In an “unprecedented” move, the FDA has granted temporary permission for Dexcom to provide G6 continuous glucose monitoring (CGM) systems directly to hospitals for use with patients suffering from COVID-19.
The technology, which allows for remote monitoring of blood sugar, will allow medical care providers to keep a close eye on the glucose levels of their coronavirus-positive patients without actually stepping into the same room. The G6 could therefore both save personal protective equipment and reduce the exposure of medical workers, helping to relieve two of the most critical problems for a healthcare system badly overburdened by the pandemic. The Abbot Freestyle Libre CGM received a similar temporary approval last week.
While the main impetus for the approval was limiting both viral exposure and PPE use during blood glucose checks, it is also likely that remotely-monitored CGM systems can meaningfully improve the ability of healthcare providers to track and respond to blood glucose changes in their patients. Dr. Daniel DeSalvo, a pediatric endocrinologist and expert on emerging diabetes technology, explained that the current standard of care of discontinuous monitoring in the hospital setting is outdated and inadequate:
“Generally in a hospital setting the glucose checks are performed just before meals, sometimes at bedtime, and maybe once overnight. If the patient is on an insulin drip, generally there would be hourly glucose checks. In comparison with a CGM, you’re losing the comprehensive data in between checks, and you also don’t have the trend arrows or the high or low blood sugar alerts.”
Monitoring blood sugar in COVID-19 patients is not just important to prevent hypoglycemia, acute hyperglycemia and diabetic ketoacidosis. It is widely believed that healthy blood sugar levels could help those afflicted with the coronavirus respond better to the illness:
“We know from other infectious diseases that having in-range blood sugars helps reduce morbidity and mortality. Extrapolated to COVID-19, it leads us to believe that having in-range blood sugars can help to improve clinical outcomes.”
In a press release, Dexcom announced that it would produce 100,000 sensors for hospitalized coronavirus patients, and that it would donate more than 10,000 phones and receivers.
Continuous glucose monitors should be useful for COVID-19 patients with both Type 1 and Type 2 diabetes, especially those that require insulin. Interestingly, doctors will also have full discretion to use the devices on patients without diabetes. Dr. DeSalvo explained that COVID-19 can induce an “inflammatory response that can cause a propensity towards hyperglycemia,” a response that can be exacerbated by certain medications that may be used to fight the disease. As a result, doctors may wish to monitor the blood glucose of even some non-diabetic patients who are acutely ill.
With no standard of care set for hospital use of the technology, doctors will have to work out their own protocols quickly. Dr. DeSalvo cautioned that there are still some unknowns: “CGMs may be subject to interference by certain medications used in a hospital or ICU setting that haven’t yet been well studied.” It is likely that trials studying such issues will be necessary before the FDA grants permanent approval for the system.
Nevertheless, Dr. DeSalvo is hopeful that the CGM will “become a mainstay in diabetes management.”
“We can learn a lot of lessons from this. Having CGM as a tool to support glucose management will be really important not just now, but going forward too.”