The Grouch Addresses D-Tech

I am a tech-happy Type 1 diabetic. A new diabetes device gets my heart racing and I treasure my D-devices almost as much as my iPhone and iPad. Maybe more? Nah…. Until there is an iPump, I will love my iPhone and iPad more. But my life is immeasurably better because of my insulin pump, continuous glucose monitor, and even blood glucose meters.

I have come to terms with riffraff hanging off my body and filling up my pockets. I don’t mind the daily minutiae of using these devices and I take things like changing infusion sets and poking my fingers in stride. I’m old enough that I don’t wear cute dresses any more and don’t have to worry about accessing a pump tucked in my underwear. I don’t care about black dots on my fingers and the red spots and occasional bruises that tattoo my body. I am not burdened by my diabetes devices.

At the same time I am very frustrated with my D-devices.

I have been using an Animas Ping since 2012 and am still irked by its menu system. Two years ago I made the decision to purchase this pump despite its shortcomings because I thought the release of the combo Ping/Dexcom device was just around the corner. My Bad. It’s now November 2014 and the rumor these days is that the Vibe release is just around the corner….

Some of my frustration for this delay is directed at Johnson & Johnson which didn’t submit the pump to the FDA until April, 2013 after several years of hinting that the submission would be in the near future. The Vibe was released in Europe in June, 2011 and I sit here 3-1/2 years later hoping to upgrade to one. The fact of the matter is that when the Vibe is finally released in the USA, it will be a 4-year-old pump. In some ways it will be little different than the Animas Ping as it was approved by the FDA on July 1, 2008. So you could argue that Grouch D-Tech the Vibe is really a 6-1/2 year old pump. My understanding is that the G4 software update just released by Dexcom will not be included in the Vibe. Therefore the Vibe will be an old pump integrated with an out-of-date Dexcom receiver.

In general I am incredibly frustrated with the whole FDA process. I don’t understand why it takes a couple of years to review something that has been in use in Europe for several years. I don’t understand why if Dexcom has been given FDA approval for its latest update that neither Animas or Tandem will be able to include that update in their pumps that integrate with the Dex G4. In my opinion the lengthy FDA approval process punishes innovation and motivates manufacturers to stay with old devices superficially decorated with trivial new bells and whistles. Many or most diabetes tech devices are developed by US companies and we see the overseas market getting access to them years before we do. It’s cheaper and faster for manufacturers to get approval in Europe.

Are users of diabetes tech safer in the USA than in Europe? I’ve never seen proof of that.

The iPhone 4 was released in April, 2011. Some of you might be using it happily: unless you want to use IOS 8 / unless you have a new iPad which can’t use iCloud optimally unless all of your devices are using IOS 8 / unless you don’t mind your phone freezing up on multiple websites and apps / unless you want a beautiful, new sleek device. What if you had to purchase an iPhone 4 today and pay the same price as an iPhone 6? Yeah, that’s the same excitement (not!) that I feel about the Vibe when and if it is ever released.

Yes, the FDA is trying to keep me safe. Please don’t tell them that the most dangerous thing I can do is go back to injections and accidentally substitute my fast-acting Novolog for my Lantus shot. Or carelessly give my basal insulin twice because I couldn’t remember if I had already given the injection. Insulin is a dangerous drug and everyone with Type 1 diabetes knows that we occasionally play Russian Roulette with our lives.

I recently read Cell by Robin Cook where a smartphone app called iDoc became an integral part of the medical care for test subjects. People with diabetes were implanted with an internal insulin pump that was controlled by iDoc. iDoc was a master of blood glucose control until the patient got another medical condition (cancer, heart disease, etc.) that threatened to make their health care costs skyrocket. At that point, iDoc programmed a lethal dose of insulin for the diabetic patient. Dead as a door nail. Maybe I would like some FDA oversight on iDoc….

Continuing my frustrations with D-Tech, last Thursday I read reports of the new software release for the G4 by Dexcom. I quickly tried to update, but the Dexcom website was having problems. Kind of like the FDA crash on Monday, Nov. 3 at the #DOCasksFDA event. Don’t these people know that the DOC doesn’t fool around when it comes to sharing information? We arrive quickly and in large numbers and don’t fool around. There is no such thing as a trickle down release of information in the DOC.

Fortunately the Dexcom website was back working in an hour or two and I successfully updated my Dexcom receiver. Because my current sensor was almost two weeks old, I started a new sensor to inaugurate the new software. It ended up being the worst sensor start that I have ever had in my two years of using the G4. Within a few hours, I had Dex results that were a hundred points too high. A recalibration resulted in Dex results that were 80 points too low. Two days later the results were still not in line. Argh!

I hate D-Tech.

My Dexcom debacle has a happy ending (I hope!) and several of my last sensors are being replaced. I had been having problems before the update and I think the rotten sensor start was just an unhappy coincidence. I have had superb customer service from Dexcom in the last couple of days. The jury is still out on whether my problems have been sensor related or equipment related, but I am hopeful that I am back on the right track.

Totally unrelated to my rants in this post, my pump case cracked yesterday when I inserted a new battery. I called Animas and only had to wait 2-3 minutes before talking with a Pump Rep. A new Ping will arrive on my doorstep tomorrow.

Okay, maybe I love D-Tech.

15 thoughts on “The Grouch Addresses D-Tech”

All of these tecnical advances are great until Medicare becomes primary coverage. Medicare is antiquated and will never be up to date with technology because they lag so far behind. I am T1D for 44 years, pumping for 22 years and using CGM for over. 4 years. Became Medicare eligible 12/12 andmy life changed forever. So far they haven’t paid for infusion sets and reservoirs until ALJ appeals. They haven’t paid for sensors or transmitter and now I have a new 530g pump and they aren’t paying that either. My old pump was out of warranty. I am going thru the appeals process on all denials but it is time consuming and costly. The frustration level is beyond any I have ever had before. Hopefully by the time you are Medicare eligible, they will be covering these very necessary items!

Laddie on November 11, 2014 at 11:18 am said:

Thanks for your comment, Susan. I knew that Medicare was a problem with CGMS, but I did not realize that getting pump supplies would be difficult. Medtronic made such a big deal out of the threshold suspend and it is an important step for D-tech. Unfortunately since that feature is considered part of artificial pancreas technology, it is causing some people to be denied reimbursement for the 530G pump. Medicare for sure since it won’t cover CGM’s, but also some private insurance plans who claim that artificial pancreas tech is “investigational”.

I do hope things get easier for you in your dealings with Medicare. I’ll be on Medicare in 2-1/2 years and I am definitely worried.

How frustrating! I’m with you on the “why does Europe get stuff more quickly than we do?”. I was also surprised to hear during #DOCasksFDA that, in Europe, devices and drugs can be pulled more easily/quickly when they show issues than they can here in the US. What’s up with that? I also have a love/hate relationship with tech but none of my issues effect my health.

Laddie on November 11, 2014 at 11:26 am said:

Thanks for commenting, Kate. On one hand I am so thankful for the diabetes devices that I do have. On the other hand I think my expectations are too high and I get overly frustrated with the slow release of new products and the glitches that occasionally occur with their use. Oh well, I get mad at my iPhone too….

Too often, I think we blame the FDA. This wasn’t an issue three years ago, when the FDA was very inefficient and didn’t do things as well as they do now. But these days, it’s not the agency but the other side. JnJ for example: Not submitting until April 2013 because they opted to wait until the G4 instead of going with Seven+ as was originally planned. And JnJ considered that “quick turnaround,” even though it was 6 months after the G4 approval. Shows how different our perspective on timelines really are — patient, pharma and regulatory. And then how the company did not include human factors data that it was pretty clear the FDA was interested in seeing. And so, not everything was submitted to the FDA for a full review until March 1, 2014. Yet, this information is hardly shared and it bothers me when the company says “It’s up to the FDA now” but fail to mention how they basically wasted a whole year. I get the need to be more like Europe, but many in Europe believe the devices approved aren’t safe enough and they are moving more toward our way of doing things (toward the middle, at least). It’s a tricky world, and as frustrating as it can be, I try to remember that there are many different sides to it.

Laddie on November 11, 2014 at 11:40 am said:

Mike, thanks for more of the background info on the Vibe delay and the FDA and J&J role in that. I think that you are right that patients, pharma, and regulators definitely have different opinions on these matters. During the Twitter discussion accompanying the #DOCasksFDA, you tweeted that it would be great if there could be updates and more transparency during the FDA reviewal process. That seems a great idea. I would definitely be less frustrated if I had more information.

Awesome post Laddie. I completely understand your frustration. I do think that FDA is more proactive now, writing guidelines for things like artificial pancreas devices so manufacturers know what is expected to get approval before they submit. Also, they are reaching out more to get patient feedback. I’m not sure, but I don’t think these practices were um, in practice earlier. All in all, I think everyone needs to work with a little more urgency. After all, patient lives could be hanging in the balance.

Laddie on November 11, 2014 at 1:54 pm said:

Thanks, Stephen. I know that you are in the process of evaluating pumps and I’ll be interested to see what you choose. IMO none of the choices are perfect, but all of the pumps are good at doing their main job which is to deliver insulin safely. Yes, you’re right that the FDA has made changes to improve the approval process, but I still reserve the right to be grouchy occasionally….

Laddie-
I hope you’ll like the new Dexcom software when you try it with a new sensor. I updated my receiver last Friday with my existing sensor and it has been great. I think the accuracy improvement is noticeable.
I enjoy your blog a lot.

Laddie on November 11, 2014 at 2:00 pm said:

Thanks, Melanie. My new sensor which is from a different Lot # is definitely working much better than some of the recent ones that I have used. That’s great that you can already see a difference with the software update. I think that it will take me a while to know for sure, but I am optimistic.