Category Archives: Diabetes Technology

Let’s step back and review.

March 27, 2019 – 10:11 am

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.

By StephenS | Tagged , , | Comments (1)

“If Only”

February 21, 2019 – 10:33 am

So… maybe you’re active, very active on social media. Maybe you have a child with a popular Instagram account and YouTube channel.

As a result, you or your child (or both of you) are constantly checking your phone, looking at reactions and statistics related to your various social media endeavors.

Which often leads to statements such as, “If only I (or my child) would be as diligent with my/their diabetes, I/They would be doing great!”.

Well, I have a confession to make: I am that obsessive about my diabetes.

Thanks to the Dexcom app on my phone, I’m watching what my blood sugar numbers are doing all day long. And I’m making adjustments to diet, activity, and insulin dosage based on those numbers.

It’s only natural that when you first start wearing a continuous glucose monitor, you’re inclined to find out what your glucose is doing continuously. I mean, you’re checking your phone or your receiver every couple of minutes.

I’m not checking every couple of minutes anymore, but I have to admit that I’m checking my phone about every ten to fifteen minutes throughout the day. And I’m not always looking at Facebook. I want to see those BG numbers and take action if necessary.

I did it when traveling this week. It’s no secret that when encountered with a different location and restaurant food at nearly every meal, your trend line can go up and down like a Space-X rocket shooting another satellite into space, then landing to earth.

That’s exactly what happened on this last trip. And the only way I got through most of it was by obsessing over the numbers and the trends all day long.

I should mention, however, that I didn’t stress too much about what was happening at any given moment. I just wanted to know where I was and where I was headed so I could take appropriate action if I needed to.

In my case, knowing the number and the trend gives me power to manage my diabetes, even in the most unfamiliar of circumstances.

In the end, we all have to decide how much blood, sweat, and tears we want to commit to maintaining the healthiest version of ourselves. Even though it took me a long time to get comfortable with the idea of wearing a CGM, I’ve now found it to be an indispensable part of my diabetes life.

By StephenS | Tagged , , | Comments (1)

Recent Technology Developments: Where are we headed?

August 28, 2018 – 10:11 am

I don’t want to bury the lead here. Okay, I want to bury the lead slightly, because I’m hoping you’ll take the time to think about that question from every possible angle.

Okay… with that in mind, where are recent diabetes technology advancements headed?

I really have no freaking idea.

There have been developments though, and I’m more than interested in their impact on our community. Some of it involves rollout of new devices. Some of it is a form of consolidation within industry. Some of it involves individuals taking things into their own hands and accomplishing what industry has been unable to accomplish yet.

As far as not knowing about every last thing? That’s okay with me. Because things change all the time, especially when it comes to technology. And even if I knew the implications of everything today, when things change tomorrow, I’ll be right back where I am at this moment.

We know that in most cases, change is good for the technology landscape. Innovation and success in innovation often leads to better products down the road, even if the innovation is only improving on an existing idea.

You have to admit… it’s a pretty exciting time for diabetes technology. Consider these tech innovations that have hit our world in the last year or two:

– Medtronic 670g hybrid closed loop system
– Freestyle Libre CGM (no calibrations); followed shortly by
– Dexcom G6 CGM (no calibrations)
– Improvements of and an increase in the prevalence of diabetes management apps
– The $250 Biohack That’s Revolutionizing Life With Diabetes
(from Bloomberg)

I have to admit that I haven’t followed diabetes technology developments as much as I used to. I’m just too busy. A couple of years ago, I would have been all over each of those bullet points. Today, each new development gets a quick read from me, and then it’s back to the advocacy part of my diabetes life.

But I’m still excited about the next shiny new diabetes technology toy that rolls out from one place or another. I don’t expect everything to be perfect for everyone. But let’s face it… Banting and Best had to start somewhere too.

Here’s hoping that today’s efforts result in tools that will have impacts that last just as long and help just as many people as their efforts.

By StephenS | Tagged | Comments (0)

Not exactly Spielberg, but A.I. has arrived.

April 13, 2018 – 10:11 am

It is kinda cool, at least for starters.

Wednesday, the U.S. Food and Drug Administration (FDA) approved marketing of a device designed to use artificial intelligence to detect retinopathy in people living with diabetes.

There are several things to cover here. First of all, the FDA announcement is that it “permits marketing” of the device. In other words, it can be sold to practices as an artificial intelligence diagnostic tool. There was a fair amount of testing and back-and-forth in the development and rollout of this device, and I’ll get to that in a minute.

Simply put, this is a way for non-eye doctors to use a tool (actually, two tools) to take a photo, upload the photo, and get a retinopathy or not retinopathy diagnosis. It’s not designed to avoid the more detailed examination an ophthalmologist can perform. But it’s a way to perhaps get an early diagnosis of a potential issue with your eyes.

The tools used by the doctor (presumably, a primary care physician, or GP) are 1) The Topcon NW400 retinal camera. The doctor will take a photo with the retinal camera, then upload it to the cloud, where it will be analyzed by 2) The newly-marketing-permitted IDx-DR software to determine one of two outcomes (from the FDA press release… see link below):
(1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or
(2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.”

So, where’s the “artificial intelligence” angle here? I’m glad you asked.

This is the first device (the software is considered a device in FDA parlance) allowed to be marketed to provide a decision without getting a clinician involved in interpreting the results. In other words, the software, not a human, tells you whether there’s an issue or not.

How did the FDA arrive at the level of confidence needed to arrive at this decision? There were 900 diabetes patients in the clinical study, in ten different locations. The study revealed that the software made the right decision on “more than mild diabetic retinopathy” 87.4 percent of the time, and “not more than mild diabetic retinopathy” 89.5 percent of the time. That may not seem like a lot, but to this observer, that sounds pretty good for first generation software.

One of the other things I’m encouraged by is the way this rollout was handled through FDA’s De Novo premarket review pathway, designed to help new devices that are seen as being low to moderate risk get marketing approval. Through this, FDA granted the software Breakthrough Device designation, which provided a framework for greater interaction between developers and the FDA on guidance, testing, and documentation, so the developers could work more efficiently on FDA’s concerns, and the FDA could more effectively work on review.

Hey, look… I don’t know if this software and the retinal camera needed to make it work are going anywhere. But I think this story is important to pay attention to for the way it was handled by the developers and the FDA, particularly FDA’s Center for Devices and Radiological Health; and the fact that this is software that removes the human element from at least the initial diagnosis process.

How you feel about such a development is your choice.

Read the full FDA press release HERE.

Find out about the De Novo premarket submission process HERE.

Find out about the Expedited Access Pathway Program for Breakthrough Devices HERE.

By StephenS | Tagged , , | Comments (1)

The Dexcom G5 Mobile App. I’m a fan.

June 21, 2017 – 9:18 am

After last week’s whiny post about how I’ve been so disappointed in my diabetes devices lately, I feel compelled to let the pendulum swing in the other direction and give credit where credit is due.

About a week and a half ago, Dexcom rolled out its G5 Mobile app to Android users. Finally. Okay, I said I would give credit where credit is due. And kudos to Dexcom, who, as far as I can tell, is the only device maker to develop software to use on an Android platform. Yay!

I know all of you iPhone Dexcom users are yawning right now, but please give me a moment to be happy too. I’m a person who can appreciate the wonders of a good smart phone, but I can’t bring myself to pay hundreds of extra dollars because there’s an image of an apple on it. After years (literally, years) of waiting for an Android option, Dexcom has come through.

Among other things, this means no more carrying around the receiver. I’m a guy who carries too much in my pockets already. I do not need one more thing to lug around, and even though the receiver wasn’t too big, not having to carry it around feels like a big weight off of my… pockets.

In addition, I’ve finally completed my Clarity account setup, which means my endocrinologist can get my Dex data too. No more downloading the data at the office visit. She’ll have it already. Cool, huh?

I’m getting the hang of navigating the G5 Mobile app. It took me a couple of days to realize that I needed to turn the phone to landscape view to be able to see more than the last three hours’ worth of data. Once I do, it’s just a push of a button to view my data in 1 hour, 3 hour, 6 hour, 12 hour, or 24 hour increments. If I hover my finger at any point in the graph, it will show what my reading was at that very point.

And I have to admit to having a little fun with the alert sounds. Instead of the basic Vibrate, soft, attentive, etc. settings available on the receiver, I have 23 different sounds to choose from. So if I want to have my low alert set to Truck Siren or Blamo Dings, I can do that. Nice touch.

I get that making an app work on two different platforms is extra work, but I am SO HAPPY that Dexcom has made the effort. Reducing the burden of managing diabetes is a good thing, and to that extent, Dexcom has done it.

The Dexcom G5 Mobile app for Android users is available for free in the Google Play store right now.

My apologies for the off-center views of my phone screen. Security features built into the app will not allow for a screen capture, so I had to take photos of my phone screen.

Disclosure: I was not given anything or asked to write anything about the Dexcom G5 Mobile app. All opinions are, as always, my own.

By StephenS | Tagged , , , | Comments (1)
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