Category Archives: Diabetes Technology

Getting Acquainted.

Now that I’m officially several weeks into my life on Dexcom, I just wanted to scribble down some notes for the purpose of keeping a record on how it’s been going so far.
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This is mostly stream of consciousness, but as usual, my stream of consciousness still contains several words. Hopefully, they are ones you’ll want to read. Here are eight observations on the early going with Dexcom.

1. I know that I have FDA approval to bolus based on my Dexcom G5 readings, but I haven’t done it yet. Okay, I may have pushed a one unit correction bolus through once or twice without doing a fingerstick, but that’s all. I’m not blousing for a meal based on my display. I’m confident in my Dexcom– I’m just not confident that it will be perfect 100 percent of the time, every single day. I would hate to over- or under-bolus based on the one time it’s off by a bit. I hate to think of the result of doing that. So, no dice to the bolus-off-Dex so far.

2. I’ve got to remember to order some Skin Tac or Opsite Flexfix or something to hold down my sensor, and soon. The peeling is real, folks.

3. At the Diabetes UnConference, I checked in with a couple of people to get their pointers on doing an upper arm insertion. I also looked at Daniele Hargenrader’s recent video showing her doing this. Then I did it. Then I loved it. It’s mostly out of the way, and the sensor works pretty good there. And the accuracy has been fantastic. Win-win-win.

4. I’m not interested in using my thigh or forearm for sensor placement. I use my thigh a lot for insulin pump infusion sites, and I’m guessing that using my forearm would be painful. This outlook is subject to change, as I should be from time to time. Also, I may be going back to using my midsection for a while anyway. More about that at another time.

5. Based on what I’m seeing up to now, it looks like the basal rate settings on my insulin pump are, frankly, stellar. Whether I’m high or low (you’re welcome Janelle Monae), once the peaks level out, if I don’t touch my pump, the line on my graph is pretty flat. I’m a little shocked, but happy that my endocrinologist and I were able to work this out without the benefit of a CGM to guide us.
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6. I have avoided the newbie temptation to check my CGM graph every two minutes. I think that’s because of my Dexcom experience during clinical trials. Of course, not checking the receiver all the time means I’ve made the mistake of putting it on the table and walking out of the room every so often. I never said I was perfect.

7. That said, can I just say how much I really hate the fact that I still have to look at a pager-sized display to get my readings? I’m not buying the “We’re working on an Android solution” anymore. You’re not… just admit it. If I’m wrong about that, I’ll be the happiest guy around who ever had to eat his own words, and I will gladly eat those words in this very space.

8. Like anything, when things go well, you tend to see something in a very positive light. That’s where I am now. At the beginning, I had a failed transmitter which also cost me a few sensors, and that was extremely frustrating. I realize that how I use my CGM, and how I react to various things affecting my use of my CGM, may very well change over time. But I hope things remain positive. Because for the last couple of weeks, it hasn’t been a big problem to deal with, and that’s the only way I’m going to buy into the notion of wearing my Dexcom every single day.

Those are my initial observations. I wonder how I will feel about my CGM in a year? Only time will tell. The goal is to make it to another year and find out.

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.

One for the patients, and interoperability.

There’s an announcement that went out a week or so ago from the USA’s Center for Medicare and Medicaid Services. Not much has been written about it. I thought the wording of the statement was interesting enough to spend a few minutes talking about it here.

Essentially, CMS has a regulatory requirement in place that states that providers have to maintain patient health records electronically. They’re using a phased approach toward getting everyone there, and that requirement hasn’t been met by many, mostly because of difficulty in implementing systems to handle this. As a result, they pushed back the date for provider compliance with this rule to January 1, 2018. That’s the bad news.

The good news? Well, patient health records for those on Medicaid (receiving federal or state healthcare assistance) and Medicare (federal healthcare program for U.S. residents 65 and older) will all be electronic by 2018. Also, there is a significant push by CMS to make the systems housing patient information available and accessible to patients. As in, no more wondering what is in your folder, but actually knowing what’s there.

According to the fact sheet distributed by CMS (click HERE for the full text):

”We want actionable electronic health information available when and where it matters most and for health care providers and consumers to be able to readily, safely, and securely exchange information.”

There’s incentive in this too. Eligible physicians, clinics, and hospitals who move to electronic health records receive incentive payments from the government for doing so ahead of schedule. They get their payments cut if they fail to comply by the CMS deadline.

But there were additional items that really struck me in this announcement, and I’m just going to quote them here one at a time.

”For example, the regulations will:
Shift the paradigm so health IT becomes a tool for care improvement, not an end in itself.”

CMS is focusing on using technology to improve patient outcomes, but not in a “set it and forget it” kind of way. They want health records to be useful in a patient’s care plan.

”Address health information blocking and interoperability between providers and with patients. Commenters recommended we emphasize measures that focus on interoperability instead of those that focus on data entry. We modified the measures so that more than 60 percent of measures rely upon exchange of health information, compared to 33 percent previously.”

Anyone who’s been to one doctor for one test, then another doctor who has wanted to perform the same test can tell you that being able to exchange data between providers (in a safe, secure manner, of course) will save a lot of time and money for providers, for patients, for insurance companies. Interoperability is also huge in a hospital setting, or when a patient may not be able to speak for themselves.

”We are Transitioning to a New and More Responsive Regulatory Framework”

Part of that is due to passage of the Medicare Access and CHIP Reauthorization Act of 2015, and part of that is due to the fact that, well, this is the 21st century, and we all need to use technology where it can help us. It’s a no-brainer, right?

Here’s something else to remember: If the federal government is moving toward a more patient outcome based, interoperable, responsive framework, it’s much more likely that individual providers of healthcare will do so too. Seeing how this all works out over the next five years or so will tell doctors, hospitals, and health systems what works and what doesn’t about operating with health IT as “a tool for care improvement, not an end in itself”. My hope is that they will improve upon that idea. They also have incentive in keeping us all alive longer.

So here we are… a little blip on the radar screen of our medical lives. But a significant blip, if the goals associated with these regulations actually come to pass. I’d be okay with that, and the sooner the better.
 

Technology: More to think about, in a good way.

I got through reading this thouroughly engaging post from Kerri Sparling over at diaTribe. It’s a very helpful post that gives People With Diabetes real information to consider when deciding whether to share or not share continuous glucose monitor (CGM) data via NightScout, the Dexcom G5 Mobile CGM, or MiniMed Connect/Carelink.

As I said, I thought the post was very helpful, but what also struck me was how we now have three different BG data sharing platforms to choose from.

When I considered that, I had a reaction that went something like: “Wha… what? Two years ago we didn’t have any! Now there are three!”. On the surface, it’s a no-brainer. Why not be able to share data from your CGM? But it took Nightscout, in my opinion, to get that ball rolling. Once people, and mostly device makers, saw that, and considered the possibilities for themselves, they were all on board. Makes perfect sense.

But there’s something else to consider too. Think about this: If you’re using a CGM and you decide to share, you now have to decide who to share your data with, and the rules regarding that shared data. It’s as if the gods said “Well, you don’t have enough diabetes stuff to think about already, let’s roll out something new to give you even more to worry about”.

That’s in addition to the fact that we now have, essentially, three separate apps sharing data across three separate platforms. It’s great to have choices. The more choices we have, the more likely it is that we’ll find something we really like. We need that. But again… more decisions. Which to choose? That’s easy if you’re using the Enlite sensor from Medtronic. But if you’re a Dexcom user, you have two options to choose from.

On the other hand, these are good problems to have. And parents of kids with diabetes, especially, have been wanting something like this since forever. I know, because I’ve asked them. I’ve been at JDRF Type One Nation events where parents see remote monitoring for the first time and simply ache for it. For them, it’s choices, schmoices. They’ll take anything as long as it works, because it allows for both more freedom for their child, and more knowledge of how the child’s diabetes is performing throughout the day. More choices? More decisions to make? Bring it on! They don’t care. Parents are awesome that way.

It’s very interesting for me, this realization that these three data sharing platforms seem almost ho-hum now. Sharing CGM data already seems like it’s been a part of our lives for quite a while. But it’s been less than two years between having and keeping CGM data to ourselves, and having the ability to share it with people a world away.

We live in a fast-paced world powered by technology. The latest innovations are making their way toward us faster than ever. The trick will be, of course, in not investing our time working for our data. But rather making the data work for us, for our health, for our safety, for our happiness.

You know what? We are worth it. #WeAreNotWaiting
 

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