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FDA approves T:Slim with Basal-IQ

Tandem’s t:Slim X2 insulin pump

The U.S. Food and Drug Administration (FDA) has approved the t:slim X2 insulin pump with Basal-IQ technology from Tandem Diabetes Care. Basal-IQ is a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of hypos. The pump is also designated as compatible with integrated continuous glucose monitoring (iCGM) devices. Tandem plans to launch its new product with Dexcom G6 continuous glucose monitoring (CGM) integration, the first CGM device to receive the iCGM designation from the FDA earlier this year. Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.4

Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study demonstrated a 31% relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.

“The t:slim X2 Pump with Basal-IQ technology was designed to predict and help prevent time spent low using best-in-class CGM technology,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “As the first company to launch a touchscreen insulin pump capable of remote feature updates, and now the first to have a pump approved with iCGM compatibility, we are delivering new innovation to our customers at a pace that is unprecedented in our industry, furthering our mission to help improve the lives of people with diabetes.”

Read more here.

News items and features like this appear in the Desang Diabetes Magazine, our free-to-receive digital journal (see below). We cover diabetes news, diabetes management equipment (diabetes ‘kit’ such as insulin pumps and continuous glucose monitoring equipment) and news about food suitable for a diabetic diet including a regular Making Carbs Count column. We just need your email address to subscribe you (it’s free, and you can easily unsubscribe should you wish to).

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