Tandem’s Predictive Insulin Pump Software Receives the US FDA’s Approval to Deliver Accurate Doses of Insulin in Patients Utilizing t:slim X2 Insulin Pump

Tandem’s Predictive Insulin Pump Software Receives the US FDA’s Approval to Deliver Accurate Doses of Insulin in Patients Utilizing t:slim X2 Insulin Pump

Shots:

  • The US FDA has granted De Novo marketing authorization to Tandem’s Control IQ technology, a software program utilizing reading from a CGM to automatically adjust insulin delivery to a person with diabetes using Tandem’s t:slim X2 insulin pump
  • The FDA approval is based on a clinical study evaluating Control-IQ technology controller installed on a Tandem t:slim X2 insulin pump/ CGM vs insulin pump without the controller. The study demonstrated that the controller determines effective insulin delivery from ACE pump based on iCGM readings, with limited user intervention outside of mealtimes
  • The t:slim X2 insulin pump with Control-IQ technology is designed to aid increase time in range (70-180 mg/dL) and prevents high & low blood sugar levels by adjusting insulin delivery. The system integrates with Dexcom G6 CGM, which requires no fingerstick for calibration of diabetes

Source 1, Source 2 to­ read full press release/ article | Ref: FDA, Tandem | Image: Tandem