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Entries in Insulin Pump (46)

Monday
Dec172012

Oh Canada, I have new OmniPod info

Over the weekend I received more then a few queries from fellow OmniPodders that live in Canada. All were wondering when they can expect the smaller OmniPod to arrive north of the border. So I tied a tiny electronic note to a digital sparrow and released him into the Internet. This encouraging bit of news is what came back...

 

"With U.S. FDA approval now in hand, we can move forward with our regulatory filings in Canada. We hope that we would begin selling the new OmniPod in Canada later in 2013." - Brian Roberts, CFO, Insulet

 

There you have it Canada, I hope that this was the kind of news that you were all hoping for. It's not concrete but Insulet is willing to tie themselves to a date, however vague, and I think that is worth be optimistic about. I'll let you know more when I do.

Oh, you know what, while you're here. I've been wondering this my entire adult life... What's a Canuck? Seriously, is it a bird, plant, slang or none of the above? I need to know, please. Thanks!

Friday
Dec142012

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.

Friday
Dec142012

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. 

Thursday
Jul052012

This is water

 

We had lots planned for the 4th of July 2012, Cole's baseball game was at 10am, Arden didn't want to miss a 1 pm parade that we go to every year in the next state over and we were joining our family for a picnic and swimming at my in laws. Since the parade is about 35 minutes from our house (and in the same town Kelly's parents reside) Kelly and Arden left the baseball field as soon as Cole's game ended (they won) and I stayed behind with Cole so that he could hang out with his team for a while and then get changed before we left for the picnic.

Cole and I arrived at my in laws' home long enough after the parade had ended that everyone was swimming when we arrived. We walked into the house and made our way to the sliding glass door that leads to the pool. I paused for a moment to speak with someone, during our very brief conversation a gust of wind lifted one of the tall tables next to the pool. The gust, which came literally out of the clear blue, filled the orange umbrella of the table closest to where I stood, lifting it off of the ground. Without hesitation the table and it's contents clumsily tumbled into the pool. I was shocked by the site but not overly concerned as I saw that no one was in it's path either on the sidewalk or in the pool as it fell. At first glance this all seemed like no more then an annoying situation that would need to be cleaned up. Watching all of this through the glass door gave me the sensation of watching television with the sound muted. In an instant Kelly came from stage left entering my field of vision in a full sprint, she didn't slow down as she approached the pool and jumped in with an urgency that caused me to think that someone was pushed in by the heavy glass table. I began to move outside to help when Kelly held up her right hand over her head, she was clutching Arden's D-supply bag. The bag that we keep her OmniPod PDM in. My stomach turned. When I approached the scene, Kelly was handing Arden's PDM to my sister in law, followed by her DexCom CGM, Kelly's Backberry from work and her personal iPhone.

I immediately asked Kelly when Arden's last bolus happened and what her BG was at the time. We were managing Arden's BG completely blind now and without the ability to test, bolus, or suspend basal. Our conversation indicated that Arden's BG was in a good place so instead of ripping her from the picnic to make the trip back to our house, I left to bring new supplies to her. An hour and perhaps twenty or so broken traffic laws later I was back. I switched Arden to a new pod that I'd have to link to an old OmniPod PDM (b&w screen), tested and began monitoring her diabetes 'old school' without the assistance of her DexCom CGM. It was back to timers and worrying between insulin and food. Not good but we'll be fine, the reason I tell you this story isn't because of the drama or shocking nature of loosing so much important and expensive equipment. I tell it because of the book that was on my back seat as I made the desperate drive to and from my house.

During the mad dash to retrieve all of our backup supplies I couldn't help but to think about the book on my back seat. I had a copy of David Foster Wallace's 2005 commencement speech with me because I was going to give it as a gift to a recent graduate later in the day. 'This is Water' is a book that I give to every graduate in my life. It's not really a book actually, but the text of the speech in gift book form. I try to reread the text at least once a year because it's message about choosing how to think about reality is so close to how I try to think about my own life. Wallace makes a compelling argument that every situation can be reacted to in the direction of your choosing. He uses the example of a speeding car and asks you to imagine that the driver may be speeding because their child's life is in the balance. He admits that in most cases the offending driver is probably not in a dire situation but then asks, what if "the Hummer that just cut me off is maybe being driven by a father whose little child is hurt or sick...".

As I sped to my house I had two thoughts. One, the idea that Arden's bolus might drag her BG too low while I was gone and two that I was living a part of Wallace's commencement speech and playing both roles. I was the father driving like a nut and I was the man who choose not to judge him...

Watching two thousand dollars worth of electronics being pulled from a pool was nauseating and it was truly going to cause my family a financial hardship but I never thought about the money. I did my best to keep Arden's health and safety as my only thought or concern. As I took the steps necessary to make that happen I found myself doing what Wallace suggests is possible. I looked at the world, at this situation, in the way that let's me be happy. I remained aware "of what is so real and essential, so hidden in plain sight all around us, that we have to keep reminding ourselves over and over: this is water... this is water". I hope that you take the time to find Wallace's words, they are available in book form, online and the audio of his speech is on YouTube, I've included it below.

Diabetes gives us all plenty of opportunities to see the bad in life and in all fairness and devoid of any new age bullshit, a lot of it really does suck. I just hope that you can trust me when I say that you can choose to not think of it that way, it's difficult but really worth the effort. I've witnessed people like myself who from time to time struggle greatly with the difficult moments that diabetes can present. These moments offer us the very real and easy opportunity to not just see the bad but to lay down in it and make ourselves at home. It's easy for me to say that you should resist that urge but because I know from my own life that choosing to be happy is not the simple task that just saying the phrase suggests... Consider checking out 'This is Water', it helped me to find the right path and I hope it helps you as well.

July fourth 2012 started out in fine form and then quickly deteriorated into a day we'd rather forget. I originally thought that this story was going to end with the image of our gadgets in a bag of rice but diabetes had more in store for us then I imagined. Too much for one blog post, so I'm going to have to wait until my next writing to tell the story of July 5th.

 

part1

part2

Friday
Mar232012

Basal the spike away

Standard Disclaimer: I'm not a doctor, please read the disclaimer at the bottom of the page. Always speak to your doctor, especially before trying something that came to me while I was in the shower. 

Stubborn Highs: Arden's blood glucose can rise and at times be resistant to returning to 'normal'. Happens to all of us. I bolus and wait but nothing, so I bolus again and sometimes again. It's around the second bolus when I begin to wonder, "is the site bad", "maybe the pump has been on too long", "did I grossly miscalculate carbs", a person can go batty trying to decide what has happened. It's likely that before you (or I) can ever come to a conclusion, the BG in question will return to 'normal' or head in the complete opposite direction. Either way, the whole unsightly mess is forgotten becasue you're busy chasing the next problem which leaves you no closer to understanding why this happened or figuring out how to avoid it next time.

Sound familiar? 

This type of BG struggle isn't just associated with stubborn highs: Breakfast or meal time spikes can also lead to an urge to bang your head on a nearby firm surface. Over the last few months I've been experimenting with an idea that came to me in the shower one day and I'm seeing a lot of positive results. I'm going to do my best to explain without being boring or confusing... Please note that what follows will only work for pumpers because it involves manipulating basal rates... sorry MDI and pen users!

 

Using increased temp basal rates in place of a portion of your bolus

Arden is a really good eater, that is that she eats healthy foods most of the time and in acceptable portions. If the kid has one 'vice' it's that she likes a bowl of Fruit Loops in the morning - just one cup. The BG devastation that this handful of cereal visits unto Arden was, in the past,  terrible. Her BG would rocket to 400 or more after a bowel of the colorful rings. The Loops would seem to laugh in the face of a pre bolus and administering more insulin before the meal or an extra bolus after could not penetrate their sugarific force field. Once I even thought that I saw Toucan Sam give me the finger as I put the cereal box back in the pantry.

I hate this song and dance. I hate that Arden can't have a flippin' bowl of cereal once and a while and I double hate the feeling that I live with when she eats cereal and her BG goes crazy. Foods like this don't just send her BG too high, they ruin most of the rest of her day. I'm full aware that cereal isn't a good choice for my diabetic daughter but I'm not writing about that today. Today I am talking about how, with the help of an insulin pump, we can all fight meal time spikes associated with not so great food choices and manipulate stubborn high blood glucose values more easily and smoothly.

 

My formula

Things you need to know to follow along: 

  • Arden's basal rate is .30 in the morning and much of the day.
  • For a serving of Fruit Loops she requires 2 units of insulin.
  • Giving say 2.5 units for the cereal does not change the trajectory of her BG.
  • If I go higher (say 3 units) the spike is not effected enough, topping out at 350 and Arden's BG will plummet between the three and four hour mark.

 

Time to visit me in the shower where I am apparently about 20 IQ points smarter then I am anywhere else. (I've heard that the hot water on the back of your neck may be the reason why).

I was in the shower one day pondering life and Arden's breakfast BG spikes when I first began putting the pieces together. Overnight Arden's basal rate is .20, if she's high I have to put her basal back to .30 for a bolus to have the desired effect... I wondered what would happen "if I increased the basal beyond .30", could I bring a high BG down in a safer way, steadier perhaps (because she's sleeping) then if I just bolused? I tested my idea at the next opportunity and not only did a significant temp basal bring down the high overnight BG but it did it with less insulin then a bolus would have required and the drop was smoother, it's 'landing' less erratic. My inner mad scientist was intrigued and I had just unknowingly found a big piece to the puzzle that is stopping mealtime spikes.

Proof of concept: Arden sits down and begins eating on a school day at 8:20 am. Today at 7:45 am her bg was 140, I bolused for the first 15 carbs of her upcoming breakfast, which was 1 unit or half of what a serving of Fruit Loops requires. This is a pre-pre bolus, I find that after a long night of no boluses and a decreased basal rate it can take a little longer for insulin to begin working (maybe this is part of the morning insulin resistance many experience?). At 8:10 am I bolused again this time for the remaining 15 carbs but I reduced the 1 unit of insulin by .30 (the equivalent of an hour of Arden's basal rate). Last, I increased her basal by 95% for one hour. (OmniPod won't do 100%), giving the last .30 of the 2 units via an increased basal rate. The temp basal in conjunction with a significant pre bolus seems to be the key to eliminating a BG spike. Pre bolusing alone won't effect a severe spike enough because you can't perfectly sync the insulin peak with the food spike so the BG rises quickly, drops suddenly and often bounces back up. However, when you add a pre bolus to a significant temp basal, the basal acts as a constant drag on the spike and the two together win out.

 

Breakdown

15 carbs or 1 unit, 40 minutes before breakfast - 7:45am

I can prebolus that far off in this situation without an issue because her basal was .20 all night and she's resistant in the AM, so the insulin is a bit slower to respond first thing in the morning. Plus, with Apidra, Arden rarely experiences significant BG falls so prebolusing this far out feels safe. Additionally, I have 70 points in her BG to play with and the cereal will be releasing sugar into her blood far before she gets too low... (having a DexCom CGM doesn't hurt either).

Another 15 carbs 15 minutes before the meal (withholding the equivalent of an hour's worth of basal)- 8:10

This insulin won't begin working until after Arden begins to eat, so I'm not worried about stacking. Two boluses also mean two insulin peaks while the Fruit Loops are trying to spike her BG. 

Double the basal rate for an hour to complete second 15 carb bolus.

This .30 will work better then if it was given as part of the bolus, why? I don't know, I told you, I'm not a doctor... it just does - Maybe I know this because hot water in the shower makes me smarter. btw, more then an hour of the temp basal is too much and results in a fall in the 3-4 hour range. Doubling for an hour is perfect.

Result: At 9:30 am Arden's nurse called... Arden was 240 by her CGM. The CGM indicated 2 arrows up (which was why she was with the nurse) but the double arrows only lasted for about 4 minutes. So my little science experiment took a double arrow up event that in the past would have sky-rocketed to 400 (or more) and held it to a 4 minute double arrow that never went above 250!

Arden's BG (by the CGM) at 11 am (pre recess) was 145 diagonal down, she drank 2 ounces of juice (7 carbs) and went outside to play. When she returned her BG at 11:30 am (post recess, pre lunch) was 129 by a finger stick, 140 and steady via the CGM. 

I choose and extended bolus for lunch because she was having a bagel. 60% of the 2.20 units at 11:30 am the balance over an hour (to combat the slow breakdown of the bagel). Her BG was 145 three hours later before snack time.

 

Summation

It goes without saying that what works for Arden won't work for everyone but after months of using this method I am 100% comfortable telling you that what I wrote here is well worth speaking to your endo about. The concept of using a temp basal to complete a bolus holds many possibilities beyond what I wrote about here today. Slow to break down foods and high carb meals for example are also good places to try this method. I'm using a temp basal as part of Arden's bolus on almost a daily basis. It is also invaluable in bringing down stubborn high BGs and getting a BG lower during sleep, avoiding the fear of a sudden drop and without going too low.

I wish you all good health, luck and steady BGs. I'll do my best to answer any question if you have them.