Traditionally, diabetes devices have been kind of drab and boring, right? We’ve certainly harped on that enough over the years… Even now, with a bunch of cases, covers and special skins to add some pizzazz, D-tools are generally not by design the colorful life-friendly devices we’ve hoped for.

Not until now, at least. A young Dutch startup called ViCentra plans to change that with its first device, dubbed Kaleido. (Yes, think a kaleidoscope of colors.)

The weird thing is, Kaleido is a combination of a patch pump like the OmniPod and a traditional tubed insulin pump. So Kaleido may look like just a brightly colored pod that sticks onto your body, but it actually has tubing that connects to an infusion set like a traditional pump. The user ends up wearing two separate adhesives on their skin. We also learned both the “pod” portion of this device and the controller need to be charged regularly. Hmmm…

Kaleido was touting their tagline “Injecting Colour Into Diabetes” (catchy but corny?) during their public debut recently at the big European Association for the Study of Diabetes (EASD) conference in Stockholm.

We were struggling to understand just how this system works, and the potential advantages to users, so we reached out to ViCentra’s marketing coordinator Alex Evans for this Q&A:

DM) Let’s get right to it: Can you describe Kaleido for us?

AE) Kaleido is insulin pump therapy for those who don’t believe in boring. Although our main focus is to provide an effective insulin delivery device, we also believe that diabetes is not what defines people –- instead, it’s their personality and freedom to choose. After all, if you’re going to wear something 24/7, it should look good and be something you can enjoy, right? With the choice of 10 colors, customers will be able to choose two pump colors for their Starter Kit.

Choice of colors is nice, but why this combo pump approach?

Conventional pumps tend to offer flexibility with infusion sets and insulin consumption, whereas patch pumps give a therapy that is simpler to use and discreet, too. We believe Kaleido does a great job of combining the greatest advantages of both approaches.

Kaleido has three key components:

  • Small and durable: Each pump is a little rectangle that sticks onto your body. Our pump is smaller than all the alternatives, measuring just 50mm x 35mm and only 12mm in thickness and a very light 19 grams. The small size was made possible by some cutting-edge design that has moved away from, and improved on, traditional pump engineering. It can deliver small doses (0.05 unit increments!) with incredible accuracy.
  • Handset: (the controller or PDM) Designed with aesthetics and consumer-friendliness in mind, the Kaleido handset also comes in a range of 10 colors. Measuring 107mm x 50mm x 9mm, it uses a Bluetooth LE connection to securely transmit commands to the pump.
  • Disposable insulin cartridges: These are proprietary cartridges that hold 200 units of deliverable insulin. They need to be filled by the user, and can be disposed-of after use. The cartridges are supplied, along with the other consumable items, as part of Kaleido’s monthly “Top-Up Kits.” These kits also contain Kaleido body and pump patches (used to wear and secure the pump), needles and syringes for filling the insulin cartridge, alcohol wipes and the infusion sets of the customer’s choice.

How exactly do you fill the Kaleido?

The pump is filled with a needle and syringe (provided in the monthly Kits), via a filling port in the cartridge. The process of filling and priming is one easy step. It is our plan that in the future we’ll be able to provide pre-filled cartridges, but that is not for the immediate release.

What about the charging needs of both the pod and controller portions?

The Kaleido starter pack comes with two pumps, which both last at least 3 days. It is likely that the insulin cartridge will empty before the battery. Once it is time for a set change a customer can simply use the second pump that has been charged already. A pump should only take between 40 minutes to an hour to charge fully. The handset (controller) also needs to be charged using a cable provided.

Wow, that’s a lot of charging… And don’t you think people might be averse to wearing TWO separate devices adhered to their bodies (or three, if they wear a CGM sensor too)?

The total coverage site is less than that of the OmniPod, so we do not think this will be an issue, certainly not enough to outweigh the benefits of having a modular format to the patch pump. There has been no feedback to us directly that this would be an issue.

{Editor’s Note: What?? We’re wondering if they’ve really made an effort to solicit patient feedback}

Just to clarify, the Kaleido body looks a lot like a colorful version of the OmniPod…

Yes, we also offer the advantage of being body-worn, but we are smaller and more discreet than the OmniPod. And if you don’t want to be discreet, then we think we have designed the Kaleido to be beautiful enough to show off. What the OmniPod cannot match is the choice, convenience and flexibility that the Kaleido offers. Oh, and by the way, did we mention that the Kaleido is really beautiful?

Regarding choice and flexibility: Will Kaleido use existing infusion sets, or are these proprietary?

As the tubing is connected to our cartridge, we will supply proprietary infusion sets in the Top-up Kits, as mentioned previously. We will start with 6mm and 9mm straight Teflon infusion sets.

Tell us again why you designed a patch pump that also has tubing?

We do have tubing, and we are proud of it. We think the small length (5cm) of tubing gives our customers flexibility in how they use the Kaleido. We have even gone further and designed one cartridge with even longer tubing for those who would appreciate the choice of where to position their Kaleido pump on their body. We certainly did not want our beautiful product ruining the lines of a nice dress or tight-fitting shirt.

The rather conventional infusion set that comes with the product is yet another nod to flexibility and customer choice. We hope to eventually offer the wide range of cannula options that current pump users make.

OK, and can you operate insulin delivery from the patch pump itself, without the need for the separate controller?

No. For safety and regulatory reasons, Kaleido pumps can only be controlled using the Kaleido handset. This means that you can’t roll over in your sleep, lie on your pump and accidentally give yourself an unintended bolus! If for any reason your handset is not within range of your pump, the selected basal profile will continue to run, however you wouldn’t be able to make any basal profile changes or deliver any boluses.

You talk about micro-delivery… tell us more about that technology?

The whole setup of the pump is different from traditional syringe-driven pumps. We have developed a ‘pulse’ technology, using a piston that steadily taps the cartridge membrane, inducing insulin from the reservoir, through the intelligent valves and then to our customer.

We have seen that this delivers tremendous accuracy of delivery — much better than can be claimed by other products on the market. We also offer the fastest occlusion alarm of all the current market leaders, which means that, though problems are rarer with Kaleido than with other pumps, any issues that do occur can be dealt with quickly. We need not mention that fact that just like all other products, the Kaleido brain carries out all the checks and balances that you would expect from a product of this importance, and keeps the customers safety at the heart of what it does.

And does it offer all the traditional insulin pump features?

Kaleido has been designed to be as simple to use as possible, so we’ve tried to strip out all unnecessary, complicated functionality and only include those features that are vital for successful insulin pump therapy. The two key elements of Kaleido are basal profiles and bolus dosing:

  • Our basal menu offers a customer the chance to build seven profiles that are easily modified and copied. The initial process itself is also easy, with 24-hour segments displayed on one screen and the option to dial up or down per hour, resulting in an overview of the daily total dose and patterns. The basal menu also offers temporary basal rates from 10% of the current profile right up to 200%, and these can be set for a maximum of 3 hours in increments of 30 minutes.
  • Our bolus menu currently offers two bolus options – Quick and Extended. Quick bolus allows the customer to deliver boluses from as small as 0.05 units up to 20 units immediately. Extended bolus asks for the total dose to be specified first and then for the amount of thereof that should be delivered immediately. Once that’s done, you set the amount of time you’d like to extend the remaining bolus over (max three hours) and you’re good to go!

What about a bolus wizard?

Discussions with many users of existing insulin pumps and healthcare providers have made clear just howimportant bolus wizard-type features are, so we’re adding in this extra functionality. We’re working on it as we speak, but we’re taking our time to make sure that it reaches our high standards and ticks all of the right boxes for Kaleido –- simple, effective and easy to use and understand.

What about viewing and sharing your data from Kaleido? Does it have partner software, an app or any mobile health connectivity?

By the time the first customer is using the system, we will be compatible with a third-party data site. The work is not complete yet but it is a system many hospitals and end users will be familiar with. The site also allows for other tools like Dexcom to plug in so there is a central data point.

Medical device regulations prohibit us from building an app to control Kaleido, so that’s not in the cards. We also don’t currently have any plans to build any Kaleido-related apps, but that’s not to say we won’t do something like that in the future. It’s certainly something that we can see the benefits of, if it fitted with the overall goals of Kaleido.

Will this connect to any glucose meters or CGMs?

We believe that understanding glucose values is incredibly important when managing Type 1 diabetes and that there are already some great products available to help with this. We understand that many people have their own favorites and we want to make sure they can stick with their first choice. We’re also concerned about the varying availability of strips from one location to another and would prefer that customers use a meter that is easy for them to obtain and that they are happy using.

So, in line with our desire to offer both choice and simplicity, we’ve decided to enter the market without an integrated or specifically recommended glucose meter.

When it comes to CGMs, it’s a little different as the options are far fewer. So although there is nothing in place yet, we’re looking forward to hearing what people would think about an integrated CGM and we’re open to collaborations if we can offer something that is meaningfully different. EASD was a great place to meet the sort of people who could help us with that.

What’s the product timeline?

We’re really proud of Kaleido and we’d like to make it available for use as soon as we possibly can. We also know we only have one chance to make a great first impression. Great customer experiences are something that are incredibly important to us. So, once we’ve got our CE mark approval, we’ll move quickly, but not too quickly! We’ll be conducting evaluative studies before releasing it in the Netherlands and UK.

What about the United States?

The United States would be a great place for us to come and it’s definitely in our planning. Our focus right now though is to achieve CE Mark for Europe and then sensibly roll out Kaleido over here. Once we know we can satisfy such an important market, we’ll be coming for the States!

How much would this cost?

Kaleido is a product built with sustainability in mind. Only disposing of the insulin cartridge means you don’t have to throw away expensive stuff like batteries and electronics, so we will be able to offer competitive pricing. We would like to work with payers to ensure that our pricing can help make insulin pump delivery accessible and much easier for many more people. We have the flexibility to change the way that healthcare practitioners and payers currently perceive insulin pump therapy.

ViCentra was founded in 2013 by two British entrepreneurs, Dr Joseph Cefai and Tim Oakes. Cefai actually is seen as the inventor and chief architect behind Kaleido, and he’s been in the diabetes device development world for the past 23 years. Before co-founding ViCentra, Cefai was a principle founder of Cellnovo, which has been working on an iPhone-ish patch pump for most of the past decade and just launched in mid-2014 overseas. He brings that experience to the table.

We’re told that Oaks, on the other hand, grew up watching his father live with type 1 diabetes and has always been fascinated by tools and tech prototypes, from building his own boats and rigging zip lines in his garden. He’s been in the medical device field as a designer for seven years, working on drug delivery platforms and surgical instruments.

We have to give a nod to the ViCentra team developing Kaleido, as it’s a blast of color (seriously, we just said that!) and certainly features some creativity.

But once again, we’re a little skeptical as to the perceived user benefits of this two-part system, and how it will take off in Europe, let alone the U.S.