US FDA Approves New Larger-Capacity Insulin Pump

Miriam E Tucker


January 13, 2015

A new larger-reservoir insulin pump has been approved by the US Food and Drug Administration for use in patients aged 12 and over with both type 1 and type 2 diabetes.

The t:flex insulin pump (Tandem Diabetes Care) holds up to 480 units of insulin, in contrast to the 200- to 300-unit capacity of most other pumps. It is designed for people who require more than 100 units of U-100 insulin a day, including some teenagers with type 1 diabetes and many people with type 2 diabetes.

The official indication is "for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater."

Incorporating the same design, technology, and touchscreen user interface as the current t:slim insulin pump, the t:flex "offers people with greater insulin needs the benefits of pump therapy without the frequent reservoir changes required by 200- and 300-unit capacity pumps," according to a Tandem statement.

The t:flex pump is expected to launch in the United States in the second quarter of 2015 and will be the largest-capacity insulin pump currently available there, the company says. More information is available at


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