FDA Clears Tandem Diabetes Care T:flex Insulin Pump

Tandem Diabetes Care Inc. has received U.S. Food and Drug Administration clearance to market its t:flex Insulin Pump. At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States, the company claims.

“In recognizing that one size does not fit all, the t:flex pump was developed using Tandem’s proprietary technology platform to bring t:slim’s benefits to people with greater insulin needs,” said Kim Blickenstaff, president/CEO of Tandem Diabetes Care. “This first expansion of our product portfolio reflects our ongoing commitment to deliver user-friendly products that address unmet needs in the diabetes community.”

People with diabetes require different amounts of insulin based on their level of insulin sensitivity, which can vary significantly from person to person. The t:flex pump is designed for people who require more than 100 units of U-100 insulin per day, such as teenagers with type 1 diabetes and many people with type 2 diabetes. The pump offers people with greater insulin needs the benefits of pump therapy without the frequent reservoir changes required by 200- and 300-unit capacity pumps. It incorporates the same slim design, advanced Micro-Delivery technology, and simple-to-use, touch-screen interface as the t:slim Insulin Pump.

The t:flex Pump is expected to launch in the United States in the second quarter of 2015.

Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans. Tandem estimates that 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 400,000 Americans with type 1 diabetes use an insulin pump, or approximately 27 percent of the type 1 diabetes population. In addition, approximately 75,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.

Recent studies suggest that insulin pump therapy reduces average blood glucose levels and overall insulin needs in people with type 2 diabetes compared with standard therapy using multiple daily injections.In Tandem’s market research, two-thirds of endocrinologists cited limited capacity as the number one barrier to insulin pump adoption for people with type 2 diabetes who are insulin dependent.
 
Tandem Diabetes Care manufactures and sells the t:slim Insulin Pump, billed as the slimmest and smallest durable insulin pump currently on the market, and the t:flex Insulin Pump, the first pump designed for people with greater insulin requirements. The company is based in San Diego, Calif.