Dexcom G6 Pro CGM gets FDA nod

The technology includes one-time use sensors and can switch between blind and unblinded mode.
By Laura Lovett
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This morning the Dexcom G6 Pro Continuous Glucose Monitoring System got the greenlight from the FDA. The latest technology can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode. 

In blinded mode, patients don’t see their data automatically; instead, the clinician will get the data and then be able to discuss it with the patient retrospectively. In unblinded mode, users will be able to see their data as it comes in. 

The system also uses data and patterns to give users insights into their health and how their behavior impacts their glucose level. The technology includes a one-time single-use sensor, auto-started transmitter, continuous glucose readings, alerts and alarms, and the Dexcom Clarity platform, which gives reports and patterns about glucose. 

WHY IT MATTERS

The diabetes rate is rapidly increasing in the U.S., doubling in the last 20 years, according to the CDC. However, managing diabetes can put a time burden on the patient. Increasingly, CGMs have been used to reduce the time and add to convenience of care. 

 “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock,” Davida Kruger, a diabetes specialist, said in a Dexcom press release. “It will give all my patients a chance to try the Dexcom G6 Pro under a healthcare provider’s supervision before they commit to a personal system.”

THE LARGER TREND

Dexcom has been doing financially well in the last few years. During its 2018 earnings call, Dexcom announced that it broke $1 billion in annual revenue and plans to double the production of its G6 CGM. In March of 2018, Dexcom got the FDA nod for the first version of Dexcom G6making it the first interoperable CGM to get the designation. 

ON THE RECORD

“At Dexcom, we are continuing to drive innovation in wearable health technology,” Kevin Sayer, president, CEO and chairman of Dexcom, said in a statement. “Using the power of Dexcom G6 Pro, clinicians can use the insights gained from a 10-day professional CGM session to adjust treatment plans and empower their patients to live healthier lives.”