Tag Archives: Medtronic

Let’s step back and review.

Interesting headlines this week out of the annual Endocrine Society meeting in New Orleans, as Medtronic received some scrutiny after a presentation revealed that over a third of study participants using the Medtronic 670g here in the USA abandoned the system.

This is one of those stories where I feel we need to take a step back and consider all sides of this revelation.

First, from what I’ve been hearing and reading from others, this is not a complete surprise. This is also in keeping with word of mouth I’ve been getting from users of the 670g myself. What was most surprising to this observer is that it was actually put in writing and published.

But let’s look a little closer: the study cited in the presentation included only 93 participants, aged 6 to 25… hardly a large cross-section of users of this device. In fact, I know users in their 30s, 40s, and 50s who are still using the 670g.

According to the news report linked above, while the primary reason for giving up on the system was trouble staying in automode, other reasons given included “technical difficulties with use of the system, such as frequent alarms, premature sensor failure, requirement of calibration, skin adhesion problems, and sensor supply issues”.

Most of those other reasons are things we’ve heard before, and should be things that can be improved upon. I also remember reading about sensor supply issues after hurricane Maria hit Puerto Rico… something that, again, should not be a long term issue.

Look, I get it… who wants to sign up to wear a medical device after they hear that 38 percent of users in a study don’t want to use it anymore? But let’s remember this was the first system of its kind approved by the U.S. FDA. While no one was going to make a copycat device, submissions approved after the 670g did have something to go on when seeking approval for their systems.

And let’s be honest: weren’t we all clamoring for faster FDA approvals for new medical devices just a couple of years ago? Weren’t we saying that we’d take less than perfect in order to have a better opportunity at time in range?

Now, before you decide that I’ve taken a stand on one side or other after hearing this news, please remember that I’m trying to stand right in the middle. Of course, if you stand in the middle of an intersection, you run a bigger risk of being run over by a truck. But I digress… what I’m really saying is, finding out that results of a study involving 93 people, all of whom are over 30 years younger than me, isn’t going to move the needle when it comes time to decide on a new insulin pump later this year.

We all have decisions to make when it comes to medical devices we wear, or whether we decide to wear any at all. Those are our own personal decisions. This story gives us more information to go on, but it’s still our decision to make when the time comes.

Being in a position where we actually have the opportunity to choose (I’m looking at you, United Health Care and Medtronic) is what’s most important. Because if either patients or companies are going to make decisions based on headlines like this, in my opinion, those decisions are a bit hasty indeed.

Are you okay with this?

Monday, United Healthcare and Medtronic went one step further on their “preferred agreement” to make the Medtronic 670g the lone insulin pump choice they will approve of without a fight.

Since the U.S. Food and Drug Administration has now approved the 670g for use with patients age 7 and older, now it’s the only one you can get for anyone 7 or older unless you work with your doctor to submit forms and do things that, under other plans, you wouldn’t have to do to get a new pump.

I wish I could say it in a nicer way. I have friends working at Medtronic, and friends insured by UHC.

I don’t know antitrust law. But… the largest insurer in America linking up with the largest insulin pump maker in America to effectively shut out all other insulin pump and continuous glucose monitor competition? Is anyone, at either UHC or Medtronic, benefiting from this agreement? In what way? How much?

Everyone I’ve spoken to who has used the 670g likes it. I’ve rarely heard anything negative. But shouldn’t patients be allowed to choose what they want to wear every day anyway? If they are allowed, pending certain requirements being met, to choose a different option, why should there be an agreement in the first place?

United Healthcare is fond of saying that over 90 percent of their patients with diabetes who choose insulin pumps already choose Medtronic. That’s disingenuous, because they’re effectively forcing patients to choose the 670g anyway.

Meanwhile, Medtronic has a goal of dominating the market. Until these United Healthcare agreements came into play, I believed it was because they were convinced they had a best-in-class product.

If you believe you have a best-in-class product, why work so hard to squeeze off opportunity for your competitors? It’s clear to see the detrimental effect this will have to Tandem and Dexcom, as well as any new entities working on closed loop solutions here in the USA and around the world.

There is more money to be made on pumps and CGMs in the United States than anywhere else. Medtronic seems to be doing its best to get the most of that market for themselves. Not through competition, but rather by stifling it.

United Healthcare is getting its own benefits from whatever it gets from Medtronic, the ability to streamline paperwork and approvals for 90 percent of pump and CGM patients, and the framework for similar agreements affecting patients living with other conditions.

Do you feel like this is unfair? Do you feel People With Diabetes should be able to freely choose to use any device that works best for them?
 
 
Send your e-mail to United Healthcare telling them this is wrong
 
 
Thanks to JDRF and their #Coverage2Control initiative for the link.

If you’re a person living with diabetes, or a person caring for someone living with diabetes, there is absolutely no good reason for a decision like this to be allowed to go forward without a fight.

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.

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.

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