Oh my gosh the FDA approved the artificial pancreas! No, I read the article and it's just another minimed with a TUBE where the CGM communicated automatically with the pump. Whoopie! So glad I have the Omnipod and Dexcom CGM.
I know.... I couldn't believe they actually called it an "artificial pancreas". What a joke.
But it is an improvement, on the FDA side, to open its mind to at least a little bit of innovation.
I tried the Mini-med CGM when it first became available and found it to be really hard for me to use because of all of the alsrms that continually went off. My numbers fluctuate so much and I was exhausted trying to regulate the numbers and alarms. I also hated having two sites. What do you like about the Dexcom!
I've used both Dexcom 7Plus and Medtronic Guardian. There is virtually no difference in opperation and performance. Both are most accurate in "near normal range of 80-120 and increasing inaccurate at highs or lows. Rapid changing BG will often throw both into a tailspit and both record 20 minutes in the past. Guardian is slightly smalled and the transmitter rechargeable while Dexcom is unknown lifespan (about 1 year with sealed battery. Guardian is rated for 3 days, Dexcom for 7 but both can be extended 2x-3x past the time limit. Former is supplied at 10 sensors/month and latter sends 4. Price is virtually identical. Major difference is delivery system. Dexcom uses a manual insertion device while the Guardian uses a spring loaded insertion similar to Omnipod. Both must use sites on the stomach.
BTW, I have found that saturating a site with Solar-Cane or similar for several minutes before cleaning and insertion makes the job of insertion much less painful
Gary, thanks for the detailed input on CGM stuff. I'm just now starting to look into a Dexcom device to enhance my pump therapy (or is it "artificial pancreas?" :) Also, did you mean "solarcaine"? I use Smith-Nephew No-Sting Skin Prep Protective Wipes and get similar results with the pod's insertion. Up to trying something new from time to time though.
Isn't Omnipod working with Dexcom for two way communication between the devices in the future? I'm looking forward to that myself.
I too got excited with the title of “artificial pancreas” …clicked as fast as I could…then…see their same ol pump with a tube…cue the price is right loss music…
At least things are on the right track…
To me this is great, more as a symbolic victory than anything. I think people are missing the part where the FDA approved something that lets the pump make a dosing decision for you - automatically suspending insulin delivery if the CGM shows that blood sugars are dropping at a certain rate. I think that is a pretty huge advancement, and indeed is one step closer to an artificial pancreas. It’s definitely closer than any other diabetes device company is at the moment. Sure, it’s still tubed, which is a bummer to say the least. But let’s not discount the possibilities for innovation here!! With this approval it clears the way for similar devices from other manufacturers.
Any advancement is a positive one, and this (I think) is cooler/more important than people are giving it credit for.
Solarcaine is simply a cheap OTC sunburn analgesic. I use it just for the anesthetic value. My stomach is very sensitive to punctures and the Dexcom was often torture to insert.
Neither device should be used for Bolus determination. Value is that you can often see trends in BG and usually know about lows before they become serious.
IMO "artificial pancreas" is pure hype and misleading. Until a sensor can sample blood glucose accurately in real time rather than 20 min. look back these devices can never be more than rather dumb pumps. 20 minutes with a dropping BG added to the delay in insulin abatement after stopping delivery means often lows will not be caught in time. Also, until the pump can also dispense the insulin antagonist, Glucagon these devices cannot be considered an "artificial pancrease" in any sense
I'm a huge Omnipod fan and user, so this is not some "Medtronic fanboy" defense of the new system.
That said, people here have completely missed (or at least not written about) the technology advancement that Medtronic is touting here as an "artificial pancreas".
The new system will automatically suspend insulin delivery below a set BG threshold to head off hypos. The actual decision algorithm is a bit more complicated than that, but you get the idea.
To my knowledge there is no competing system available commercially with the feature. This is the first.
And it's a very big deal... The elderly, heavy sleepers, hard of hearing, those living alone, and many other T1's who face very real risk of night-time hypos, progressing to serious danger, can be much more easily managed.
Personally me, a T2 with hearing impairment in my right ear, need this sort of technology. Not enough to make me switch from the pod+G4 to this system (too many other advantages with what I'm using), but there have been times my wife has woken me in the middle of the night because my CGM was rattling loudly in that glass on my nightstand when I was seriously low (below 55, getting the klaxon alarm), and didn't hear it because I was laying on my good ear.
Can't imagine the same scenario if I lived alone. I'd simply have to tolerate higher BG overnight.
Gary, the specs for the G4 state about 15 minutes delayed; however, controlled research adn personal anecdotal experimentation by many have found it is more like 4-8 minutes in most people. Mine seems to track about 5-6 minutes behind fingerstick measurements. Some of this depends on where you place the sensor -- I get much better (lower delay) on my upper arms than I do on my belly, where I hate to put it anyway.
YMMV.
On a different note, I agree that treating highs based on the CGM alone is very iffy. However, if I get a hypo alarm and I can feel symptoms (even slightly), I munch a carefully calibrated blood glucose increaser (15 skittles :-)) without checking with a finger stick.
Also, I'm shooting for very tight control, target 85, and have found my G4 to be quite accurate 70-140 when kept calibrated, and BG is stable (flatline for hour or more). In those cases, I'll risk correcting without a finger stick check. Haven't ever had a problem.
The Dexcom is the only CGM I have tried but I love it. It's very accurate and the range is great I can basically be anywhere in the house and it transmits.
Thanks for posting this, Dave. It’s the same thing I was getting at in my post above. People are all too quick to “poo-poo” on new technology they don’t take the time to think about or understand, but this indeed a big step in the right direction. Good for Medtronic for getting something this vital to pass through FDA approval.
Gary
I totally agree with your comments - it is misleading and actually I wonder how or why they got the Label of "Artificial Pancreas".
I am glad that this has been raised. I use Omnipod and Navigator - both very exact and precise. But this whole thing will have the ups and downs i guess.
Gos
I think many don't understand what an enormous development this is.
The degree of safety and risk control required by the FDA for anything is substantial. The hoops jumped through to get this approved are stringent.
Yet, they were able to put a system together, develop algorithms, and software that even with the time-resolution shortcomings of CGMs, works good enough to pass both efficacy and safety requirements of the FDA.
The implication of this is huge for all diabetics. This is just the first -- I'd expect similar capability to find its way into the Omnipod and other competitor's products within a few years.
I'm most excited about the work going on at Pancreum, a small startup. Their concept is fabulous, and the modular, all-in-one plug-n-play design will dominate the market if they can successfully engineer the system, get approval, and come to market. That's a tall order though.
Check them out: pancreum.com
Sorry to burst your bubble, Scott, but Insulet and Dexcom broke up a while back :( Insulet is going with another sensor and trying to work on a device that is only on one real estate location. From their earnings report about 6 months ago, I think they were on pig trials. Can someone back me up on this one?
Agreed! I also think that using the "Artificial Pancreas" name is misleading, but this is the first step to a closed loop system and THAT is worth taking note of!
I heard the same from Insulet management a few months ago
Hi Dave,
I agree. Medtronic shouldn't call that an "artificial pancreas" but they did have to go through a lot to get such a relatively simple feature approved by the FDA. Hats off to them. By the way, this feature had already been approved in Europe and other places for a couple of years.
Thanks for mentioning our work at Pancreum. You can imagine what we will have to go through to get our software approved by the FDA. However, the first version of the software that we will submit to the FDA will have limited "closed-looped" features, mostly being just a tool to manage all 3 devices from the same hand-held controller.
I just hope that the FDA's apparent reluctance in accepting innovation won't just make us give up on the U.S. market, and only pursue approval in Europe and elsewhere. I must admit that's an alternative for us.
Take care.
Gil
It strikes me that the CGM market in the US has been dominated by Dexcom for a few years now. The fact that they may have fallen out with Insulet begs a few questions. The OmniPod is still the only truly tubeless pump. The ability for CGM to "talk" to another device is indeed a ground breaking step for Medtronic, but not for technology, but FDA approval that this is acceptable. I agree that its the way forward but there is so much more that can be achieved by precise systems.
Gos