Tag Archives: Medtronic

Device failures.

I’ve nearly had enough.

The past few weeks have been full of diabetes device failures, and I’m actually asking myself how much more I can take.

Dexcom sensor failures are frustrating me more than I can express here. Since January, roughly one out of every two sensors fail without working more than a day, or ever working at all. I mean, how long do you put up with that kind of unreliability before you chuck it into a box and give up?

And believe me, I’m doing the insertions exactly the way I’m supposed to. Every time I do an insertion, I’m still going back to the online tutorial to make sure I’m not missing anything. The failed CGM sensors have definitely become my biggest diabetes nightmare.

I’ve even stopped contacting Dexcom support about it. The calls are all the same: the support person goes through their script so they can cover everything they need to cover… I get that. Usually, after about half an hour on the phone, they agree to send me a new sensor. But… how much is the sensor, and what is my time worth? In addition, I’ve had to replace a transmitter and a receiver too. In a little over five months. It’s quickly becoming not worth it.

But my pump issues are still there too. I have an Animas Vibe pump where a 200 unit limit to my reservoir isn’t really an issue. But it’s not really 200 units. Because once the pump says the reservoir is at 0 units, the pump stops… even though there are usually around 20 units left in the reservoir. So, something that could last 3 ½ days (for me) winds up lasting barely 3 days, if I don’t have other issues. Why do I have to waste 20 units of insulin every few days?

Which I almost always do, because my Medtronic infusion sets can’t seem to go more than 2 to 2 ½ days before they just don’t want to work as well anymore. At that point, I still seem to get insulin, but instead of hovering between 80 mg/dL and 120 mg/dL, I suddenly go up to 220 to 320. So I have to bolus huge amounts of insulin to try to bring my glucose level down. When I change out the set my BGs go immediately down to a reasonable level again. Why can’t an infusion set be made well enough to last the FDA-mandated three day limit? Or greater?

These are all issues that I did not experience in the five years I was managing diabetes through my previous pump and no CGM. Let me put it another way: my A1c is climbing, due only to medical device failures. This leaves me asking even more questions. Like:

Why can’t device makers make something that is simple, and not as susceptible to breakdowns?

I understand the all-consuming need to develop the next special product with all the bells and whistles, but… why can’t there be a simple option that I can use? My previous pump seemed to do everything I needed it to do. Why can’t I just choose a new version of that?

I actually like my Dexcom when it works… why can’t it work more often, with fewer breakdowns of the individual parts?

I hate to pick on individual companies. But the truth is, if these were cars, I would probably choose not to drive as opposed to breaking down on the side of the road every few days.

Granted, there still aren’t many (in a trending sense) people who are managing their diabetes through pumps and CGMs. But I don’t think that should be a reason for me to settle for inferior products. It certainly isn’t a reason for me to continue to pay for said products without noting where they are coming up short.

And without saying that maybe some device companies need to go back and make their current products as reliable as they can before devoting resources toward the Next Big Thing.

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Diabetes By The Numbers: Medtronic on the Medtronic 670g.

About three weeks ago, the U.S. Food and Drug Administration approved the MiniMed 670g, Medtronic’s hybrid closed loop system, for people with diabetes over the age of 14.

This news has generated a lot of excitement, and also a lot of questions. I was fortunate enough to connect a little over a week ago with Karrie Hawbaker and Michael Hill of Medtronic Diabetes (which is why then I was saying the approval was two weeks ago), who went on the record about how the 670g works, the new CGM sensor associated with the 670g, and the upgrade pathway for existing Medtronic customers. Which is still a little murky, but they recognize that every customer is different, and they’re willing to talk to you about it. There’s also a little at the end about how Medtronic is leveraging IBM’s Watson supercomputer to crunch data.

Here then, is everything you want to know about the 670g. Thanks Karrie and Mike!

DBTN

Reference Material – Click below for more information on this topic

Karrie Hawbaker is Senior Manager of Social Media for Medtronic Diabetes, and Michael Hill is Vice President of Global Marketing in the Intensive Insulin Management business unit at Medtronic:
medtronicdiabetes.com

If you’re an existing Medtronic pumper, and you’re interested in upgrading to the 670g in the spring, here is all the information on the Priority Access Program:
medtronicdiabetes.com/products/priority-access

The MiniMed 670g

The 670g is here!

Now what?

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.

What’s Next?

Like you probably did, I read Kerri Sparling’s blog post about how she’s still unhappy that nothing has happened since the United Healthcare/Medtronic Diabetes dustup. Like her, I can sense the dust settling at this point, and I wonder if anything meaningful will come of all our vitriol just a month ago.

I’ve thought about this from time to time since the announcement was made back in May, and I’ve come to the conclusion that there are some things I know, and some things I don’t know about all of this. While we know the issue, and what’s at stake, we all undoubtedly feel a sense of resignation, that “this is how business works and there’s not much we can do about it”.

Well, that may be true. Maybe there’s nothing we can do about it. I don’t think it’s that simple though. I do know that if we’re going to turn the tide of businesses trying to rule our access to tools designed to help us be as healthy as possible, certain things need to happen. In no certain order, here are just four of those things.

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Holes need to be poked in this arrangement. I’ll bet you can state one or two things that are wrong about this business deal right off the top of your head. We need to find more things that are wrong with this, and point them out, over and over again, to anyone who will listen. We need to find out things that are wrong about the businesses and the people running those businesses that are wrong. I’m not advocating personal attacks, of course. But is there a track record here that needs to be noted? Maybe an indicator of what’s to come based on similar tactics these companies/people have employed in the past? And we need to keep hammering those points home. In the current business climate in the USA, these people already know that they can get away with making arrangements that only suit themselves and not patients. We need to make it uncomfortable for them to do so. As uncomfortable as possible, even if it’s one blog post at a time, one insurance claim at a time, one protest at a time, one person standing up and stating what is right. We cannot let injustices go without standing up and pointing them out. Over and over again.

Tweak the message. Why do you think JDRF gets such big dollars for research? Let me ask you another question: do you ever see someone like me in JDRF literature? Of course you don’t. That’s because even though I have the same disease as a cute ten year old, time and again people will react positively to the message that a child doesn’t deserve to live with this, even if I’ve been living with it for at least fifteen years longer.

Okay, I’m a little off topic here, so let me bring it back to the issue at hand. Anger is good… it gets our blood flowing, it’s often the catalyst for developing platforms for change. But if you can’t tell a story, a compelling story, a heart wrenching story about why all patients need access to the best care and drugs and devices, people are going to question why they should care. This is where I’m at a disadvantage. I’m good at telling you what’s happened, but I’m not always good at making it overwhelmingly compelling. But I know I need to do that. We need to turn our outward message of anger into inward concern for actual people. And quickly.

These companies need to be hurt where it counts– in the financials. Sorry to be the one to tell it so bluntly. But let’s face it: by and large, as long as company execs are getting their bonuses, they really don’t care about you or I. This deal falls apart when it no longer makes financial sense, from either a corporate or a personal point of view, for it to continue. I don’t know if that means we find a legal way to keep them in court fighting for their stupid deal (and fund the fight), or if that means we encourage a boycott of United Healthcare and Medtronic for years to come, or if it means that we encourage patients to find ways to make United Healthcare pay more in claims under this agreement (which they would fight). But when the money is no longer there for this deal, there will be no reason for it to continue.

Relentlessness. Do you think The CEO of United Health Group, or the President of Medtronic Diabetes are actually thinking about any of this anymore? They’re not. Of course they’re not. They knew that there would probably be an initial reaction. They knew that the initial reaction would probably die down. Now they’re just going on with their lives like nothing ever happened. You’re just a dollar sign… you’re not a person to them.

I’m not a big believer in the fact that everything needs a coordinated effort to accomplish a big goal. But here’s one instance where a little coordination could come in handy. I’ll give you an example: sit-ins at lunch counters in the south back in the 60s. White authorities were sure that all that was needed was to arrest the African-Americans sitting at the segregated lunch counter, and it would all be over. But as soon as the initial protesters were arrested, new protesters immediately came forward and sat down in their place. Authorities only thought there were a few protesters… they didn’t count on many, showing up over and over again. That’s what we need.

As a community, our initial reaction to all of this was wonderful, and creative, and even inspiring. But now there’s nothing. A coordinated effort that has one person writing about it this week, another meeting with their elected officials the next week, bombarding state insurance commissioners the following week– that’s how we start to chip away at the wall that’s been built between business and patients. Little by little, over and over, never giving up, until we either force an end to this type of practice or make it unsatisfying for companies to engage in this kind of behavior in the first place.

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As U.S. citizens, we believe in our original Declaration of Independence and our Constitution, which promote the idea of choice as a basic right for all people. Those documents don’t say anything about the right to squeeze out as much profit as possible, or that doing so at any cost to patients is okay.

I don’t have a great plan, or anything nearing all the answers. But I do know that the one thing we can do, all of us, is continue to assert that our human right to choose is the most important message in this debate. You think this collaboration between UHC and Medtronic fosters innovation? I don’t care if it does… it destroys my right to choose (and it doesn’t foster innovation– quite the opposite). You think it gives patients a best-in-class platform to manage their diabetes? I don’t care… it destroys my right to choose, today and in the future, so if a better product becomes available, I might be unable to choose it. You think having a “clinical exception process” in place for people who want to choose a different option actually proves you’re still allowing choice? You’re wrong… it destroys my right to choose, and it gives other greedy businesses a template for denying choice, and I’m not okay with that.

This attitude needs to be here, on the faces of the Diabetes Community, in every interaction with these entities, until policies like this are a thing of the past. They’re only trying to get everything they can. I’m fighting for what I want too, and what I want is more important. And I am not ashamed to say so. Yesterday, today, and tomorrow.
 

Choice Is Necessary.

United Healthcare has decided that, as of July 1, adult patients with diabetes on certain UHC insurance plans who want insulin pump therapy should only be allowed to choose a Medtronic insulin pump. Hat tip to DiabetesMine for breaking the news.

There’s a lot more to it than just that one sentence, and obviously, people have a lot of questions.

Let me first say this: people who work for medical device makers and insurance companies are actual people, and they have families and concerns of their own, so I don’t think it’s fair to equate companies and their practices with the people who work hard for them every day.

That said, it’s really hard to find anything good in this discovery. Let’s be honest, okay? There is nothing good in this discovery. It is only benefitting those implementing the rule, and only harming those affected by the rule.

There was some explanation from United Healthcare about why they’re going down this road, and it’s a ridiculously weak argument. You can come to your own conclusions about it after you read what they have to say about it. But my take is that they’re not even trying to give a good explanation for this. Medtronic, for their part, has remained silent.

Did UHC get something for making Medtronic an exclusive provider? Or are they just being lazy, deciding they don’t want to keep up on all of the insulin pump manufacturers out there? Is Medtronic out there trying to cut similar deals with other insurance companies? Does this put pressure on other device makers to try and secure their own piece of the pie? Most of all: What if an actual artificial pancreas solution is approved by the U.S. Food and Drug Administration, and it’s not a Medtronic solution? Does that leave UHC patients out in the cold?

I’m not even going to try to answer those questions. They’re not important. They just don’t matter.

Because any way you slice it, this is bad news for People With Diabetes.

United Health Group, parent company of United Healthcare, has this as their mission statement:
 
 
“We seek to enhance the performance of the health system and improve the overall health and well-being of the people we serve and their communities.”

“We work with health care professionals and other key partners to expand access to quality health care so people get the care they need at an affordable price.”

“We support the physician/patient relationship and empower people with the information, guidance, and tools they need to make personal health choices and decisions.”
 
 
It appears that the latest about this exclusivity arrangement shows UHC’s mission statement to be rather disingenuous. In fact, it looks like they just took a giant shit all over it and its claims to “expand access to quality health care so people get the care they need at an affordable price”.

Reducing Eliminating choice for patients is wrong, it reduces innovation, and in no way does it “improve the overall health and well-being” of People With Diabetes, or even save them money.

I’m going to start saying something, and I’m going to repeat it any time someone asks me why something like this is a big deal.

Choice isn’t just important… choice is necessary.

Companies love to talk about how competition is good for the marketplace, good for consumers. Apparently, it’s not good enough for United Healthcare, because they just turned a fire hose on the idea of competition. You know, there are studies that show People With Diabetes do better when they have more information, more tools, and yes, better tools to help them manage their condition. I can’t find a single shred of evidence anywhere that says removing choices for patients with a chronic condition helps them live better lives.

You are wrong, United Healthcare. You’ve made a decision that only benefits you, and does not ensure even one better outcome for any of your patients. You are wrong, and I will keep telling your rotten story to as many people as I can. Including my elected officials, and news agencies.

For my part, I wish I would have had access to this information when I visited Medtronic a couple of weeks ago. The upper echelons of Medtronic Diabetes management was there that day, and someone must have known that this decision was imminent. But they didn’t share it with any of the advocates in the room. I would have liked to have asked questions and share my view directly with Medtronic brass that day.

Just as there are actual people working for these two organizations, there are actual People With Diabetes insured by UHC. And those people deserve and are entitled to choices when it comes to how they manage their diabetes. Patient trumps proprietary. And it always will.
 

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