News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Such a small, non-invasive glucose monitor would capture and transmit data to the Cloud, making it feasible for clinical laboratories to collect those tests results, and keep a record of each patient’s glucose results

Probably no single area of medical laboratory testing has the greatest potential to help the largest number of patients with a chronic disease—and make a lot of money for the in vitro (IVD) manufacturer who is first to market with the right diagnostic product—than glucose testing and continuous glucose monitoring (CGM). Pathologists and clinical laboratory managers know why this is true.

Reports from the Centers for Disease Control and Prevention (CDC) and the American Diabetes Association, state that more than 29 million Americans (about 9% of the U.S. population) have diabetes. Nearly 28% of these (about eight million) are undiagnosed. The reports also stipulate that fasting glucose or A1C levels have shown that more than 80 million people over the age of 20 were prediabetic in 2012. Based on trends since then, we can safely assume that the number of prediabetics in America has grown. And what is true in the United States is general true in most developed nations throughout the world.

Collaboration Involves DexCom and Verily (Formerly Google Life Sciences)

Thus, it is big news when a healthcare business unit of Alphabet, Inc. (NASDAQ:GOOG) (now the parent of Google) enters into a collaboration with a glucose monitoring company. The technology partnership includes DexCom (NASDAQ:DXCM), a San Diego-based company that develops and markets CGM systems for diabetics, and Verily (formerly known as Google Life Sciences), a subsidiary of Alphabet.

Their goal is to develop a new generation of CGM products designed to be wearable, less expensive than existing CGM monitors, and disposable, according to a DexCom statement. The technology also will be connected to cloud storage and provide real-time data to providers, Medical News Today reported.

“This partnership has the potential to change the face of diabetes technology forever,” said Kevin Sayer, President and Chief Executive Officer of DexCom in the company press release. “Working together, we believe we can introduce products that will move us beyond our core Type 1 business to become the standard of care for all people living with diabetes.” (Caption and photo copyright: DexCom.)

“This partnership has the potential to change the face of diabetes technology forever,” said Kevin Sayer, President and Chief Executive Officer of DexCom in the company press release. “Working together, we believe we can introduce products that will move us beyond our core Type 1 business to become the standard of care for all people living with diabetes.” (Caption and photo copyright: DexCom.)

Google Life Sciences Has Worked to Develop CGM Devices

Some pathologists may already be familiar with DexCom and its glucose testing products. However, they might not be aware that Google Life Sciences (now known as Verily) also has been developing CGM devices.

In fact, clinical trials are anticipated to begin this year for Verily’s patented contact lens that monitors glucose levels in the tears of diabetics, reported Inquisitr. Verily signed an agreement with Novartis (NYSE:NVS) to develop blood glucose monitoring contact lenses—a product that was spotlighted in the company’s reorganization plan, FierceMedicalDevices pointed out.

Aiming Toward a New Standard of Diabetics Care

Today’s generation of continuous glucose monitoring devices are rather large. The current technology now commonly used in clinical settings generally includes a sensor that measures glucose levels under the skin; a transmitter that sits on top of the sensor; and a receiver that displays glucose readings, states DexCom’s website.

DexCom and Verily are intent on creating a new wearable, relatively inexpensive device that would become the standard of care for diabetic monitoring, eventually replacing the fingerstick glucometer, Medical News Today reported.

Finger-prick glucose monitoring, which many diabetics use to test themselves, only produces a single reading. By contrast, a continuous glucose monitoring device can provide hundreds of readings per day. CGMs are primarily intended for use by people with type 1 diabetes who take insulin, however, some type 2 diabetics who are on insulin also rely on CGMs, stated an Endocrine Web article.

Type-1 diabetes is an autoimmune disease that usually affects children. By comparison, type-2 diabetes has traditionally affected adults, and is the result of insulin resistance and beta cell dysfunction.

One Goal Is to Develop CGM Devices to Help Type 2 Diabetics

In working with Verily, DexCom aims to expand the company’s CGM offerings beyond its type-1 diabetes core business. DexCom said its “next generation” of CGM products will incorporate Verily’s miniaturized electronics platform and DexCom’s sensor technology as a way to combine each company’s technology.

“We’re committed to developing new technologies that will help move healthcare from reactive to proactive. This collaboration is another step towards expanding monitoring options and making it easier for people with diabetes to proactively manage their health,” stated Andrew Conrad, PhD, Verily’s Chief Executive Officer, in the DexCom statement.

The new DexCom/Verily continuous glucose monitoring device will be powered by a miniaturized electronics platform made by Verily. This device will include a battery, radio, processor, and antenna inside a transmitter. DexCom will fabricate the sensor that will be used in the device, explained Digital Trends.

CGM Device Expected to Be the Size of a Band-Aid

Executives at both companies predict their CGM will be inexpensive; wearable (about the size of a Band-Aid); disposable (probably weekly, when the sensor needs to be changed, noted Endocrine Web); connected to the Cloud to enable real-time sharing of measurements; and contain an advanced analytic platform that could be tapped for reporting to physicians.

“It talks to your phone. It doesn’t have to be calibrated. You don’t take finger sticks anymore. There really isn’t a reason you could not get significant penetration in the type- 1 [diabetes] market in the U.S.,” noted Steve Pacelli, DexCom’s Executive Vice President of Strategy and Corporate Development, in the Digital Trends story.

Opportunities for Pathologists and Clinical Lab Mangers

The Verily/DexCom joint venture promises to produce valuable and highly marketable CGM systems at a time when health consumers are opting to wear monitoring devices in record numbers. So, the partnership, aimed at developing breakthrough diabetes management technology, should be of interest to pathologists and laboratory executives, as new lab techniques and procedures will most likely be required to receive and process data coming from the new CGM devices. Labs would have an opportunity to add value if they could collect the test results from continuous glucose monitoring devices and combine that data with other lab test data to maintain a complete record of the patient’s diagnostic test results.

In addition to making care less-invasive and less expensive for patients, the new generation of CGM devices, may also offer up a treasure trove information for Big Data reporting.

DexCom anticipates bringing the first generation of monitors to market in two to three years, and rolling out a second product in five years, Medcity News reported.

—Donna Marie Pocius

Related Information:

DexCom to Collaborate with the Life Sciences Team at Google on the Development of Breakthrough Technologies to Change the Future of Diabetes Management

Google to Collaborate on ‘Next-Generation’ Glucose Monitoring Devices

Alphabet Introduces Verily, A New Name for Its Google Life Sciences

Google Contact Lens Testing to Begin Tests Glucose Levels in Patients

FDA Approves First Self-Contained Mobile Continuous Blood Glucose Monitor

Google DexCom Partnership Blends Data, Diabetes Devices

Google Reveals a Tiny Disposable Monitor That Tracks Glucose Levels

Google DexCom to Lower Cost and Size of Continuous Glucose Monitors 

Introducing Our Smart Contact Lens Project

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