The FDA recently granted Breakthrough Device Designation for the use of Dexcom’s continuous glucose monitoring (CGM) with diabetic patients in hospitals. Chalk up yet another potential digital health tech win with direct ties to the COVID-19 pandemic. The FDA gave emergency authorization to use the Dexcom CGM in hospitals during the pandemic. Based on that positive in-hospital experience, the FDA went the next step and granted Breakthrough Device Designation.
This is a significant development as it marks the movement of a consumer wearable from the home to clinical settings, which is metaphorically swimming upstream against the flow of current trends. The adoption of this device has been driven by stresses on our healthcare systems. Hospital staff have been challenged to monitor patients along with other duties in the best of times, but staff shortages due to COVID-19 infections have made the problems even more difficult. Constant monitoring of blood glucose levels helps ease some of the workload in tracking diabetic patients.
Breakthrough status isn’t a guarantee of a permanent approval by the FDA. The designation simply speeds the regulatory review and approval process. Breakthrough Device Designation is reserved for medical devices that can potentially provide “more effective treatment or diagnosis” for diseases or conditions that threaten patients’ lives or debilitate them irreversibly. Specifically, in this case, because the Dexcom CGM proved its potential for greater patient satisfaction and care quality as an alternative to conventional fingerstick blood glucose tests in hospital applications during the pandemic, the FDA concluded that the technology deserved fast-tracking for further development and review.
From a broader perspective, this is a story about how health tech can make significant changes in how we deliver healthcare, both in clinical settings and in the home. Expect to see more examples of wearables and other connected devices bringing more efficiency and convenience in both places.