There has been a lot of confusion this past week about what the heck is going on with the next-generation, not-yet-to-market Medtronic Enlite CGM sensors. And it’s perfectly understandable — it was confusing!
But guess what? The Enlite sensor has just received CE (Conformité Européenne) Mark approval in France, and “is being launched subject to other local approvals in more than 35 countries outside the US,” so there’s finally some official information to share with you all. According to the press release:
“Significant design improvements make Enlite sensor more comfortable and easier to use than the previous sensor. In a clinical study… 85% of patients agreed that sensor insertion was pain free and 86% agreed that the Enlite insertion device was easy to use. The Enlite Sensor is a significantly smaller sensor compared to Medtronic’s previous product — 69% smaller in sensor size by volume, 38% shorter in length. Adding to patient convenience, the Enlite Sensor can be worn on the abdomen and buttocks and used for up to six days…”
“When the Enlite sensor is used with the predictive alerts feature on Medtronic systems, diabetes patients have access to hypo detection rates up to 98%. This helps give early warning to people with diabetes so they can take action to prevent dangerous hypoglycemia, which is one of the major concerns of people living with diabetes.”
A first look (thank you to Medtronic for these exclusive photos):
Medtronic Enlite sensor - it IS smaller
Medtronic Enlite - no gi-normous adhesive patch needed!
Enlite is labeled for use with all of Medtronic’s 522 (small reservoir) and 722 (larger reservoir) systems, the Guardian REAL-Time Continuous Glucose Monitoring System, their Paradigm REAL-Time System (pump and CGM combo), MiniMed Paradigm Veo System (the enhanced version with low-glucose suspend, currently available in Europe only), and the iPro2 (their clinical CGM system).
So why do we in the US still have to wait for these “landmark” new sensors while they’re out in European markets?
We don’t know exactly. They won’t tell us. They can’t, according to FDA regulations. Although we were honored to be part of a select group of D-bloggers invited to Medtronic’s recent Diabetes Advocates Forum, that doesn’t mean we were given the blueprints to their every move. Much of Medtronic remains dark and mysterious.
We spoke with Karrie Hawbaker, Medtronic’s PR Manager, who explained that FDA rules forbid companies like Medtronic from doing anything that could be construed as “marketing” for not-yet-approved products. As PR Manager, that means her lips must remain sealed. But companies are able to do some previewing of products under development in “scientific” settings (or in focus groups, where participants are required to sign non-disclosure agreements).
Even though Karrie was unable to comment on this, we have deduced what we believe to be the holdup here: the FDA won’t approve new sensors to be used with current systems set up for only three-day wear because this would require the patient to circumvent the system’s existing instructions and restart the sensor. In Europe, the Veo is already set up to work with a 6-day sensor, and users of other Medtronic systems will simply receive new instruction kits on how to safely restart.
But in the US, a medical manufacturer isn’t allowed to market something that requires the patient to ignore the instructions of a previously FDA-approved device. Them’s the rules. We’re pretty sure Medtronic is feverishly after a work-around. They want the product on the US market as much as we do. Stands to reason, no?
“We really cannot speculate on FDA timelines… Getting a new product approved is an ongoing dialogue between the FDA and the manufacturer,” Karrie says.
But just because Medtronic’s PR team isn’t talking doesn’t mean they’re entirely mum. Last August, Gary Ellis, Senior Vice President and Chief Financial Officer of Medtronic, stated on a financial call for the first quarter of fiscal year 2011 (ending July 30, 2010): “Looking ahead, we plan on launching our NexSensor in the US later in FY11, and the Enlite sensor early in FY12.”
Medtronic’s fiscal year begins May 1st, so “late in FY11″ indicates sometime this spring, and “early in FY12″ would be sometime later this fall.
And btw: what the heck is the NexSensor? Karrie couldn’t tell us, naturally, and all we could find was a reference to a study of 6-day use, same as the Enlite. Why would the company launch two new sensors one right after another? Without any insight here, it sounds like a colossal waste of resources…? Another TBD.
Meanwhile, something else juicy from the rumor mill, which we’ve been able to validate this week with some details:
Animas’ new pump-CGM combo system in development, called the Animas Vibe, has been filed for CE Mark approval in Europe with a planned launch there in 2011, according to that company’s PR Manager Caroline Pavis.
As you may have heard, Animas is partnering with DexCom to develop this CGM-enabled pump system, which combines DexCom’s continuous glucose monitoring system with an Animas insulin pump “to provide greater insight into glucose level trends.” Animas recently offered an exclusive “first look” at the Animas Vibe at the ATTD and Diabetes UK meetings in London, where the product was displayed under glass — as is typical for pre-approved systems.
We’re told that the Vibe will use Dexcom’s fourth-generation sensor, which will be smaller and more accurate than the SEVEN PLUS (!), and be based on the same platform technology as the Animas 2020 pump (although slightly elongated to accommodate the CGM), including features like:
- Waterproof pump casing, in choice of colors
- High-contrast color screen
- Small basal rate increment (0.025 U/hr)
- Personalized audio alerts – Compose your own tune or set to vibrate (I wish the OmniPod had that!)
That’s all we know about that for now. Except of course that Europe will get the Vibe first.
Invented here; Enjoyed there. Grrrr.
****
UPDATE 4/28/2011
We just got our hands on a first-look photo of the Animas Vibe. Check it out:
“That’s all we know about that for now. Except of course that Europe will get the Vibe first.
Invented here; Enjoyed there. Grrrr.”
OK, I’m actually slightly put out by this, if I’m honest. The UK is so rarely ahead of the curve in any tech – CGMS are virtually impossible to get over here, and so few people have access to pumps full stop. We’ve only just had the Omnipod released. I can understand frustration that you’ll have to wait for the Vibe – I have the 2020, and would love to have the option of CGM function that the Vibe will offer, but I’ve got another three and half years left on my 2020. So whilst I understand the frustration, I resent the implication that we in Europe shouldn’t be allowed access to new developments, and that it should always be released in North America first.
I’m sure I’m taking this a bit too much to heart, and of course it’s hard to read tone over the internet. I usually love the content here, and when something like this bothers me, I just feel I have to say something about it.
- Becky
Just to clarify, we live in BC Canada and we just got our son on the Minimed Veo, it is available in Canada and we have been to the Enlte will be here very soon as well
Due to some issues regarding the 510(k) process at the FDA, the FDA has become much more conservative in the last few years. Many Medical device companies are now looking to receive CE Mark (European approval) prior to FDA PMA or 510(k) approval. The combo OmniPod/Seven Plus and Animas/DexCom products have both been delayed due to tighter FDA standards. Unless things change at the FDA, Europe will proabably see more of these products before the US does.
I know that we can (within limits) import drugs for personal use. What about devices?
I think the FDA has been very reactive to criticism of mistakes made in approvals. I’m sure the EU process has similar mistakes though they’ve probably not made news over here. I am concerned that our process seems to be getting slower and more obtuse while the EU one appears to be better defined and more predictable. I do hope the FDA woes are resolved, and I really how that the DOC can engage with the FDA in a useful way that perhaps helps this process when it comes to devices for diabetes.
Am I the only one thinking “what does it matter if the Medtronic sensor is smaller and less painful if the accuracy/reliability doesn’t improve.” Now, I understand that it is not in Medtronic’s best interest to flaunt any improved accuracy until the new product is available, because it essentially acknowledges that their current sensors leave something (read: A LOT) to be desired.
Thanks Amy!
Is there any information on how the calibration process might change (read: be improved) with the Enlite?
Thanks,
Brent
@Becky – Wow, we would never intentionally imply that people in Europe should NOT BE allowed access to new developments – what the heck?! All we’re saying here is how frustrating it is for us stateside PWDs to have to watch from the sidelines and not have direct access to these newest tools ourselves. In other words, booh on the FDA.
Here is a link to a study (came out last October) comparing the FDA and Europe in terms of costs and approval process.
http://www.massdevice.com/news/study-fda-related-activities-cost-24-million-510k
@Amy
Oh, booh to the FDA I can totally get on board with
Like I say, I was sure it was just me being overly sensitive and reading into the tone something I wasn’t there. I don’t see any reason there can’t be a universal release either.
come on FDA!!!!!!! very cool news about the Vibe.
Thanks for this update. It’s so frustrating waiting and waiting for the next best d-tech to come along…and I feel incredibly privileged to be able to even make that statement, given that I’m lucky and in the small % able to have both pump and CGM. I’ve been waiting for that integrated animas/dex for nearly 2 years, though, and eagerly anticipating the day it will be available in the U.S.
I am interested in hearing you are on a pump with CGM. Did you get funding for the CGM from your PCT or Hospital, or are you funding it yourself, if so can you tell me approx how much a month it cost.s. i am on an Animas 2020 and have been trying to get a CGM for 3 years now.
Seriously….they put a man on the moon with less technology than I carry in my purse. So where’s the Vibe remote? I’m not buying this “radio frequency” stuff. Don’t make Animas users choose between a CGM and a remote. Figure it out. Now.
I’m not very enthused about the name of the Animas Vibe – imagine the TSA conversations alone.
Time to slow down that automatic every-three-month sensor order w Minimed. Hate it when they phase something out and I still have three months left!
Great news. Heard it here first! (Agreed they HAVE to be aware of all of our sensor problems – this HAS to be an improvement!)
(PS Am I the only one who thinks it’s funny that the Paradigm 523 has a Link Sensor option for “Reconnect old sensor” that is disabled? I mean, c’mon!)
Funny. The “reconnect old sensor” on my 523 works just fine. Better get yours checked.
Well, both my Medtronic 722 pump and my CGM will both be out of warranty in 2012. Maybe a good time to take a close look at the Animas/Dex. Medtronic sensors do leave something to be desired — some have been spot-on for days, and others wacky right from the start-up. Maybe the Enlite will be better, but who knows?
Nice update
@Amy, I totally get what you say about the frustration of being on the sideline of new releases – that’s exactly how it feel here in Denmark (and probably also most of the time in the UK, @Becky), regarding most pumps, insulin, CGM systems, you name it. And even though the Paradigm Veo apparently is available in the UK, I haven’t heard it should be in DK, European Union regardless.
And another thing, it’s actually funny (not in the good way) that something like disregarding guidelines might be the FDA argument for halting the Enlite release – I bet most of us PWDs at some point, if not on a regular basis, have disregarded guidelines, whether it be for replacement of needles and lancets, or CGM sensors. I for one have been using the Metronic CGM for 4 years now, on and off, and have never discarded a sensor after just 3 days; I always restart it for at least a total of 6 days
Honestly, this could have been easily solved by Medtronic seeking 6 day wear approval for their sensors years ago. As a couple of posters have noted, absolutely no one I know wears them for only 3 days.
My MM 722 is out of warranty right now and I so was not a fan of the MM CGM. I fought the denial and won, but then hated the thing.
Someone please help me decide if now after 8 years should I swith pump makers and go with the Animas because of the Dexcom/Vibe? Plus I need all this decided before 2012 as my medical insurance is gonna go through the roof because I have a chronic illness.
Will the animas vibe still have the one touch meter remote? Please say yes!!!
I would love it even if the remote didn’t show the cgm info. As a pump, the remote is a MUST.
please note Medtronic Paradigm Veo is available in Canada since 2010 . I got mine , Feb. 2011.
Just came across this video for Animas Vibe..
http://www.youtube.com/watch?v=hgtuoFVKFds
Becky – No one wants to deny Europe access to the innovations – we just want them too – our complaint is not against Europe it is against our own overly restrictive FDA . They have taken a zero risk policy which is stupid. One can’t walk across the street with zero risk so would they have us stop walking across the street?? (I think they would if they could the current administration is regulation happy – They think the government should control every aspect of our life). As an american manufacturing engineer – I think its great that we can export American designed goods anywhere in the world. Its good for the exporting country and also good for the importer. One has access to jobs and the otgher access to technology. I just we could use what we invent and make!!
I’m new to the CGM and have learned more from this blog than from all the user guides I’ve read. Can someone help me with this? There have been on a couple of occasions a 100 point discrepancy between my sensor readout and my glucometer. I calibrate at least four times an day. A 50 point difference is not unusual. Is this a problem with other CGM users or am I doing something wrong. I’ve asked my trainer and she says a 50 point difference is not unusual. But how do you calculate the correct bolus if you’re going by the sensor if you’re 50 points off? I find I’m testing now more than before I got the CGM. Thanks for any pointers for this newbie.
Is there any way to find out where the Enlite sensor is with FDA approval status? I tried calling the FDA got a freaking answering machine after I pushed 3,000 buttons to get the right office. I have also asked MM but they won’t say a dang thing. I am currently fighting my insurance to get CGM but if the Enlite is near approval I will wait. Does anyone know anything?
Megan, I just stumbled across a link to Medtronic’s Australia website that has a lot of infomation on the Enlite sensor:
http://www.medtronic-diabetes.com.au/Enlite-sensor.html
As far as getting it here in the US, if I were you I’d go ahead and get the approvals needed for the current system. From the info on the Australian site, it appears to be compatible with the existing US pumps and transmitters already, so it probably means you just have to alter your standing prescription for the sensors to get them when they’re finally available.
As far as the FDA approval, if there’s a snafu in getting the US pumps to let these run 6 days instead of 3, I think there will be unspoken knowledge that the sensors will safely go 6 days and you have to manually restart the sensor on day 3 to go another 3, just as we all do now with the current sensors (with my doctor’s full approval, I might add). If/when the FDA approves the 6 day use, you’ll probably have to trade up to a new pump since it’s in the pump’s firmware, but Medtronic has beeen very generous in the past in providing hardware upgrades at a reasonable cost to existing customers so I’m not concerned about that.
Myself, for a variety of reasons I stopped using my Medtronic CGMS system about six months ago, mostly due to the sensors being buggy and a pain to use (literally and figuratively). These new sensors would definitely put me back in the active user category again, from what I’ve been reading about them. Hope this helps.
I would like to know the steps or (procedures) used to extend the use of a Glucose Sensor beyond three days using a MiniLink Transmitter and Real-Time REVEL MM pump
I moved from US to UK for school and although I got the Veo (switched from the Revel) the CGMS wasn’t approved (apparently usual practice). Then, mind you, I found out that the radio frequency is different so I can’t use my old transmitted with the Veo. The support team said that I was going from a US pump to a worldwide one. What a stupid issue! And I have to spend money on a new carelink for an issue of radio frequencies?
It’s nearly a year after this article was published and there’s still….. nothing. I wish there was more transparency to the process. What stage of approval is the animus vibe and enlite sensor in at the moment? What’s holding it back? Do they even have a time table for approval?!?
Damn. I was reading this page thinking it was written a few weeks ago when it was actually a year ago… Any more news on the Enlite sensors? I’m just too skinny for the other sensors.
Does anyone have any news when anyone will finally have a system with blue tooth and running on and controlled by a smart phone app, instead of their primitive display/interfaces?
Also, has anyone ever looked into jail braking any of these hellish / restrictive devices. I’m an engineer, and if I could reprogram some of these insanely annoying, ruin my life, and almost kill me, ways things work, my blood pleasure would probably drop significantly, not to mention have better control.
I mean, can anyone even figure out the algorithm the mini med uses to map isigs to what it logs/displays? Whatever it is, it is insane, and blinds us from the most important trending data contained there in – again, ruining my life, like so many other terrible things.
Brent,
I’m also a bit technically minded – not as much as you, though. But i do have statistical skills (multiple regression using Stata). Maybe we could join forces if you can figure out a way to jailbreak the minimed.
Accu -Chek has a new pump with a BLUE TOOTH meter remote. It is called the Combo and has been out in Europe and Canada for a bit. It looks nice.
The use of a smartphone to control the cgms and pump features would be fantastic! This should have been part of the next step, when planning to advance care and improve BG management, using cgms/pump systems!