FDA approves Tandem’s insulin pump with Dexcom CGM integration

Tandem Diabetes Care has earned FDA approval for its touchscreen insulin pump for use with Dexcom’s continuous glucose monitor. The combined system is the first approved sensor-augmented insulin pump that allows patients to make treatment decisions without pricking their finger.

Dexcom’s G5 CGM system uses a sensor, inserted just under the skin, to measure glucose levels in the interstitial fluid. It is the only FDA-approved therapeutic CGM, meaning it is used to inform treatment decisions. Other CGMs on the market are used as adjunct devices—the information they provide must be used alongside data from other devices, such as blood glucose meters. However, the Dexcom system does require frequent fingerstick calibration, to ensure the sensor is on track.

The integration is approved for patients aged 6 and older. Tandem is rolling out the new software to people who already use its t:slim X2 insulin pump via a remote update. Now, users may view their insulin delivery activity alongside CGM data from the Dexcom sensor on the t:slim X2’s screen.

Tandem’s device is the only insulin pump that allows users to perform remote updates using a personal computer: "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," said Tandem CEO Kim Blickenstaff in a statement.

"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.

Tandem and Dexcom are also working on a system, using the t:slim pump and the G5 CGM, that automatically stops insulin delivery when a patient’s blood glucose levels are predicted to fall.

And the pair is collaborating with TypeZero Technologies on a closed-loop system for blood glucose control. While the system currently runs TypeZero’s closed-loop algorithm on a smartphone, the trio hopes to integrate it directly into the touchscreen of Tandem’s t:slim pump.