FDA Approves First Interoperable CGM… Let’s Check-It Out!Katie Taylor
The FDA has just approved the latest and greatest continuous glucose monitoring device. It’s got all the gizmos. It’s got all the gimmicks. It will solve problems you didn’t realize you had.
What? You’ve heard it all before? Fair enough, but the G6 does sound legitimately exciting, and it blazes some new trails for future CGMS and gives us real hope for closed-loop insulin delivery systems. Here’s how the Dexcom G6 is different from its predecessors:
The FDA has authorized the G6 as the first fully interoperable CGM
Does that mean what we think it means? Yes, the Dexcom G6 will be marketed as an integrated continuous glucose monitoring system. It’s the first CGM that the FDA has approved for integrated use with insulin dosing systems, insulin pumps, and blood glucose meters. That means a closed-loop, set-it-and-forget-it (within reason) system. It will also sync with apps for both iPhone and Android.
The FDA hopes that the G6’s ability to work with other diabetes-management devices will give people more flexibility in how they manage their diabetes. If integrated with an automated insulin system such as a pump, the CGM could communicate directly with the pump and adjust for a rise in blood sugar all on its own.
Those compatible pumps are on the way. Tandem Diabetes and Insulet are working with Dexcom to create patch pumps that will seamlessly integrate with the G6 for eventual closed loop systems. Tandem predicts that their compatible pump will be available in the United States in early 2019, and the G6 itself should be available in mid-2018.
What else is special about Dexcom G6?
What we really like about the Dexcom G6 is its new and improved status with the FDA. Previous CGMs were class III devices, which means that they were treated as high-risk and had to go through the FDA’s most rigorous evaluations before approval. Because the G6 is designed for seamless integration with other devices, the FDA wants to use the G6 as an chance to “reduce the regulatory burden for this type of device […].” The G6 is classified as a class II device with only moderate risk, and that means faster approval times for future devices.
This decision should make it possible for similar interoperable devices to receive FDA approval much sooner and therefore reach the people that need them more quickly.
Why Should I Consider the G6 if I don’t use a pump?
This CGM has bells and whistles for everyone. Here are the things that people are excited about:
- The device is factory calibrated. You do not need to calibrate it with finger pricks before using it, though you can do so if you prefer.
- The sensor is good for 10 days. Dexcom hopes to have a 14-day sensor available in 2019.
- A one-touch auto-applicator.
- An alert that will tell you when you are about to experience a low.
- A lower-profile wearable transmitter.
- No more interference with Tylenol—the device will work fine when taking acetaminophen doses up to 1,000mg.
- The device is approved for children as young as 2 years old.
- As with previous models, the G6 will send readings to a compatible receiver every 5 minutes, will be compatible with smart phone apps, and allow for personalized alerts.
Dexcom hopes to keep improving its CGM and make the sensor even smaller. In an interview with diabetes advocate Kerry Sparling, Dexcom’s CEO said, “When I see kids running around with the sensor on, I look at them and say, ‘This has got to be smaller.’”
We love smaller. And better. And more convenient for people with diabetes who have to manage their blood sugar every day. We hope this device makes lives easier—at least until there’s a cure.
Stay healthy, friends!