A new insulin pump launching outside the United States this week is going where no commercial diabetes product has gone before: it is embracing the do-it-yourself diabetes community by actually including two-way communication capabilities between the pump controller and smartphone apps.
This allows it to interact with do-it-yourself data-viewing technology and the Android version of a homemade closed-loop system, essentially making it easier for the tech-savvy D-Community to use the device in ways that best fit their lives.
This is virtually unheard-of to date in the commercial diabetes industry. While other companies in the U.S. and globally have talked about open interfaces and design and are exploring that for future tech, the new DANA Diabecare RS insulin pump from South Korean company SOOIL Development appears to be the first D-device to actually make it happen. They even collaborated with the European DIY community for design advice.
Today at the big #EASD2017 diabetes conference happening in Portugal this week, SOOIL announced a launch in Asia, Europe and other places outside the U.S. after securing regulatory approval in July for those countries. The hope is to file this device with America's FDA regulators at some point in early 2018.
Although the grassroots #WeAreNotWaiting patient-led diabetes tech innovation movement began here the States, it's taken on global momentum, and now has an industry champion in this South Korean company, thanks to SOOIL training manager Justin Walker. He's located in New Zealand, and has been living with type 1 himself since the late 80s. He also personally uses the open-source closed loop technology with the Dana RS pump.
“We certainly support and appreciate all the work the whole Nightscout community has done over the past several years,” Walker says. “It’s been fantastic to see and we’re thrilled to embrace that spirit.”
Wait, What's a Dana Pump?
Many here in the U.S. may not be familiar with the Dana Diabecare pumps, since they are only available overseas. Here’s a rundown of the basics:
- Horizontal face and display, and comes in 5 colors -- red, white, black, dark gray and bright green.
- Holds 300 units of insulin
- At only 62 grams with battery and full reservoir of insulin, it’s roughly half the weight of comparable 300-unit pumps on the market
- Takes a proprietary style of battery, but SOOIL is considering a change to a universal AAA battery in the USA version of the DANA RS model
- With two-way Bluetooth Low Energy 4.0 connectivity, the DANA RS can communicate with a smartphone app to remotely operate the pump, change settings, and change basals or delivery boluses. “Anything you can do on the pump is identically icon-based on the phone.”
- The BLE wireless connectivity is also significant, as it will allow this DANA RS pump’s firmware to be updated remotely, much like the Tandem X2 platform can be now updated from home like smartphones. This enables future integration with CGM so that data can go directly to the phone instead of a separate receiver or paired device
- New mobile apps work with the Dana RS pump, one for the native Android devices that has already gotten CE Mark approval and an iOS version that’s still pending regulatory OK but is expected soon. They are appropriately named AnyDANA-A (for Android) and AnyDANA-I (for iOS).
This is not SOOIL’s first pump, by a long shot. Actually, this family-owned company was founded by a professor of endocrinology and has had a pump on the market longer than anyone in the world, with its first pump hitting market in 1980 – three years ahead of Minimed and other early pump vendors.
The last version was the Dana R, introduced in 2009.
“To most people worldwide, the Dana R is a bit of a dated pump now and hasn’t evolved or changed since then,” Walker says. “I describe it as a modern but outdated pump. In 2009, with a Bluetooth-capable pump with remote control, it was leading the world and miles ahead of everybody at the time. But it’s slowed down and become an old and dated pump since then.”
The new DANA RS pump has an updated display interface to make it more user-friendly and more modern-looking, Walker says. We're certainly not jumping up and down over the look/style, but we do appreciate the company's forward-thinking move to vastly improve the BLE connection, allowing more reliable and powerful communication with the smartphone apps and other DIY technology without compromising the battery life.
For his part, Walker says he loves this D-device and the tech developed by SOOIL, which he’s been consulting and working with in some capacity since 2009, after the downfall of the Deltec Cozmo pump by Smith’s Medical.
He’s been a pivotal part of spearheading the DANA RS through the company’s development process, and largely made it possible to bridge the gap to the #WeAreNotWaiting community.
First to Embrace Real Openness
At the big diabetes events this year – ADA Scientific Sessions in San Diego and the AADE conference in Indy, as well as EASD happening this week – the company reps (including Justin) had on black shirts with familiar images and wording: the Nightscout logo and #WeAreNotWaiting hashtag on the back, and “I pump with Android APS” on the front.
They've got the street cred to carry it off too, having already developed technology that by design is able to integrate with the DIY AndroidAPS -- the Android version of the OpenAPS developed by Scott Leibrand and Dana Lewis (no connection to the DANA pump name!), that currently has about 500 users in total.
What a cool opportunity for a small, European-based player to lead the way on embracing grassroots innovation! And it definitely fits in with the company's mission statement: "to bring more joy to people with diabetes."
D-Dad Milos Kozak, whose 7-year-old daughter was diagnosed about four years ago, is one of the drivers behind that Android APS ecosystem, and Walker says Milos’ work in hacking the Dana R pump for connectivity with Nightscout and homemade closed loop paved the way for SOOIL to build that into its new DANA RS insulin pump.
In other words, Kozak is the one who helped SOOIL integrate two-way connectivity and make the device safer with the app talking to the pump and vice-versa.
“It wasn’t easy from the beginning, but once they understood that it’s great for patients and available for everyone immediately they became very supportive,” Kozak tells us. “It's still a company protecting their interests, but they provide what I need and are adding features for APS based on my comments. This current Dana RS is more about cooperation, and they’re open to open-source solutions.”
OpenAPS inventors Lewis and Leibrand agree that what SOOIL is making diabetes tech history.
“We're very excited to see how SOOIL has embraced and supported the #WeAreNotWaiting community,” Lewis says. “I'm hoping more awareness of their collaboration will encourage U.S.-based manufacturers to step up and collaborate with the community as well!”
What to Expect in the U.S.
Walker says SOOIL has been talking with a California-based company to facilitate and conduct usability testing, and eventually the FDA submission. He says this same company has worked with Dexcom and at least one other California insulin pump company in the past, so there’s a good regulatory relationship in place.
“We expect that FDA shouldn’t be as big a hurdle as previously, in regard to Bluetooth and cellphone integration. Remote control is looked at more positively today than it used to be,” he said.
The company is also working on a DANA-U pump, that will have the same BLE connectivity for smartphone integration with a color touchscreen display, to give users choices. They hope to get that to the European market in the next 12 months before eventually eyeing the U.S.
Walker says the company’s also focusing on integrating more closed loop technology into their DANA pumps, but that is further off until regulatory trials begin. Doing some quick research, we can see that some studies are underway globally, testing the DANA R pump and the Abbott Libre Flash Glucose Monitoring system. Very cool!
“I love the whole philosophy of Nightscout and #WeAreNotWaiting, it’s just a beautiful analogy,” Walker says. “I think all the new platforms have enabled this type of technology to come to the market sooner rather than later, and it’s helped the whole process.”
For our part at the ‘Mine, we 100% agree and here’s to hoping for these new open devices to reach us sooner rather than later!