Efforts to build artificial pancreas (AP) systems under open protocols will get a boost from JDRF, a multinational group that funds Type 1 diabetes research and other programs. The organization has announced a new initiative to not only provide funds for these DIY and frequently reverse engineered projects, but will also provide the regulatory and liability guidance necessary for a public release.
Progress has been steady on professionally-made AP systems, which often take the form of a continuous glucose monitor (CGM) and an insulin pump paired with an interface for users to manually input their carbohydrate consumption. To more easily regulate users’ glucose levels. The first commercialized option, Medtronic’s MiniMed 670G, received FDA clearance roughly one year ago, while researchers are still investigating ways to make APs even more streamlined.
While these devices have helped patients avoid hypoglycemia and hyperglycemia, Aaron Kowalski chief mission officer at JDRF, noted that some have taken a less standard approach to AP development.
"The data behind [commercialized APs] has been really, really strong. It really helps people with diabetes on a number of different fronts,” Kowalski told MobiHealthNews. “In parallel, there’s been this DIY movement in the diabetes community, and what we’ve seen has been innovation such as cell phone integration, iWatch integration, customizability — just really impressive, and it’s helped a fair number of people.”
However Kowalski noted that this movement generally has to do its tinkering under the table, and very often is working with older devices that wouldn’t be offering all of the advantages of newer systems. Dan Finan, research director at JDRF, agreed, and explained that many of the benefits of these systems can be offset by bigger issues.
“I don’t want to take away from the therapeutic innovation and value that [these DIY systems are] giving to a lot of people — they’re fantastic,” Finan said. “But one of the reasons that we’re launching this whole initiative is that the communication systems that they’re using in these DIY systems are neither open, meaning protocols that are openly published, or secure, meaning that they don’t have robust authentication systems or data encryption. I think what we’re trying to do with this initiative is … bring this above the table and secure the systems, but at the same time allow innovation to keep chugging along at a rapid pace.”
Kowalski explained that outside of providing funding, JDRF is targeting three major areas in which to help open-protocol system developers serve a wider audience. The first and simplest of these would be technological assistance, which would require working with manufacturers to ensure all new devices can be safely modified. The second focus would be on streamlining US and international regulation of these implementations, while the third involves the issues of liability that come with adjusting implementing medical devices for purposes outside of their original use.
Overcoming these issues and establishing an alternative pathway for AP innovations could breathe new life into the industry, Finan said, especially when considering that many of the systems available today fall short when it comes to the open protocol movement’s primary expertise — user convenience.
“You look at some medical devices out there, and the user experience is pretty rough,” Finan lamented. “You only have maybe two buttons to press. There is one touchscreen device out there, but putting things onto an intuitive platform like a cell phone is going to be absolutely huge for adoption.”
Kowalski agreed, and stressed that new options permitting discreet management through consumer devices would be a game changer for younger users or others who may be self-conscious about their condition.
“You can poke your fingers a lot of times a day, and you can wear a pump with a sensor, but that adds a burden,” he said. “What you’ll hear from the community is that they want less burden, they want it to be easier. … To be able to do things easier, having better user interface to make it more discreet, to make it be able to check your glucose off your watch or your iPhone or your Android phone — these things are valuable to the community, and that one of the things that we’ve heard really loud and clear.”Air Max 90 LTHR Suede