FDA clears Freestyle test strips for use with OmniPod

 

"The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod," Insulet confirmed in an email to MassDevice. "The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week."

It's official, after more then a year and I can only imagine how much cost to taxpayers, the FDA finally has said that we can use Abbott's butterfly test strips in our OmniPod PDMs.

I'm not all that excited and am about to be a bit snarky about this announcement because I figured this out over a year ago for free and it only took me two days.

I completely understand and support that medical devices, equipment and the like need to be safe, accurate and durable but come on - test strips? I asked myself last year, "why would Abbott develop and manufacture a test strip that wouldn't work with their business partner's testing devices". I found the common sense answer to simply be, "of course they wouldn't do that". Then I conducted my own test and began using the strips with Arden's PDM in December of 2010, we have never looked back.

I'd like to congratulate the FDA on once again turning something simple into a train wreck, you guys are nothing if not consistent. Maybe now they'll (FDA) have time to clear Insulet's latest OmniPod design, from what I understand it's being held up because the "documentation can be confusing". To be clear, I've seen the documentation, used the new pods and not only couldn't the documentation be any simpler but it's about 99% the same as the current generation's instructions. In my opinion the new OmniPod design is being held up because of bureaucratic and political BS.

Our representatives in D.C. love to say that business should allowed to thrive but they'll take any chance to stand in it's way. Insulet is not a huge or rich company. They make a wonderful product that every day helps countless people live easier and more healthy lives. I'd very much like to see the FDA give them a chance to make a profit so that their amazing insulin pump can be around until type I diabetes is cured. Hopefully that cure, when discovered, won't be held up by the FDA forever...

I assume that most of you, because of necessity, have already implemented the "new" strips but just in case you were waiting for official word, you can find it here it's entirety.

Follow @twitter  

Update on Thursday, January 12, 2012 at 10:38AM by Scott Benner

Insulet has posted a link to updated information.

I just unintentionally saw Twilight

Arden and Cole both received the same Christmas gift from their grandmother... Gift certificates for dinner, book shopping and a movie with Grandmom. Arden wasted no time and exercised part of her gift tonight, asking to see Twilight. My mom isn't able to manage diabetes on her own so I tagged along to set Arden up with snacks and insulin. I was going to sit in the lobby or another movie so Arden could feel like she was by herself with her grandmom.

In the beginning things were going well. Arden's BG was 120 and drifting down as we took our place in the concession line. Everything was set up perfectly for Arden to enjoy the evening and I thought that we had handled an earlier meal well, putting her in a great position to watch Bella and the gang stare lovingly into the camera and/or off into space.

The concession line was very long and moving insufferably slow so I suggested that Arden and my mom head into the theater to find their seats. Arden was so excited, she was about to spend two hours feeling independent and hanging out with her grandmom. I was equally happy and loved the idea of her spending this time away from the constant overseeing... sadly diabetes had other plans. I watched the time closely as I waited for the popcorn because Arden's DexCom was still indicating a diagonal arrow down when she walked away. The concession line continued to crawl along, taking twenty plus minutes to get snacks and return to the girls.

I thought that I'd find Arden with a BG of around 100 when we met next.

When I arrived at Arden's seat she said, "did you get my text - I feel really dizzy". The long wait in line had set me back about ten minutes but I didn't think it was an issue becasue Arden was going to text if there was a problem. It turns out that I wasn't receiving my text messages (due to a week cell signal in the lobby), these messages came through a few minutes after I got to Arden...

Arden didn't take steps to control her BG drop because she thought that I'd be there any second with her food and "(I) didn't want to get too high so I waited".

I tested Arden as the opening credits rolled, her BG was 47 and still falling. I quickly gave her a glucose tablet and she began to eat her movie treats but it was too late, she was beyond dizzy. It was then that Arden asked me to take her home... I immediately felt incredibly sad for her.

I suggested that she stay, promised that she'd feel better soon and that she could still enjoy the movie. She agreed, I sat on the floor in front of her (the theater was full), she continued to eat. The DexCom finally indicated that her BG fall had stopped so I bolused for the snacks, she said that she felt better so I went to the lobby to give her the alone time that she had so wanted. fyi, I did get to see Bella marry that British kid before I left.

About twenty minutes later I received this text from Arden, "I feel dizzyer and the cgm says that I am 108". I went back in, we talked and she asked for some candy. A little while later she indicated that she felt better and said the sweetest thing. She said, "a feel a little better but I think that I get more dizzy when you leave", she paused and looked a bit uncomfortable. I told her that I could just stay with them but she indicated that I should go... I could tell that she wanted me to stay. I asked her why she looked conflicted, it was then that Arden told me that she believed that I was in a different movie and she didn't want me to miss it. Her concern for me was so sweet... I told her that I was just reading in the lobby and that I didn't mind staying, she smiled and sat back in her seat. I tried to find a good position at the top of the stairs to watch the last hour of the movie. By the time the film ended my left leg, butt and lower back were numb, perhaps as dead as Bella after she completed her transformation but I didn't mind. After the movie I tried to apologize to the woman sitting next to Arden but she wouldn't let me, she smiled in a way that said she understood and put her hand on my arm.

I am happy to tell you that while this evening didn't go even slightly as planned, it was still a success in Arden's eyes. She had a great time and called the movie "creepy but good". I am so proud of her, she never gave in tonight, she's the toughest person that I know.

My Twilight seat

Without a CGM and the information that it provides we would have never been able to make the adjustments necessary for Arden to remain in the theater. In kind, having an insulin pump and the ability to suspend background insulin was equally pivotal in navigating this diabetes moment. Type I diabetes made this night a challenge but having the correct tools and attitude were the key to not letting it get the better of us. Tomorrow, lunch and book shopping with Grandmom. I'll be outside... just in case.

Why can't I count carbs?

Some days I can't count carbs, not the easy ones, not the ones that are printed neatly on the wrapper - the other ones. The ones that you measure, weigh and eye up in a restaurant. There are days when I feel like they're may be no one on this planet worse at it then I am. 

The other times, I am the man! Last night for example, Arden had a girlfriend spend the night, great girl, very polite, even brought a gift with her. She arrived during dinner because of poor planning on our part... Chinese take-out. I of course had recently given Arden a monster bolus and we had only just begun to eat when she arrived. Maybe two minutes after Arden's friend sat down, Arden decided that she was finished eating. She was excited to run and play but there were carbs that weren't accounted for. I told her that she needed to eat a little more rice to cover the insulin - Arden declined, politely and then her friends says, "I brought cookies, she could have a cookie!".

Kelly looks in her bag and pulls out the cakiest, sweetest looking cookies that I had ever seen. Without missing a beat and it should be noted that these cookies are not a mainstay in our house, I said, "26 carbs, I bet they are 26 carbs". As you can see they were...

My question is this. How can I, at times, be so spot on and at other times miss so badly? It's frustrating to say the least. I measure and count and get all of the math right and still bad results. When I finally come to the conclusion that perhaps basal rates or insulin to carb ratios need to be adjusted - we experience three perfect days in a row. 

School day breakfast

Arden has the same breakfast everyday, she is not a huge breakfast food lover and often defaults to cereal which drives her blood glucose sky high. It took me weeks to figure out the proper prebolus/extended bolus mixture but now I can keep the spike to a minimum. Except on the days when my it inexplicably doesn't work.

Last week she ate the same thing everyday. Four of the five days her BG was 170 before recess, 135 after recess and before lunch (lunch is after recess so it's perfect). Good pre lunch number, safe range for recess and the insulin was finished before the next bolus. Except on the fifth day, on that day with all the circumstances the same, Arden was 65 before recess.

I know that there are many constants with type I diabetes. I'm not looking for answers, more just sharing about it to let you know that this is normal. If you are new to all of this, you will definitly experiance moments when you feel as if you are doing everything completly wrong - you are not. Even those of you who have been managing type I for years will have days when everything feels out of control and that's normal as well.

Step back, take a deep breath and start again. Most of all, please know that all of this is normal, diabetes normal.

OmniPod Rash?

If you've ever experienced a rash under your OmniPod, CGM or infusion set adhesive, read on.

Before I begin I need to say that I'm not a doctor and you should never confuse me sharing my experiences with health care advice. Never make adjustments to a care plan without first checking with your physician.

In the summer of 2010 Arden began to develop a rather severe rash under her OmniPod. I was confused because she had been wearing her OmniPod for a rather long time with no issues and it seemed random that she would suddenly have such a reaction. I turned to the internet, called Insulet and was presented with a number of "solutions". My problem with the answer that I was given was that it included buying more stuff and it complicated the pod application process. I really believe that the simple answer is often the best, so I held off on putting the conventional fix into practice and took another shot at diagnosing the issue myself.

Before I could put my thinking cap on I noticed that I was rubbing my finger tips against my thumb and that my finger tips were sore. I looked at them and saw that they were dry and begining to crack. I drifted away from Arden's issue momentarily to wonder about my own and then it hit me - I'm always touching alcohol swabs, that's probably why my fingers are so dry.

That realization led to an epiphany and suddenly I (thought) knew why Arden was developing rashes. At Arden's next pod change and every DexCom and OmniPod application since, I have cleaned Arden's sites with warm water and a clean towel - nothing else. Not only has she never had another rash but her pods don't stick to her like they've been cemented on when it's time for them to be changed (don't worry, they don't come off prematurely).

Turns out for Arden, chemically wiping away the oil that her skin makes naturally and then covering the area with an adhesive strip, wasn't a good idea.

I've shared our process with Arden's endo NP. She wasn't thrilled that I stopped disinfecting Arden's sites before poking a hole into her but she does acknowledge that we may have had to discontinue using Arden's pump without this adjustment. For us it's a calculated risk, you and your doctor can decide if it's the right thing for you to do. I wish you much luck!

When diabetes throws you a curve... just go with it

My son Cole is a baseball player and we talk about different aspects of playing the game with some frequency. He's a good listener and he makes adjustments most times with ease. There is this one pitch that he struggles to hit, it's low and just a bit outside but is almost always called a strike. Cole won't swing at that pitch no matter how many times I assure him that he can reach it. I tell him all the time to, "just go with the it" but he resists.

Perhaps 'just go with it' is something you have to feel and not something another person can describe but I'm still going to try.

Managing your day-to-day stress as it relates to your child's type I diabetes is, if you can find a way to 'feel it', as easy as just going with it...

Arden's BG was pretty perfect Sunday evening when we changed her OmniPod, except for her basal she didn't get any insulin for the remainder of the evening. By midnight her BG had drifted up to around 180 so I delivered a small corrective bolus. An hour later her DexCom began to beep and indicated that her BG had risen above our high limit, which was odd because I definitely expected that the last bolus would bring her to 120 but instead she was more like 220.

Getting the idea that the last bolus wasn't making a dent in her number, I gave a little more and then waited two hours to see where we stood.

Two hours later was about 3 am and her BG had not moved, I knew now that we either had to push a large bolous and everything would be great or change the site and start over. I wanted to bolus big but at that time of morning I couldn't be sure that I'd be in any condition to act if she was suddenly 45 at 5 am so I gave another small correction and set an alarm for 6:30 (an hour and a half before Arden gets up for school).

When the alarm sounded I felt like I had sand in my eyes. I checked her CGM and saw the steadiest line you could imagine, steady but too high. I bolused this time for the full correction plus the 36 carbs that Arden would be eating for breakfast. I then literally thought, "that'll do it" as my head hit the pillow to get my last 45 minutes of broken sleep.

In the morning I got Cole off to school and went back upstairs to wake Arden whose BG I was sure was going to be in range and heading south just in time for breakfast. The rest went just like you think it did. Her BG was a little lower, falling but in no way was she feeling the full effect of that last bolus. The site needed to be moved.

In that instant my entire day changed.

Arden wasn't making the bus and I needed to wait out the last bolous before she could even eat. It was a mess but I didn't let the sudden upheaval of the day rattle me or Arden. I explained how our day changed so Arden wouldn't be flustered, we pulled out some books to read to help take her mind off of her hunger. I moved an appointment, slide a number of to-dos to the next day, emailed the nurse and her teacher and then refocused on my new goal for the day - getting everything back to normal and salvaging as much of Arden's school day as I could.

I realize that being a stay at home parent helps lessen some outside influences. I don't have a boss to report to so I can be flexible but it's not the mechanics of the day that I'm most proud of. I'm proud that when the pitch tailed away from me I didn't complain that it was a ball or that the ump was screwing me. In fact I didn't even wait for someone or something else to tell me what my reality was going to be.

I just went with it, I dictated what happened next.

There is a moment in almost every situation when you make a choice. You can dress it up anyway you like but in the end you decide how you feel and what you'll do next. If you go with it and just except that in this moment you took the best option available to you, well, I don't understand how you can be upset. We may not control the when or why in our lives but we sure can have our say in the how.

When my son learns to let go and swing at that low outside pitch he's going to miss a few, he'll foul off even more but once in a while he is going to drive that shitty pitch so far into right field that it'll make all the swings and misses very worthwhile.

Arden got to school at noon. Her BG was in range, she had breakfast and was ready to learn. We even got to spend some great time together. I did the best I could with the pitch I got.