Omnipod Q3 Earnings Call - DASH PDM Update

omnipod
future_tech

#1

I read through the transcript of the Insulet Q3 Earnings call. There were a couple of updates on the new DASH PDM (you known - the locked down android phone that communicates via bluetooth to the pod.) so I though I would share to save you the googling. Also Horizon is the new Omnipod “automated pancreas” system.

Here are my highlights:

  1. The DASH PDM 510 (k) will filed at the end of the year and should launch mid 2018. During the Q&A they said they were comitted to a 2018 release date.

  2. It sounds like Insulet and Dexcom are talking. The DASH/Horizon is being developed to work with both the Dexcom G5 and the upcoming Dexcom G6 sensor/transmitters. There was a reference that DASH is able to talk to different CGM devices and may be able to talk to Libre for the European market, likely though a phone plug-in app, but I cannot be certain.

  3. There is a focus on our data: Bluetooth will make it easier to collect and aggregate data from the PDM and other diabetes tech devices. Looks like there will be a phone app with a Dash board (pun intended) as well as other apps to send data to doctors etc. Like most data things I am happy/sad about this. Happy that my doctor and I can get access to data but sad because they are giving it to the insurance company. (I use xdrip+ so I already have all the data I can use in the same place, but I am happy to see something mainstream coming.

  4. The Omnipod Horizon (automated pump) is being tested in a “hotel setting” and tests have been promising. Everything is “on track” and it still sounds like a 2019 (or early 2020) release. It sounds like they are learning from the Medtronic release and want to have their trainers trained and enough stock before they release.

  5. Earnings are up. It sounds like Insulet is not going out of business any time soon.

  6. Animas - In the Q&A there were lots of questions about people switching from Animas to Omnipod. Insulet stated that they see their biggest growth from MDI folks and not from Animas users who use tubed pumps. Although they did say they are working on Dexcom integration. I read this as, some of the Animas folks will go to Tandem and Medtronic, but for those who do not want Medtronic sensors - we will have Dexcom integration.

A couple quotes from the transcript caught my eye (These are quoted from Seeking Alpha and there are only 379 words so it meets their copyright policy of only allowing up to 400 words quoted :slight_smile: )

“We now have more than 50,000 Omnipod customers, well over half of our U.S. installed base, using Insulet Provided Glooko. This enables incredibly rich, large population, real-world data sets to demonstrate the value of Omnipod to payers, clinicians, and to end users.”

“The most notable change is in what you can’t see, the Bluetooth connectivity. This connectivity liberates the data in our PDM and pod to provide all of our Dash customers with unique meaningful benefits. For the payer, this means access to aggregate diabetes and outcomes data on their specific membership populations through their Omnipod Dashboards. For the clinician, this means less time training patients on pump therapy and immediate access to their diabetes data for streamlined office workflow and improved interactions with their patients. And for the patients, this means insulin delivery control at their fingertips, easy access to their pod therapy information on their PDMs or on their mobile phone, and the ability to share their diabetes data with caregivers via our Dash View mobile app. Their Omnipod PDM data will be an app on their phones right where they view their CGM data or their health and fitness data.”

“We are very pleased to report that we have successfully completed our summative (18:17) human factor studies for Dash, and based on early feedback, we are confident our customers will love this new product platform, which will transform the way they manage their diabetes. We are on track to submit our 510(k) to the FDA around the end of this year and anticipate a limited market launch mid next year. This marks a very important milestone for Insulet, since Dash is the platform for our future product innovations, including concentrated insulins and our Horizon Automated Glucose Control System.”

“We continue to make great progress on our Omnipod Horizon development program. We now have 118 patients including pediatrics, adolescents, and adults monitored with our Horizon algorithm. We are currently underway with our third IDE, which is taking place under normal living conditions, in a hotel setting with the patients spending a longer time in our hybrid closed-loop phase. The study results continue to demonstrate that our Horizon algorithm performs very well, and is safe during the day and night across all age groups.”

For those who need to google it IDE = Investigation Device Exemption which means FDA allows testing of a medical device that is not approved yet.

Transcript is here:

You can listen here:
http://investor.insulet.com/events.cfm


#2

Quite the stock price jump. Investors seem quite excited with what was stated on the earnings call.


#3

Ok - so I left all the boring stuff out that was not diabetes tech related :slight_smile: which may have been the reason the stock price jumped.


#4

@Aaron that was a great post!


#5

This would be enough for me to steer clear of this device. All the G-D insurance company needs to know about my outcome is if I am still alive enough to pay their outrageous premiums next year.

I understand that manufacturers need to make their devices as attractive to payers as possible, but that is just more evidence of how screwed up our medical care system is.


#6

Aggregate data is specifically designed to provide overall information without it being possible to tie back to an individual.


#7

I don’t know if it’s old news or not, but yesterday I saw an article that says the Omnipod DASH is now FDA approved. They’re starting with a limited release, and if it’s working ok they’ll go to wide release in 2019. They say that at this time the old omnipod system is not discontinued.

https://www.myomnipod.com/DASH_FAQs


#8

Curious if there is anything people are interested in with the new one.

No BG meter and no CGM. Smaller PDM and better food library.

Supposedly it will be easier to change settings on it, but who really knows if it is easier or harder without using it.


#9

It is recent news but as a pod user I am not too excited yet…

The old PDM may be a brick, but it can take a good amount of abuse and keep working.

Maybe when they release the horizon with the CGM integration and the closed loop control I may be more interested… but given how the Mediteonic closed loop think rolled out, I am not really excited yet.


#10

How do you feel about touchscreen?

I really like the buttons on the PDM. I can do it without looking.

On the current PDM, programming it is a PITA, but once you have it setup, the push buttons are easy.


#11

I like the buttons and can navigate the menus while looking. I do this bike riding.

…but if they had a watch with buttons that could communicate to the PDM that would be awesome.

I used to use a pebble watch with buttons and it was awesome. My Sony watch has a touchscreen only and it is more of a pain to acess things. Then again AndroidAPS has a remote bolus from the sony watch that works pretty well from the touch screen - too bad it does not work with the pods yet.

I worry with the new PDM you will need to enter and 8 digit password every time you want to use it (not trying to start rumours I am just worried.


#12

I was told 4-6 digits for the password.


#13

■■■■■■


#14

Do you think touchscreen would be difficult while riding a bike? I know it would be harder for me.

The nice thing about the current PDM is that the buttons are all thumb-accessible. So you can hold it securely and get to everything with your thumb.

BTW, did you ever try my “no-looky” bolus trick?

I do this all the time:

power on
left button
middle button
left button
right button
right button
up arrow 
right button
middle button

#15

Yes - i use it all the time - it was the missing link in bolusing without looking.

I think using a touchscreen while biking is difficult becasue I have to look at the keypad when I enter in the 4-6 characters. When I used a blackberry with a keyboard, it had some raised dots on some of they keys so you could orient your fingers to the keyboard and type without looking. When I changed to the touchscreen phone, I find it a pain to type and I make lots of mistakes.


#16

Don’t use Medtronic’s system as your model. I see no fundamental reason the commercial systems can’t approach the performance of openAPS and LOOP, which both seem quite good. I’m hoping the t:slim system works well, but we won’t know until next year.


#17

Yes - I was being a bit negative in the previous comment. I agree. openAPS and LOOP have had a large success rate in the community (and I sometimes use AndriodAPS open loop so I know), but for some reason Medtronic has me spooked. To me it seems like these commercial systems (ok - maybe just medtronic) are all about taking control away from the “patient” while the open systems are all about giving PWD extra information and control to help them out. I can actually tell how openAPS makes its calculations and there is visibility enough for me to say - yes I agree or no - I think I can do better than this.

Hopefully Omnipod has a system that is equal or better to the options on the market, that is transparent to how it makes it’s calculations, and allows the user to customize/tweak things sufficiently to work well.