TANDEM DIABETES CARE ANNOUNCES FDA CLEARANCE OF THE T:SLIM™ INSULIN DELIVERY SYSTEM
Smallest Insulin Pump System and First-Ever with a Touch Screen
SAN DIEGO, November 16, 2011—Tandem Diabetes Care, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). 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 Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare 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.”
Of approximately 1.5 million people in the U.S. 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 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 every day.”
The t:slim has a vivid color touch screen and was designed to make 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.
As part of Tandem Diabetes Care’s commitment to excellence, the Company will be building its customer support, sales, clinical, and business operations in preparation for U.S. launch during the first half of 2012.
For broadcast quality B-roll footage, please visit: http://videostorage.prnewswire.com/storage2/download/53296HD.zip
About the t:slim Insulin Delivery System
The t:slim is a modern, programmable insulin infusion pump for people with diabetes mellitus age 12 and greater who require insulin. The pump’s streamlined interface provides users with quick and easy access to all the device’s functions. The t:slim features Tandem’s proprietary micro-delivery technology, which provides safe and accurate insulin delivery from a 300-unit cartridge, and allows for the device’s slimmest-in-class form factor.
About Tandem Diabetes Care, Inc.
Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a privately held company with novel technology and a comprehensive, user-centric and integrated approach to product development and customer care. Tandem is based in San Diego, Calif.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetesCorp
Tags: news, pumps, technology
Replies to This Discussion
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Permalink Reply by Franco on
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I saw it and played with it at the ADA Expo in Seattle in April. There's a lot I liked but the deal killer for me is the need to recharge, it just won't work for me. Just like the Dexcom which, when I'm often away from electricity on sailboats or backpacking, only lasts two days unlike my, now not U.S. available, Navigator cgm & 7year old Delcec pump which will last forever with backup AAA's. This just limits my freedom and is unacceptable! Too bad 'cause there's a lot to like about it.
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Permalink Reply by still_young_at_heart on -
That's not even considering what happens during a power outage..
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Permalink Reply by Janice L Cotton on -
You would think that this device would not have been cleared by the FDA if this wasn't considered and resolved. Perhaps there's something that we are not aware of.
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Permalink Reply by still_young_at_heart on
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I'm sure it was considered and perhaps the FDA is OK with the small additional risk that is involved but I don't feel any need to accept it just to have a pretty screen.
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Permalink Reply by CarbMom on -
I've read a little about it. I'm considering it for my son...for his first pump. I think the charge is supposed to last at least 5 days. They recommend you top off every day. You can also charge with the USB. I've see some recharging devices that Duracell makes for any USB device..... I would think you can buy one of those for a backup.
I didn't think about breakability.... I shattered my iphone within a month of owning it... have to consider that with a teenager!
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Permalink Reply by Parrformance on
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Gas generator at the ready:)
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Permalink Reply by Leotha Fleming III on -
I actually started the process to allow them to get insurance information. I actually just started on the Animas Ping, but that I actually got the Ping under my Pediatric Endo. Now that I'm with an Adult Endo, I'm holping my insurance would approve it with new paper work.
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Permalink Reply by CarbMom on
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When did you get your Ping? Animas told me that they have a 30 day return policy
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Permalink Reply by Christalyn on -
we don't we try and do something about Type 2's having the ability to get a pump? I am an insulin dependent diabetic but I am not seeing anything being done to help in this area for Type 2's. I think a pump would help me alot but my doctor refuses to get me one. I am personally having a hard time injecting myself several times a day.
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Permalink Reply by DianaS on -
I'm Type 2 and I've been on a pump for over 11 over years now. In this area most physicians who prescribe pumps have type 2 patients on pumps. They base their decisions on therapy needs not just diagnosis alone. Type 2's can get pumps if they qualify per insurance. Medicare excludes type 2's though so if your insurance follows medicare guidelines then they won't cover it. If your doctor is that rigid ie refusing to discuss it when your insurance would cover it then I would consider finding a new doc.
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