The Dana RS Insulin Pump Embraces #WeAreNotWaiting Open Design

This week outside the United States a new insulin pump is launching. And it is going where previously no commercial diabetes product has been. This product is actually embracing the DIY diabetes community by including two-way communications capabilities between smartphone apps and pump controller. This product allows you to interact with DIY data-viewing technology. And also with the Android version of the homemade closed-loop system. Simplifying things for the tech-savvy D-Community to use this device in ways that will help to fit best into their lives. This is something unheard of till today in the commercial diabetes industry. Some companies in the United States and companies, in general, have discussed the design and open interfaces. In the meantime, the South Korean company SOOIL Development that made the DANA Diabecare RS insulin pump seems to be the first initial D-device to make it happen. This company for design advice also collaborated with the European do-it-yourself community.

We Are Not Waiting

Yesterday, at the #EASD2017 diabetes conference happening this week in Portugal, SOOIL announced that they plan to do a launch in Europe, Asia and other countries outside the United States. This will happen after they secure the regulatory approval for those countries in July. The aim is to file the device with the American FDA regulators in early 2018. The grassroots #WeAreNotWaiting movement that was led by diabetes patients to make tech innovation about diabetes devices began in the United States it is taken on global levels. Now, this movement actually has an industry champion in the South Korean company all thanks to Justin Walker the training manager of SOOIL. Walker is in New Zealand, and he has been living with type 1 diabetes since the late 80s. Also, he personally uses the Dana RS pump with the open-source closed-loop technology. Walker says that they appreciate and support all the work that the Nightscout community has done over the past years. Also, he says this is something that is great to witness and that they are excited to embrace that particular spirit.

What is Dana Pump?

Many people in the United States are not familiar with the Dana pumps because these pumps are only available overseas. The basics:

• Horizontal display and face come in 5 colors – dark gray, bright green, red, black and white.
• This device holds 300 insulin units.
• It is only 52 g with a full reservoir of insulin and battery, it is half the weight of the pumps with 300 units on the market.
• This device takes a battery of proprietary style. However, SOOIL considers changing the USA version. To be more specific, change only the battery to universal AAA.
• It has two-way Bluetooth low energy 4.0 connectivity. And with this, the Dana RS pump is able to communicate with an app on your smartphone and remotely operate the pump itself, deliver boluses, change basals and change settings.
• Also, the BLE wireless connectivity is important because this connectivity will need the firmware of this pump to be updated remotely. Similar to the Tandem X2 platform that now can be updated from smartphones.
• This enables for integration with CGM so that the data might go directly to the phone instead of a paired device or separate receiver.
• There are new mobile apps which work together with the Dana RS pump. iOS version that is pending regulatory and one for native Android devices that have CE Mark approval.
• These mobile apps are appropriately named for iOS - AnyDANA-I, and Android AnyDANA-A.

This pump is not the first for SOOIL. Actually, this company had had a pump on the market longer than anyone else.

The First Pump

The first pump of this family-owned company was on the market in the 80s, 3 years before some early pump vendors such as Minimed. The last version of this pump was Dana R; this pump was introduced in 2009. Walker notes that for most people, the Dara R pump is dated now and has not changed since 2009. In 2009 this pump with Bluetooth and remote control was ahead of time. However, it is now outdated. On the other hand, the DANA RS pump contains an updated display interface, and it is more modern looking and user-friendly. Walker says that he appreciates the forward-thinking move of the company to improve the BLE connection. Also to allow more powerful and reliable communication with smartphone applications and do-it-yourself technology without compromise the life of the battery. Walker says that he personally loves the tech developed by SOOIL and this D-device. He has been working and consulting with SOOIL since 2009 after Smith’s Medical and the downfall of the Deltec Cozmo pump. Walker was a pivotal part of the whole spearheading the pump through the development process of the company. In addition, he made it possible to bridge the gap in the #WeAreNotWaiting community.

First to Embrace Real Openness

This year at the big diabetes events such as the AADE conference in Indy, EASD this week, ADA Scientific Sessions in San Diego – the reps from the company, this includes Justin, wore black shirts with familiar wording and images. On the back the hashtag #WeAreNotWaiting and Nightscout logo, and on the front the wording “I pump with Android APS.” They have already developed certain technology which by design can integrate with the do-it-yourself Android AP. Developed by Dana Lewis and Scott Leibrand the android version of Open APS, this version at the moment has around 500 users. This fits in the mission statement of the company.  It goes like this “to bring more joy to people with diabetes.”

Kozak and His Contribution

One of the drivers of this Android APS ecosystem is Milos Kozak. His 7-year-old daughter got diabetes diagnosis 4 years ago. Walker notes that Kozak's work regarding hacking the pump for connectivity for homemade closed-loop and Nightscout paved SOOIL's way to build that into their new Dana RS pump. To be more specific, Milos is the one who aided SOOIL to integrate the two-way connectivity. He also helped to make this diabetes device safer thanks to the app that talks to the pump and vice-versa. Kozak says that at the beginning things were not going smoothly. However, once they understood that this is good for the patients and available for everybody they became supportive. The current RS pump is more about cooperation, and the company is open when it comes to open-source solutions. Leibrand and Lewis, the inventors of Open APS, say that SOOIL is making history when it comes to diabetes technology. Lewis says that they are excited to see how SOOIL has supported and embraced the #WeAreNotWaiting community. Lewis hopes that this will encourage the manufacturers based in the U.S. to make a step forward and collaborate with the #WeAreNotWaiting community.

What Should U.S. Expect?

According to Walker, SOOIL has been communicating with a company in California to conduct and facilitate usability testing and FDA submission. Walker says that there is a good regulatory relationship. This is because the company previously worked with Dexcom and other insulin pump company. Also, this company is working on the pump DANA-U. The pump will have same BLE connectivity when it comes to smartphone integration with a color touchscreen display that gives a choice to the users. They hope in the next 12 months to get that into the European market before eyeing the United States. Walker notes that this company also focuses on integrating closed-loop tech into the pumps DANA. Some studies test the Abbott Libre Flash Glucose Monitoring system and DANA R pump. Walker says that he loves the philosophy of #WeAreNotWaiting and Nightscout. He believes that these new platforms enabled this kind of tech to enter into the market sooner and that this helped the entire process. We hope that these devices will enter the market sooner rather than later and will be of significant importance. Source Health Line | OpenAPS | University of Cambridge | Clinical Trials