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