Closed loop technology is no longer a pipe dream, with the first of these next-generation systems set to hit market within the coming years.
Today, we're welcoming to the 'Mine a friend from the Diabetes Online Community over in England, who has been closely following a new offering on the closed loop tech circuit. Tim Street is a type 1 techie and blogger at Diabettech, and he's been following a China-based company called Medtrum, which is moving quietly toward launching a closed loop system known as A6 TouchCare. It includes a disposable patch pump and continuous glucose monitor, and it may very well be available outside the U.S. before the end of this year. If that happens, it would be the world's first initial Artificial Pancreas system without any tubing!
Please read on to hear what Tim has learned about the Medtrum closed loop system:
Medtrum Report by Tim Street
I’ve been a type 1 for nearly 28 years, under the care of the NHS (National Health Service) in the UK. In that time, I’ve moved through the various forms of treatment and seen the progression in blood glucose monitoring without seeing what I’d describe as significant progress in any of these things. Due to these factors, I mostly disengaged with what was up to date in the diabetes care world as it was simply new insulins and due to the care model in the UK, access to the newer technologies was, at best, tricky.
I’ve always just got on with life, and diabetes has come along for the ride. That includes working, traveling and playing. I’ve participated in (and won) Tae Kwon-Do tournaments, played cricket for 25 years and generally don’t consider myself to be inhibited by the condition.
A few years ago, I discovered the online community and realized there was an opportunity to get more involved. For me this meant that I started to write a blog, DiabetTech, and started to attend the various events -- including JDRF Discovery Days where this story starts.
That event in London was sponsored by a diabetes product-maker like many of these are, except this time it was a company very few of us had ever heard of: Medtrum, which aims to develop and commercialize "innovative solutions to improve the lives of people with diabetes” and has been working with JDRF. It's a China-based company that just recently in June 2016 expanded into the UK with an office incorporated here.
This is what they're developing:
- A semi closed-loop with Predictive Low Glucose Suspend to anticipate a hypo and stop insulin delivery in advance, to prevent that Low from happening. The Medtronic Minimed 640G available outside the U.S. offers this PLGS currently, and those in the States should see this feature first in the Minimed 670G hybrid closed loop expected after mid-2017.
- Tubeless (!), weaving together an insulin patch pump called the P6 EasyPatch and a disposable CGM system called the S6 EasySense.
- Both the pump and CGM components are connected through what's called the EasyTouch mobile app, where you can share and integrate all of the data.
- Thinner, smaller and lighter than anything on the market, including the OmniPod patch pump.
- Each patch packet includes a 200-unit insulin reservoir, infusion set, pumping mechanism, and power supply.
- A controller that is “compact and lightweight that fits in your pocket and can be used with just one hand.” This has Bluetooth built in and offers real-time monitoring using the CGM system.
- Easy remote bolusing capability, as the patch pump has a button on the side to dose insulin in case you don’t have the controller nearby.
- Basal patterns are stored in the patch pump, and delivery continues even if the controller is out of range.
- Uses a “tiny, flexible, hair-like sensor” designed to last at least 7 days. The transmitter looks similar to the Dexcom CGM transmitter, with some small differences.
- Takes glucose readings every two minutes, providing 720 readings per day. Stores 15 days worth of data, so it can "catch up" without any lost data if a wireless connection is lost.
MARD accuracy scoreis supposed to be ~9%, which is equivalent to what the Dexcom G5 is shown to be.
- Shows 7 trend arrows depending on how your glucose values are reading on the CGM -- straight right arrow for constant levels, 45-degree up arrow for slowly rising, one or two arrows up for rising and rapidly rising, 45-degree down arrow for slowly falling, one or two straight down arrows for falling and rapidly falling.
- Waterproof design.
- Has an “automated sensor insertion” process, as the company says you just need to press a button or two on the device to insert the sensor.
One thing worth noting is that based on the products shown at the JDRF event, the controller for the A6 system doesn’t have a built-in glucose monitor. Glucose levels must be entered manually and will require that a separate monitor is also carried. That is definitely a downside.
The Medtrum sales director told me in an email correspondence that the A6 system has CE Mark approval in Europe and will be available to patients starting in September (!). They have also filed with the FDA for commercialization in the United States. The hope is to make that happen by early next year. But he didn’t clarify which products the FDA submission was for, so it’s unclear whether this is for the pump, the CGM system, the semi-closed loop system or all three.
If you're curious, I found the User Manual for the A6 System on the FCC website, and the documents include details of the CE mark Medtrum's obtained.
In addition, Medtrum has a number of patent applications that were just recently granted for its products in June 2016 -- including the disposable tubeless fluid delivery system and analyte biosensor system (for the CGM), plus a single needle artificial pancreas that uses a coating on the outside of the fluid delivery cannula to reduce the number of insertions needed, and a film for biosensors and preparation method that is core to the system.
As of now, Medtrum says it's trying to establish pricing models. But the expectation is that the S6 EasySense CGM component will be 40% less expensive than what Dexcom costs per month.
For those of us in the UK, where obtaining CGM with government funding is especially difficult, this brings full CGM in at a price range that is similar to that of the Freestyle Libre product by Abbott Diabetes. In and of its own, this would be entirely disruptive in the UK. It makes CGM much more readily available, and if the uptake of the Libre is anything to go by, being offered at this price changes the diabetes care game, especially for the industry incumbents.
If their costs for the whole TouchCare system are in line with those of current CGM, they would certainly undercut every pump company on the market, which would be hugely beneficial for pump uptake where the cost of pump access is still an issue.
Of course we have to temper all of this with the company's own optimism, but if they reach their goals there’s a real possibility that this might be the first closed loop patch pump system on the market, at least in Europe and even in the U.S.
And let’s be honest, who wouldn’t be interested in a remote controlled patch pump with suspend before low capabilities? It has certainly piqued my interest.
This is something a lot of people want to see!
(Please also see my comprehensive post on Medtrum at my blog, DiabetTech, and I'll plan to keep tabs on this as it comes to market and is available for people to use)
Thanks for this report, Tim! Sounds like a fascinating AP system in the works, and we wish Medtrum every success, in the name of improving life with diabetes.