant, portable access for their conditions helps users plan their day or week ahead so they can remain active, which ultimately improves their quality of life.

“Collaborating with Ford is the perfect extension of this objective,” Fisher said. “We are happy to support Ford’s initiative of connecting drivers with resources and services important to their health and wellness.”

WellDoc: Ford and WellDoc, a recognized leader in the emerging field of mHealth integrated services, have joined forces to integrate in-car accessibility to WellDoc’s comprehensive cloud-based personalized solutions for those with asthma and diabetes through SYNC Services. Using voice commands, SYNC users could access and update their WellDoc profile to receive real-time patient coaching, behavioral education and medication adherence support based on their historic and current disease information.

“WellDoc was founded on the concept of helping patients manage their disease with everyday, personal tools that are easy to use and can be easily accessed,” said Dr. Anand K. Iyer, president and COO of WellDoc. “Through our partnership with Ford, we’ve created a unique in-vehicle environment that supports patients so they can continuously maintain their daily routines without interruption.”

Well on the way

Although still in the prototype and research phase, Strumolo acknowledges that many of the health and wellness features and services being explored at Ford have fairly short-term implementation requirements, such as the Allergy Alert app.

Ford is also examining other more long-term health and wellness technologies and ideas related to, for example, heart rate, relaxation and reducing stress. Ford and the Massachusetts Institute of Technology (MIT) have long been studying the correlation between stressors and driving performance, wrapping up a nine-month advanced research project last fall that showed drivers are less stressed when using selected vehicle technologies such as Ford active park assist and cross-traffic alert.

“Health and wellness provides a tremendous opportunity for Ford to provide peace of mind and a personal benefit to drivers and passengers while they are in our vehicles,” said Strumolo. “As more and more devices and technologies lend themselves to such connectivity in the car, it is our responsibility, our philosophy, to examine those possibilities and open our doors to industry relationships that can help us do it intelligently, efficiently and economically.”


About Ford Motor Company

Ford Motor Company, a global automotive industry leader based in Dearborn, Mich., manufactures or distributes automobiles across six continents. With about 166,000 employees and about 70 plants worldwide, the company’s automotive brands include Ford and Lincoln. The company provides financial services through Ford Motor Credit Company. For more information regarding Ford’s products, please visit

Time has come for when your car not only tells you when it’s low on coolant, but also when you’re low on sugar. In addition to warning you about road construction on the way, how about a notice when you’re entering a high pollen zone? Ford is partnering with a number of medical technology companies to address some health issues relevant to driving. A sudden drop of blood glucose, for example, can force a diabetic to pwzz3vp2 Ford Partners with Medtronic, Others for In Car Health Managementlose consciousness, a particularly dangerous situation when behind the wheel.

By wirelessly linking Medtronic‘s Bluetooth-enabled continuous glucose monitor to Ford’s Sync hands-free entertainment and control system, a driver can receive real-time warnings when glucose levels go out of predefined bounds.

Using WellDoc‘s disease management platform, patients can view and update their profiles including documenting things like asthma attacks, glucose levels, and allergic reactions, all without letting go of the steering wheel. Though maybe it’s best to first pull over and get that inhaler out.

Additionally, drivers will be able to access data from SDI Health‘s Allergy Alert app that can provide local allergy related information as well as some other environmental health indices.

Here’s a demo of the prototype integration of DiabetesManager:

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