Memorandum

FDA Now Allowing Use of CGM for Patients in the Hospital During COVID-19 Pandemic – April 8, 2020

Abbott and Dexcom already making CGM available in hospitals; Abbott donating 25,000 FreeStyle Libre sensors to hospitals in “outbreak hotspots,” Dexcom to donate 10,000 phones and readers

This morning, Abbott published a press release announcing that the FDA was allowing FreeStyle Libre to be used in hospital settings during the COVID-19 pandemic. Shortly after, Dexcom told us they’d received a similar green light from the FDA allowing the use of their CGMs in any patient in a hospital setting (i.e., not limited to people with diabetes) during the course of the pandemic. In fact, Dexcom told us their CGMs are already being used in a “number of hospitals.” Presumably, the FDA’s sanctioning of CGM use in hospitals would apply to all commercially available CGM systems (i.e., including Medtronic’s and Senseonics’ CGMs); however, we’ve only gotten official confirmation from Abbott and Dexcom. (See below for a note from Medtronic.) Of course, CGM accuracy has not been tested in patients with COVID-19, but we would note that BGM accuracy (the other glucose monitoring alternative) has not been tested in this population either. Being able to continuously monitor glucose in the hospital for patients with diabetes is obviously a very welcome change during this pandemic, but it also begs the question of why CGMs haven’t been cleared or approved for use in the hospitals in the first place. In fact, we’ve even heard horror stories of patients having their CGMs removed when admitted to the hospital. We’re hopeful that the FDA will soon recognize the value of using CGMs in hospitals even after the pandemic subsides.

As part of Abbott’s press release, the company also announced it will be donating 25,000 FreeStyle Libre sensors to hospitals in “outbreak hotspots” in partnership with ADA, Insulin For Life USA, and the Diabetes Disaster Response Coalition. Abbott also points out a report from the CDC showing how valuable CGM could be during this crisis: more than 50% of people with diabetes who’ve been diagnosed with COVID-19 so far have been hospitalized. According to an email from Dexcom, the company began shipping CGMs to hospitals on April 4 and the company plans to produce “100,000 sensors” and will sell them to hospitals at “special pricing.” Additionally, Dexcom will donate 10,000 phones and readers to hospitals. Dexcom has set up a valuable support page for CGM in the hospital and notes that CGM could help reduce interactions between HCPs and patients and also reduce use of personal protective equipment.

Close Concerns’ Questions

  • What sort of submission (if any) did the FDA require to get the green light for this?

    • From Dexcom: “Dexcom held several discussions with the FDA as a manufacturer of a real-time CGM regarding use of its devices in hospitals during this pandemic. FDA notified Dexcom that it will not object to Dexcom’s provision of CGM systems for remote monitoring of glucose to support COVID-19 related healthcare efforts.”

    • From Abbott: "Abbott worked with the American Diabetes Association and FDA to ensure hospitals across the country can use its FreeStyle Libre technology, the leading continuous glucose monitoring system, during the COVID-19 pandemic."
  • How will providers respond to the change? How will hospitals integrate CGM into their workflow?

    • From Abbott: "We have already received initial orders from hospitals who would like to use the FreeStyle Libre technology in addition to our donation of 25,000 sensors in partnership with the American Diabetes Association, Insulin for Life USA and the Diabetes Disaster Response Coalition."
  • How can patients be best prepared and facilitate efficient use of CGM in hospitals?

  • How have Dexcom and Abbott communicated the change to patients and providers?

  • Does the same FDA sanctioning of CGM in hospitals apply to Medtronic and Senseonics CGMs?

    • From Medtronic: “Medtronic has been discussing Medtronic CGM use in hospital settings as well, and we will provide more details when we’re able.”

  • Could this make it easier to bring CGMs into hospital settings after COVID-19 subsides?

  • Will hospitals re-use Dexcom CGM transmitters from patient to patient?

    • From Dexcom: “At this time, the only components being reused are display devices. Display devices will be sanitized following the sterilization protocols at each hospital.”

 

--by Albert Cai and Kelly Close