Tandem diabetes care announces fda clearance of the t:slim™ insulin delivery system

Diabetes Technology Insulin Pumps
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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

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Hi Emily. Thanks for this posting. One possible advantage of the color touch screen is that young people would like to use it more than the current types of pump, hopefully leading to better control and fewer eating disorders. I think it would be fun myself! Waterproof and fitting neatly in a pocket is really nice, too.

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I agree! Looks like they're gonna ride the iPhone wave... I've used an Omnipod patch pump for several years and it would take something pretty spectacular for me to return to using a tubed pump, but this IS pretty tempting :)

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The touchscreen is what is really drawing me in. The size of my Ping doesn't bug me, but a touchscreen would be awesome. I think I'd be more 'enthused' about taking care of my D if I felt like I was having fun with it at the same time? Lol.

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I think the touchscreen sounds really cool, too, but when I think of how often my iPhone starts doing things without my permission because it's knocking around in my purse and getting "touched", it makes me nervous. I'm sure great precautions have been taken to ensure the pump doesn't "butt call", but it still seems a smidge dangerous... ?

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Lots of well known folks on the board here. Glad to see new things coming along, but just as glad I got a new pump now. The way my HMO approves things, it's gonna be another four years anyway.

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This would be so great for my bad eyes and shaky hands!!!! Not to mention having a regular number pad to enter sugars! Not having to squint at the Animas screen to see it fly past the number I'm at and have to go back and forth just to enter my sugars and then the bolus!!!! I CAN'T WAIT FOR THIS ONE!

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I’m on omnipod also & was wondering if this was tubed… I don’t think I can go back to a tubed pump I really dont like how big the omnipod is but its is way better than tubed pumps…

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I hear you! Yes, the t:slim is tubed. I really don't understand why more companies aren't developing patch pumps. It seems to me like an obvious next step, but most of them are going for slicker, better interfaces instead. I guess not enough people are showing interest?

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Maybe I'm overlooking something but I can't find any specs. A lovely interface doesn't make much difference to me if the basal increment is too coarse, if the temporary rates aren't flexible enough, if it uses proprietory sets etc.

Maurie

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I think most people on tubed pumps don't mind the tube. Most people on pumps are on a tubed system. So, if you go out to the DC and ask: What do you want? Most of them would likely respond with something to do with interface because getting rid of the tube is probably quite a bit lower on their priority list.

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I agree Maurie. Maybe it is our age range, but I could care less if the screen is a touch screen and looks high tech ( I own not an ipad (sp?) nor a "smart" phone, and I am missing neither from my life) I just want it to work at the same level with the same micro-adjustments. Now if my MM had an "app" that included a list of food carb counts and a memory of frequently chosen items, which I think is available on some other types of pump models, but not on the MM I am using;I would go for that, too. Just as long as it had the basal increment and temporary rate features you mentioned Being little and thin is a plus, too.( The pump I meant, not me-lol)

God Bless,
Brunetta

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Maybe it has a 'slide to unlock' feature? :)

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It looks as if it's NOT a luer lock, so prob proprietary. I agree that it needs to have incremental rates as small as my ping, as well as other features. The touch screen is very attractive, for the reasons Todd outlined. Size looks really nice too, though it looks as if it's thinner but the length and width may be a bit larger? Where does the reservoir they show on the page go?

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It certainly looks snazzy! I'd wonder though 1) how durable is it and 2) how legible is it? I yutz around with my MM pump while I'm running, biking, driving (I know...BAD!!), etc. and it's pretty easy to read, even in direct sunlight. I can't see anything on my phone in certain conditions and it would be sort of useless to have a pump and have to ride off the trail into the bushes to find shade or whatever?

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It is great to see new products come to the market like this one but I have a few concerns about this at first glance...

1. It looks HUGE vs the MM7xx. They say it is 'up to 25% thinner' but it seems to be much larger overall
2. It does not seem to have wireless technology to upload data to your computer which means you need a physical plug which is super difficult to make water proof
3. The large color touch screen is super cool but how would it stand up to a few drops, bangs, or whacks? If it is anything like a touch screen mobile phone it will break far easier than others.
4. Rechargeable battery is an issue in that I like the ability to swap out the single AAA battery and always know I have power even if I am in the middle of nowhere. Also, I did not see how long the rechargeable battery lasts between charges or what happens when its life comes to an end; important in that I normally need to replace the battery in my laptop every 12-18 months.

Also, other than the color touch screen I don't see that it adds any NEW therapy features to the pump world...it is still just a pump. Where is the next generation integrated CGMS for example??

Feedback form anyone with more information would be most interesting.

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I love the features right on the screen: IOB, insulin remaining in units, battery percent, bolus and options separate. It looks fantastic. I don't care about the size issue. I do hope there is a battery though. Of course, I have 5 years (Medicare) before I can switch unless they have a good deal for switchers. I kinda even like the splash for the bolus!

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I actually prefer having the tube. First, the pods with the Omnipod are just too big for me. I'm very small and the pods are large enough that they bulge significantly under my clothing (especially tighter clothing). I also found that the trial pod I wore felt too heavy to do things like exercise comfortably.

Also, I feel safer with the tubing. Maybe it's just me, but I like being able to see the insulin in the tube, confirm there are no air bubbles, etc.

At this point, I am sticking with tubed pumps. The tubing really doesn't bother me at all and I actually prefer it. That said, I like that there are options. We all have different things that are important to us and I like that there is competition. I hope it stays that way.

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Excellent point. I love technology and I LOVE my iphone, BUT...when it comes to an insulin pump, I want something more than just a pretty interface. My iPhone is fun and functional and I definitely rely on it quite heavily. But at the end of the day, my life doesn't depend on it. When I go to sleep at night, I don't have to worry about it malfunctioning and killing me. For me personally this is why I'm sticking with my Minimed Revel for now. It has been completely reliable and Minimed is time-tested. It's also really durable and I would be worried that this pretty pump can't provide the durability I need in a pump (my Minimed pumps have taken quite a few beatings and kept right on ticking...)

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Yep, these were all EXACTLY my concerns too. Also, with a pump you're not just buying a device, but a whole customer service experience that comes from the company providing the pump.

For me, Minimed's Carelink service has been invaluable to me. It has helped my control so much and results in better medical care overall because my doctor's office looks at my data as well. In addition, I have had to do things like get loaner or replacement pumps before and Minimed provides excellent customer service in this regard.

Finally, durability is key for me. I LOVE my iPhone, but you've gotta be careful with it. I don't want to have to worry about my pump too! My minimed revel is tough and I know I can do things like go hiking or camping with it and it's not going to break.

And definitely removable batteries are key.