Minimed® 530G with Enlite®. Five questions.

So the Medtronic 530G and Enlite sensor are here, featuring a new pump and a new CGM (continuous glucose monitor) that talk to each other, with a never-before-available-to-the-public Low Glucose Suspend (LGS) feature. Essentially, when your CGM hits a pre-determined threshold, the new Med-T pump will suspend itself for two hours (or less, if you’ve recovered from a hypo event before the two hours are up).

This is a super development. It’s great that advances in glucose monitoring and insulin delivery and interaction between the two are making their way to the market.

Being the inquisitive sort, after I got excited about the news, I started asking myself questions. Five came to mind in about ten minutes. I don’t have answers to these questions. Maybe no one does. But since it’s my blog, I thought I would ask them here.

A couple of my questions came after reading a fine piece on the 530G at Diabetes Mine. They interviewed company officials and provided some information that I’ll be referencing here. If you’d like, feel free to read their story, then come back here.
http://www.diabetesmine.com/2013/09/new-medtronic-device-gets-fdas-nod-but-dont-call-it-the-veo.html
 
 
Now, the questions:

1. Who gets priority when the orders start coming in?
Will it be new Medtronic customers? Replacements? Upgrades? Influence-peddlers (bloggers, diabetes organization muckety-mucks, etc.)? In all honesty, this is kind of a non-starter for me, because a)There’s really no way for me to find out, and b)The supply will probably outstrip the demand for the product within the first year anyway. By then, we’ll forget how bad some folks wanted it right now back in October 2013.

2. In replacement/upgrade scenarios, what happens to used pumps?
I could (and should) have asked this long ago, but what happens to the old pumps? If the 530G is the greatest system out there, I certainly would like to upgrade. But if someone can’t do that, either because of cost or other factors, I would feel great knowing my Revel™ pump is still going strong, working its magic for another patient. Is that even possible? If not, will the pump’s material be recycled somehow? How does this work today?

3. New users of the 530G will work with a trainer, like they do when starting on other Minimed pumps. What kind of education will 530G users get?
I ask this question because while I was trained, I was not educated about insulin pumps and pump therapy in general before starting on my pump. I was good at getting my A1c down, but there was still a lot I didn’t know. Thanks to my fantastic endocrinologist, I was able to get up to speed pretty quickly. Still, I did not know what insulin on board meant until I read about it online. So theoretically, I could have had the 530G, stacked my boluses up to the ceiling one evening, had the threshold suspend feature kick in on my pump, and still had plenty more insulin acting in my system for a while. Without knowing what was happening to me or why.

I don’t want a new user of the 530G to find out about IOB the hard way like I did.

4. The Diabetes Mine piece mentions that the 530G will not communicate with Medtronic’s MySentry remote monitoring system because the FDA didn’t clear it to communicate wirelessly. Isn’t the CGM communicating wirelessly already? And why do they need FDA approval for something like that?
I remember being at the JDRF Research Summit in Bethesda, Maryland back in March. People working on artificial pancreas technology at the University of Virginia’s Center for Diabetes Technology presented, and among the things they revealed was a remote monitoring feature. Parents in attendance were super-interested in this, and they asked the presenters about whether something like that might be available soon. I remember the UVA presenters said that they didn’t anticipate rolling out the remote monitoring ahead of any device they might be working on. But they also said that they didn’t believe something like that needed FDA approval, because it wasn’t doing anything medical. It was just reflecting what was already going on with the AP system, and the remote monitoring itself wasn’t being used to make any medical decisions for patients.

And like I said above, the Enlite CGM will be communicating wirelessly with the pump already. Shouldn’t be too hard to get it to talk to the MySentry too.

5. Finally: What’s all this artificial pancreas posturing about?
You knew I would ask this, right? This is a little touchy for me. Rhonda at FifteenWaitFifteen wrote about being uncomfortable about this too. Medtronic, and by extension now, many in the media, are using the term “Artificial Pancreas” when referring to this system. The LGS feature in this system is very AP-like. But after seeing numerous talks about artificial pancreas technology, from more than one source in the past year and a half, I can tell you that the 530G is not an artificial pancreas device in the way I think of one.

Last time I checked, no one copyrighted the term “artificial pancreas”, so Med-T is within their rights to tout it as an AP device if they want to. But I worry about two things: First, will using the term with this device, which doesn’t have all of the features of artificial pancreas technology, cause non-D friends, family, and co-workers to think this is the holy grail, and now we shouldn’t have any trouble with our diabetes from here on out? Second, will using the term “artificial pancreas” like this eventually dilute the term for all of us, to the point where just a CGM that talks to a pump will be considered an AP device? We’re just now making big strides in technology that will benefit many with diabetes. When an outfit uses the term “artificial pancreas”, I don’t want it to be less than I’ve been led to believe it will be. Just my two cents. Feel free to disagree.

Full disclosure: Okay, half disclosure. I have a particular interest in this topic, especially right now, and I recognize that this may skew my viewpoint. More about that next week.
 
 
So those are my five (plus) questions on the Minimed 530G with Enlite. As with almost everything, time will probably provide the answers. Do you have any questions of your own? Have any answers for mine?
 
 
 

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Comments

  • Laddie  On October 2, 2013 at 3:56 pm

    When I purchased my last pump a year ago, I went with Animas because of the future integration with Dexcom. I hate the Animas Ping, but am still optimistic that the Vibe will correct some of the things I hate. I still miss my Medtronic pump.

    Two big questions I have are: 1) how will the Enlite sensor compare to the Dex G4 in accuracy and lifespan? 2) I cannot successfully use straight-in sets like the Mio and Quicksets without pain and a high failure rate. So will I be able to use the Enlite which is going to be a 90 degree set without pain?

    But because I won’t be pump shopping for three more years, I will have a lot of time to consider my options.

  • Jessi  On October 2, 2013 at 6:59 pm

    I really like #2. When I was looking at getting my pump my husband really wanted me to get a used one off of craigslist, but I wasn’t comfortable with that. If there was a way to get a used one and know it would be okay we, would have done it.

  • Scott E  On October 3, 2013 at 7:07 pm

    Regarding #4, the Revel pump existed long before the MySentry did — so the MySentry just piggybacked off of some feature that was already built-in to the pump. So I’d be surprised if the MySentry doens’t work with the 530G but the meters and CGMs will. I suspect, like the Enlite sensor with the Revel, it isn’t “approved” for that use (even though the Enlite uses the same Minilink transmitter and others who’e gotten Enlites overseas reported that it DOES work). Of course, this is just a guess and nobody reading should make a purchase based on what I’m writing.

  • Jmkcee  On October 19, 2013 at 4:19 pm

    FYI- it does communicate with Mysentry- as you all were assuming- it was just faster for them to get it through the FDA w/o that piece included in the approvals. Medtronic will not tell you this.

  • Jmkcee  On October 19, 2013 at 4:22 pm

    Also, for those who have another brand, like Ping, or Dex, there will be incentive programs, buybacks, ect, but the details of those are yet to be released. So, depending on the details, you may not have to wait to full 3 years. Guess we will all see what they have to offer.

  • W. Kristoph Nolen  On November 12, 2013 at 6:38 pm

    As far as #5 goes … that’s my question, too. I didn’t really think of this as a “true” artificial pancreas. In my research, it turns out that the FDA has classified 3 types of AP devices:
    Threshold Suspend Device System
    Control-to-Range (CTR) System
    Control -to-Target (CTT) System
    I don’t think that it’s just Medtronic coming up with the term and using it for their own marketing … unless we want to believe that the FDA has defined the devices this way because Medtronic wants them to. (and that’s just a little too much conspiracy theory for me.)
    At any rate, more info can me found at FDA.gov, or by following the web address below:

    http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/ucm259555.htm

  • Bill  On March 10, 2014 at 9:35 pm

    I just received my 530G with the Pathway upgrade program. This program is a big failure on a multitude of levels with a few good points. Here are the failures:

    1) When ordering the upgrade I specifically asked it the sensors would be included, and I was told yes. So I said since the Sof-Sensor is not compatible, I need to pull it from the order that you are processing and the sales rep did so. Upon received the pump, there were no sensors included. (Thus delaying in swapping to the 530G)
    2) Upon ordering the sensors, I specifically stated I needed 2 months supply as I wanted the sensors and infusion sets on the same order cycle. When they shipped out the sensors they sent 3 months supply.
    3) The insertion device between for the Sof-Sensor is not compatible with the Enlite. I had to find that out on my own, I was never told this and will now need to order the insertion device (Thus delaying in swapping the 530G out again).
    4) Minimed mandates that you take a survey every 3 months for the 530G, if you do not agree you do not get the pump.They state that the FDA is mandating that they do the survey.

    Positive notes:
    1) When I spoke to Minimed, my glucose had bottomed out while asleep and I had callapsed off the bed and cut my eye open. They were able to get the pump to me in 5 days. (I have had the pump for 2 weeks now and still cannot swap out as of the issues above).

    I was optimistic of Minimed and have used them for years, but after this upgrade, I will have to reconsider my pump manufacturer when it comes time to get a new pump.

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