SAN DIEGO — Dexcom, a maker of wearable glucose monitors for people with diabetes, has begun shipping devices to hospitals to track blood sugar levels in COVID-19 patients.
The company won authorization from federal regulators recently for use of its continuous glucose monitors in hospital settings. It aims to manufacturer 100,000 sensors for hospitalized coronavirus patients at its factories in San Diego and Arizona.
In addition, Dexcom will donate more than 10,000 phones to hospitals to enable remote blood sugar monitoring, which will augment manual finger pricks by health care professionals in isolation units.
“People with diabetes are one of the more at-risk groups once they get hospitalized with COVID-19,” said Chief Executive Kevin Sayer. “It appears to wreak havoc with their systems, and trying to control glucose for patients in the hospital with traditional point-of-care glucose meters …. doctors were looking for a better way.”
The move highlights how hospitals are turning to remote monitoring inside their walls to limit staff exposure to the novel coronavirus, as well as preserve scarce gowns, masks and other personal protective equipment.
It also points to the willingness of regulators to loosen restrictions on the use of certain medical devices and diagnostic tools in an effort to battle the pandemic — at least temporarily.
While continuous glucose monitors have been approved for diabetic patients outside of hospitals for years, they only gained permission for use inside hospitals since the virus outbreak.
“The FDA is allowing it, and I think the overall goal is to preserve PPE and reduce staff exposure,” said Dr. Daniel DeSalvo, assistant professor of pediatrics with a focus on diabetes and endocrinology at Baylor College of Medicine/Texas Children’s Hospital.
“Having said that, I think there are important lessons learned coming out of COVID-19 that are in many ways — as terrible as the situation has been — providing that disruption that health care in some ways has needed in terms of delivery of care in a smarter, safer and more efficient way.”
To date, a lack of studies on how certain medications interact with wearable glucose sensors, and how effectively other connected medical gear share airwaves with wearable glucose monitor transmitters, has held up FDA authorization for hospital use of the devices.
Dexcom’s G6 continuous glucose monitor includes a sensor inserted just under the skin that lasts 10 days. A transmitter sits on top of the sensor and wirelessly sends real-time blood sugar levels to either a Dexcom reading device or smartphone within a 20-foot range.
Through Dexcom’s sharing feature, the smartphone/reader links to a cloud server and delivers the patient’s glucose data to a tablet or phone of care providers wherever they are.
Dexcom is not the only continuous glucose device maker to win FDA approval for hospital use related to COVID-19. Last month, Abbott received permission for its FreeStyle Libre 14 day continuous glucose monitor in hospitals for COVID-19 sufferers with diabetes
The FreeStyle Libre still requires a manual scan of the wearable sensor with a reader or smartphone to get a real-time glucose level, while the Dexcom G6 sends the data directly to the receiver/smartphone via Bluetooth, where it can then be uploaded to the Internet cloud and distributed without having to enter the room.
The FDA also authorized Dexcom’s G6 monitors for use on all COVID-19 patients, even those without diabetes. Sayer said the company has heard from clinicians that both diabetic and non-diabetic COVID-19 patients tend to experience a higher risk of elevated blood sugar levels.
“By putting a sensor on one of these patients, we can detect when somebody has rapidly rising glucose, and the health care professional can come in and take the necessary action,” he said.
The company is charging lower prices to hospitals than its standard rates, which are typically covered by insurance or Medicare, said Sayer. Roughly 100 hospitals have reached out to the company about its system.
“We really just got started with the approval two weeks ago, and we started shipping three or four days after that,” said Sayer. “The inquiries are rising. We are now serving hospitals and getting as much information as we can.”
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