COVID-19 Pushes FDA Approval of Breakthrough Device Designation for Dexcom CGM in Hospital Settings


 

On Tuesday, March 1, 2022, the FDA granted Breakthrough Device Designation for the Dexcom continuous glucose monitor (CGM) use in hospital settings. FDA Breakthrough Device Designation is granted to “novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” 

Throughout the COVID-19 pandemic, the FDA has allowed hospitals to use the Dexcom CGM to help patients manage blood glucose levels. Though people with diabetes aren’t necessarily immunocompromised, if they acquire an illness like COVID-19, it may take them longer to recover from it in some cases. It is critical for people with diabetes to be attuned to their blood sugar levels, especially during sick days. When someone with diabetes is ill, they may be at a higher risk of life-threatening complications like diabetic ketoacidosis or hypoglycemia

“What started as a response during the pandemic has shown promise as a better alternative to fingerstick blood glucose tests with a greater quality of care and patient satisfaction,” explained Gil Rivas, vice president, general manager of hospital at Dexcom.

While it’s true that the number of new diabetes cases increased during the COVID-19 pandemic, it’s also true that we have seen the number of new cases of diabetes increase for years. COVID-19 alone cannot be blamed for the onset of type 1 diabetes, specifically. The cause of type 1 diabetes is unknown, and it is too early to tell what impact COVID-19 has regarding its onset. Today, 1 in 10 Americans have a form of diabetes.

The Center for Disease Control and Prevention anticipates that 1 in 3 Americans will have a type of diabetes by 2050, making the need for continuous glucose monitoring all the more important as devices like the G6 have been shown to help lower A1c levels among patients with type 1 and type 2 diabetes. Blood glucose meters (BGMs) can only provide users with a single glucose level reading at a time, while a typical CGM (like the G6) can provide readings up to 288 times over 24 hours. CGMs benefit people with diabetes and their caretakers who need continuous insights into their blood glucose levels.

CGMs like the G6 provide patients and their caretakers with trend reports that demonstrate how blood glucose levels shift over a given period. With the Dexcom Clarity app, users can see their A measurement that tells you what percentage of the day your blood sugars are in your goal range.time in range over a 2, 7, 14, 30 or 90-day frame. They can also see blood sugar level patterns through the app, which helps doctors and patients be more informed and conscientious in developing personalized in-patient hospital care plans.

“In our extensive use of Dexcom CGM in our hospitals as part of exploratory studies over the last seven years, more than 800 of those patients treated during the pandemic, we have found that the device improves glucose control without any increased risk in hypoglycemia,” added Athena Phillis-Tsimikas, M.D., endocrinologist and corporate vice president for the Scripps Whittier Diabetes Institute in San Diego.

The Dexcom G6 system is helpful for patients with diabetes and their healthcare team in hospital settings. When someone is sick and managing diabetes, they need all the support they can get. Breakthrough Device Designation for devices like the G6 can help hospitals provide the best quality of care to their patients and reassure patients their health is in the best hands and technology possible to fight illnesses like COVID-19.


Learn more about the impact of COVID-19 on the onset of diabetes here.

WRITTEN BY Julia Flaherty, POSTED 03/02/22, UPDATED 03/02/22


Julia Flaherty is a published children’s book author, writer and editor, award-winning digital marketer, content creator, and type 1 diabetes advocate. Find Julia’s first book, “Rosie Becomes a Warrior.” Julia finds therapy in building connections within the type 1 diabetes community. Being able to contribute to its progress brings her joy. She loves connecting with the diabetes communities, being creative, and storytelling. You will find Julia hiking, traveling, working on her next book, or diving into a new art project in her free time. Connect with Julia on LinkedIn or Twitter.