After years of wishful thinking, the ability to control your insulin pump directly from a smartphone is finally close at hand! (pun ;)

Massachusetts-based Insulet, makers of the OmniPod tubeless insulin pump, announced on Nov. 7 that the company has teamed up with Samsung to allow the Samsung Galaxy phone control of their newest system, called OmniPod DASH. This already FDA-approved system is being rolled out gradually ahead of a full commercial launch expected in March 2019. Initially, it will only speak to an app run on a locked-down Galaxy smartphone provided to patients. But in the long-term, the companies plan to eliminate the need for that separate device so people can simply use their own personal Samsung smartphones to control insulin dosing and all other functions of the pump.

This is a milestone because despite all the ways smartphone technology is being employed for health and medical apps, it has to date never been utilized to actually administer medication.

Pump users: just imagine the ease of use and potential to integrate data from other devices into the mix for making smart dosing decisions. Of course, it’s been a challenge to overcome concerns about safety and security.

“We are thrilled to announce that following remarkable work from our technical and cyber security teams and productive meetings with the FDA, we now plan to launch Omnipod Horizon and future generations of Omnipod DASH with personal smartphone control," says Insulet's President and Chief Operating Officer Shacey Petrovic.

 

Controlling OmniPod from a Galaxy Phone

As a reminder, the OmniPod Horizon system is Insulet's next-gen closed loop product under development. This system has been granted an accelerated FDA review process through the FDA, meaning the anticipated launch in late 2020 may very well happen sooner.

The new OmniPod DASH system that is already FDA approved adds Bluetooth connectivity, a new touchscreen controller, a new rechargeable battery -- and yes, it will use new Pods. Read all the details of the DASH system here.

Dr. David Rhew, Chief Medical Officer and VP of the Samsung’s Healthcare Division explained to MobiHealthNews: “First, there’ll be a locked-down version of the phone which has the security platform called Knox… but the long-term plan is to enable users to manage and administer their insulin using their own personal Galaxy smartphones, thanks in part to Samsung’s hardware and software-level mobile security platform."

“Because all these Galaxy devices already have [Knox] embedded, we can enable that to be used with this application, and now you have a personal device that does much more than simply view data. It can potentially administer medication, it could potentially be used to capture other types of information from other devices [and] communicate with others. [It’s] a tremendous amount of opportunity if you think about consolidating all these different functions on a smartphone.”

Insulet’s Petrovic added, in a statement: “For us, because we are delivering a life-sustaining drug, it’s critical that we have the highest measures of safety and security in place. We are thrilled to work with Samsung, the global leader in smartphones, to lead the way in offering phone control of an insulin pump in a way that is simple, safe and secure.”

 

Insulet’s Loop Pledge, Pioneering Connectivity

Just last week, Insulet also announced it will be the first diabetes device maker to sign on to the Tidepool Loop project, which will turn the DIY-created #WeAreNotWaiting closed loop functionality of Loop into an FDA regulated commercial mobile app.

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That project marks the first time that DIY diabetes tech that's been largely a "use at your own risk" proposition will come into the mainstream, allowing for a product that's not only FDA cleared but also one that healthcare professionals may be more comfortable prescribing and discussing with their patients. Insulet has pledged that the OmniPod will be a part of that in whatever way it materializes.

With that and pioneering the smartphone-as-pump-controller, these are exciting times for OmniPod, indeed!

Note that the idea of turning a smartphone into the central controller for diabetes devices has been around since at least 2009, when the winner of our DiabetesMine Design Challenge envisioned just such a system.

But it’s a been a slow process that some thought impossible due to FDA concerns about safety and security. It’s fantastic to see there is now a real and tangible path forward, thanks to modern platforms such as Samsung’s Knox, and FDA’s willingness to discuss and act on new digital health solutions (see FDA Fast Tracks Mobile Health – Diabetes Tops List).

To be clear, we still must wait a bit; OmniPod DASH with the Samsung connectivity won’t likely get into our hands until mid to late next year.

But for the first time, this connectivity is actually on the horizon (ending pun intended, Folks!)