FDA approval for Minimed 670G:
This is the closed loop, hybrid pump coming from Medtronic. Will you get one?
My understanding of the 670G system is that it will turn off basal insulin if the system predicts a hypoglycemia event in the near future. This is an important step toward future pump/sensor systems that will provide more aggressive insulin dosing changes automatically.
But itâs still a baby step. This change alone will not induce me to seek the 670G for my diabetes treatment. From here on out, I believe the manufacturers must provide an explicit and clear upgrade path commitment to any purchaser of an introductory/evolving artificial pancreas system. It makes no sense for the person with diabetes to take a risk of being held back from future advances in artificial pancreas systems for up to four years.
We have all been teased and disappointed by the promise of great diabetes treatments or even a cure âwithin the next five years.â As we enter this exciting phase of relatively rapid D-tech advancement, no manufacturer should punish early adopters with a âno-exitâ four-year commitment.
I am not personally tempted by this Med-T baby step but understand that itâs needed. In the meantime I will look to the diabetes activists in the âwe are not waiting movementâ to provide a working artificial pancreas much sooner than the commercial firms. I feel like we patients finally have significant influence on the real world players in the D-tech marketplace.
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Wow Medtronic is going to join the current century! And waterproof to boot. I had long feared their pumps were going to end up in the dustbin of history along with Nokia cell phones-- thought the only thing keeping them on the big stage was preferential insurance contracts. I applaud them.
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From what I understand this is not the one that simply suspends when low,
itâs the hybrid closed loop. Itâs certainly limited â you canât
automatically meal bolus and from what I understand you canât really aim
for very tight targets, but itâs an automated closed loop.
We are fortunate to have great insurance that allows an update every year,
so weâre not as concerned with the upgrade issue. But I agree, the
four-year commitment does put a wrench in the works for many in the market.
Thereâs no doubt that the next iterations of the loop will be dramatically
more impressive. If I had a teen, i would most probably get this, as Iâm
guessing the most dramatic improvements will be seen for those with the
worst control.
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From what I can tell from Medtronic website, the only closed loop feature theyâre advertising is bolus suspension for up to 2 hours if an alarm is not acknowledged and bg levels are below target
Iâd be excited by this if:
- Medtronicâs âhybrid closed loop systemâ utilized the Dexcom CGM (ainât going to happen for obvious reasons).
- This was actually a true APS. In my book, a system doesnât qualify as an Artificial Pancreas until it is a bi-hormonal system, i.e. utilizes both rapid-acting insulin and âshelf-stableâ glucagon administered within a closed-loop system.
I realize that the 670G does utilize an âauto-suspendâ feature when predicted (and/or actual) BG is low, but this feature has so far proven (in a large number of those who have used it) to be âtoo sensitiveâ in that it suspends delivery of insulin far earlier than it needs to and resumes insulin delivery far later than what is actually required.
That being said, I hope this pump will provide those who choose to use it better BG control and an improved quality of life.
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I thought the 670G is the new hybrid closed loop?
So I think they previously announced a baby step (something like 640g or somethng like that) from their past âthreshold suspendâ or âlow suspendâ or whatever, which I agree was basically underwhelming. But this is the FDA submission for the full hybrid closed loop system they submitted just in June or so. At least, thatâs my understandingâŚ
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Hereâs the FDA Press Release on the approval.
From what Iâve read, it features two suspend modes, one when the floor threshold is crossed and another mode when a target floor threshold level is predicted to be crossed soon. Itâs a good first step on the way to better designs later.
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I think youâre right I may have been looking at the 630g. Iâll be looking forward to hearing some user reviews of the 670g system
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Iâm not impressed by this to say the least.
From what I saw, it didnât deliver much better control than what a person can currently achieve with just a meter, a CGM and a pump (or even just a meter and MDI). The A1C results of the people participating in the study were high (in the 7%) which means their average BG levels were 170 mg/dl. That isnât even close to a healthy average.
As of now with only MDI and no CGM (though not by choice), and eating LC, my A1C is 4.7 so I really donât see any advantage here. Just more $$$ in someone elseâs pocket. This is not a cure or anything close to one in my opinion and Iâm not seeing how this is much better than the technology thatâs already out on the market and currently in use.
I also donât see CGM readings as being accurate enough to dose by so this seems almost dangerous to me and purely driven by greed.
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I think thatâs a little over the top.
These are all first generation systems. It going to be a few years until we start seeing full feature APâs.
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And by then perhaps the technology will have taken a completely different directionâŚ
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If you have a 4.7 A1C, keep on rocking whatever youâre doing! You have
cracked the code. But I see this as a tremendous benefit for those who
are *already
*using a pump, have crummy control, and feel like their diabetes is ruling
their life. Sure, they could adopt a low-carb diet and eat to their meter
but most wonât. Some, like little kids, really canât do this. I see this as
particularly beneficial for teenagers who forget to bolus for meals, never
check their blood sugar and generally run around eating pizza, pop tarts
and other junk food and are clocking horrifying A1Cs. If you can make them
calibrate once in the morning when you see them and once at night, then you
basically guarantee that during the day thereâs something preventing them
from going into DKA and keeping them out of the 300s.
It only adjusts the basal profile, apparently, no automatic bolus thus far anyway, Iâm not exactly sure what that means since itâs all the same insulin⌠Other than it must just the basal rates adjusts within a narrow set of parameters and wonât do a big insulin dump when it detects blood sugar skyrocketing⌠Hopefully thatâs around the corner.
Iâm more excited about the prospect of smart insulin and smart insulin patches than I am about AP. IMO the limiting factor of insulin pumping is the current analog insulin themselves not the pump technology⌠So I do have a hard time getting excited about this or any other pump technology, but if it helps anyone then itâs a good thing
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Assuming no extended hypos, I think that means youâre almost never above 100. Agree with @Tia_G, whatever youâre doing, youâve got something good going!
Clearly this Medtronic thing is for a different segment of the D market.
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There is no code to crack, and itâs not perfect but yes, @truenorth, Iâm mostly under 100 mg/dl. I maintain a low carb diet and am very mindful of what I eat, when I eat it, quantities etc. I also exercise regularly and yes, I âeat to my meterâ as @Tia_G put it. I admit that Iâm very strict with my D management but the payoff is so worth it, and I honestly think you donât have to be as strict as me, and be under 6%.
Statements like these make me sad. Itâs not some great secret or a magic pill. If Iâm able to do so after 30 years with type 1, thereâs no reason others wonât even give it a try. There are many kids on this way of eating, teenagers too, many are athletes who play team sports in school. If a teen wonât even check their BG regularly then this device isnât really for them as it wonât bolus for meals. Thereâs always a bit of personal responsibility when youâre type 1, and this is coming from someone who rebelled a lot during my teen years including omitting insulin, drinking and smoking.
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Well, theyâre putting so much money into the development of this device that wonât even do much more than whatâs already out there, instead of researching an actual cure or prevention.
Iâve been at this for decades now and honestly havenât seen much progress in 30 years, just the same rehashing of the same old things. Iâm sorry if I sound bitter, I promise you that Iâm not normally when it comes to my diabetes. I do however get mad at the healthcare in this country (US) and how corrupt everything is here when in comes to pharmaceuticals and insurance companies. Dealing with them has worn me out more than the disease itself ever did.
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Well, perhaps it makes you sad, but it really shouldnât. Seeking out food is one of our most basic physiological drives, itâs VERY hard to rewire that system. Beyond that, eating is a very social experience: Iâm a pretty healthy eater but if I go out with friends who want to eat pizza, I will feel awkward and isolated if I donât eat with them. That feeling is especially strong for kid; Iâve seen that with my own. My kids eat whole, unprocessed foods at home. But if they go to a birthday party, their whole experience is basically ruined if I say they cannot eat as others do. So I donât think itâs sad that doctors arenât asking people to radically rewire their social and physiological drives in order to preserve their health. I think itâs a realistic weighing of the relative merits of things.
Iâm very happy that you are able to stick to a low-carb diet and I would cheer on any person who can do so, but the data shows that many, many, many people are unable to adhere to ANY diet at all in the absence of environmental changes such as shifts in the food industry, lifestyle, or social circle, etc. So to me, the relative benefits of promoting something that might work magically IF adhered to, when adherence is largely unattainable, is roughly the same as promoting a technology that IS easy to adhere to but produces mediocre results by comparison. I think doctors should be promoting healthy food consumption and point out the positive results some of their patients have achieved using your method, but ALSO be providing some vaguely efficacious medical care to people in the place they are in their lives â which often includes pop tarts, pizza and junk food. Someone who uses this device and is running a 9% A1C and gets down to an 8% will see a dramatic reduction in their risk factors. And maybe getting down to an 8 and feeling better will motivate them to aim for 7, and theyâll realize that changing their dietary habits will help. So i donât see it as either/or
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First I need to acknowledge that in 1971 when my mom was part of one of the first pump trials, this is what was envisioned at that time as the ultimate goal. Somewhere my mom is smiling a million smiles today. Itâs been a long time coming.
Second I have to acknowledge that I am hopeful for Medtronic. I feel the insulin pump is becoming almost a utilitarian item. The question in my mind is the sensor that was announced today,. I hope it works spectacularly and with such precision that it blows everything else on the market out of the water. If that happens, we will have a leap in technology and that will make for more leaps by Dexcom and so on. As I have said for several months now, it is the sensor that is important not the pump. I hope the pump is great, but we need the new sensor also announced today to be revolutionary.
Third, is this the way forward for CMS approval of the sensor technology? Remember even if this works well at present it is out of reach of many of brothers and sisters who have Medicare as their primary insurance because Medicare will not pay for the sensor. Unless Medicare changes its rules, this places those at second most risk for insulin errors two generations of pumps behind. If this is anything, it must be a call to redouble our efforts to secure approval of the sensor technology.
Finally, I have to say I am disappointed in JDRF for using the words artificial pancreas in relation to this device. In the various releases, I read today Medtronic (who took so much heat for using the term artificial pancreas with the release of this prior pump) did not use those terms. Yet JDRF made it the keystone of their press announcement. This is not an artificial pancreas. Yes a step, but not there yet.
So I am happy for the announcement, and I want it to be a great product if only because even if we dislike Medtronic, advances in this arena anywhere floats all of our boats a little higher.
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