Sunday, June 03, 2012

Another Insulin Pump is Coming

By Dr. Bill Quick, Health Pro Thursday, November 17, 2011

Yesterday (November 16), I received an e-mail from a publicist that stated "Tandem Diabetes Care today announced FDA approval of the first-ever insulin pump to utilize touch-screen technology. It's much smaller than current technologies and looks like an iPhone -- more like a consumer electronics product than a medical product." They are calling their pump the "t:slim."

 

As of today, there's little about the pump on the company website, and nothing on the FDA website, but the patents are available for review (see below).

 

I wrote to the author of the e-mail and inquired about the technical specs for this pump -- about all I can see in the company's press release is that it has a 300-unit capacity, and that it's due to be available in the first half of 2012 (I'd guess it will be introduced at either the ADA meeting in June in Philadelphia, or the AADE meeting in August in Indianapolis).

 

I inquired about the following; in quotes/italics are the answers I received:

 

What battery does it use? "The t:slim battery is rechargeable, much like a smart phone battery, using a micro USB cable that can be plugged into the wall, the car, or your computer. The pump can be charged will delivering therapy giving users flexibility as to when to charge. A full battery charge is designed to last up to 7 days under normal conditions. Charging the t:slim's battery from empty to full takes approximately 2.5 hours. A full charge will be maintained by charging every day. The full length of a charge time depends on the electrical current from the power source."

 

Dimensions? Weight? "The device is narrower and thinner than an Animas Ping and 25% smaller than a Medtronic Paradigm REAL-Time. Actual dimensions will be made available in the first half of 2012."

 

Does it use a standard LuerLock connection? "Standard luerlock infusion sets will be compatible with the t:slim."

 

Is it water-resistant or waterproof? "The device is watertight to the industry rating IPX7." (I had to look up whatever IPX7 means, and found the standard requires that "Ingress of water in harmful quantity shall not be possible when the enclosure is immersed in water under defined conditions of pressure and time. Test duration: 30 minutes; immersion at depth of 1 meter.")

 

I also asked about whether a User's Guide is available. "User manuals will be available for download in the first half of 2012."

 

One question I didn't ask about this pump was whether it's integrated with either a meter or a CGM device, but the patent information I reviewed indicates that it is not.

 

For instance, U.S. patent 2011/0144616 has lots of information: the pump displays and alarms are indicated in Figure 26, and a flow diagram of the sequence of steps the user should perform are in Figure 29; line-drawings of what the touchscreen looks like are shown in Figures 31-39 of the patent. Figures 45-47 show how to insert a new reservoir. Figure 50-53 show what the touchscreen displays are like. Figures 54 and 55 show BG and insulin graphs over time. There's tons of very detailed descriptions about each facet of the pump's capabilities; I honestly got eyestrain staring at the information! One interesting feature is a countdown timer that counts down to zero when you choose a bolus dose, before the dose is actually given. The home screen is customizable to display information in "graphical, numerical, textual [and] symbolic" forms.

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By Dr. Bill Quick, Health Pro— Last Modified: 11/17/11, First Published: 11/17/11