With companies like Amylin Pharmaceuticals, ViaCyte Inc., DexCom and others, San Diego has earned a reputation as a leader in diabetes research. With a recent approval from the Food and Drug Administration, the industry can add Tandem Diabetes Care Inc. to the list of local leaders.
Last week, the FDA granted the company clearance to market the t:slim Insulin Delivery System. This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA's new Infusion Pump Improvement Initiative.
"With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy," said the company's President and Chief Executive Officer, Kim Blickenstaff, in a written statement. "In creating t:slim, we spoke with more than 4,000 health care professionals and people with diabetes, and the clear message we heard was, 'make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.'
"The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike," he added. Before joining Tandem Diabetes Care, Blickenstaff was chairman, CEO and co-founder of Biosite Inc.
The t:slim is designed to have a vivid color touch screen in hopes of making diabetes management easier to teach and easier to learn. Additional user-oriented features of this insulin pump include an eco-friendly rechargeable battery and USB connectivity to a web-based therapy management software.
Of approximately 1.5 million people in the United States with type 1 diabetes, industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life. Tandem Diabetes Care said it believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy.
"Medical devices are often designed for the hospital setting, not for everyday life. Things like size, look, and feel are often overlooked," said Dr. Timothy Bailey, director of the Advanced Metabolic Care and Research Institute. "Patients need an insulin pump designed to easily integrate into their daily lives. The device needs to be unobtrusive and look more like the consumer electronics they already use everyday."
Tandem Diabetes Care plans to build its customer support, sales, clinical, and business operations in preparation for U.S. launch of the product during the first half of 2012.