To make a splash in an insulin pump market dominated by Medtronic, Tandem designers seemed to take Apple’s slogan to heart to think different when they created the t:slim insulin pump. These designers focused on creating a touch-screen user interface that was more user-friendly than existing pumps on the market, and they wanted the pump to look more like a smartphone or mp3 player than a medical device; one of the biggest selling points of the t:slim was that it was shaped to be about 30% thinner than other pumps.
Now, Tandem designers are trying to have their cake and eat it, too, with the new Tandem t:flex pump, which a company spokesman promises will hold more insulin while trying to maintain the pump’s sleek design. The t:flex pump should be available for sale in the United States between April and June.
Company spokesman Steve Sabicer says the new design is focused on offering greater flexibility for the user. While 200-unit and 300-unit pumps have been on the market since 2007, a 480-unit pump can provide more options for daily diabetes care, he says. Tandem’s innovation is meant to address a need which researchers see as still largely unmet within certain user profiles, he says. The t:flex improvement incorporates a larger reservoir cartridge, allowing the pump to maintain the trim dimensions of Tandem’s existing products, and employs the same touch-screen interface and other user-friendly features, he says. The pump will be 7% larger than the t:slim, but still 25% smaller than Medtronic and Animas pumps which hold 200 to 300 units, according to Sabicer.
The t:flex pump reservoir is designed for three days’ usage 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. More than 400,000 Americans with Type 1 diabetes and approximately 75,000 with Type 2 are pump users. Endocrinologists cited in the research literature suggest that limited capacity is the number one barrier to insulin pump adoption for people with Type 2 diabetes. At press time, details of the FDA clearance record had not yet been published. However, according to Sabicer, FDA granted an optional 90-day fast-track review, commenced in November and completed on January 12. The expedited review process allows improvements to existing medical device technology to reach the user market based upon prior clinical trial outcomes and post-clearance reporting, thus substantially shortening the time table for market availability.
Only time will tell if Tandem’s expanded insulin pump reservoir will give the company an expanded foothold in the pump marketplace.
An earlier version of this story incorrectly stated that the pump might be effective for women with gestational diabetes. We apologize for the error.
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