How Covid-19 can guide a new role in continuous blood glucose monitoring

IIn early May, the Ohio State University Wexner Medical Center building was eerily empty. As the pandemic intensified, the patient’s space was wiped out. But it wasn’t wasted.

Inside, a group of nurse practitioners were playing digital tag games. Lauren KurzanovskyPeople with type 1 diabetes wore a continuous blood glucose monitor. This is an implant with a transmitter that sends real-time blood glucose measurements to a dedicated receiver. That day she was trying to figure out how far her CGM would work from the receiver.

Hospitals across the country were competing to answer the same question. They usually monitor a patient’s blood sugar levels with blood tests that are done several times a day. But when Covid-19 began to spread aggressively in the United States, “we all started looking at each other and thinking.” Patients conscientiously when nurses had to go hourly How can I administer IV insulin to my patient? Said Irene Falls, an endocrinology nurse practitioner who works with “” Chrzanowski At OSU.

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Part of the answer was remote monitoring. In April, the Food and Drug Administration temporarily allows hospitals to monitor blood glucose levels using CGM (approved for home use only) until a public health emergency has passed. I called. By May, several hospitals across the United States, including OSU, had received hundreds of free, low-cost CGM units from manufacturers, including: Abbott And Dexcom.

To use them with patients, they needed to understand how to adapt devices designed for home use. This is why the OSU team was playing tag.

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on the other hand Chrzanowski Staying in a windowed room, Falls zigzag around the floor, carrying a CGM receiver. From the nurse’s chart station outside the door, they learned that they could check the receiver about 10 feet away from the patient’s bed and inject the required insulin from a 20-foot tube. Other hospitals simply taped receivers like the PalmPilot to the patient’s door frame.

Early data suggest that these jury rigging systems improved inpatient care and outcomes. Also, some healthcare providers believe that wider adoption of CGM may improve inpatient outcomes.

Although the FDA does not approve CGM for that purpose, the data collected on the use of CGM during a pandemic has helped establish remote glycemic monitoring in hospitals as a standard treatment and has been used by manufacturers of these devices at all. Bring new markets.

For people with type 1 diabetes (and some with type 2 diabetes), the benefits of CGM at home are clear. The embedded sensor means you don’t have to stab your finger. Instead, a small needle is located just below the skin, constantly measuring the substitution of blood glucose levels in the interstitial fluid around the cells of the body.

Thanks to that data flow, many people who use CGM have shown improved control of blood sugar levels. This will be the two numbers displayed on the receiver. The average blood glucose level and the range of times (called time) that value falls within a particular goal. Both can be improved by changing diet and insulin administration.

For diabetics, Christina Astley, a pediatric endocrinologist at Boston Children’s Hospital, said, “The same thing that outpatient settings can improve time within range leads to inpatient settings.”

The evidence appeared before the pandemic. The standard method is to remove CGM when the patient enters the hospital, but some doctors, such as Irl Hirsch, have allowed the patient to maintain CGM.

Hirsch, an endocrinologist at the university, said: “Patients wearing Dexcom can go ahead and share the data with me or their service associates to make sure they aren’t having any problems. At the Washington Institute for Diabetes.” Fellows at 3am I wasn’t crazy about the phone ringing. “

Learning how to respond to these alarms that sound when a patient’s glucose rises or falls dangerously is one barrier to the systematic implementation of CGM in hospitals. While it takes time and money to train hospital staff to use new technologies comfortably, Faulds says providers have a vested interest in using technologies that reduce workload and improve safety. I emphasized that there is.

Then there’s the technical problem that the OSU team encountered in May. Some CGMs have the ability to send results to the phone app as well as the receiver, “we intended to use the phone as well,” says Falls. However, it was equipped with SIM cards and data plans that could jeopardize the privacy of patient data. The team got the torn down phones, but most of them still didn’t go through the hospital firewall. After all, the only option was to use a traditional receiver.

Despite these hurdles, many care providers and device makers have advocated the use of CGM for inpatients long before the pandemic. It was even higher regulatory hurdles that prevented them from moving forward.

“There were a few issues with chicken or the egg,” said Matthew Taylor, a medical device analyst at UBS. “Dexcom talked about this in a past conference call,” he said. In a conversation with the pre-pandemic company, “The FDA basically says,” I think this is a good idea in terms of value for patients, but we need data comparing the use of CGM with that of not. ” Said.

But CGM certainly Improvement result For diabetics, denying technology to a subset of patients in randomized trials can be unethical. FDA spokesman Audra Harrison said the FDA could not comment on ethical issues related to future data submissions, but sponsors said they could “choose the right controls for their research and endpoints.”

However, so far, few hospital CGM studies have studied patient outcomes. “There are more than 50 studies for using CGM in ICU, but they really focused on accuracy,” Falls said. CGM interstitial fluid measurements often require calibration against actual blood glucose levels, and patients may encounter stressors and medications in the hospital, which can interfere with accuracy. Still, Falls said: “I don’t think accuracy is the number one issue. I think it’s just demonstrating how it relates to patient outcomes. I need result data.”

With a silver lining, the pandemic offers some of it.

“The pandemic is [manufacturers] It’s a kind of backdoor that can generate data, “says Taylor. OSU, along with partners at Mount Sinai, Emory, Stony Brook, and the New York Presbyterian Hospital, is pooling data on inpatient outcomes during a crisis.

“This is not a randomized controlled trial. There are no controls here. This will be a problem,” says Faulds. “But if we can get all these agencies to publish the data, we hope they will continue to allow us to use the device.”

Strong results will take longer, but small studies based on the use of in-hospital CGM during a pandemic have already shown better results.On average, 110 non-ICU patients with type 2 diabetes were seen at the Scripps Whittier Diabetes Institute in San Diego. Lowering blood sugar and improving time within range.. In a similar group of patients in Baltimore, Randomized controlled trial The use of CGM has been shown to reduce hypoglycemic instances and lower blood glucose levels than normal.

On the other hand, Dexcom Run your own registry Track the results. “This is what Dexcom is doing very seriously to develop a path to improvement,” said Tomas Walker, US Health Director of the company.

“We have a very close relationship with the FDA and are always working with regulators to maximize what we can do for our patients,” he added.

“I think that’s the most likely result. [FDA] We will require some more data to make the approval permanent and formal, “says Taylor. He added that it is not yet clear what format the data will take, such as registries and new studies. “We encourage you to collect data on the safety and efficacy of these devices in inpatients,” Harrison said. “If their use is safe, such data may help to support the authorization or authorization of these devices for this use in the future.”

For Falls, the permanent FDA’s green light for using CGM in hospitals will be a major step forward.

“I’ve been managing diabetes for inpatients for eight years,” says Falls. “And I can’t even tell you how this will change nursing practice. It will change the way we manage patients in hospitals, it will be huge. This is the future of glucose management. There is no doubt about it. “