The explanation for the delay of deployment for new customers was provided by Duane DeSisto, President, Chief Executive Officer and Director, beginning with the discussion of greater than anticipated interest from new customers resulting in greater demand than original expectations:

“With this significant uptick in demand we did make the decision to delay the transition of existing customers for approximately ninety days in order to build additional OmniPod supply. While the manufacturing process continues to improve we had an unexpected component issue that resulted in lower than planned production in the latter part of Q1. While this component issue was quickly identified and remedied…we determined it most prudent to build inventory to ensure that both manufacturing lines were operating efficiently before we commenced the transition of over 45,000 customers to the new OmniPod. At this point we expect that conversion to start in the next few weeks and we remain confident that nearly all customers will be transitioned by the end of the third quarter.”

Later on in the call when asked: “Do you have inventory levels today to support that transition, or do you think you will have that by the end of the month?” Answer was: “We will have inventory levels here in the next few weeks that we will start converting people.”

Other news:

Lilly Partnership to develop a new OmniPod targeted toward highly insulin resistant people with type 2 diabetes to deliver Humilin U500 insulin. 

As previously disclosed, Insulet has signed a development agreement with an unnamed CGM partner for the development of a sensor to be included in the OmniPod. Human trials are hoped to begin in early 2014. This would be make Insulet the only provider of a system with one product on the body and one handheld device for both insulin pump and CGM.

Listen to the entire call here.

Information is helpful. Thank you for sharing, Insulet. Keep it coming, please.

Read it here.

Live Sunday, April 28th 9PM EST on Blog Talk Radio.

Yes, it’s the missing SpiBelt, and thus missing DexCom receiver. It’s around Coach Dave’s (dad’s) neck. Yet another example of the amazing range of DexCom G4!!!

Filed under: DexCom Tagged: DexCom, G4, Range ]]> http://thisiscaleb.com/2013/04/22/i-spy-caleb-pitching/feed/ 8 thisiscaleb Pitching Fall 2012 Pitching Spring 2013 http://thisiscaleb.com/2013/04/10/like-you-really-like-it-you-want-more-dexcom-g4-share/ http://thisiscaleb.com/2013/04/10/like-you-really-like-it-you-want-more-dexcom-g4-share/#comments Wed, 10 Apr 2013 14:21:41 +0000 Lorraine http://thisiscaleb.com/?p=3638 Continue reading →]]> I do REALLY like it, and I want more, and there are hints more may be coming!

Do you follow diaTribe®? If you do not, I highly recommend it. I read about DexCom Share from diaTribe® today.

Caleb has been using DexCom G4 for over five months. He used the Seven Plus system for three years prior to the G4. The G4 is a remarkable improvement.

• The accuracy is significantly better. There are times that we confirm a DexCom reading with a fingerstick hoping that DexCom will be wrong, as it often was with the Seven Plus, but it never is. Okay, maybe once since Caleb’s been using it, it was off. True story. No joke.
• The range – OH THE RANGE! It is unbelievable. Everything is different with the range. As the caregiver, the controls are now in my hands, where they should be. This allows Caleb a little freedom not to have to think about his BG constantly or have me constantly asking him what DexCom says, (as used to be the case, evidenced by this video).
• Although not at the top of the list, the color screen makes the whole experience more pleasant.

So here is the news from diaTribe® on DexCom Share, read the full post here:

Dexcom is also working on a new remote monitoring product, Dexcom Share. The product is a cradle that holds the G4 Platinum receiver and plugs into a power outlet at a user’s bedside. Data from the G4 Platinum are then sent via the cradle (using Bluetooth) to a nearby smartphone. That phone then uploads the data to a web-based platform, where it can be monitored by parents or caregivers on their own cellphones.

Why I am excited about this:

• I’m the main caregiver to Caleb (aside from himself, of course). I’m on overnight duty. Traveling stresses me out. This will change that – completely!
• Sleepovers. Need I say more?
• Progress – we are moving in the right direction. In January, DexCom’s CEO spoke of DexCom’s Gen 5 which he was using at the time - the transmitter speaks with mobile devices (without the cradle) and texts alerts to caregivers. Are you drooling like I am? DexCom Share seems like a fantastic intermediary step which makes me feel like the Gen 5 is within our reach.

Speaking of DexCom’s CEO, Terry Gregg, he will be on TuDiabetes Live chat this Thursday (tomorrow).

Before your brother was born, your dad and I led very similar lives. We met in college and each started working with an accounting firm after we graduated. We spent years working long hours and advancing our careers.

Then Colin was born.

Dad continued to work, and I spent my days with Colin. Then you and Colin. Then you, Colin and Lila.

That’s what you’ve always known. You’ve always known me to be the anchor at home because Dad’s schedule is unpredictable. It isn’t unusual for Dad not to know where in the country he will be two days before he needs to be there.

Dad’s here helping in the house a lot. He coaches all your sports. He cooks many meals, he reads with you guys, plays games and all that other stuff. But he’s also got a demanding job that means there are lots of nights with just the four of us at dinner and many mornings where it’s just the four of us getting ready for our days.

There are many things that you, Colin and Lila do primarily with me since I’m the one who is always here. One of those things is managing your diabetes. Whether it’s just deciding on what to do with a blood sugar or prepping your gear each day or managing things at school, it’s mostly just you and me. Dad helps here and there, but you and I are the team when it comes to diabetes.

There is something that I need you to know, Caleb. Your dad has always been there for you to support you and whatever has come your way because of diabetes. Always.

He was the one doing most of the overnight checks in the early weeks. He gave you as many shots as I did when you were first diagnosed. It was a challenging time for all of us. So much had changed and none of us knew where we fit in this new normal we were trying to create. The distinction in our roles in your diabetes care developed over time out of necessity. I was here at home all the time and Dad was not. It’s just that simple.

What I need you to know, Caleb, is that when times became very challenging for us relative to diabetes when you were nine, your dad was there fighting for you as fiercely as I have ever seen him fight for anything. He spent countless hours working to protect you, despite the demands of his job. Nothing was more important to him. Things were hard for us, Caleb. But your dad remained steadfast in his defense of you. I could not have gotten through that time without him and his focus and determination to care for you. You, Colin and Lila mean more to him than anything else in this world. If he could move heaven and earth to protect you, he would.

When you grow up, you will likely look back on your childhood and think of me as the person who cared for your diabetes. For the most part I did. But what I need you to know, Caleb, is that Dad was always there too.

Caleb with his first Pod.

It was at this time of year six years ago when David attended an informational session for the OmniPod system, just a few weeks before Caleb started pumping. At that session – six years ago – the sales rep spoke about a new, smaller Pod that would be available “soon”.

Six. Years. Ago.

This past December, Insulet announced that FDA approval had been obtained for these new Pods. Wahoo! They were careful to set expectations clearly – they are not available yet, but distribution would begin at the end of February and when it’s time to reorder, you’ll get the new system. I thought that was great – be upfront with your customers and don’t over-promise.

It’s the end of March and there is no sign of us getting the new system. When we ask Insulet representatives, there is no clear response and we get some mumbo-jumbo about needing to set up training for the new system.

It’s been over three months since the announcement. When Insulet made the announcement, they stated they had planned for this transition for over a year. We’ve waited patiently since December. We are ready to reorder, which we were told was the basis for the transition and would be seamless. But we are now told we can only have the older generation Pods, and there is no clear expectation of when Caleb can begin using the new system.

Six years, Insulet. Does that count for nothing? We have been loyal and supportive. We don’t expect a red carpet, but we don’t think it’s unreasonable to expect you to acknowledge your long-standing customers in some way. We’ve stood by you for six years. We haven’t complained. But now, I have to be honest, I’m irked.

I see new customers with their new systems. They have been loyal to other pump companies, even critical of OmniPod in some cases, but they are getting priority. This isn’t sitting well with me.

I get the business end of this – I do. But part of good business is setting reasonable expectations for your customers. In my mind, Insulet has over-promised and under-delivered.

We will remain loyal, Insulet. We believe in your product. I can’t say I don’t feel a little taken advantage of by being put at the end of the line after all this time, perhaps because you know we are so loyal.

It’s been six years.

I read this somewhere some time on some forum. It made sense to me so I tend to believe it. I don’t know if it’s accurate.

After using Apidra® for a while and having great success, I started to notice that toward the end of a 1000 u vial of insulin, numbers seemed to creep up a bit. To isolate this variable to be sure the higher BGs coincided with the age of the insulin vial takes data tracking and analysis. The work I did in this area was not extensive, but in general, I think the older the vial, the lesser the potency.

I did not see this with Novolog®. Once I took a vial out of the fridge I didn’t put it back. I continued this practice with Apidra®. I had heard Apidra® was more vulnerable to spoilage from heat. So at first I tried to keep the vials in the fridge between changes. That became cumbersome.

My dear friend, Cari, told me that she uses pen vials for her son’s insulin source (a fellow OmniPodder). This serves two purposes:

1) It allows for flexibility if you need to give an injection. Say you have a pump delivery issue (and yes, ours are almost nonexistent at this point, but not completely eradicated) rather than needing to change a Pod or draw up a dose with a regular needle because perhaps it’s not exactly convenient to do so in the middle of a restaurant or when you’re on the pitcher’s mound, you are prepared with the ease and convenience of an insulin pen.

2) The amount of insulin you have unrefrigerated at any time is significantly less. The vials are 300 u rather than 1000 u. Instead of using one vial per month, we’re using one a week.

Poof! The monthly bg creep issue was eliminated. I no longer worry about the age of the insulin and whether it’s gone bad.

With so many variables to manage with diabetes, being able to eliminate one is a win! With two day site changes and smaller vials, we’re up to two! Win, win!!

I wrote about my love of Apidra® – quick onset, short tail. We tackled 140 carbs at a restaurant with relative ease. 

Shortly after that post, things went a little sideways and I didn’t know why. He had unrelenting highs at night. I would correct mid 200s all night long to no avail and end up with a wee hour Pod change. Then two nights later it would happen all over again, just like Groundhog Day.

I’ve brought you right to the punchline, so the problem is probably crystal clear to you. It was anything but clear to me at the time. This is why:

- Caleb had been pumping with Apidra® for about two months with no issues at all. His Pods would last the full three days and even up to eighty-hours with the 8 hour grace period.

- The “sideways” path started around the holidays. The variables were greater at this time. Timing of meals, content of meals. Schedules in general were off. BG control can easily be less than optimal in these circumstances.

- The pattern of highs every other night had not quite established itself. We were still getting some Pods through the full three days without an issue.

- Not a single person I knew who was Podding and Apidraing had this problem. All sailed smoothly through their full three days.

- Then there was the night when he actually did correct and I convinced myself that it couldn’t be the insulin clogging in the pump. Remember, I was not sleeping much during this time, so my reasoning was less than optimal.

I tested EVERYTHING. Food. Activity. Basals. Site locations. Moon phases. I called EVERYONE. Users. Insulet. Sanofi. Insulet again. Sanofi again. More users.

I thought Caleb might have to change pumps. If you know us, you know Caleb has only pumped OmniPod®. It’s been six years. We’ve never considered anything else. But Apidra® had been so effective, I was considering a pump change rather than an insulin change.

Finally, I tested the insulins. I put Caleb back on Novolog®. He went a couple of weeks and managed through day three without a problem. I put him back on Apidra® and the second day highs came right back.

It was clear. At right around the 48 hour mark, insulin seemed to have trouble getting through.

The photos in this post are of different cannulas from problematic Pods with what seems like obstructions. I had seen many a cannula before this issue that looked much the same. These other cannulas had been delivering insulin freely according to Caleb’s BGs. So even the visual evidence found in these photos didn’t convince me right away.

So we had to decide whether pump changes every two days would be worth it. I look back now remembering how difficult a decision it was, yet today it’s no big deal. It’s a slight nuisance to change Caleb’s Pod 15 times a month instead of 10. Nothing more.

And it’s worth it.

He’s using his pump of choice and my insulin of choice.

There are some benefits to more frequent site changes:

- Caleb’s sites heal MUCH more quickly. His scarring is greatly reduced. I noticed this almost instantly.

- He almost never has a kink, failure or delivery issue in any way, shape or form. This has been HUGE. When we were changing his sites every three days, that third day could be rather suspenseful. I only realized this in retrospect, now that the suspense is gone. I used to wonder more about what might be causing an unexplained high and take a gamble on whether it was just diabetes being diabetes or if there was a delivery issue. Many a time I took the wrong bet and took off a kinked or clogged Pod. Now it’s almost always diabetes just being the PITA that diabetes is, and we can correct and move on with confidence. To me, this has really had a great impact on Caleb’s overall diabetes management: increased confidence = better decisions.

Although this doesn’t seem like a prevailing issue, I know we aren’t the only ones experiencing this. If you’re having a similar challenge and haven’t quite decided what the problem is, I hope this post may help a little.

Next up: Eliminating Another Insulin Variable.

We know that should never be the case. Although not a cure, insulin is a life-saver and should be available to anyone in the world diagnosed with diabetes whom needs it.

You can help.

The Spare a Rose, Save a Child campaign is the idea of some of our dear friends in the diabetes community. The idea is simple: rather than buy 12 roses for your Valentine, purchase 11 and donate the value of the 12th to save a child’s life.

I challenge you to take it a step further. Skip the roses. Tell your Valentine you love them and that you spent the rose-money to keep someone else alive in their honor.

Donate now. It’s easy. You don’t have to visit any store. It’s meaningful.

Happy Valentine’s Day!

Caleb’s medical diagnosis date is January 3rd, 2007, but I often say it was his preschool teacher who diagnosed him on January 2nd.

It was much like yesterday – the first day back to school from the holidays. We suspected diabetes, but it seemed improbable. Impossible. I dropped Caleb off at school and casually asked his teacher to keep an eye on him to see if he was going to the bathroom more than usual. I barely finished that statement when she let out a little gasp and put a hand to her mouth. It gave me a split second of hope because I just knew she was going to tell me about some virus going around. That hope was dashed when the word “diabetes” passed her lips in a whisper.

Just like that, hope turned to dread. At that moment, I knew in my heart it could be nothing else.

Because I didn’t understand the risks, I left Caleb at school planning to call the doctor later that day. I went directly to have my license renewed. I remember it clearly. I cried all the way from the school to the AAA office.

I haven’t been able to look at the picture on my license without remembering that day. I see the puffiness in my eyes and the forced smile. I remember standing on the mark to get my picture taken – I was numb.

I had planned to go back to that AAA office today, but Caleb woke up unwell. He takes great pride in his perfect attendance, so I knew when he said he wasn’t up to going to school, he wasn’t. Thankfully, he’s more himself tonight, so I’ll go for the renewal tomorrow. Six years and one day after.

I’ll have a new picture, and in a very peculiar way, it will be a new beginning.

The whole story of When It All Changed,

When I Knew,

and how We Were Lucky even though we waited. 

Update January 4, 2013, New beginning begun: