Medtrum. Disruption in the CGM and Artificial Pancreas Marketplace…. Coming Soon?

Last night at the JDRF Discovery Evening in the City, a company named Medtrum sponsored the event. A company many of us have never heard of. But what they were talking about was very, very interesting.

Why? Their product set. Their product suite is known as the A6 Touchcare System and is described on their website as:

“The A6 TouchCare TouchCare System is the world’s first and only tubing-free artificial pancreas system which integrates an insulin patch pump, a continuous glucose monitor (CGM) and the Predictive Low Glucose Suspend (PLGS) mechanism. “

Yes. You read that correctly. A company we have never heard of with an equivalent to the Medtronic 640G, in patch pump form. And in discussions with them last night, we were told that the product will be available in the UK “during September“. The product set consists of two separate product lines, that appear to combine to create the A6 TouchCare system. These are:

• S6 EasySense Disposable CGM System
• P6 EasyPatch Disposable Pump

The items were all on display last night and have a physical presence, so we were able to pick them up and feel them. They look, well, medical, but what else did you expect?

So what are the products?

Products

S6 EasySense Disposable CGM System

What’s also interesting is that they sell the CGM product on its own, and have a MARD of 9% on this. This is the S6 Easysense, and is described as a disposable CGM system. Their website states that there are no upfront costs, and that the sensors last 7 days. The product runs solely from a mobile app.

More importantly, when we asked them about cost last night, whilst they admitted that they hadn’t fully determined what their pricing would be, they talked about it being 40% cheaper than Dexcom per month.  When you consider that Dexcom costs £205 a month for the sensors now, that means something in the region of £120 a month for CGM. Yes. You read that correctly. We are talking Libre territory on the pricing, which all of a sudden opens it up to far more people. The website clearly states “No upfront cost” as well. This gets more and more interesting.

When asked last night, the implication given was that the transmitter was replaced monthly, when you bought four more sensors. I’ve asked them directly whether this is the case.

Given that the MARD they are promoting is 9%, or equivalent to the Dexcom G5, all of sudden, there seems to be a lot more competition about to land in the CGM space. And it looks disruptive.

The CGM also has a couple of other differences, and dare I say it, benefits, compared to the others on the market. It tests interstitial glucose levels every two minutes, which is more than twice the frequency of the Dexcom and Medtronic products, and the transmitter stores 15 days of data – yes – 15 days. That’s infinitely more than Dexcom, which doesn’t store any, 45 times more than the Libre, which stores 8 hours and 36 times more than the Medtronic Guardian 2 transmitter, which stores 10 hours. This looks like a CGM where you will struggle to lose data.

In terms of physical presence and design, the sensor and transmitter looks a lot like the Dexcom kit, with the exception of the sensor inserter, which is an automated system, rather more like the Abbott Freestyle Libre than anything Dexcom have at the moment.

From what we saw last night, it looked smart enough, and offers an app for monitoring the pump. Word has it that there are features of the Android app relating to adjusting TBRs and Boluses that may be software disabled, which provides some interesting opportunities.

From a physical perspective, it’s also, apparently a patch pump with a 90 degree cannula and it includes a bolus button on the pump, in case a handset fails.

The pump webpage shows lots of headlines but is limited on the details front. Having found the A6 Easycare Manual on the FCC website (https://fccid.io/pdf.php?id=2956807) the abilities of the pump appear to be what we expect. Temp basal rates be defined and Medtrum use the terminology Extended Bolus for Extended/Square Wave and Combo for Dual-/Multi-Wave. It looks as though the pump has everything we’ve come to expect in that respect.

The A6 TouchCare System

Now I could be wrong here, but it looks as though the components of the first two items here are integrated together to form the Artificial Pancreas product. The marketing information is mentioned earlier. It all seems to be integrated and the Predictive Low Glucose Suspend is described as:

“Insulin delivery will be automatically suspended when the sensor glucose is predicted to reach the low limit in a set period of time, and basal insulin will be automatically resumed when the sensor glucose is within the target range and is predicted to be at least 20 mg/dL higher than the low limit in half an hour.”

It all sounds a lot like SmartGuard, just with a less catchy name!

Projected Low Suspend

Digging into the user manual, the Projected Low Suspend functions similarly, but slightly differently to that in SmartGuard. It’s more flexible.

On SmartGuard there’s a specific Algorithm that is used (which is detailed in the manual) and suspend occurs if you are predicted to hit a glucose level 1.1 mmol/l above your low setting in the next 30 mins.

On the A6 system, you can set the time period within which the rate of change of your glucose level will result in you hitting your Low Suspend limit, in other words, if your Low Suspend limit is set to 4.0, then you might set this to 25 mins and if the system thinks that you’ll be hitting that value within 25 mins, it will suspend the insulin flow. It appears that you can set this to values from 15 mins up, but what the maximum value is is unclear.

What we can take from this is that the Medtronic system is perhaps more conservative than that from Medtrum in terms of when it will activate. It does mean that both HCPs and users need to be aware of the distinctions between the two systems if moving between them, and how they can best be set up for an individual user.

The pump and CGM features all align with the above products, while it also comes with a PDM. This, I assume, is a requirement for FDA approval (as other manufacturers, such as Bigfoot, have found). The documents show it works in a similar fashion to the 640G and SmartGuard, which makes it very interesting.

The other aspect that’s slightly different and welcome is the “rate of change” alarms. According to the manual, this is a rate than can be set by the user, if they wish, making it more flexible than some are.

Given that the above products seem to have links to a mobile app in their standalone form, it can’t be too far from that mobile app having the ability to perform the PDM function, and eliminate the need for it altogether. If the phone app is only software disabled rather than missing functionality, could it be possible that we might see the first phone based system coming from Medtrum?

That’s the product set, but who are Medtrum and what are their technologies?

The company and its techonologies

Who are Medtrum?

According to their website About page, “Medtrum is a company dedicated to developing and commercializing innovative solutions to improve the lives of people with diabetes. Our dedication has led to the development of a series of revolutionary products that completely change the way we treat diabetes. Our products are all built upon our values of convenience and simplification, so that you may have the time and energy to focus on the things in life that matter to you most.”

Having a dig around the Web, we find that they have a Companies House entry and in reading this, the UK entity was incorporated in June 2016. Their officers list a Chinese Gentleman as Director, and Medtrum Technologies can be found to be a Shanghai based company, which just happens to correspond with the correspondence address of the Director.

So it suffices to say that they are a Chinese company that is now expanding, and they have a product portfolio that supports this.

They currently have two websites. A UK one, as linked to at the start of this post, and a second one alicefun that has an English and Chinese language option. Neither is complete, and although there are links on the UK one to User Guides and a Community, these links don’t yet work.

What about their technologies?

This is where it gets interesting. There are a number of Patent Applications that appear to have been granted very recently (June 2016) in the US. This may be why we are seeing them come to market now.

These include:

• A single needle artificial pancreas – which uses a coating on the outside of the fluid delivery cannula to reduce the number of insertions needed
• A film for biosensors and preparation method, which would align with the first item
• An Analyte sensing system
• A disposable tubeless fluid delivery system

There are also a number of FCC approvals for the radio devices in their products.

European Medical Agency Approval and a CE Mark?

So the next question is, what about European Medicines Agency approval and a CE mark, or perhaps an FDA submission? All implantable medical devices require a CE mark, so, as an implantable medical device, I’d expect both the Pump and CGM to have one. This is where it gets a little more interesting. I can’t find anything on the web that says they have the CE mark or that anything has been submitted to the FDA.

Giving the benefit of the doubt to Medtrum, this may be because they haven’t issued any press releases talking about achieving this, so I’ve asked them directly whether this has been achieved, and I’ll update the blog post once I have further information.

There is, also nothing showing in terms of FDA submissions or clinical studies for these devices on the web, however, that’s not to say that they haven’t submitted. Until approval, this information is not publicly available.

Comparing to recent product launches, e.g. the Abbott Freestyle Libre system, there was a lot of “noise” and clear evidence of clinical trials being undertaken, so this seems a little strange.

I’ve now received an email from the team at Medtrum and to quote:

“Yes, all our products have CE mark.S6 disposible CGM go with 1 transmitter and 4 sensors. The transmitter can support 4 sensors and each sensor can use at use 1 week, mostly use 1-2 weeks.  Totally 4 sensor usually can use 1-2 months.

Summary