Trial-Testing Medtronic"s 670G Hybrid Closed Loop System

http://type2diabetestreatment.net/diabetes-mellitus/trial-testing-medtronics-670g-hybrid-closed-loop-system/

We"ve heard the big news that Medtronic has filed with the U.S. FDA its much-anticipated hybrid closed loop system, which is expected to be the first "pre-artificial pancreas" system to hit market sometime in 2017.

At the ADA"s 76th Scientific Sessions in early June, Medtronic presented pivotal trial data on this Minimed 670G showing it reduced glycemic variability and lowered A1C. That key data needed for FDA submission was certainly one of the most widely-covered news stories from the conference. No one knows how long FDA evaluation could take, as MedT submitted thousands upon thousands of pages (possibly as many as 10,000 pages!).

Whatever the timetable, we were glad to have the chance recently to chat with Les Hazelton from Minnesota, one of a small group of patients who"ve been trial-testing this futuristic new system now. Here"s what Les has to say:

Interview with Minimed 670G Trial Participant

DM) Les, can you first tell us about yourself and your diabetes diagnosis?

LH) Diabetes didn’t come into my life until later. I’m currently 60 years old, and was diagnosed with late adult-onset type 1 (LADA) in 1999 at age 43. It was quite the lifestyle change, and didn’t know that I had the diabetic symptoms until after I was diagnosed. After that, it all made sense.

I live in Minnetonka, Minnesota, and I’ve been an art director in the creative world for over 35 years. That means I’m not a writer, I’m the visual guy. Through the years, I’ve done TV, radio, print, billboards… all the media assets that make up the advertising world. I"ve learned a lot over my years and worked for some great advertising companies. I have worked in other places, like North Carolina, and I actually am a Michiganer from many years ago, growing up in the Lansing area. I am still a die-hard Tigers and Red Wings fan.

What did you do as far as treatment before starting on this hybrid closed loop system?

Right after I was diagnosed, I only did injections. But about six months into it, I started using inhaled insulin for a time. I was actually part of an 18-month study for the first inhaled insulin Exubera back in the early 2000s. I was a big fan and thought it was amazingly fast-acting at the time. I liked not doing the injections, other than for my background insulin at night.

After that study, I went back to injections. It wasn’t until about 2005 or so that I got my first insulin pump. In 2008, I was displaced during the ‘Great Recession” and lost my health insurance, and so I went back to injecting. I really couldn’t afford all the pump supplies. But I eventually found a job here in the Minneapolis area and got insurance, and was able to go back onto a new Minimed pump.

That’s when I was invited to be part of this hybrid closed loop study, thanks to my endo here at the Park Nicollet International Diabetes Center. I hadn’t ever used a CGM until enrolling in this program, and I was the only one in my group who hadn’t ever used a continuous monitor. I think it’s pretty amazing too, and I’m seriously considering getting one once this trial is finished.

When did you start the 670G study?

The first phase of this was a six-month study that started in August 2015 and lasted through the start of this year. Now, I am in the second phase for two years, meaning I get to use this through early 2018.

I learned a ton, not only about the technology but about the disease and my own body in managing my diabetes.

How was the study setup as far as clinical visits and using the 670G at home?

During those six months, I had monthly clinic visits. We got started on the closed loop during a five-day session offsite at a hotel. Everyone was monitored constantly, getting all our settings and recalculating depending on how it worked. Once we left, we would come to the clinic to be monitored in person once a month.

Everyone seemed to have a positive experience, from what I’ve heard. Now I am mostly on my own. I have a two-hour clinic visit every three months, and I still upload my 670G data weekly using CareLink Connect so the researchers can see all the stats. There’s a 24-7 customer support system at Medtronic if there’s any problem.

What has the experience been like for you, in terms of life with diabetes overall?

Diabetes was limiting before doing this. My endo at the time phrased it well, and I like to say that I was always "chasing my numbers." After I was diagnosed, I was super-high all the time, and even after getting my A1C down to single digits, I still felt that I was chasing my numbers. I wasn’t in control of my life.

How has that changed now, with the 670G?

What surprised me was that I no longer had to chase my numbers. Before I had issues yo-yoing from low to high and back to low again, and visa versa.

Before going into the study my A1C was 7.6%. After the first six months, I came out with a 6.5%. It’s the device that is really being studied, not me. But learning about the technology and how it works allowed me to manage a lot better. This was a big eye-opener in taking better care of myself!

Any other surprises you’ve found with this technology?

One thing that I’ve noticed that many people like to refer to this as an "artificial pancreas," as if it were fully automated. It really isn’t, in my opinion. It provides you a lot of the benefits of continuous micro-boluses, but you still have to manage your diabetes on a daily basis in order for the device to work as it needs to. You’re still thinking about diabetes just as much -- at least that’s what I have found.

Also, you add on the CGM capability with a continuous readings, and it’s not always as accurate as it needs to be. If you’re calibrating with blood sugar readings the way you should to adjust the algorithm, then it can work amazingly.

How does it handle during the day?

Daytime was much better than a normal day on my pump (without CGM). As noted, I"m a creative director in advertising and my days can get incredibly busy -- I could forget to take a BG test and a bolus dose. The 670G has reminders that can be set, as well as alarms that will warn before a high or low. This was very helpful.

What about about overnight, when hypos can be even more dangerous?

My nighttime numbers leveled out, which was enormous because the worst time to have a hypo event is in the middle of the night, of course. According to my stats, nighttime has been incident-free and very stable this past year.

How does the 670G compare to a standard insulin pump-CGM combo?

In this system, the CGM is predicting whether your sugars are going up or down, and the pump dispenses micro-boluses every five minutes, depending on where you are in relation to target range.

I’ve gotten better at my carb counting, but I’m pretty anal and really have the same thing every day for breakfast and lunch. But with this system, I found it’s easier to splurge for dinner. That’s just a personal lifestyle menu decision for me, not something dictated by the closed loop system.

If you are off on the carb counts, can the system adjust enough for you?

No, not really. Rather, it uses a lot of bells and whistles to tell you ahead of time in what direction you’re trending with one, two, or three arrows depending on how rapidly. When it goes up, I take another blood sugar reading with my fingerstick meter and I can adjust with another bolus. If you get high enough and you’re not getting enough micro-boluses, the system will alert you to take a new bolus.

That’s a real issue in this artificial pancreas idea, that the pump should be very judicial in what it will give you over time. It can’t make an automatic decision for you.

Are you still taking a lot of fingerstick BG readings?

Yes, I am still testing my blood sugar with a glucose meter seven times a day. I calibrate the pump and sensor a few times, to know the differences in what the results are. It will calculate the bolus I need in the pump, and I’ll calculate for whatever I’m eating just like I would on my old pump. Really, it hasn’t changed how much I think about my diabetes. I still take my blood glucose 30 minutes before I eat, tell the system how much I’m going to ingest and let the insulin bolusing start. Then I test three hours after I eat.

Anything you’d like to see changed before this comes to market?

One frustration I have is that you can’t do a bolus if you’ve calibrated and are within range. I’m pretty picky that every time I take a blood glucose, I want to use that to calibrate this system. If I’m within 10 points of my meter, then I’m good.

Sometimes I am spot on. But sometimes there’s a bigger spread, from 185 on meter compared to my CGM sensor saying I’m at 143. So if I want to calibrate and bolus based on that, it won’t let me because the sensor says I am in the range. If I’m below that level it won’t allow me to administer a bolus if I haven’t eaten anything. If I’m over 150, it will tell me to bolus and then I can’t calibrate until after the bolus is done. It may sound trite, but when you’re working with both you want to get everything done at once. I’m busy and often distracted at work or home, so when I want to do everything together in those few minutes.

Some people using the Enlite CGM sensors talk about false lows… have you found that with the next-gen Enlite 3 you’re using?

No, I’ve not had those very often. A majority of time, probably about 90%, if it tells me I’m below 70, that is accurate. I’m hypo unaware at times and don’t feel my lows until I get into the upper 50s, so it’s a safeguard in making me aware that I’m going low.

Sounds like you’re having a great experience with the 670G…

I feel better today and since going into this study, than at any point after I was diagnosed – physically, emotionally, confident in how I"m managing my diabetes. Type 1 PWD Les Hazelton

Bottom line: I feel better today and since going into this study, than at any point after I was diagnosed – physically, emotionally, confident in how I"m managing my diabetes. You can get emotional about it. On the good days, if there are enough of them, you recall how feel -- that’s how I feel almost every day now. That’s what it has done to help me.

How has the new system impacted your family?

I have two children in their late 20s and early 30s, and they’re my biggest advocates, along with my wife. But they couldn’t comprehend what I had to go through at the time I was diagnosed. Now they’ve become more well-informed about what I am doing and about diabetes in general. We talk about it all the time. All of this learning, thanks to this technology, can help so many people and give them confidence and more control of their lives.

How does it feel seeing the recently-published 670G data and knowing you’re one of those trial participants?

One of the big reasons I got into this study is to help people going forward. As someone with late-onset, I think we’re going to see a cure in my lifetime. If I can participate in something that will help younger generations manage better, or have a better lifestyle until we get to a cure, that’s part of my charge. If there’s going to be a breakthrough, and Medtronic is at the forefront of it, I’m fortunate enough to be a part of this in order to give someone else going forward a chance to live a better life.

Thanks for sharing your story, Les! Great to hear about your experience with the Minimed 670G, and we"re excited to see this is now in the hands of regulators, of course.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

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