Tandem Diabetes Care (NSDQ:TNDM) this week announced that it won FDA clearance for its Basal-IQ technology for interoperable automated glycemic control (iAGC).
The FDA has only classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, an integrated continuous glucose monitoring and an iAGC.
“Aligning Basal-IQ technology with Control-IQ technology under the FDA’s new regulatory path helps streamline our internal processes and provides us with a consistent approach to making future product enhancement,” president and CEO John Sheridan said. “Customer choice is a core tenet of our company and this clearance supports our commitment to the interoperability of our AID technologies with our current and future insulin pump offerings.”
The t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from a Dexcom G6 continuous glucose monitor to predict and prevent low glucose levels without fingersticks.
Basal-IQ uses CGM values to reduce the frequency and duration of low-glucose events. It predicts glucose levels 30 minutes ahead and stops insulin if they are expected to drop below 80mg/DL or if the CGM reading falls below 70 mg/dL. Insulin delivery starts again when glucose values rise.
