As the race towards a full-fledged Artificial Pancreas system charges forward, it's exciting to see the second-ever early "hybrid closed loop" system now ready to hit market overseas. It comes from French company Diabeloop that secured regulatory approval in Europe on Nov. 7. This approval is a big deal, as it's the first early AP system to follow the widely-publicized debut of the Medtronic Minimed 670G approved in the U.S. in 2016.

Diabeloop becomes the first regulatory approved system using the Dexcom CGM (continuous glucose monitor) -- although Dexcom is used widely in do-it-yourself (DIY) closed loop systems that more than 1,000 are using worldwide. Still, this marks a milestone for our Diabetes Community in having another officially regulated, commercial option on the market.

You may not have heard about Diabeloop before, or the colorful hybrid patch-tubed pump Kaleido that the first generation will work with. But Diabeloop presented at our recent DiabetesMine D-Data ExChange event on Nov. 2 (just prior to their approval), and we learned some fascinating details about this soon-to-launch technology.

What's especially cool is that Diabeloop is working directly with PWDs (people with diabetes) in their design process, collaborating with the #WeAreNotWaiting community to bring us more customizable, practical technology instead of the usual "engineer-friendly" devices we're used to seeing. Evidence of that can be see in things like a "Zen Mode" feature that lets users raise BG targets slightly to avoid alerts after a meal, and a "Privacy Mode" where you can black out data and go off-the-grid in case you need a break from sharing.

We spoke with Diabeloop's leadership team headed by CEO Erik Huneker for a look at this new tech that now has CE Mark approval:

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Diabeloop's New DBLG1 Closed Loop Tech

DM) First off, what's behind the DBLG1 name?

DBL) G1 stands for “Generation 1.” As such, DBLG2 will include a new version of the software. However it’s not to be the commercial name. We're still working on that.

OK, how does this work?

DGLB1 is hybrid closed-loop system that connects three components: a continuous glucose monitor (CGM), a patch insulin pump and a locked-down smartphone hosting the Diabeloop algorithm and user interface. Every five minutes, a glucose measurement is transmitted via Bluetooth to the phone handset. DBLG1 artificial intelligence analyzes data in real time and takes into account the patient's physiology parameters, history and data entries (meals or exercise) to determine the correct dose of insulin to send to the pump.

Which patch pump will be used in this initial version just approved?

In order to secure commercial launch, we’re moving forward with Kaleido pump while pursuing work with other partners, including CellNovo.

Developed by a Dutch startup ViCentra, the Kaleido pump is a hybrid device -- it's both a patch pump and has infusion set tubing. The design is a little rectangle that sticks onto your body, similar to how OmniPod works but smaller, measuring just 50mm x 35mm and only 12mm in thickness and a very light 19 grams. It can deliver small doses (0.05 unit increments!) with incredible accuracy. There are many different colors for the patch pump itself, and aside from that it actually has short traditional tubing that connects to an infusion set just like a traditional pump and is also stuck on your body where the insulin goes into your body. So yes, the user ends up wearing two separate adhesive sites on their skin.

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Instead of using controls on the Kaleido pump as you normally would, the pump's connected to our Diabeloop system on a locked-down smartphone (Sony Xperia Z1) that also feeds in data from the Dexcom G6 CGM and that's where the algorithm lives to making diabetes dosing decisions.

Can you describe how the #WeAreNotWaiting community and DIY work have influenced the development of this?

We looked at their work, and discussed quite a bit with the DIY community. There was a lot to learn, in particular on what users were looking for in a closed loop. We also compared our algorithm with the DIY systems, and contributed significant amount of code to Tidepool, for example. Diabeloop does believe in disruptive innovations and we think ours is one of those, on the verge of entering the market today, following all regulatory and industrial aspects of the medtech industry which we belong to.

Following feedback with patients, we developed a "Zen Mode" feature. It's an option that slightly raise your glycemic target for a short period of time to avoid hypos and any alerts/alarms that usually prevent the risk. This is particularly convenient during a movie, for example. There is also a "Privacy Mode," in which no data is uploaded to the server at all, for when you want to it to stay confidential.

Can users choose their own target range for blood sugars?

Yes, users can adjust the algorithm target between 100 and 130. They can also adjust preferences between a lower mean (but higher probability of hypos) or higher mean, but with much lower hypo risk. The hypoglycemia threshold is also customizable.

How do carb-counting and meal announcements work in this system?

The user still have to announce meals. Of course, the more precise he/she is with carb counting, the more accurate the algorithm will be. Also, the system allows you to save personalized preferences for each meal (eg: typical small breakfast 20g - medium 40g - large 80g). So you can choose this option when announcing a meal. That’s why you can decide the level of precision you want to play with.  In any case, the algorithm will learn to adapt and correct.

How exactly is AI (Artificial Intelligence) employed in DBLG1?

Our system is developed using machine learning methods for a given population; when the system starts, it will then learn the person's physiology and/or lifestyle and will adapt over time to individual requirements. However, this adaptive machine learning system will follow first and foremost the preferences of the user (glycemic target, etc.)

Is there a plan to eventually allow for direct-to-phone interface and control? Or at least mobile app data display planned for the first generation?

It’s not planned for the first commercial release but we’re definitely looking into mobile app data display, especially for the kids version. Closer integration with the phone will surely follow.

When you file for FDA approval, will the system include any different components than what's now been CE Mark approved?

We will launch in Europe with Dexcom G6, as it’s a product clearly superior to the G5. Also, G6 does away with the interference from acetaminophen (Tylenol), which is a big plus in a closed loop environment. It’ll be an update to the existing CE Mark. There is no plan at the moment to use different components in the U.S.

What is the actual launch plan?

Gradual launch is planned to start in 2019 in Europe. Beyond France, which is our “home country,” primarily countries will be where there is appetite for innovative medical devices and fluid reimbursement mechanisms. Besides that, we have just launched a second financing round in order to support further R&D and commercial interests such as European launch, kids' approval -- our FDA submission and preliminary market introduction in the U.S.

And of course, on R&D efforts we’ve started working on “DBLG2” already, and should be able to integrate some additional items to make life even easier for T1D users of the DBLG1 system. We have a few scenarios, but we don’t have a timeline yet.

While pricing isn't finalized, can you say what supplies would people buy from Diabeloop, versus from Kaleido or Dexcom respectively?

We are currently fine-tuning distribution and commercial agreements on our prior markets and cannot give more details at this time.

Finally, can you tell us more about Diabeloop itself and the company origins?

Founded in 2015, this small company of ~50 employees is based in Grenoble, France, and is a unique collaboration between scientists, healthcare clinicians and patients. As we’ve seen with others in the closed loop space, Diabeloop was founded as a way to take AP research into a commercial space. One of the co-founders, Dr. Guillaume Charpentie, began the Diabeloop research back in 2011 at the Center for Studies and Research for the Intensification of Diabetes Treatment (CERITD). He teamed up with Erik Huneker (now CEO) to create the startup company, and a few years ago both Diabeloop and CEA-Leti, a major research collaboration in France made up of 12 university hospitals, clinicians and patients, joined forces to create a lab where they’d work on this closed loop system. 

And now, here we are.

 

We're pretty excited about a new player offering another option for a regulated closed loop system! Can't wait for this to come to the USA and hopefully bring with it new insulin pump choices from Kaleido and CellNovo as well.