t: slim X2 automated insulin pump gets FDA nodFebruary 5, 2020
US FDA has cleared the t: slim X2 insulin pump with Control-IQ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL).
t: slim X2 is the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar, Tandem Diabetes Care said.
The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no finger sticks for calibration or diabetes treatment decisions.
Control-IQ technology for the t:slim X2 insulin pump is the first automated insulin dosing software in a new interoperable automated glycaemic controller category that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled
insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
This is the third category classified by the FDA for the interoperability of devices as a complete automated insulin dosing (AID) system.
The t: slim X2 insulin pump with Control-IQ technology uses CGM values, in conjunction with other variables such as insulin on board, to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped.