FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Tandem Diabetes Care Begins Enrollment for Insulin Pump Pivotal Trial

Aug. 23, 2017
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Tandem Diabetes Care has begun enrollment in trials for its touchscreen insulin pump.

The company announced the enrollment of the first patients for the at-home pivotal trial for the t:slim X2 Insulin Pump, which uses the company’s predictive low glucose suspend technology.

The study is a multi-center, randomized crossover trial comparing two three-week insulin pump use periods, one involving the pump and the other involving another pump without automated insulin suspension. It will include 90 type 1 diabetic patients aged six and above.

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