Today is a happy day for fans of Insulet’s tubeless insulin pump system! The FDA has finally approved the next-generation OmniPod, which is 34% smaller, 25% lighter, and 16% slimmer — yet still holds same 200 units of insulin.
The new design will also feature a “pink slide insert,” that pushes a piece of pink plastic to be visible through a new, second window in the center of the Pod, to “help users verify that the cannula has deployed” (see photo below).
The PDM (Personal Diabetes Manager) controller is also being updated, with the following enhancements:
- The status screen will now always show details about your current insulin on board (IOB). This will include info on BOTH corrections and meal boluses (yay!)
- The communication distance between the PDM and Pod is increased up to 5 feet (although the two must be side by side at start-up)
- There’s now a vibration option available for certain reminders and safety notifications (exactly which reminders are required to have an audible alarm will be published in the company’s new Quick Start Guide, which they’re working on now)
But the smaller Pod profile is the biggest change. “It’s just a significant difference in wearing it — a huge difference!,” says Hjalte Hojsgaard, Insulet’s Manager of Consumer Marketing, who does not have diabetes but has worn both systems.
It seems the diabetes community has been waiting on this FDA approval for a very long time (FDA submission happened in May 2011, but we saw conference demos long before that), and now it comes suddenly. “It was expected, but you never know until it’s all tied up — we just got a fax this morning with the green light,” Hojsgaard says.
“Now we’ve got to focus on training of healthcare professionals, training our own staff, and making sure we get volume on the manufacturing line. We’ll be converting about 40,000 patients; that’s a lot of pods, so there’s a lot of preparation that has to happen.”
Note that this is a whole new system: the old Pods won’t speak with the new PDM and vice-versa, Hojsgaard tells me. Costs will remain the same for users: around $35 per Pod, and a system setup cost of around $800 depending on your insurance. There will be no change to the Abbott FreeStyle test strips used in the PDM, btw.
The company expects to begin shipping the new system between late February and end of March 2013. But users like me will of course want the new Pod now, and want to know what they can do to get it asap. Here’s what the company tells me:
Transition Made Easy (i.e. Automated)
“For 18 months we’ve been working diligently to set up a detailed process for communicating the switch to current users and transitioning them in a safe, easy and efficient manger. It’s all going to be automated,” Insulet’s Senior Director of Marketing Sean Gallagher says.
Patients still under their four-year warranty will be automatically “switched out” to the new system, according to their regular reorder date. Anyone out of warranty would of course need to buy the new product. But Insulet is emphasizing that if you’re thinking of just starting with the OmniPod, there is no reason to wait!
“You’ll get transitioned easily as the new system becomes available,” Gallagher says.
Existing customers will receive an email notification about the transition according to their appropriate reorder date. They will be prompted (and given a unique link) to complete a short online training program — a brief introduction to the new system — that will be tracked by Insulet. Once this is complete, “we put you in line to get on scheduled reorder,” Gallagher says.
“If you don’t respond to the emails, we’ll call you. We’ll reach out… so people don’t need to worry about what they need to do to get the new system,” he says.
Some especially anxious customers (hello!!) may be wondering if they can do a trade-in of a box of older Pods for the new ones. That’s a no-go, sorry. “Keep in mind that millions of these are made and sent out every month. We have to do this transition in a way that is practical and convenient for everyone,” Gallagher says.
The biggies are training HCPs so they’re aware of the new system, and beefing up manufacturing capacity so that inventory doesn’t become a problem.
In case you’re wondering about CGM integration (as I was!), nothing new to report at this time. “We’re still working on the best possible integrated solution. We don’t have any firm timeline,” Gallagher says.
Business Notes
What are the implications of this next-gen Pod in the diabetes device market? Not surprisingly, prolific D-industry analyst David Kliff (a.k.a. Diabetic Investor) has a few thoughts on that:
“Although not mentioned in the press release, it is well known that this new Pod lowers Insulet’s cost of goods by approximately 20%+ which should help the company as it drives towards becoming truly profitable. The key now becomes insuring that the new Pod does not experience any manufacturing or quality issues. Diabetic Investor has been following how the new pod has been doing in Europe, where it is already on the market, and has yet to see any indications of any serious quality issues.
“This news also places even more pressure on Medtronic, who so far has only been able to sue Insulet and not come out with a
patch pump of their own. As everyone knows, Medtronic has been doing lots of talking when it comes to the patch pump market, but this talk hasn’t led to any actual product going to the FDA. Just as the company is falling behind Dexcom in the continuous glucose monitoring market, they are now in even further behind in the patch pump market.”
Kliff says that if the OmniPod updgrade goes off without a hitch, this may put Insulet in an ideal position to reach their end goal — being acquired by a larger player.
As an OmniPod user, I’m just really excited about smaller for now.
{Look for updates on Insulet’s NewOmniPod website.}
 OmniPod Approved by FDA!)
OK. I may not be married to a diabetic anymore but this absolutely fantastic! I’ve been waiting for this since he went on a pod and will make sure he knows and has all the information needed. I just did a happy dance in my head.
[...] even more information, Diabetes Mine posted some details that I hadn’t read anywhere [...]
I’ll still be sticking to my tubes for now. I have a life where I change rooms every 30m. for meetings. I already need to carry my phone for my schedule; having a pump with a clip allows me to clip the pump to my pants, freeing up hands, and not weighing my pockets down. CGMS is integrated, so no third device.
If I were to go omnipod, now I have to carry three devices? an iphone, a PDM, and a CGMS? NO THANKS! I’d need a freaking tool belt!
I think OmniPod should make the controls for the device into a software program that would work on SmartPhones so you do not need to carry around a big clunky controller.
Susan F — you don’t have to carry the PDM around with you at all times. I also work in an office where I am constantly in and out, and I never have my bag with me. You only need the PDM to be within 3 (now apparently 5) feet of you when you’re bolusing or doing any other non-preset activity.
I agree on the CGM, though. Keeping THAT monitor close was when I did a trial a few months ago.
Er … keeping the CGM close was awful. Apparently the comment thread wasn’t happy with the phrase I used (it was totally PG, I swear!).
Does the smaller pod work with the same PDM
@Amira – no, as reported above.
[...] similar. To check out some more detailed recaps of the new product from Insulet, read what Scott, Diabetes Mine and Rachel had to say. I guess we will have to wait a couple of months to get our hands on this [...]
[...] NewsFlash: Next-Gen (Smaller) OmniPod Approved by FDA! Posted in: Uncategorized Dec 15 2012 By DiabetesMine [...]
Can you suspend the basal rate if needed?
Yes. If exercising and don’t want to snack to compensate, you can say how long up to 2 hrs. I love my life with this pump. It is so user friendly, neat and discreet. I have been using this product for over a yr.
I used the omnipod, have the newest PDM and have like 60 New pods sealed in their boxes. Omnipod with its continuous occlusions, cannula needles that does not retract, annoying alarms that forces you to change the pod when they say so and malfunctions. No thank you. I already have to deal with my diabetes, i do not want to be controlled by my pump. Pods are now past their expiration date, if anyone wants it, its yours, let me know.
My company supports a local Diabetic support group. We would love to donate them. If they are still available then you can mail them to; ALL HOME INFUSION INC.
5380 Old Bullard Rd, Suite 600
Tyler, TX 75703. They have many kids on them they would love to use them.
If you send a receipt with them we will mail you a check to reimburse the shipping charge.
I would really like to see Insulet create a program for iphone/ipod/android. Most people have their phones or music devices with them. No need to take another piece of hardware. Also, all data could be synced automatically to the cloud. If you lose your phone, you can always bring up data on another device to bolus. Pod would of course need to be able to check blood autonomously which is now a reality (see animas.com).
The other cool thing about Internet integration would be you could set alerts if you are a caregiver or parent. If you have aging parent and you get an alert they are dangerously low blood sugar, it would prompt you to make a visit.
Hopefully they’re looking into this and don’t think short term on how much money they’ll lose from not selling the PDM. I think the one we got for our daughter was over $7K, so it wasn’t cheap.
Their is a company that makes a GM for the iPhone it’s pretty small just a little bigger than the old end on iPod devices.
As a juvenile diabetic since age 2 which im now 38 i can honestly say if it wasnt for omnipod i wouldnt be on any insulin device.I dont like being restricted of movement w any of the tube pumps.Ive been on Omnipod for a year now and use 2 boxes of pods a month and have not experienced any problems as others are saying.They are probably doing something wrong or getting occlusions for putting it in the same spots.Omnipod is very user friendly and the list of things you can customize is phenominal.I do however wish insulet would make a holster w revolving clip so i may wear it on my belt.
I’m 26 and have had diabetes for 13 years, 11 of which I’ve been on various pumps. I’ve had the OmniPod for 5 years and think it’s fantastic. No tangled tubing or having to detach to take a shower or getting tangled up in the middle of the night and tearing out your site. I admit in the beginning (OmniPod was like a year old) the pods had some problems. Occlusions, pod errors. But they have always replaced any malfunctioned pods and VERY RARELY do I have issues now.
I would also love for the PDM to live on a smartphone and have been secretly begging for them to do it. One downside though — how often does your phone die? Because my dies at least once a week (especially if I’m out of town or taking lots of pics). I would hate to be stranded somewhere starving with a dead phone (chargers are pretty inconvenient on camping trips or at Bonnaroo). Plus, with an iphone you can’t just carry around a spare battery or put in some fresh AAA’s…
Very excited about the smaller pods though! It’s about time. Frustrating how it takes 2 years for the FDA to approve. How do we keep up with technology at that pace?
Omnipod made a bad business move. They released the new smaller pod to new users only, the customers currently on the pod do not have a date as to when they will receive their new pods. Why in the world make us wait, no reason in the world is good enough
we are having to wait months to get the newer pods. have been a customer for a couple of years now and they wont upgrade . keep saying 3-4 months. this is very poor customer service!!!!!!