The FDA has approved Tandem’s t:slim X2 Insulin Pump with Dexcom G5 Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger. Tandem has announced the launch of the new pump and will also make the software featured on this pump available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.
This approval marks the Company’s fifth new insulin pump launch in only 5 years and the second featuring Dexcom technology. It is the only available pump that conveniently displays a user’s insulin delivery activity and Dexcom G5 Mobile CGM data together on a single device. The t:slim X2 Pump is also the only insulin pump capable of remote software updates, allowing existing users to add features like CGM integration from home. It is up to 38% smaller than other pumps, but includes advanced features like a large color touchscreen, Bluetooth radio, rechargeable battery, USB connectivity, 300-unit insulin capacity and watertight construction (IPX7).
“We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “The t:slim X2 Pump is designed to accelerate the pace in which we can bring new innovations to people with diabetes, which is of particular importance as we develop software updates to add automated insulin delivery algorithms to our platform.”
“Dexcom has been moving its technology forward at a rapid pace, and Tandem’s ability to roll out remote software updates like this opens up exciting possibilities for faster integrations of our future products,” said Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom. “We are excited to have our latest CGM technology integrated with their t:slim X2 Insulin Pump, and to see it offered not only to new customers but also to existing t:slim X2 Pump users.”
The t:slim X2 Pump can operate as a stand-alone insulin pump without CGM, or be paired with the Dexcom G5 Mobile CGM to track glucose continuously and display that information directly on the pump’s home screen. Dexcom G5 Mobile is the only CGM system FDA approved to let users make treatment decisions without pricking their finger. Dexcom is also consistently rated the #1 CGM brand in independent patient surveys. In addition to integration with the t:slim X2 Pump, dynamic glucose data from the Dexcom G5 Mobile CGM can be easily accessed and shared using a compatible mobile device.
Tandem users that are on Medicare, you will not be able to use your pump with the Dexcom G5 CGM. I was just approved to get a CGM from Medicare and I’m already have a Tandem pump, as I was getting ready to use the G5 I called Dexcom for help and was told by Dexcom I would not be able to use my pump or any mobile device. Medicare will consider only their receiver as it is a durable medical equipment, not your pump or mobile device because they are not durable medical equipment. They told me that they… Read more »