Insulet Investor Call Q1 2013 | New OmniPod

Insulet released Q1 earnings today and held a related investor call. There were statements made that give me the impression there may be a light at the end of the waiting-for-the-new-system tunnel.

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.

“Like, you really like it, you want more.” | #DexCom Share G4

Caleb Blue WDDI 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).

What I Need You to Know, Caleb

Screen Shot 2013-04-06 at 4.03.56 PMDear Caleb,

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.

IMG_2799He 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.

Six Years of Waiting | #OmniPod®

Caleb with his first Pod.

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.

Looking back over the years and some of Caleb’s activity with OmniPod:

Smaller Vial Equals Improved Potency

ApidraThe unofficial theory I’ve heard is: that which makes Apidra® work quicker (remember apidra is Pig Latin for rapid) also makes it more susceptible to “going bad” quicker. I think of it this way: its composition is broken down allowing it to do it’s job faster, but that broken-down state means that it’s closer to losing its potency.

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:

Apidra Pen1) 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!!

Apidra® | Pumping 48 hours

Caleb has been pumping with Apidra® for over two years. Prior to that, he used Novolog®.

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.

IMG_8529I 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.

IMG_9009

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.

#Dexcom #G4 Range

This was a-ma-zing! Rather than be on the edge of my seat about whether the dinner underbolus was too conservative or if the fact that he started sweating three minutes into the game would make him plummet, I sat smiling at the pretty dotted line that kept updating me during the game no matter where he was on the court. He could play and I could monitor. Bliss!

I was CERTAIN I had no chance of the range reaching my bedroom from his. We are on opposite ends of the house, and unlike the basketball court, there are several walls in between. But it reached. Just over 50 feet. It didn’t consistently read from my nightstand, but within arm’s reach on top of my covers it got a signal ALL NIGHT LONG. Sa-weeet!

Then I thought I’d go hog wild and see what happened when he was in bed upstairs and I was two floors down in the basement watching Modern Family with Dave. Consistent signal. No more running up and down two flights to check and see what the extra songs of Just Dance did to his blood sugar. Holla!

We’ve had it just over a week. In addition to the amazing range, it’s simply slick looking and I could barely pry it out of Caleb’s hands for the first several days. He calls it “Hawkeye” after one of his favorite Avengers. He mentioned that Hawkeye’s “real” name is Clint Barton which is strangely similar to Clara Barton for which the diabetes camp where we spent a week as a family is named.

It’s probably too early to comment on accuracy, but I have to say, the experience has been very good thus far. It’s missed a couple of lows, but I think that’s due to the typical delay between interstitial fluid and blood. What we haven’t had are those riding along without a care in the world thinking everything’s wonderful until the fingerstick comes up with a 250 situations yet. I could really get used to this. I’m afraid I may already be used to this.

And did you notice my World Diabetes Day blue fingernail? ;) I didn’t think so.

Related post: DexCom Adhesive Irritation and Allergy

Tip for Documenting Pump Settings

This is probably a very obvious thing to do, but I want to share anyway…

Caleb and I maintain a chart of his bgs and a schedule of all his settings in a spreadsheet using “Numbers”. I have this application on all our iOS devices and any updates made to one device automatically update to all the other devices.

I love the graph I can make of his bg history. I showed Caleb’s school nurse his stats one day. Her response was, “Wow! You should get him a shirt with a picture of that saying, “This is how my week went, how about you?”

A recent three week period of Caleb’s bgs. Legends intentionally left blank.

Occasionally, I find myself wanting to record his settings but can’t take the time to update the spreadsheet. An example was this weekend when I made a few adjustments to his IC ratios while sitting in church waiting for mass to start, or the night before ROI camp when I wanted to be sure I had all his settings up to date before he hit the slopes the next day with his PDM is his chest pocket.

I’m often tempted to press the home and on/off buttons of the PDM simultaneously to take a screen shot. But since that’s an iOS device function not a PDM function, I do the next best thing – take photos of the screens on my phone.

Now I’ve got a permanent record of the settings that are most important to us. I can either just keep these photos in my gallery or use them to update his spreadsheet when I get the chance.

Medical ID | Road ID®

Can you tell who uses his more?

I can’t remember if I first heard about Road ID® from Harry or Gary – they both wear them. But I do remember later hearing about it being used as a medical ID for kids from Reyna – that woman is full of helpful tips!

For years, Caleb used silicone bands that were engraved with all the critical information right on the band. He had several colors and patterns and he loved them. It was always a very sad Caleb that got off the bus with a broken band in his hand when one bit the dust.

The price for those bands got to be a little too much for my liking and although Caleb still had several in inventory, I kept my eyes peeled for an appropriate replacement. Road ID® fit the bill!

Santa had the same idea. He brought both Colin and Caleb Road ID®s this past Christmas. They each have the Wrist ID Thin with several different colored bands to switch out. Colin has one because he runs and bikes by himself quite a bit. The difference between Colin’s and Caleb’s is the extra info of “Type 1 Diabetic/Peanut Allergy” on Caleb’s.

How can I not love the fact that something that Caleb needs because he has diabetes is something that non-D brother Colin needs too? Surprisingly, this was one of Caleb’s favorite Christmas presents, and Lila actually felt a little left out that Santa didn’t bring her one. (Her birthday is coming up though, and it’s on her list).

I must mention that their customer service is amazing! Santa used their measuring chart to determine what size band to get but he must have been drinking spiked coco because the one he chose was a bit too big. Getting them replaced was easy and pleasurable. They have our family’s business for life.

Caleb had his Road ID® on at TriCamp and guess who else wears one! ;)

I just ordered another and was reminded that they contribute a portion of your purchase to an organization of your choice – I chose JDRF!

I just got a coupon promo code if you plan to place an order for $1 off! ThanksLorraine17663773