Speaking of iPhone-ish diabetes devices (aren’t we always?), a number of readers asked us lately for an update on the new Tandem insulin pump, which could hardly look more Apple’esque if it tried:
The San Diego-based company has been developing this one for several years, and recently added some famous names to its Clinical Advisory Board: insulin pump experts Dr. Bruce Bode, CDEs Virginia Valentine and John Walsch, and Dr. Steven Edelman of TCOYD fame.
None of them could tell me anything, as Tandem is still pre-FDA approval, and under strict NDA. So I turned to the company directly, chatting briefly with CEO Kim Blickenstaff last week.
I say “briefly” with emphasis, because it seems Tandem is a classic case of stuck-in-FDA-purgatory.
“As you know, the FDA has swung towards heightened safety scrutiny… A major concern is that user interfaces on medical devices can be a source of error,” Blickenstaff says.
Yet the Tandem isn’t actually integrated with a phone or other consumer device; it simply offers “the entire interface experience via touch screen — so all profiles, settings, etc. are menu-driven to be more intuitive, more self-instructive,” he says.
So what’s the holdup, I wonder? Touchscreens can easily feature safety locks so that buttons don’t get pushed by accident. And this is a traditional, tubed pump that works with standard infusion sets. Are there other new and special features that might raise eyebrows at the FDA — and lure pumpers away from other models we’re using?
“For anybody that likes style and design … we think the ‘consumer design appeal’ is a major advantage,” Blickenstaff tells me. OK, I certainly get that. But is it really enough to make a success of an otherwise-standard insulin pump from a smaller player, that might not have the resources and reach of a company like Medtronic or Animas, nor the wireless appeal of the OmniPod?
“We’ve conducted focus groups across the country, talked to thousands of patients, and identified that there still are unmet needs. We’re working to meet those needs… But we’re very limited in what we can say publicly while we’re waiting on the FDA.”
Hmm, unmet needs? Ya think so? I bet folks here could name a few.
My thoughts are: the Tandem pump looks cool. I’d like to know what else it can actually do to improve life on insulin. And I sure hope it gets through FDA before the touchscreen interface becomes old news.
I tried to get a look-see at the CWD conference last year, but they weren’t showing anything, which is a shame because I’ve got experience in designing and implementing touch screen interfaces.
One think I’d love to see is a delayed bolus. That is where I’m going to eat a meal but my BG is low, so I know I can’t bolus at that time but I don’t want to forget to bolus later. So I can enter meal carbs and current BG level, it can figure out how insulin I’d need for the meal less the amount of carbs needed to correct my low and then let me deliver the insulin after an amount of time, say 1 hour later. Of course there’d have to be an option to cancel or further delay the bolus: perhaps it would warn the user about 5-10 minutes before it was going to deliver so they could see where their BG was at that time.
I do also hope (and pray) that they open up their data interface, so we can easily download and look at data from the pump. How about a standard mini-USB or bluetooth connection and data exportable as XML or CSV format?
A delayed bolus feature is a good idea, so is ability to execute an extended bolus even if one is already active which would really help those of us with slow digestion and use extended boluses with every meal.
As for the FDA, it is like a bad joke. I was just thinking yesterday that I bet we see the Jewel in Europe for years before it gets FDA approval.
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I agree with David and Bernard (above) re the extended and delayed bolus options. I saw the pump at AADE in San Antonio. Very nice, but wondering why they had so much space at the exhibit hall when it seems approval is so far off. By the time they come to USA market, those who have been using touch interface technology for years will have moved on to something newer. Amy is right: how will it make life on insulin better, especially if it doesn’t have those features mentioned above?
here here on the delayed bolus. delayed basal would be helfpul too.
Another thought. How about an extended bolus where it can be extended for more than 8 hours? If I’ve taken a high fat meat I may want to spread the insulin over a longer time to allow for the long-term rise in BGs due to the fat.
animas allows a 12-hour extended bolus.
Since John Walsh is involved, I hope the Super Bolus option is something one can select too.
@Ellen – I agree, although the Super Bolus can be tricky (hypo alert!) Please see my coverage of the Super Bolus method here:
http://www.diabetesmine.com/2007/05/dont_just_bolus.html
Another request, more control over temp basals. I use temp basals a lot to correct minor lows or would be lows.
Ideally, I’d like to say “temp basal 0% for 1 hr, followed by temp basal 95% for six hours”
what Susan said!! I can’t tell you how many times I’ve wished for this feature…
Sure looks cool!
I know a handful of folks at Tandem, and they are all solid, brilliant people.
We all know that it is a compromise between innovation and safety when viewed through the FDA’s eyes. I’m anxious to see how and where Tandem strikes that balance.
A lot of the features that have been requested above were included in my Cozmo pump. I really miss it. I was able to set correction boluses to increase (e.g.+10% if I was over 200 bg), it reminded me when to change infusion set, I could get average bg’s, suffice it to say I wish I had hung on to it instead of trading it in. Since I am near Tandem’s hq, I would have loaned it to them to see what features to add. From what I understand, Cozmo was a Bristish company that didn’t think it could compete with the giants over here (minimed and johnson & johnson)