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Sansum Diabetes Research Institute was one of four research centers across the United States that studied Tandem Diabetes Care Inc.’s t:slim X2 Insulin Pump with Basal-IQ technology, recently approved by the U.S. Food and Drug Administration (FDA). It is the first automated insulin delivery system approved for use by children as young as 6 years old and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices.

The t:slim X2 Insulin Pump’s predictive low glucose suspend feature is designed to help reduce the frequency and duration of low glucose events (hypoglycemia). Tandem plans to launch its new product with Dexcom G6 CGM integration, which requires no fingersticks for calibration or diabetes treatment decisions. Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018.

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 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.

In February 2018, Tandem reported results from the six-week PROLOG (PLGS for Reduction of Low Glucose) pivotal trial, a randomized crossover study comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with Basal-IQ technology, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The study included 103 participants with type 1 diabetes age 6 to 72 at four research centers across the United States, including Sansum Diabetes Research Institute in Santa Barbara, CA.

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