The newest insulin pump system on the U.S. market is the smallest, and the first to feature a color touch screen.
The Food and Drug Administration granted clearance on Nov. 16 to Tandem Diabetes Care Inc. to market its t:slim Insulin Delivery System. It is the first to be cleared under the FDA’s Infusion Pump Improvement Initiative, which established requirements for infusion pump manufacturers and aimed to facilitate device improvements and increase user awareness.
According to a company statement, the t:slim was designed to make diabetes management easier to teach and to learn. Additional user-oriented features of the insulin pump include an eco-friendly rechargeable battery and USB connectivity to Web-based therapy management software.
Among the 1.5 million people in the United States with type 1 diabetes, about 20%-30% use an insulin pump, according to industry estimates. Clinical evidence supports the use of a pump to improve glycemic control and quality of life. "Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy," according to a company statement.
Tandem plans to launch its marketing of the device during the first half of 2012.