FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

March 29, 2018  Source: MedCityNews 199

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system —  the G6 — that requires no fingerstick calibration.

The device cleared for patients 2 years old and higher and can be used both as a stand-alone CGM as well as for integration with automated insulin dosing systems.

The regulatory nod “comes several months ahead of management’s” guidance, wrote Danielle Antalffy, an equity research analyst with Leerink Partners, a healthcare investment bank, in a research note Tuesday after the announcement was made.

But perhaps more importantly, the fact that it can be integrated with automated insulin delivery systems bodes well for DexCom’s role in the artificial pancreas market. Antalffy pointed out that the DexCom G6 can work with insulin pumps being developed by Tandem Diabetes and Insulet with whom the San Diego company has partnerships.

This ‘puts DexCom another step closer towards establishing the pathway for an artificial pancreas,” Antalffy wrote.

While all this is good news for DexCom, the de novo clearance is also good news for diabetes patients who may be using CGM systems that still require finger sticking for accuracy and proper calibration. And that, in turn, may drive adoption of CGM into the broader type 2 diabetes population.

“We continue to believe the CGM market is expanding dramatically as new products come to market, driving penetration meaningfully higher from current high-teens levels in Type 1s and mid-single-digits in insulin-dependent Type 2 patients,” Antalffy wrote.

Here are some of the features of the device, per the news release:

  • Easy Sensor Applicator – The sensor applicator has been redesigned and now allows for one-touch, simple insertion.
  • Discreet and Low Profile – The transmitter has also been redesigned and now has a 28 percent lower profile than the previous generation Dexcom CGMs.This means the device comfortable and easy to wear under clothing.
  • Acetaminophen Blocking – There is no medication interference with the new CGM that should mean more accurate readings.
  • Predictive Low Alert – Another new feature can alert patients by predicting hypoglycemia before it develops to help avoid dangerously low blood sugar episodes.
  • Extended 10-Day Sensor – The device has a 10-day sensor that provides for 43 percent longer wear than previous generation Dexcom CGMs.

Like other DexCom CGMs, the G6 can automatically send glucose readings to a DexCom receiver or a compatible smart device every five minutes. The device works with mobile apps such that data can be shared by up to five people. Patients can also personalize alert schedules so that he or she is aware of dangerously low glucose levels in the blood.

DexCom is not the only company seeking to expand its footprint into the broader Type 2 diabetes market. A competitor, Medtronic, announced earlier this month that FDA approved it latest CGM system – the Guardian Connect – which uses artificial intelligence technology to help type 2 diabetes patients beat high and low-glucose related events. The Guardian Connect, which is already approved for type 1 diabetes patients, works with the Guardian Sensor 3 which is the latest sensor from Medtronic and powers its hybrid closed-loop insulin pump, the 670G.

Meanwhile, the reimbursement landscape for CGM has improved greatly and has likely benefited DexCom. CMS announced its decision to cover the CGMs for Medicare patients in January 2017 and in March of last year said that patients who have either Type 1 or Type 2 diabetes and who must intensively manage their insulin will be able to obtain reimbursement for the devices.

Correction: An earlier version of the story incorrectly characterized the Guardian Connect CGM system. It is powered by the Guardian Sensor 3 which is the latest sensor from Medtronic.

By Ddu