Tandem's plans for hybrid closed loop

Tandem has today updated its “Pipeline”.

October 12, 2017
Tandem has reiterated the pivotal study for its first generation Automated Insulin Delivery (AID) called the Predictive Low Glucose Suspend (PLGS) is anticipated to conclude by the end of 2017. The PLGS will run on the Tandem t:slim X2 using sensor data from the Dexcom G5. Based upon FDA approval, Tandem continues to have the goal to launch the PLGS via remote update in the summer of 2018.

Tandem’s second generation AID called the Hybrid Closed Loop (HCL) will also run on the X2 using technology from TypeZero and using sensor data from the Dexcom G6. This system will both increase and decrease basal insulin based on predicted BG as well as deliver automated correction boluses. Tandem has pushed this out and the current goal for this is the first half of 2019.

Tandem also has under development the t:sport. It is expected to be half the size of the t:slim and “designed for people who seek even greater discretion and flexibility with the use of their insulin pump”. No date is set for this.

Tandem is planning to launch a first generation mobile application in 2018. This will connect via Bluetooth to the pump. Initially it sounds like it will simply upload the pump information to the Tandem cloud (t:connect). A future generation will support pump-control capabilities however possible not for the t:slim X2 but only for newer pumps currently under development. So this sounds to be a number of years down the road. R&D. Don’t hold your breath.

A few company / business points:
Tandem has shipped more than 60,000 insulin pumps since their initial launch in August 2012.
Tandem expects to have 11% of the USA insulin pump market at the end of 2017.
Tandem believes they can be profitable when they reach 15% USA market share for which their goal is 2019.
Tandem is potentially planning to launch internationally in 2018.

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I heard about this a year ago from a Tandem rep, and my understanding at the time was that the t:sport would be tubeless and compete with the omnipod in the tubeless pump space. That is something I would be interested in. But if it is just a smaller version of the tubed pump, it would mean nothing to me personally.

Any idea about that, Thomas?

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My first thought was: vaporware? lol. But then I considered it a bit more.

I also thought it had an Omnipod sound about it. I mentioned it as it sounded mildly interesting and was the first I had heard of it. Also as this was direct and specific from the company and not just internet chatter.

I agree with you Eric. Just a smaller version of the t:slim pump doesn’t really make sense and would seem to have little commercial value. Already Tandem advertises the t:slim as the smallest pump or something like that. So, there would have to be significant differences between the t:sport and the t:slim. Being tubeless does seem to be an obvious assumption. Probably this is going to have to get further down the R&D process before we get additional details.

If a company has actual products out (such as Tandem obviously does) then it actually is nice for them to also mention what they may have going on in their R&D which may or may not ever see the light of day. The flip side of that was Animas who (as I recall) seemed to have a policy of never saying anything about what they might be doing and blamed it on the FDA for not being able to talk which was a load of bull. Maybe the Tandem t:sport will show up in a few years and maybe not - but nice to get an idea of things they are kicking around.

There were a couple reasons we switched from the Animas Ping to the Tandem t:slim X2. Among those, was the failure of Animas to provide any public details of what they might be working on. This was as compared to Tandem which has their “Pipeline” of t:slim X2 updates published on their website.

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An ideal pump for me would have the tubeless aspect, but also the single button quick bolus on the side that Tandem has for some of their stuff. Currently, the omnipod takes a minimum of 7 button pushes to take a bolus.

When you talk to your rep, let them know there is a market for tubeless and easy!

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The t:sport isn’t exactly tubeless. The idea is that you can have a very short tube to a conventional infusion set. Rather than a 1-piece pod, this makes two smaller pieces that sit side-by-side and protrude less. The pump is small and has no controls on the pump body. In the picture at https://www.healthline.com/hlcmsresource/images/00_Diabetes-Mine/Product-Shots/Pumps/Tandem/TandemTsport.jpeg the top pump is a regular t:slim, and the bottom pump is the prototype t:sport.

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@bkh - Nice link !!!

(from the link provided by bkh above)
Tandem t:sport
“It will be quite a bit smaller overall and reduced cartridge size from the regular t:slim pump, and the screen display will be eliminated, in favor of having all the data displayed directly on a smartphone. It will be a disposal stick-to-your body device, but not quite a full patch pump, as it would still need the four-inch infusion set connector for tubing.”

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Now THIS would appeal to me. I don’t like the OmniPod primarily because of its size and the fact that it’s limited to one infusion set. The only thing that could make this better, as @Eric said, would be to have a “touch bolus” button on the pump itself so that boluses could be delivered in the absence of a controller.

I love the idea of a pump like this and a Dexcom receiver and a smartphone. The bonus being that having everything controlled via a smartphone would make it fully accessible to people with visual impairments. If I had a pump like this, though, I’d get a smartphone and battery case dedicated to controlling the pump/CGM and another for my actual cell phone. One thing I like about having a separate Dexcom receiver is that I only have to worry about the battery dying once a week or so as opposed to once a day.

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@Jen - Just get a portable USB battery. Half the time one of my kids just plugs his phone into the portable battery 'cause it is more convenient and carries it around so it charges while he is on the move!!!

(About the size of a tube of chapstick)
$15 ~ $20 depending on color
1.0 amp output (half full speed)

image

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Hey bkh, welcome to the site! Are you affiliated with Tandem or are you a user?

Just a user. I always read the quarterly investor conference transcripts for tidbits about what’s coming up from Tandem and Dexcom, and will post my summaries if nobody else is doing that here yet. The upcoming Dexcom conference call is November 1, so the transcript should be out by 11/2. The Tandem conference call hasn’t been scheduled yet (as of yesterday).

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lol.
ditto.
They are full of little nuggets !!!

Awesome thanks! Glad you joined!

Post over on the introduction thread when you get a chance.

Tandem Diabetes has now scheduled its Q3 2017 Earnings conference call for 4:30 PM ET on Thursday, October 26th, 2017. Transcripts of the call are made available shortly afterwards.

Tandem Diabetes Care Schedules Third Quarter 2017 Earnings Press Release and Conference Call

In conjunction with the Tandem intention to make available new technology via remote update as previously discussed, Tandem has now (as of yesterday, October 24, 2017) also announced that all (FDA approved) updates (features) in 2018 will be made available to all in-warranty users at no additional cost.

Tandem Diabetes Care to Provide All t:slim X2 Insulin Pump Features Approved in 2018 to Users at No Cost

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The Tandem conference call transcript finally came out after a significant delay, and is available via https://seekingalpha.com/article/4117701-tandem-diabetes-cares-tndm-ceo-kim-blickenstaff-q3-2017-results-earnings-call-transcript

Here’s the news as I see it.

Discussion of forthcoming pump technology did not go beyond what we already saw in the press release that @Thomas posted, namely they anticipate FDA approval of the predicted-low-suspend firmware in mid 2018 (free upgrade to t:slim X2 pumpers), and of the hybrid closed loop based on the TypeZero algorithm with Dexcom G6 sensors in 1H19.

I think that their goal for the conference call wasn’t to impress us with tales of great new technology in the future. The focus was on refuting rumors that Tandem is going out of business.

Tandem said “Our position as a relatively small business is not yet profitable, is one that our competitors use heavily against us and regularly spread rumors that we are going out of business. In today’s environment, it’s marketing the fear rather than pump versus pump, since that’s the front in which we’ve demonstrated the superiority of our products.”

To state it more nakedly, Tandem believes that the t:slim pump is more attractive to customers than is the Medtronic pump, and their integration with the Dexcom sensor is more attractive than Medtronic’s sensor, so all Medtronic can do is to scare customers away from the t:slim by instilling fear that Tandem will go bankrupt.

From my point of view, Tandem is hurt by lagging behind Medtronic on the release of AP features such as low suspend and hybrid closed loop, but is helped by integration with Dexcom CGM, and is helped by the exit of Animas from the pump market: 45000 US Animas pumpers and another 45000 international Animas pumpers are looking for a new pump company, and previously those customers didn’t pick Medtronic.

So it all comes down to the state of the business. Tandem pointed out their steady improvement in financial metrics, which are heading toward profitability in 2019, plus their track record of successfully raising incremental funding as their financial results steadily improve. They also discussed their reasons for believing that their cash-burn rate is manageable. And they derive lots of optimism from a qualitatively improved trend in pump sales pre-order contacts from customers. They attribute this improvement to the new G5 integration with the t:slim, interest in the forthcoming AP features, Medtronic customer disappointment with the slow roll-out of Guardian sensors and upgrades to the 670G, plus the exit of Animas from the pump market.

Tandem is making lots of money from increased infusion set sales forced by their adoption of a proprietary connector that replaces the luer lock (I may grouse about that in another thread,) and Tandem wants to be selling pumps in Canada in early 2018, which also would help the business.

The forth quarter usually is the largest one, and I expect the next conference call to give significantly clearer insight into their business conditions. For now, (I am biased as a t:slim pumper) I see good reasons to be optimistic.

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@bkh
Great summary. I totally agree.

Except that I think Tandem is slightly sandbagging (hopefully I am using the term correct? lol) their estimation of profitability. I fully expect them to show profit possibly by Q3 2018 but no later than Q4 2018. Based on current progress and taking into account the various factors which you went through, I really do not see it taking them into 2019 before showing a profit.

Underpromise and overdeliver. The alternative courts disaster, which they can’t afford.

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Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2™ Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom® G6 Continuous Glucose Monitoring (CGM). This pilot study was the first of three in the National Institute of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in the first quarter of 2018. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration.

[news release continues in the link below]

https://www.businesswire.com/news/home/20180108005568/en/Tandem-Diabetes-Care-Reports-Successful-Completion-Pilot

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I for one, am happy they made this business decision, it will allow them to stay in business, which for us, is more important than the reduction in choice. It was too easy to go to an alternate source for infusion sets with the universal connector which had the potential to kill their cash flow.

It’s true that they expect the proprietary connector to make millions of dollars, and this helps them survive. I understand that when a company is struggling to survive, screwing their own customers to raise immediate cash can be the correct business decision even if it damages long-term customer relations.

But for me it’s a problem. I intensely dislike the only 90 degree cannula set that they offer with their proprietary connector. For me, it is excessively frustrating and physically painful to reconnect after disconnecting when the infusion set is in a place that I can’t see and that is hard to reach. Their needle connector must be guided precisely into a small orifice at exactly the right angle and for my old hands that’s a real obstacle.

When I started with the t:slim I tried three sets. The 90 degree cannula they still offer, plus the Cleo from Smith Medical, which has a hub that fits over a post in 1 of 8 positions, and then pinching the hub forces a needle into an orifice in the hub. The design automatically guides the needle in the right direction and I found it quite acceptable. The third set I tried was the quickset from Medtronic, and this was by far my favorite. I find it easy to operate in any location I can barely reach, because I just feel around until the hub fits over the post, and then a small twist on the hub (or by pulling on the tube) locks it. I also like the fact that the quickset uses a high-quality permanent inserter, rather than a flimsy 1-time disposable inserter that comes with the set.

Before they discontinued the luer-lock cartridges, I was a big fan of t:slim even though they are late with low-suspend and AP features. But now I have a problem. My temporary solution has been to re-use each of my remaining luer-lock cartridges as many times as possible before throwing it out. In practice, I’m getting 900u of use: the original fill plus 2 refills, and this lasts me around 17 days. I tried a 4th fill once, but it seemed that maybe the plunger in the cartridge was starting to get bypass leakage, so I was not getting all of the insulin that the pump thought it was delivering.

Currently I’m making preparations to start LOOPing with my old Medtronic 723 pump and an iPhone when I run out of t:slim luer-lock cartridges. I hope that the 723 will remain operational until there’s a new pump available with an infusion set I like, and that either has reasonable AP features or has an open radio interface for LOOP/openAPS (such as the Korean SOOIL pump.)