The 670g is here!
To begin with, I’m not going to get hung up on how they name this system, because really, I care more about what it can do. At some point, I might or might not talk about JDRF’s decision to label this an artificial pancreas. But that’s another discussion for another day.
Okay… where was I? That’s right, the hybrid closed loop system that was approved by the U.S. Food and Drug Administration on Wednesday. There is a lot to cover. Here we go:
1. First, I’d like to offer this quote from Medtronic Diabetes CEO Hooman Hakami, who posted this on Wednesday:
”This approval is a significant milestone in the history of diabetes management, and a culmination of many years of dedicated work. With this approval, we are one step closer to delivering a fully automated closed loop system.”
All of this is true. They’ve been working on it for a while, using many resources, conducting many clinical trials. And true, it’s not quite yet a fully automated closed loop system (which would be many people’s definition of an artificial pancreas).
I should mention that during the Medtronic Diabetes Advocates Forum back in April, we talked about artificial pancreas terminology, and “hybrid closed loop system” was terminology that was mentioned. Kind of like, “what would you think if we used the term hybrid closed loop (I’m paraphrasing)? I remember thinking, “well, tell me what that means and I’ll tell you whether I like it”. I suspect others in attendance might have thought the same thing, and I understand now why Medtronic couldn’t reveal why they brought up that terminology. Now, before I get too far off topic…
2. It’s not fully automated? What’s not automated? The system has algorithms to help determine your insulin needs. If the system suggests a correction bolus, you have to accept that before it will deliver the insulin. When you eat, you still need to enter information through the bolus wizard and accept the results. A fully closed loop system would do all this for you, though most of the systems being worked on today will still require some sort of user entry to determine a mealtime bolus. By most measures, this is a marked move forward in insulin delivery systems.
3. About that algorithm… it’s a new algorithm, called SmartguardHCL, which is supposed to improve on what was used in the glucose suspend systems previously released.
4. There’s a new sensor. This is the Guardian sensor. It will work the same as the previous Medtronic CGM iterations, meaning it will insert at a 45 degree angle, the transmitter will have the seashell design we’re used to, and it will need to be taped down to be flat against your skin like the previous versions. But a new sensor should mean more accuracy, and we know users of this system will be counting on accuracy more than ever with a system that is giving you insulin dosing recommendations and the ability to commit to them.
5. The 670g is expected to ship in the Spring of 2017, which means if you’re considering this option, there will be plenty of time to anticipate and do more research.
6. If you started on the 630g recently, there is a an upgrade available. Called the Priority Pathway Program, this will allow those who ordered the 630g (current model) at any time since August 11, 2016 to upgrade to the 670g for $299.00(US). That’s a little more than upgrades have been for other products in the past… but I get it, new and exciting system, it’s not 2010 anymore, this is the price. And considering the rollout is in the Spring, letting people use their current system for six months will hopefully help the nearly three hundred dollar upgrade price go down a little smoother. Or not. Everyone is different, and I get that too.
Look, I’ve been critical of Medtronic in the previous months, and there’s nothing that has changed with regard to the United Health Care issue or other concerns that many people may have. With regard to the 670g, as I said on Twitter, I suspect this news will go down the way a lot of big news goes down. Some will love it, some will hate it, some will be wait and see. That’s okay. No one product will be perfect for every person living with diabetes.
But let’s look at this one development on its own merit, okay? Kudos to Medtronic for working to bring this to the approval stage, and for getting it approved by FDA so quickly. We now have what may be considered the final link in the chain that began with separate pumps, separate CGMs and no way for them to communicate with one another; and will end with a fully automated system that does all of its own thinking for the person with diabetes.