Wednesday, December 14, 2022

One of the smallest, most discreet Continuous Glucose Monitoring (CGM) Systems receives FDA Clearance

One of the smallest, most discreet Continuous Glucose Monitoring (CGM) Systems receives FDA Clearance

Dexcom’s revolutionary new Continuous Glucose Monitoring (CGM) System G7 has now hit global markets, having received CE Mark for ex-US markets in March 2022 and FDA Clearance in US markets in December 2022. Built in partnership with Verily, through a user-centered design approach, the G7 is lighter and more convenient, supporting people living with diabetes in achieving more control over their HbA1C and time in range. Sixty percent smaller than its predecessor, this innovative G7 feels noticeably different for someone relying on the blood glucose measurement throughout their day. People can shower, sweat and swim without worrying about their CGM.

Now approved for use in the United States, United Kingdom, Ireland, Germany, Austria, Hong Kong and New Zealand, this revolutionary new technology will give more people with all types of diabetes (types 1, 2 and gestational) ages two years and older access to a powerfully simple diabetes management solution. Dexcom expects to initiate a US commercial rollout of Dexcom G7 in early 2023 and is also working quickly to introduce G7 in additional markets as soon as possible.

The need for continuous glucose monitoring

The prevalence of diabetes is steadily increasing worldwide due to the increase in associated risk factors such as being overweight or obese. More than 422 million adults are living with diabetes.1 Given these staggering figures, it is clear our traditional care model is not working for people living with diabetes. There is not enough access to quality healthcare for prevention and treatment, leading to poor health outcomes and complications such as heart disease, stroke, nerve and kidney disease and vision loss.1

Continuous Glucose Monitoring (CGM) systems, designed to enable continuous subcutaneous monitoring of the interstitial fluid, help people manage their diabetes in a convenient at home setting without the burden of frequent finger pricks, driving valuable insights. CGMs are the current standard of care for people with type 1 diabetes, and are becoming increasingly relevant for people with type 2 diabetes who want to control their diabetes with timely, actionable information. Helping people living with diabetes have a continuous view of the impact of lifestyle on glucose levels and time in range empowers them with the information needed to better manage their condition. When combined with chronic condition management programs, like Onduo by Verily, CGM systems enable individualized interventions and drive more personalized, precision health, improving quality of life and reducing diabetes-related complications.

For the Verily Medical Devices team working in partnership with Dexcom, it’s been thrilling to see this product go from ideation into the hands of patients. We sat down with Zita Netzel, Head of Diagnostics Engineering and Devices Incubator, and Mark Valkenburgh, Alliance Manager, to hear their thoughts on the latest release.

Tell us about Verily’s collaboration with Dexcom.

Zita: This next generation CGM - G7 - represents the culmination of years of progressive innovation and collaboration between Dexcom and Verily. I am grateful and humbled to have worked on this product with an amazing Verily team and our partner Dexcom continuing our mission to bring precision health to everyone, every day.

Mark: We have been fortunate to work alongside an industry leader for several years in the development of a revolutionary device that will ultimately reduce the daily burden of disease and improve the health and lives of people with diabetes. I am proud of how far we have come in our partnership with Dexcom and by what we have accomplished together, and grateful to have worked with so many talented people along the way.  Together with Onduo by Verily, our virtual care platform, which incorporates health coaching and personalized tips for healthy living, G7 highlights Verily’s diverse set of capabilities and will begin to fulfill our mission of making precision health accessible to everyone.  This mission is well-aligned with Dexcom’s mission of “empowering people to take control of health” and has been foundational to the partnership. We congratulate Dexcom on achieving such a significant milestone and look forward to continuing to support G7 in the years ahead.

What are you most excited about with the G7?

Zita: In March 2022, Dexcom received the CE Mark for the G7, announcing one of the smallest, most discreet CGMs. Now it is debuting  across multiple countries and reaching millions of people with diabetes globally.

Mark: I am incredibly excited for what lies ahead, and the immense value G7 will bring to the diabetes community.  Specifically, I am confident that G7’s smaller size, low profile, superior comfort and ease of use will drive greater adoption, ultimately equipping more people with continuous insight into how their lifestyle impacts their glucose levels and time in range, especially when integrated with a virtual care platform such as Onduo.  This will empower more people to better manage the condition and lead healthier lives.

What did Verily bring to this partnership?

Zita: Our core competencies of innovation and miniaturization of electronics helped enable Dexcom to reduce the size of the G7 by 60% compared to its predecessor, into an all-in-one, discreet wearable.  We are so excited to have had the opportunity to work together with a fantastic team at Dexcom and now see the G7 available to people managing their diabetes today in a way that can be seamlessly integrated into their lifestyle.

Congrats Zita and Mark and congratulations to the Dexcom and the Verily Medical Devices teams!