Almost 10 months after the Tandem Diabetes t:slim insulin pump hit the U.S. market, we finally have access to the pump management software that goes with it.
Tandem released their much-anticipated t:connect pump software last night (read: very early today) at the stroke of midnight on the East Coast. The cloud-based software, which works from either a PC or Mac (!), merges data from t:slim pumps and an assortment of seven different blood glucose meters to create striking visual graphs and reports to help users and healthcare providers get a clearer view of the relationship between the pump settings, insulin, food, behavior, and blood sugar.
You should remember that I'm someone who helps people in a clinic to optimize their pump settings, so I spend a lot of time every week working with a whole bunch of different pump software. And I can tell you without hesitation that what Tandem has created made me drool.
I am a t:slim user myself and I've shared my thoughts on this pump before. What makes this newsworthy, not only to t:slim users but to anyone with a vested interest in what the FDA does regarding diabetes devices, is that Tandem Diabetes is the first company to push pump cloud-based software like this through the regulatory agency's new stricter guidelines.
Yes, it took a little longer than company officials expected.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
Snail Uses Insulin to Poison Fish
New study shows these slow-moving creatures use toxic form of insulin to capture prey.
A New Square Patch Insulin Pump
TouchéMedical's new Bluetooth-enabled patch pump is supposedly the world's smallest and cheapest.
For almost a year now, Tandem's been selling their touch-screen pumps sans software after receiving FDA approval on the pump in November 2011. All the while, Tandem tells us there was a lot of "back and forth" between the company and the federal agency. Tandem got the regulatory approval on Feb. 26, 2013, and then it took another whole month for the company to get it finalized for market: making last-minute tweaks, preparing all the official labeling, and making sure tech support and sales people were fully trained and ready to help.
So, was it worth the wait?
Well, Tandem bills the software on their website as the "visual way to fine-tune your diabetes management." Wow, sounds magical! But is it Disney magic or Hogwart's magic?
Maybe my initial insights can help you decide if you haven't had the joy of using t:connect yet.
Getting it Up and Running
Startup is very user-friendly; I was able to download and install everything in a few minutes. When I plugged my pump in for the first time I got a popup that said, "Holy crap you have a lot of data! This will take a while!" (Or words to that effect.) Of course my pump is a 'virgin' that has never been downloaded, and it's been in use for over 90 days, so there's a lot of data stored in there. It took about 90 seconds to export the pump to computer, then about five minutes to upload it to the cloud. But I'm told that t:connect is a smart system, and that next time it will be much faster as it only uploads data it hasn't seen before. If you upload on regular basis, it's supposed to take no time at all. (So it's not like changing their cartridge, which is actually a pretty slow process.) The t:connect software, and your data are hosted on "highly secure and HIPAA-complaint servers."
After initial set up, any time you do a fresh upload, the software takes you directly to the "Dashboard," where the first thing you see is a trio of large color-coded numbers showing your highest, average and lowest blood sugars for the last three days. You can also click to see your data for a week, two weeks, a month, or any custom date range you choose. For fun -- and to just to see how much data the pump could store -- I went back to the week after Christmas 2012 when I first got my pump. My very first week of data was there. And it wasn't pretty:
The Dashboard also shows the distribution of your blood sugars; a quick summary of insulin usage; and the average time between cartridge changes, site changes, and cannula fills—all of which were in bright red on my download. My pump is trying to rat me out to my doc by showing that I'm not changing these things as often as I should! Of course, the pump doesn't know I'm in a protracted fight with my health insurance company, which covered the pump but won't cover enough supplies to make it work, but that's a story for another day...
Next, I went back and plugged in my recently recalled Verio IQ, which comes in the package with each new t:slim pump (Note: the recall came down early this week, and only reflects a problem with super-high readings, above 1000 mg/dL). The software also supports OneTouch UltraMini, OneTouch Ultra 2, FreeStyle Lite, FreeStyle Freedom Lite, Accu-Check Aviva, and Accu-Check Compact Plus meters. If your insurance company doesn't cover one of those meters, any reading you entered into the pump manually will still download along with your pump data. How did they choose the meter line up? Tandem says those are the most popular meters being used, so it's just common sense.
The meter upload was straightforward and fast, the data merging seamlessly with the data from the pump and filling in some missing info. To keep your average accurate, the Tandem people tell me the system will delete identical readings, identical being defined as the same BG level twice within a 10-minute time window.
The development team at Tandem tells me that they designed the software the same way they did the pump: by asking potential users what they needed. They had two over-arching goals: to make the download process simple; and to make the color-coded reports and graphs easy to understand.
They nailed the download. It's very straightforward and fast. You just plug in your pump and press a few buttons on your computer. You don't need to suspend insulin, and you can be charging your pump while you download. You just ran out of excuses for why you can't download your pump.
What Can You Learn?
Once you've downloaded...err... uploaded... uh, reloaded... oh, whatever—once your data is in the t:connect system, the software generates a wide array of graphs and reports to give you insight into your diabetes and your diabetes therapy. This is the visual magic to help you fine-tune! I think it's frickin' awesome and I can't wait to get to work with it on our t:slimers. But as to how useful this might be for John (or Jane) Q who may not have a lot of help from a clinician, let's look at the data itself.
t:connect provides three basic reports: Therapy Timeline, Blood Glucose Trends, and Activity Summary.
Activity Summary is a trio of pie charts that show the percentages of various levels of blood sugar; the breakdown of types of insulin used; and a break-out of the types of boluses given.
A quick glance at my Activity Summary's blood glucose pie chart for the last month shows that I'm high 23% of the time, above target 19% of the time, in target 41% of the time, below target 11% of the time, and hypo 6% of the time. It also gives us the overall average and the all-important Standard Deviation. And we are sooooo not going to talk about my standard deviation score.
I hate dealing with patients like me.
Looking at the insulin delivery pie chart, you can see that 69% of the Novolog the pump delivers to me is in the form of basal (not too far off base for low-carb eaters like me, who generally use less bolus insulin than the traditional 50/50 split we are all taught), and11% of the insulin is corrections. Looking at the bolus usage pie chart you can see that I take corrections with meals 12% of the time: so either I'm not checking my BG before meals as often as I should, or I'm generally close to target before meals.
The Glucose Trends report is a classic x/y overlay with some sexy features. Time of day runs horizontally, while elevations in blood glucose—color coded of course—run vertically. You can connect the dots by day, or hide the lines that connect blood sugar readings taken on the same day. You can hover over any point for more info, and you can change the targets if you want to. You also have the option of viewing by day of the week instead of by time. When I checked mine for three months, I didn't see any major difference between weekdays and weekends, but if I had, it might have been a clue that a different profile would be in order for the weekends. When I looked back at three months of data, a helpful popup appeared on the screen telling me that the study period included a daylight savings time change, which I should keep in mind when looking at the numbers. Smart software! Still, this report isn't much to write home about, and most meters come with something almost as good.
Oh, and don't forget that I'm a CGM (continuous glucose monitor) user. That means I don't do fingerstick tests as often as a non-CGM pumper should. The only blood sugar data you are looking at is my calibration fingersticks and the ones I take when the CGM lets me know that the s*** has hit the fan.
The Therapy Timeline report shows us a "global snapshot" of what's happening in our personal D-worlds. Here, all in one place, are your fingersticks, your basal, any temp basals you ran, and your boli: meal, correction, combo, and extended. And there's one other cool and innovative feature. See the blue "sails" on the graph following each bolus? That's a visual depiction of my IOB (Insulin On Board). It shows the volume of insulin still in play in my body, and the period of time that it lasted in my body. How frickin' cool is that? As far as I know, Tandem is the first to get something like this through the FDA.
See how much fun this is? This kind of info is really useful for me, clinically, but will you find it useful at home? I don't know. You tell me. In comments.
You can also bypass the charts and graphs and go old-school with a logbook style view, and all that info with pump settings can be printed out so you have a back-up copy of your settings.
More Connections Needed
Still, the t:connect does leave some things to be desired. For example, we can't yet download any CGM data. Tandem isn't saying when that might be available, which probably means they're working on it. As to when, I couldn't hazard a guess -- and I doubt the Tandem crew could guess correctly even if they were allowed to say. But it's safe to say that the folks at Tandem know we WANT this.
For anyone hoping this might be a "smartphone-capable" software, don't get too excited. PC mobile devices with Flash capability will be able to view data in the cloud and generate reports from uploaded devices, but mobile devices can't serve as upload stations. Sorry, iPhone crowd: Apple mobile devices can't be used to view data, at least not yet.
And at this point, data only flows from the pump and the blood glucose meters to the cloud. You can't use t:connect to program your pump on a computer, a standard with many brands of pumps in the "old" days, that seems to have become extinct in recent years. Tandem's crew tells us that we might see this in the future, but it was not pursued largely because they felt they had created a device that is easy to program directly on the machine with their profile-based menu system. It's true: I've found t:slim is the easiest pump on the planet to program, IMHO.
Worth the Wait?
Yes, I think it is. The t:connect is slick. I'm looking forward to using it on myself and on my patients. And it's smart. But it's not intelligent -- as in it doesn't provide clinical decision support or actively call out potential cause-and-effect relationships like we see in CareLink Pro or to a lesser degree in Dexcom Studio. But of course, those are both programs that make use of CGM data. Still, I think t:connect is pretty awesome based on the features it does offer.
Down the road at some point, when CGM data can be imported to the same cloud and we have more two-way interaction and connectivity available, we're gonna see a helluva rain storm of good information!
To me, that's when the real magic will appear.