FDA Gives Green Light to Dexcom G6 Glucose Monitoring System

FDA Gives Green Light to Dexcom G6 Glucose Monitoring System

By NaDica | Articles

Apr 24

There is great news for the diabetes community, the FDA, i.e., Food and Drug Administration approved the new Dexcom G6. This happened only 6 months after it had been submitted to the FDA.

Yes, in fact, both the FDA and Dexcom issued news releases about this. As a matter of fact, this occurred on the 12th anniversary of the first product approval of the CGM company in 2006.

The diabetes community is excited about this approval for a good reason.

The latest generation of Dexcom CGM G6 is the first that offers direct-to-phone connectivity, and there is no need for fingerstick calibrations and a separate receiver.

Also, this marks exceptional regulatory move which paves the way for quicker regulatory approval of CGMs and other devices for diabetes in the future that might be easy to use.

The launch is expected in June, and on the other hand, the international launch is expected to happen in the second half of this year after it gets its approval.

You should know that the latest device improves the G5 regarding convenience and accuracy, making CGM a diabetes management tool more acceptable to more people who have diabetes. Read on to find out more about Dexcom G6.

Dexcom G6 – The Device That Takes Diabetes Management to the Next Level

With this device, we actually have the first approved CGM sensor for wear of ten days which continuously transmits data to a smartphone.

So, these are the biggest changes. However, there is so much more to this next generation Dexcom, so read on to find out.

Range and Transmitter

The brain of this device is the transmitter. Now it is around a third smaller, lower-profile and thinner in comparison to the previous model. Also, it comes with new sugar-analyzing algorithm inside.

Still, it has 3-month battery life and a brief grace period on its last part. However, there is a built-in Bluetooth connectivity which allows it to transfer results every 5 minutes on compatible devices and the app on your smartphone.

The transmission range is the same as the prior generation – 20 feet.

No Fingerstick Necessary

This new device no longer needs once or maybe twice on a daily basis fingerstick calibrations. It is great that even this device is factory-calibrated, it has the capability for customers to enter calibrations still if they want to do that.

Ten Day Wear Sensor

It is said that the water-resistant sensor of the G6 is more reliable and accurate. Also that you can wear it for ten days in comparison to the current 7 days.

Every single sensor has built-in shutdown which is separated from the calibration code, and it will stop functioning at its mark after ten days.

Disposable Auto Inserter

Now customers will be using a self-contained, spring loaded and plastic auto application which demands to press an orange button in order to inject a brand new sensor.

Approved for Young Children

One great news about this new device is the fact that is approved for kids of age 2 and older. This is undoubtedly another advantage to the G6.

No More Tylenol Effect

There will be no more interference from drugs which have Tylenol, i.e., acetaminophen, that has been a problem regarding the CGM world.

This device comes with a specific membrane on each sensor that removes the body chemistry interference from these drugs, which previously could deliver false high sugar results.

The Receiver in the Box

A receiver will come with every device for now, even if people choose not to use it and rely on the smartphone app.

Mobile App

This new mobile app will begin presenting sugar results on the G6 mobile app. It shows a circle with the current real-time sugar level and suitable color code – Yellow, Red or Gray. This color code depends on whether you are in high, low or in range.

Both Android and iOS

Another great news is that both Android and Apple will support this new device.

Predictive Alert s

Whenever the sensor picks that sugar levels are falling fast and that you will drop to around 55 mg od dL within 20 minutes, you will get an “Urgent Low Soon” alert.

Customizable Alerts

This allows you to set various alert preferences for different times of the night or day.

Cost of This Device

So, the inevitable question comes – “How much does this device cost? Well, the company had not disclosed the price for this device. This is a crucial question, given the automatic ten-day shutoff which means sensor wear cannot be extended in order to save money and units.

The company says that the latest generation G6 shall be more economical. A box of 3 sensors which last ten days each is equal to thirty days total. This is in comparison to a box of 4 sensors which last 7 days each which is equal to around 28 days in total.

Medicare Coverage

This is another problem as well. The company got Medicare coverage for the G5 in 2017, but the CMS, i.e., the Centers for Medicare and Medicaid Services refused to grant beneficiaries to use the data-sharing function and smartphone app of the continuous glucose monitoring.

The company has been working with the agency and having regular meetings in order to solve this problem, but it is still unresolved. We hope it will happen fast. See how the device looks in the video below.

Conclusion

People are thrilled to see this approval of the G6 and they are impressed with how the Food and Drug Administration showed its willingness to put products out so rapidly. So,what about you,  are you excited about this product?