Business Wire05.05.20
Tandem Diabetes Care Inc., an insulin delivery and diabetes technology company, has announced U.S. Food and Drug Administration (FDA) clearance of its Basal-IQ technology as an interoperable automated glycemic controller (iAGC). This is the second system to receive iAGC designation by the FDA, following the Company’s clearance of the t:slim X2 insulin pump with Control-IQ technology in December 2019.
The FDA has classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, which include an alternate controller-enabled insulin pump (ACE pump), an integrated continuous glucose monitor (iCGM) and an iAGC. The t:slim X2 insulin pump was also the first to receive an ACE infusion pump classification in February 2019, and the first insulin pump designated as compatible with iCGM devices in June 2018.
“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 enhancements,” said John Sheridan, president and CEO. “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 simple-to-use t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from an integrated Dexcom G6 continuous glucose monitor to predict and help prevent lows with zero fingersticks.1,2,3 Basal-IQ technology uses CGM values to help reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL or if a CGM reading falls below 70 mg/dL. Insulin delivery resumes as soon as sensor glucose values begin to rise.
Tandem Diabetes Care and Basal-IQ are registered trademarks, and t:slim X2, Control-IQ and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. All other third-party marks are the property of their respective owners.
References
1 If glucose alerts and CGM readings do not match symptoms or expectations or if taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, use a blood glucose meter to make diabetes treatment decisions.
2 Dexcom G6 CGM sold separately
3 The Dexcom G6 CGM transmitter can only be paired with one medical device (either a Dexcom receiver or t:slim X2 pump) and one consumer device (phone or tablet) at the same time.
The FDA has classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, which include an alternate controller-enabled insulin pump (ACE pump), an integrated continuous glucose monitor (iCGM) and an iAGC. The t:slim X2 insulin pump was also the first to receive an ACE infusion pump classification in February 2019, and the first insulin pump designated as compatible with iCGM devices in June 2018.
“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 enhancements,” said John Sheridan, president and CEO. “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 simple-to-use t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from an integrated Dexcom G6 continuous glucose monitor to predict and help prevent lows with zero fingersticks.1,2,3 Basal-IQ technology uses CGM values to help reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL or if a CGM reading falls below 70 mg/dL. Insulin delivery resumes as soon as sensor glucose values begin to rise.
Tandem Diabetes Care and Basal-IQ are registered trademarks, and t:slim X2, Control-IQ and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. All other third-party marks are the property of their respective owners.
References
1 If glucose alerts and CGM readings do not match symptoms or expectations or if taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, use a blood glucose meter to make diabetes treatment decisions.
2 Dexcom G6 CGM sold separately
3 The Dexcom G6 CGM transmitter can only be paired with one medical device (either a Dexcom receiver or t:slim X2 pump) and one consumer device (phone or tablet) at the same time.