Integration, Baby!

In honor of my 29th birthday, Insulet and Dexcom have a little announcement they would like to make:

Insulet and Dexcom Agree to Develop a CGM-Integrated Personal Diabetes Manager
New Insulet PDM Will Receive Dexcom G5 CGM Sensor Signals

BEDFORD, MA — (Marketwired) — 08/05/14 — Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, and DexCom, Inc (NASDAQ: DXCM), the leader in continuous glucose monitoring (“CGM”) technology, today announced their intention to allow information from Dexcom’s 5th generation CGM system to be identified, received and displayed on Insulet’s new Bluetooth-enabled Personal Diabetes Manager (“PDM”), currently in development.

This project expands upon the initial agreement announced in June to enable the Dexcom mobile app platform to integrate data from Insulet’s OmniPod System. That platform will be the first of its kind to enable glucose and pump data to be displayed on a smartphone.

“We are pleased to expand our development relationship with Dexcom to receive and display Dexcom G5 Sensor data on our new PDM, eliminating the need to carry a separate CGM receiver,” said Duane DeSisto, President and Chief Executive Officer of Insulet. “This collaboration furthers our shared vision of helping people living with diabetes by providing greater access to the data they need to make smart and effective decisions to better manage and control their disease.”

“We are pleased to be back working with Insulet to bring our leading-edge technologies together to help people living with diabetes better manage their disease,” said Kevin Sayer, President and Chief Operating Officer of Dexcom.

Click here for the full press release and disclaimers.

 

Alright, I’m just kidding. Insulet and Dexcom didn’t decide to restart their partnership in honor of my birthday. But the timing is impeccable, isn’t it?

Recall Q&A With Abbott Diabetes Care

About a week and a half ago, news came out that there was a recall on Freestyle test strips, one for the strips Omnipod users use and one for users of older Freestyle meters. A lot of patients took to Facebook and Twitter to rant about the various ways Abbott mismanaged the recall announcement.

On Friday, I had the opportunity to speak with Jessica Sachariason, the Public Affairs Manager for Abbott Diabetes Care. I relayed to her the different complaints and concerns that I had heard, and I also asked her a series of questions that I felt Abbott had not yet addressed. However, she had to go back and get the “proper” answers to meet Abbott’s legal department’s requirements, so the answers are somewhat formal and stilted. That being said, I feel a bit better knowing that Abbott has now heard at least some of the complaints and issues that arose from this recall.

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What was the issue that caused the erroneous low blood sugars? Was this a technical defect or was it a quality control issue? Why does the Freedom meter work but not the PDM or the older meters?

The root cause has been determined to be a strip manufacturing process error, which only expresses when a strip is used with a non-applied voltage meter (FreeStyle, FreeStyle Flash, and the FreeStyle meter built into the Omnipod system).   The manufacturing error causes a decreased response in the system glucose readings. Meters, such as the FreeStyle Freedom, with applied voltage are not impacted and do not express a decreased response in the system glucose readings.

What has been done to resolve this issue?

Abbott has implemented additional quality control processes. At Abbott, the health and safety of patients is our highest priority. The replacement test strips provided to OmniPod users have undergone additional quality testing to ensure they produce accurate results.  Going forward, all test strips will receive this testing.

How long had Abbott known about the defect? Does this stem from the November 2013 recall of your test strips?

Following the conclusion of the investigation linked to the November recall, Abbott expanded the recall.  Abbott contacted the FDA and promptly initiated a product recall in affected markets and has communicated with all affected parties.

How will customers know they are getting accurate test strips moving forward?

Strip vials with expiration dates of August 2015 or after are strips that are safe for you to use with your OmniPod.  Strips with expiration dates before August 2015 should not be used with your OmniPod, but can be used safely with a FreeStyle Freedom meter.

Are you working with pharmacies to prevent old test strips from going to customers who don’t have the Freedom meter? Are pharmacy stocks being replaced with the new test strips? When is it safe to reorder test strips?

Approximately 99 percent of the U.S. customer base who use Abbott’s FreeStyle family of meters are not impacted as they do not use FreeStyle Flash or FreeStyle Blood Glucose Meter systems.

In regards to the question about the replacement strips for OmniPod users, the 400 replacement test strips will be about a 2 – 3 month supply of strips. This amount should cover the customer until the customer’s next visit to the pharmacy to replenish their next test strip supply.

Due to these factors, there is no action required by doctors, pharmacies, and suppliers. If an HCP, pharmacy or supplier has a question, they should contact Abbott’s diabetes care customer service and a representative will provide support.

As mentioned above, strip vials with expiration dates of August 2015 or after are strips that are safe for you to use with your OmniPod.  Strips with expiration dates before August 2015 should not be used with your OmniPod, but can be used safely with a FreeStyle Freedom meter.

How are you handling international customers?

Abbott is working with the appropriate Regulatory authorities

Some customers are still complaining about inaccurate readings with the new test strips. Who can customers contact with any concerns they may have?

If a customer is an OmniPod user they should contact Abbott Diabetes Care Customer Service at If a customer is a user of the FreeStyle Flash or FreeStyle Blood Glucose Meter they should contact Abbott’s Diabetes Care Customer Service at

Why did the letter require a signature? Many users received the letter even later because of this.

The letter required a signature to ensure proof of delivery to  the customer affected, and ensure privacy.

Why did so many users find out about the recall via letter four days after the recall was announced on your website? Why did they not come out the same day?

Abbott and Insulet worked to notify OmniPod users as soon possible. We posted the letter to the website as soon as we could and then started the process of sending out the letters to affected customers.

Why have customer service reps been asking for insurance and doctor information? What is the purpose behind that?

Customers are being asked to provide doctor/insurance information in order to determine the most appropriate route for future strip replacements.

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It does appear that it will on the onus of the customer to make sure the test strips we receive moving forward are going to be the newest ones, and not older ones that the Freedom meter users can still use. This is disappointing, but I also suppose realistic if Abbott views those test strips as not being completely invalid. Test strips do cost thousands (possibly millions) to manufacture, and if we really are such a small portion of the population, I suppose I can understand. But I wish Abbott put a little more thought into how educating pharmacies about the issue to prevent the older strips from getting into our supplies.

And of course, the logic behind Abbott’s announcement of the recall was severely misguided and mishandled, but that’s hardly something they are going to address. The only thing I can hope is that they think about this a little bit more next time.

That being said: Omnipod is changing meter companies! DiabetesMine shared last week that the new Omnipod PDM will be made with the Lifescan Verio meter, and will hopefully be approved and on the market next year. This is actually not new news… it was first announced that Omnipod and Lifescan were working together in 2012 but that was well before I had any vested interest in the partnerships of Omnipod. So we’ll be stuck with Abbott for a little longer, and while Lifescan is certainly not a perfect company either (their accuracy standards leave something to be desired…) it will hopefully be a better partnership for the companies, and of course, for us!

What do you think of Abbott’s answers?

Omnipod & Freestyle Users: Test Strips Recall!

1-recall-boxAttention fellow podders!! Abbott has issued a recall for its Freestyle test strips that are used with the Omnipod PDM. According to Abbott, the strips may be reading erroneously low blood sugars. You should contact Abbott to receive a new supply of 400 test strips.

But that’s not all: there is also a recall on the strips for the Freestyle Flash and Freestyle Blood Glucose meters. So, you know, that’s awesome. The only blood sugar meter from Abbott that works is the Freestyle Freedom glucose meter. So if you have that, you’re golden. If you’re like me, you’re SOL.

I called Abbott this afternoon before going to the pharmacy to pick up my new order of test strips, so I’m glad I heard about this before plopping down a bunch of money on test strips, what with it being the beginning of the year and my deductible not being met. I should be receiving the replacement strips in 3-5 days. I don’t have another Freestyle meter, so I’m going to go ahead and use the strips because from what I can tell, it has not been negatively affecting me.

My biggest beef with this recall is how the information was disseminated. This press release came out yesterday and I found out about it today. On top of that, do you know how I found out about it? Through an email from my fellow podder, Stacey, who emailed dozens of people on the system. Not a word from Insulet or Abbott yet. So what gives? This is a massive recall for people who use the Omnipod system, and yet Insulet is completely mum on the issue. Several people in the Omnipod Facebook forum report finding out about the recall through social media.

Social media is an excellent avenue for dispersing various bits of information and to stay in touch with the pulse of the community. But when it comes to a recall that affects the health of thousands of individuals, get your collective act together, Insulet and Abbott, and send out a proper email or make a phone call. You should know better.

 

Omnipod: First Thoughts

????????????????????????????Review posts of all kinds are incredibly popular in the Diabetes Online Community, so I would remiss if I didn’t jump off the bridge with everyone else. I have been on the Omnipod system for all of three days, but so far, I’m liking it just fine. But let’s dive a little deeper into what exactly I like and what, if anything, exactly I don’t like.

Likes:

  • I like having my glucose meter and pump as one contraption. I feel like it has encourage me to test my blood sugar more often, especially right before I eat something. Since I already have to get the PDM out to bolus, it’s not much extra effort to check my blood sugar. It’s similar to why people like the Medtronic CGM/pump combo (although for me the inaccuracy of the Medtronic was such that it was almost pointless to try using it, but I digress into a totally different topic).
  • I like that it doesn’t influence my wardrobe choices, at least not yet. I’m sure there will be at some point a skin tight something or other that will reveal an irregularly shaped bulge in my side that makes me cringe and cry “Why do I have to be a Borg?!” But I’m not there yet. Right now, I’m wearing shirts and skirts comfortably that almost entirely hide the pod-shaped lump under my clothes.
  • I like that the PDM is very easy to read and to use. I like black text on a white background (although I wish that purple background color ran through the PDM a little bit more). I like that it uses a little bit of color. I like that the menu is easy to click and scroll through. I like that the Status screen has pretty much all the info I need and that the bolus feature is the first option on the menu. Pretty much everything else is just additional, so the flow works for me.
  • I like the all the stats and graphs. It’s fairly comprehensive, although since I’ve only had it for four days, there’s not much I can work with just yet. But I like that there is something there, built into the PDM so I don’t have to download (although I’m sure I will soon enough).

Dislikes:

  • I don’t like how slow the PDM takes to wake up. This is probably my biggest pet peeve. I have to hold down the on button and then it still takes a second to wake up and retrieve the data. It just seems like it could be faster.
  • I don’t like that it won’t break down and show me the amount of insulin for corrections and for food when doing the calculations. It’ll confirm the amount of food and your blood sugar, and then it will give you an insulin amount factoring in your food, blood sugar and IOB. But it won’t actually tell you how much insulin you are getting for each category, which is something Medtronic does before you confirm. It’s something I was used to and liked reviewing.
  • I don’t like that I can’t find out how much insulin is in my reservoir. It only has an icon the shows that it’s more than 50 units, so I find it a little weird that it won’t actually tell me the number.
  • I don’t like how big the PDM is. It’s seems bigger than it needs to be. It’s pretty heavy. It’s not the end of the world, but it’s definitely something I noticed when I took it out of the box.
  • I don’t like that you can’t move the pod. It’s one of the things that I didn’t like about the pod when I first saw it many years ago, and I’m still not a fan that you can’t move it. I wish, like regular pumps, there was a way to have the set and the pod separate so that if you needed, you could change the set but still keep the pod if it had insulin.

That’s pretty much it right now. I would say the pros outweigh the cons by a lot. Of course, no system is perfect and I’m sure I’ll get used to Omnipod’s way of doing things soon enough. I will also say that the size of the current Omnipod is basically the max of my comfort level. I would love it if they were a little smaller although obviously you need to have some room to put insulin and the device’s brains. But if it were any bigger, I don’t think I would like it. They are small, but they aren’t that small.

Anything else you want to know?

The New Adventures of an Old Pumper

BR6ApDlCEAApO49.jpg_largeI’m officially 36 hours into my new adventures on the Omnipod.

I received the call on Wednesday that my insurance company had approved the insulin pump but I wasn’t able to get a hold of anyone at Insulet until Friday. When I finally spoke to someone, I told them I was ready and to send out the insulin pump. They told me that I would receive the pump in about 3 to 5 days, and to go ahead and make an appointment with my CDE to get trained. Little did I know that 3 to 5 days would be shortened to just one day! On Saturday evening, when I came home from work, the Insulet box was sitting outside our apartment!

I debated for, oh, five minutes about whether or not I should go ahead and boot myself up. As you can probably tell, I went ahead and booted myself up. Having already been on an insulin pump for a solid 12 years, I knew the pumping lingo and could read the instructions and the PDM easily enough. I had also seen Gary demonstrate how the Omnipod works in May, so I felt I had a clear idea what was going on. Not that there weren’t nervous moments, and I jumped a bit when the Omnipod finally injected into me. Having using a silhouette for many years, I’m used to doing things manually.

Because I still had Lantus in my system, I didn’t start the basal portion of the Omnipod until Sunday morning so that I could make sure it was a good 24 hours since my last injection. That meant I was a bit high overnight (although that ice cream probably didn’t help), but I was back to normal quickly enough with a correction dose. And boy was it nice to just push a few buttons instead of taking an injection. Lordy, I was hating on injections toward the end!

I haven’t really been on the Omnipod long enough to make any real solid observations, other than to say that I like it a lot. There are a few things that I’m not so keen on, but there aren’t any red flags that make me want to send it back. My main issue right now is just simply adjusting my insulin doses from MDIs to an insulin pump. My basal, and likely my bolus ratios, are going to change now that I’m back on an insulin pump, just as it did when I went off the insulin pump. I’m spending a lot of time testing my blood sugar. That 50 mg/dl I woke up to at 4:30 this morning was none too pleasant!

In lieu of proper CDE training, is there anything you think I should know about the Omnipod? (And don’t worry, I know about the doors!)

Disappointing Diabetes Day

angryThere are times in your life where you really wish you didn’t have to admit something, but you sort of have to because eventually people are going to start asking questions.

So here it goes:

Last Tuesday, as I was finishing up a much-needed post-semester massage, I received a call that my insurance company, Cigna, was requiring that I have a C-peptide test done in order to approve my request for the Omnipod. For those of you who don’t know, a C-peptide test shows whether or not you are making any insulin. Considering I have been a type 1 diabetic for almost 20 years, and have 20 years worth of A1C results, co-pays for endocrinologists appointments and diabetes supplies, and, you know, another insulin pump, I find this request borderline insulting. Do they really think I’ve been making up this diabetes business for twenty years for shits and giggles?! I mean, really…

I have to get my labs done anyway, so I’m trying to not be too annoyed, but it’s putting a delay on my Omnipod order which is why I haven’t mentioned going on it yet. I should get it sometime in July and then I’m hoping to have Gary Scheiner train me when I go to AADE next month (or, you know, one of the other 10,000 CDEs who will be there, including my roommate, Kelley Crumpler!).

Having to get a C-peptide test is more of annoyance. The real tragedy is what follows:

I lost my Dexcom G4 transmitter.

Or better yet: I probably threw it away. I was at work a couple weeks ago when the sensor felt particularly itching and annoying. It was in fact getting a bit infected, which I have a history of with Medtronic but so far not with Dexcom. Rather than put up with the itching, I ripped the damn thing off. And promptly threw it away. Without, you know, taking off the transmitter first. Since I was getting a massage done a few days later, I decided to forego putting another sensor on, which is why it was a good four days later that I realized I no longer had my transmitter.

I called Dexcom and the rep told me they would replace the transmitter — hold your enthusiasm — for a mere $199. Yikes. Apparently some folks have their transmitters replaced by their insurance company, but it isn’t very likely. I haven’t decided if it’s worth the fight or if I should just hold off for another two and a half months until my warranty runs out and I’m eligible to submit for a new one. Considering they are forcing me to get a C-peptide test to approve an insulin pump, methinks my chances are not very good.

I’m irritated by the C-peptide request, and I’m just plain mad at myself for losing the stinking transmitter. But most of all, I’m mad at diabetes for adding even more stress and to-dos in my life. As if I don’t have enough going on!