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FDA Approves Dexcom G6 Pro CGM for Use in Diabetes

Dexcom has announced that the US Food and Drug Administration (FDA) has approved its G6 Pro Continuous Glucose Monitoring (CGM) System for healthcare professionals to use with their patients aged 2 years and older.

“Dexcom G6 Pro is the first and only single-use, professional CGM that gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded mode,” Dexcom notes.

In blinded mode, patients wear a sensor for 10 days, then return to their physician’s office to review the data; the real-time glucose data is hidden from the patient and reviewed retrospectively with their healthcare professional. It is indicated for assessing glycemic variability in patients.  

In unblinded mode, patients can see their glucose data throughout the 10-day sensor wear to gain insights and make treatment decisions in real-time. Patients can view glucose data in real-time on a mobile app throughout the 10 days.

No fingersticks are needed for calibration or diabetes treatment decisions; the Dexcom G6 Pro does have alarms but only in the unblinded mode. It has an easy sensor applicator, allowing for one-touch, simple insertion, and the sensor is disposable.

Regardless of mode, glucose data gathered by the Dexcom G6 Pro enables healthcare providers to adjust a patient’s diabetes therapy plan, and they can use the data to help patients modify their daily behavior after seeing the effects that variables such as food, exercise, stress, and medication have on glucose levels, the company says.

The consumer version of the Dexcom G6 for personal use by patients was approved by the FDA in March 2018.

A “Real-Time Snapshot”

Although she says she hasn’t used the Dexcom G6 Pro yet, “I’m really excited about it,” Anne Peters, MD, Keck School of Medicine and director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles, told Medscape Medical News.

“This is something I can put on in the office and there’s no training involved, I get over the barrier of teaching the device, and you can have the patient see [the data] or not see it, and I think that’s really important,” she said.

“Sometimes you don’t want a patient to see [the data] because they are going to overreact. But a lot of the time you want a patient to see it. I’ve always wanted the ability to give patients a real-time snapshot of what their life is,” she noted.

“The current blinded [professional] CGM [FreeStyle Libre, approved in 2016] is good for me and something I’ve loved, because it gives me 2 weeks of data…but it’s not so great for the patient because they don’t see what’s happening in real-time,” she explained to Medscape Medical News.

Peters sees the new Dexcom G6 Pro device as having different roles for different patients.

For patients with type 1 diabetes, “this might be a good way to introduce them to a CGM to see the utility of it,” she noted.

And for patients with type 2 diabetes, this could be “a powerful tool to teach patients in real-time and start the behavior change.”

And the fact that, in unblinded mode, patients can see alerts and alarms “could really change their perspective,” Peters added, although she acknowledged that, in this mode, the patient will still require some training on how to handle and respond to the alarms.

But it will give them a taste of what is involved, she said, noting that, nevertheless, for some people, “the reluctance to wear devices…is greater than just seeing that it works.”

Peters said ultimate uptake will depend on the cost and reimbursement of the G6 Pro CGM.

Peters serves on the advisory board for Medscape Diabetes & Endocrinology. She has reported serving on advisory boards for Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, and Zafgen. She has received research support from Dexcom, MannKind, and AstraZeneca, and served as a member of a speakers bureau for Novo Nordisk.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and Facebook.




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