Please Test

I need this post to accomplish two distinct and important goals. The first one will be simple. I want to thank my wife Kelly and my daughter Arden for both being so amazing. You'll see why in just a moment...

Second and maybe more importantly, I want to take this opportunity to remind everyone that while CGM technology is fantastic, it isn't foolproof. Because of that sometimes ignorable fact, we always have to test. Normally when we speak about this topic it's in response to the notion that you shouldn't bolus based on a CGM number. While bolusing without testing is something that we should never do, most of us probably have... but we shouldn't becasue CGM technology is designed to be used in addition to testing, not in place of.

Tonight while I was with my son Cole at his baseball practice (yes I know it's January) Arden's CGM alarmed and reported, "101 arrow straight down". Kelly, being the D-mom rock star that she is, tested.

Please test because sometimes, not often, but sometimes, 101 is actually 36. The DexCom CGM technology is so wonderful that it's easy to forget that it isn't perfect. I've been as guilty as the next person of leaning on it too much when I know that it isn't always spot on. It's difficult not to, especially after the sensor has been on for days and consistently reporting numbers that are so close to our tests. Next time that I'm inclined to think that way, I'm going to remember something that Arden and Kelly told me when I got home and I hope that you will too.

Kelly later said that she tested Arden because Arden said that her eyes "felt funny". Arden told me the next morning that it felt like she had been looking, too long, into a computer screen and then suddenly turned away. "My eyes were getting dark" she told me, with no inclination for how her words were breaking my heart. 

I gave her the bolus a few hours before at dinner that caused this low... and her eyes got dark.

Most moments with type I diabetes are uneventful. Our vigilance gives us the sense that we have the disease under control, but that's a foolish notion. It's only under our control until it decides that it wants to run away. When diabetes decides to run you can't stop it. Your best hope is to chase after and keep it in sight until it gets tired of running. Then you can stand next to it again, pretending that you are partners.

We're vigilant because we can't predict when diabetes will take off running, that's why we test. You aren't taking the test, it isn't you that's being judged. It's a test of diabetes, an indicator for whether diabetes is going to stand next to you and play nice or run away.

Please test.

New OmniPod Pictures and Information

It's official! The next generation of the OmniPod Insulin Management System has been approved by the FDA!

I've just finished speaking with Sean Gallagher, Senior Director, Marketing for Insulet, person living with type I diabetes and OmniPod user. We spoke for a bit this afternoon and I have some fresh information about the new Pods and PDM to share.

The name remains the same: You won't be wearing the OmniPod G2 or OmniPod Lite. Just good old OmniPod.

Pricing: There will be no price increase for the new system.

Transition: Insulet has been working for "18 months" to make the transition to the new smaller pod "easy" and fast for us the users.

How the upgrade happens: Current OmniPod users will receive an email stating that upgrading is possible. All you have to do is contact them back to get the ball rolling. Sean stresses that the process will be super easy, fast and efficient. They are working hard to make the transition a pleasure.

When? When can I get them?: There is some training of staff, endos and the like that's happening now. Expectations are that those steps will be finished and the new Pods will begin being delivered in the first quarter of 2013. I know you feel like you've heard that before but this time the ball is completely in Insulet's court, they have control, I'd bet anything that this time frame is accurate.

More when: For customers that are currently under warrantee. Your new Pods will arrive after you've exhausted the stock that you have in your home. Upgrades will happen at re-order only.

Any insurance stuff to worry about?: Simply, no. If you happen to be outside of your warrantee there will be some steps to take between Insult and your insurance company but Sean assures me that most of that process will happen on their side of the equation, requiring only a minor amount of effort on your part. The man said, "easy" is their goal, I believe him.

Interesting technical stuff

• The insulin reservoir capacity remains the same even though the pod is smaller.


• I asked Sean, "how did your R&D people accomplish the size reduction?" He responded simply by saying, "they're brilliant!". The slightly more technical reasons however include, the insulin reservoir shape has been changed to an oval and flattened. Plus the new Pods require only three, instead of four batteries because of enhancements that lessened power requirements.


• The new PDM has a dramatically improved stated signal range of five feet, but between you and me, I've seen and used one during FDA required Human Factor Testing... I'd try backing up if I was you.


• The smaller Pods have a new feature called a 'pink slide.' When the cannula deploys correctly, it pushes a piece of pink plastic to be visible through a new, second window on the top of the pod's surface. You can use this together with the regular viewing window for additional confirmation of insertion. - Info and picture added at 5 pm on 12/14 after second conversation with Insulet.

Why the long wait:

I expressed to Sean that the long wait for the newer, smaller, lighter OmniPod made me wonder if they were ever going to see the light of day in the U.S.

Sean indicated that the Human Factor Testing requirement from the FDA was in it's infancy (my word) when they were seeking approval and that both sides lived through a learning curve. He did stress that he genuinly belives that the "process is valuable" and when I asked if it was fair to say that the process provided me (and you) with a better, safer insulin pump, he did not hesitate to say, "yes".

Sean closed out our discussion with two thoughts that I will share.

He hopes, for two reasons, that those of you that may be preparing to begin pumping with OmniPod don't feel as though you should wait for the new Pods to become available. His first point (that I can completely agree with) was simple. The current version is a great device. I can't argue with that. If you start today you will be using a wonderful insulin pump, one that has benefited many including Arden for years. His second point was a reminder that the transition to the new Pods will be so easy that it won't even cause a blip in your day to day life. So there's no reason to wait.

I'm choosing to include his thoughts, that you may read as marketing (and perhaps it is) not just because I believe in the company, but also because I know that Insulet is a small company. I don't know for sure, but I'm willing to guess that they wouldn't do well financially with a less then normal amount of new customers over the next three or so months. That's my honest take on this issue, I make no secret that I'd like Insulet and OmniPod to thrive, it's good for my daughter and for all of you that wear the pump.

Lastly:

Sean wanted all of us to know that he and Insulet appreciate all of our paitence during this long journey. He is thrilled by the reception that OmniPod receives in our community and is touched by the eagerness that the new generation OmniPod is being greeted with. He said, "I am happy and excited to put the new OmniPod into hands".

Now for the pictures, you know you want to see the pictures!

Hi-Res version are available in the Visual Record section of the blog.

Update on Monday, December 17, 2012 at 12:46PM by Scott Benner

I have good news about the new OmniPod for my Canadian friends right here

BREAKING NEWS: Smaller OmniPods approved by FDA!

From Insulet

"The new OmniPod System, comprised of a smaller Pod and an updated PDM, has received clearance from the U.S. Food and Drug Administration (FDA). This means Insulet can begin manufacturing and selling the new OmniPod in the U.S. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features."

more from Insulet here

Insulet's investor statement is here

More statements of interest from Insulet/OmniPod

"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," said Mr. DeSisto. "We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013..."

"If you are currently an OmniPod wearer, you don't have to do anything right now. We will reach out to you when it's time for you to convert to the new OmniPod and give you all the information you'll need. Converting to the new OmniPod will be EASY! And you can be confident that we'll give you plenty of notice before your new OmniPod is shipped."

Well, it took wayyyyy longer then any of use could have predicted or hoped but all of that is behind us now! Whose excited?!?! I for one can not wait to tell Arden, she is going to be so happy. 

Update on Friday, December 14, 2012 at 12:45PM by Scott Benner

@diaTribeNews is reporting via their twitter feed about the new OmniPod:

"Insulet upgrading all current OmniPod users free! New PDM/pods come 2 US early '13. New pod rocking in EU, upgrades done in next 60 days"

"For people new to OmniPod - very nice that the new PDM will cost exactly the same as old one - no price increases for a better product."

If you've never visted http://diatribe.us you should!

Update on Friday, December 14, 2012 at 2:55PM by Scott Benner

Check out my latest post about the NEW OmniPod complete with information and pictures I bet you haven't seen before!

http://www.ardensday.com/main/2012/12/14/new-omnipod-pictures-and-information.html

First Impressions: DexCom Platinum G4

It's been about a week since Arden's new DexCom Platinum G4 arrived and I've spent enough time with it to share my initial thoughts from the perspective of a type I CareGiver. 

The G4 is smaller, lighter and more modern looking then the 7+. All good stuff. The wire that inserts into the wearer is smaller to try and further minimize the pain felt at insertion. A number of people have mistaken it for an iPod. The signal range is vastly improved and I'm seeing more accurate readings. Best of all, Arden loves it.

Arden's Reaction

Arden's face lit up when she opened the box and found a pink CGM looking back at her. Her excitement level was just as high, if not higher then when we bought an iPad. She was genuinely happy to get the G4. I never thought that I would see a person, let alone a child, that joyous over a medical device but wow was I wrong. 

BG Accuracy

The G4 began to send accurate and reliable readings immediately after the two hour marrying period. We've only inserted one sensor thus far and perhaps we won't get the same instant feedback next time, but I was not accustomed to being able to rely on the 7+ on day one, so hour one was not even in my mind. I'm also seeing a great deal of numbers within what I would call acceptable range of finger stick testing, both up and down the spectrum, 400 - 75 (Arden hasn't had a significant low this week). Last evening, I missed on a late night snack bolus, and when I tested Arden around midnight I got this...

Even though I have no scientific data to back up my statement, I'm comfortable saying that the G4 is more accurate then it's predecessor. Which is to say that it seems, so far to me, to be closer to finger sticks then the 7+. Time will tell how true my initial observations remain.

Signal Range

Sadly our bedroom and Arden's are at completely opposite ends of our house, not even the vastly improved range of the G4 can reach my bedside. While that was a momentary bummer, the rest is all great news. Arden is able to untethered herself from the CGM in our house and other relaxed situations while still benefiting from it's feedback. The range is quite impressive. A few days ago Arden had dental work performed and I was able to wait in the lobby instead of lurking around her during the procedure. The G4 sent it's signal to the receiver in my pocket, the distance wasn't great, maybe ten feet but I was on the other side of a wall. The 7+ couldn't even send a signal through Arden's hip so drywall is a a big leap forward!

We kept her a little high for the procedure

In the past I would have needed to go in and out of the exam room to watch Arden's BG, interrupting the doctor and making Arden feel awkward. But now I'm right where I should be...

Ease of use

We found no confusion moving from one version to the other. Even though the button configuration is slightly different and the screen is redesigned, neither Arden or I experienced any slow down or inability to use and understand the new receiver. There was no transition to speak of, I found the change completely intuitive and unremarkable.

Wrap

The DexCom G4 is smaller, lighter, nicer looking and it works better. Arden has never once mentioned that the transmitter is taller or that she in any way misses the 7+. I haven't asked her level of comfort during the insertion yet, I will, but asking her the first time wasn't going to yield an accurate reply, she was too jazzed up as we put in on.

Meanwhile her poor 7+ is just sitting on the counter as I search for a way to legally donate it to a child in need, which is not as easy of a task as you may think.

More information and final thoughts

Everything you need to know about the G4 can be found on DexCom's website. Colors, size comparisons, tutorials, cute little videos... it's all there. I can't tell you for certain that I would stop using a working 7+ and rush to buy a G4, I'm far too thrifty for that. We were lucky in that our 7+ had run past it's life expectancy and was about to be replaced by our insurance when the G4 hit the market. I would have waited for financial reasons if that was not the case. Never-the-less, if you are eligible for upgrade or thinking about using continuous glucose monitoring technology for the first time, I can't recommend the G4 Platinum strongly enough. It makes our days and nights better and aids me significantly in my daily dance with type I diabetes. I'll post more thoughts when we've been with the system longer. Please feel free to ask any questions that you may have and I'll do my best to answer them. 

Neither I or 'Arden's Day' is compensated for my thoughts or opinions. There is a "I'm not a doctor' spiel at the bottom of this and the main page, please remember it when you make decisions about health matters.

Update on Monday, December 3, 2012 at 11:22AM by Scott Benner

The second part of my review DexCom G4 Platinum: Second Look, can be found here.

DexCom G4 Platinum Overview

DexCom just updated their site with a ton of G4 information!

DexCom says:

• 25ft range for flexibility and convenience
• Beautifully colored receivers to fit into your lifestyle
• Less than 1/2 inch thick
• Customizable Alarms -Tones and melodies to suit any environment - Examples of the alarms are available at the bottom of this page.
• New software, DexCom Studio (I'm not seeing a Mac version)

Orders are being taken now at 888-738-3646. I'm on the phone with customer service now... they are unsure of when new G4 will be delivered if you order. I'm being told that a rep will call me back tomorrow with details.

My post with the press release is here.

Update on Wednesday, October 10, 2012 at 3:43PM by Scott Benner

I've ordered Arden's G4 9(in Pink) and the rep tells me that shipping begins on October 29th! 

Update on Wednesday, November 14, 2012 at 11:15AM by Scott Benner

Please follow this link to read my First Impressions of the DexCom G4.