AsÂ reported last week, FDA is allowingÂ both Dexcom and Abbott to supply continuous glucose monitoring (CGM) systems for use in the hospital setting during the coronavirus pandemic. This allows frontline healthcare workers in hospitals to remotely monitor patients’ glucose levels while minimizingÂ exposure to the virus that causes COVID-19 and preservingÂ use of personal protective equipment.
Dexcom CEO Kevin Sayer said the company had conversations with healthcare providers in Europe about the need for CGM technology for COVID-19 patients and the company started conversations with FDA early on about getting emergency approval for in-hospital use of the Dexcom CGM system.
“The reason people were so attracted to the Dexcom technology over others relates to a couple of factors. Our iCGM classification, meaning we perform very well in the low and the high range so people knew it was accurate and they could depend on it, and then second, the telemetry aspect of all this,” Sayer told MD+DI.Â “Literally, if we can put a sensor on a patient and get it communicatingÂ directly with a phone and possibly use the Share/Follow app, you have the ability for patients not to be bothered by healthcare professionals continually to have their fingers pricked, which is currently the standard.”
What was happening, he explained was that the glucose levels of diabetes patients hospitalized with COVID-19 were running way too high, Sayer said. But they’re not the only ones experiencing that problem.
“It is not just diabetes patients who are running high glucose values, it is other patients in the ICU and other patients in the hospital with COVID-19,” he said.Â “ThereÂ appears to be a correlation either between the virus or the other treatments they’re taking, possibly the steoroids for their respiratory systems, that is causing their glucose values to go high,” Sayer said. “So they’ll use it wherever they see fit and the FDA has given us permission to do that.”
At first, Dexcom rolled the technology out to hospitals quietly because the company wanted to make sure it had the logistics down and a purchase order structure in place for the hospitals, as well putting togetherÂ specific training materials for the hospitals to use because it’s not always an endocronologist on the backend using the technology in the hospital, it’s other healthcare professionals who may not be as familiar with CGM.
Sayer said the company has learned that the best configuration for thisÂ program is to have the dataÂ go directly from the sensor to a phone rather than to a Dexcom receiver, so the company has purchased thousands of phones that will be donated to the hospitals as part of the system offering, so while the hospitals will pay for the sensors and the transmitters, the phones that will receive the data are being included at no cost. He also said the offering to the hospitals is priced below Dexcom’sÂ commercial pricing.
“Our people have literally worked around the clock getting this thing set up the right way. There are a number of ways we could have done this, we could have just put them on a truck and shipped them and said figure it out, and everybody would have been happy for a day, but we didn’t want to do that,” Sayer said. “We want to make sure this creates an infrastructure that is sustainable and actually helps people and doesn’t frustrate them.”
As for the production end, Sayer said the company really can’t ramp up production much because of the precautions in place to keep Dexcom’s factory workers safe during this pandemic.
“We have them working in small groups, we have them taking their breaks only in their small groups, we’re waiting for one entire shift to leave the building before letting another shift come in,” he said, adding that the workers are also undergoing temperature scanning at the start of their shift.
Sayer also emphasized the importance of meeting the company’s obligations to the peopleÂ with diabetes who use this device to manage their glucose levels everyday at home. So far Dexcom has had about 70 hospitals express interest in purchasing a CGM system to monitor COVID-19 patients.
“We are monitoring very closely the demand from the hospitals because what we don’t want to do is either A) underserve them, or B) ship them product in a panic that they can’t use and [end up]Â taking a bunch of product back that [other] patients could have actually used,” Sayer said.Â Â “So we are managing this and we put really good controls and good people around it to make sure that we are meeting their needs, yet still meeting the needs of our patients.”Â
But the emergency use approval does provide an opportunity to possibly expand the use of the technology down the road to include hospital use beyond COVID-19.
“There’s a lot of complexity around running this product in the hospital and we do appreciate the FDA working with us and talking to us. I mean, when you think about a patient in the ICU and all the other vital signs that are being measured and all the other signals going back and forth, we now have an opportunity to make sure our product can function in that environment,” Sayer said. “On top of that, the sensor on the body, we want to make sure that all of the drugs and the compounds that these patients are subject to don’t interfere with the sensor’s accuracy. So we now have an opportunity, in real time, to see how the product performs and we are going to gather up all this data and build the file and show real-time data on how it works. And if it does work the way we think it’s going to and the way we think it does, we hope to turn this into a longer term situation with the hospitals.”
Sayer said the protocol in a couple ICUs he’s visited prior to the pandemicÂ is for diabetes patients on an insulin drip is toÂ prick their fingerÂ every 30 minutes to monitor their glucose levels.
“When you start counting up the hours spent everyday by a healthcare professional on finger sticks when in reality, if this technology performs the way we hope it does you could sit in a nurse’s station and all of the data could be fed there to a central screen over time, this is a great opportunity for us, and a great opportunity for healthcare professionals to provide better care and then focus on other things,” he said. “So overtime we’ll gather this data, we’ll discuss it with the FDA, and we’ll do what they ask us to.”
Sayer said Dexcom has had ongoing hospital discussions around this for quite some time, but the emergency approval duringÂ the COVID-19 pandemic accelerates that objective.
For more of MD+DI’s ongoing coverage ofÂ resources, regulatory support, and solutions for responding to the COVID-19 pandemic, visit ourÂ COVID-19 News CentralÂ page.