Another Insulin Pump is Coming   (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.

Although the company website doesn't have much detail about the pump, it does list the members of their Clinical Advisory Board, and I was pleased to see that I recognized most of the names as experts in the field.

Granted what I now know about this new pump, would I be interested in getting one? I think that my best answer is to quote Alexander Pope: "Be not the first by whom the new are tried, nor yet the last to lay the old aside." There are too many unknown factors about any new insulin pump.

First, what will the pump's reliability be like? With pumps, where one is depending on the device to keep you alive, the main concern is reliability. No one will know about the inevitable software or mechanical glitches until it's in common use - there's no requirement from the FDA for massive clinical trials for devices, as there is for pharmaceuticals, and most companies don't publish the results of their clinical trials for devices. (I can find only one study run by Tandem at ClinicalTrials.gov, which was a "simulated useability study ...to demonstrate the user interface and software design [and] mitigate potential safety concerns," and none at PubMed.)

Second, excellence of customer service (for instance, 24 hour/day access to pump experts, and 24-hour turnaround on sending replacements) has become the norm for pump companies, and presumably this company also. We shall see.

Also, does the company have sufficient financing that they won't go broke after a year, leaving the pumper with an orphan product?

And a stand-alone pump, which isn't integrated with either a meter or a CGM device, is rapidly becoming an outdated concept.

Finally, pricing of the pump and supplies will be a huge determining factor in acceptance of this pump. If it's priced at half of the price of current pumps, it'll gain market share without trying. If it's priced higher than current pumps, the inevitable question will arise about whether it's worth the touchscreen and other features.

It will be interesting to watch the marketing of this pump evolve over the next few months, and see if this pump can become a competitor in this market.