Diabetes Cure

The Dexcom G7 Has (Finally!) Been Approved by the FDA

Huge news for the diabetes community: the Dexcom G7 has been approved by the FDA for sale in the United States!

Dexcom made the announcement on December 8. The brand-new continuous glucose monitor (CGM) is now approved for people with any type of diabetes over the age of 2.

We’ve been waiting for this for a long time — Dexcom has been talking about the G7 for years — and it will soon be here.

When Will the G7 Be Available?

When Diabetes Daily spoke to Dexcom CEO Kevin Sayer over the summer, he assured us that Dexcom would be ready to rock as soon as the regulators gave the thumbs up: “The limiting factor will not be our ability to build it.”

Now it’s only a question of how quickly Dexcom can strike deals with insurers and pharmacy benefit managers, so Americans can get the new device through their insurance. Sayer told me that those negotiations typically take 90-120 days for Medicare and Medicaid, and slightly more for private insurers. The launch is planned for “early 2023.”

The press release also indicated that Dexcom “will have accessible cash pay options in place,” indicating that customers that don’t want to wait will be able to purchase the new device without using insurance at all. There was no word on how quickly cash-in-hand purchases will be available.

The Dexcom G6 and G7, side by side

Let’s take a look at some of the features:

The Size

The G7 is tiny! Dexcom reports that the new device is 60 percent smaller. Even if nothing else about the technology were improved in any way, that slim profile would be well worth looking forward to.

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Bye-Bye Transmitter

Here’s the other big change: you’ll be able to kiss that transmitter goodbye. The G6 system requires two pieces of hardware, a sensor that attaches to the skin and lasts 10 days, and a transmitter that snaps into the sensor and works for about 3 months. But the G7 is an all-in-one device, sensor and transmitter both, and it is fully disposable. You insert the little sensor onto your body and then remove it 10 days later. It should make switching sensors a whole lot easier.

Warm-up Time

Here’s another big improvement – the 2-hour warm-up time will be reduced to a mere 30 minutes.

The Accuracy

The G7 rates as highly accurate and, unlike the G6, it is approved for wear on the arm as well as the abdomen.

In fact, the G6 itself has been getting more and more accurate since its original release, as Dexcom refines its algorithms and updates its software. There’s no reason to expect Dexcom to stop targeting continuous accuracy improvement.

Calibration will work the same way it did with the G6: It’s optional. The G7 is factory-calibrated and is meant to work perfectly straight out of the box. Users that prefer to calibrate with their glucose meter will still be free to do so.

The Wear Time

The Dexcom G6 is only approved for 10-day wear. However, many users try to circumnavigate this by hacking their sensor to get more days out of it.

Dexcom is very aware of this fact, just as it is aware that its major competitor, the FreeStyle Libre 3, is approved for 14 days.

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While in the past Dexcom has promised to push its sensor towards 14 days, it looks like the G7 will debut with a 10-day wear time, just like the G6 did. Maybe that will change in the future – Chief Technology Officer Jacob Leach told us that “the platform is designed to extend the wear beyond 10 days,” so, in theory at least, later G7 releases might lengthen the wear time. But at the moment it appears that the company isn’t satisfied with the G7’s reliability after 10 days.

The Cost

The high cost of the G6 has been a sticking point for some patients. The G6 costs a pretty penny if you’re paying out-of-pocket, and there’s almost no telling how much your insurance provider will pitch in. Dexcom has publicly promised that the G7 will, at worst, be priced similarly to the G6, but we don’t have an exact number yet.

Insurance coverage for CGM use has gotten better and better over the years. Dexcom reports that a third of patients with commercial coverage pay $ 0 for their G6, and a majority pay less than $ 40 per month.

Sensor Insertion

Dexcom stated that the product will be even easier to apply than the G6, and that the applicator will be much smaller than the G6, reducing the environmental footprint.

The Adhesive

Many people with diabetes struggle with CGM and insulin pump adhesives — there’s an entire Facebook group, with over 15,000 members, dedicated to troubleshooting rashes and adhesive allergies from CGMs.

The G7 uses a different adhesive than the G6, and the company reports that during testing it’s receiving fewer complaints about skin irritation than ever.

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Integration with Other Systems

The G7 won’t be ready to integrate with the Omnipod and Tandem insulin pumps immediately. CEO Kevin Sayer told us, “It won’t be ready out of the gate. Both of our insulin pump partners have their engineering teams working to integrate it. That’s on their end. We offer whatever resources we can to help them.”

There’s little question that Dexcom will get closed-loop integration going as quickly as it can. The G6 is already a leader in system interoperability, and Dexcom has always been ahead of the curve in securing relationships with other smart diabetes device makers.

The G7 will be compatible with both Android and iOS smartphones, and Dexcom also produces a dedicated a receiver for those patients who prefer not to use a smartphone to track their blood sugar. The G7, just like the G6, will work with an Apple Watch and Garmin devices.

Diabetes Daily