In October, JDRF took the organization’s first step into the burgeoning world of DIY diabetes technology when it announced a new initiative to speed the development of “open protocol” insulin delivery systems (or artificial pancreases). Over the past several years, there have been a variety of projects where people with diabetes and their families have come together in an open-source way to build what are essentially DIY automatic pancreases; the most prominent are Open APS and Loop , which rely on CGM data, a predictive algorithm, and a build-it-yourself tiny computer to control the actions of an insulin pump. The systems are proactive rather than reactive, and remove the burden of constant decision-making—Is my basal rate too high? Will I need some juice at night?—that people with type 1 diabetes have to bear. Users have reported strikingly good results in terms of A1C (from an average of 7.1 to 6.2) and time in range (from 58% to 81%), with fewer extreme lows and highs. More than 450 people worldwide are now DIY closed looping—including JDRF’s chief mission officer, Aaron Kowalski. According to Daniel Finan, a research director at JDRF who will be helping to lead this latest initiative, “Aaron Kowalski says it’s been a game changer for him and for so many other people out there.”
But DIY closed looping isn’t for everyone. Most closed-loop systems are built using an out-of-date Medtronic pump bought on places like EBay (certain Medtronic pumps had a security flaw, now fixed, which allowed them to be remotely controlled from the outside). And building the mini computer system that connects the pump and the CGM is complicated, and not for the technologically faint of heart—though both OpenAPS and Loop have thriving online communities offering advice and support.
JDRF’s plan is to step into the breech, and help consumers and companies address the technical, legal, regulatory, and financial issues that may keep all but early adopters from embracing open-source closed loop technology. Finan envisions a “plug and play” system, where consumers could pick their favorite pump and match it with their favorite CGM and their favorite algorithm—essentially, the formula that controls how much insulin to give and when. “We want to have our cake and eat it too, if you will. We want to harness this speed of innovation that the DIY community is bringing into the space, but at the same time we want everything to be above board, with more transparency and more safety,” says Finan. Some of the issues JDRF will be working on are pushing manufacturers to include easy yet secure ways for CGMs and insulin pumps to communicate with one another; figuring out liability issues (including who is responsible if something goes wrong with insulin dosage); and creating a pathway to FDA approval for artificial pancreas systems that have grown up through the open-source ecosystem rather than through traditional channels. As Aaron Kowalski said on the day the initiative was announced: “To support innovation and enable type 1 diabetes families to use an open-protocol approach safely, we need to ensure the regulatory pathway is clear, and we will work with industry stakeholders to make devices compatible. By making this approach more accessible to a wider group of people with diabetes, users of insulin delivery devices will be able to manage their blood glucose levels better, and in a way that works best for them.”
Dana Lewis, one of the people behind the OpenAPS movement, is excited for the possibilities that JDRF’s involvement may bring. She worked with Ben West, a software engineer with type 1, John Costik of Nightscout fame, and with her now-husband, Scott Leibrand, to develop a hybrid closed-loop pancreas (hybrid because people still need to bolus for meals) which stands at the center of the OpenAPS system. Through the OpenAPS Web site, people can find the step by step instructions for how to build the computer that links CGM data with an insulin pump and tells it what to do, and they can get support from others in the community in a chat room on Gitter. But closed-loop technology could be available to a lot more people if the device manufacturers made it easy for CGMs and pumps to communicate. As Lewis told me about JDRF’s involvement: “I think it is fantastic. JDRF has essentially endorsed the DIY community, which they haven’t before. They’re willing to put up money to help the companies with the liability and risk concern, which is a huge motivation for the companies.” Lewis points out that while right now, the DIY diabetes community is having to spend time trying to figure out ways to hack into insulin pumps (the old Medtronic pump they’ve been mainly relying on is no longer available for sale or protected under warranty), with device manufacturers’ cooperation the process could be quicker and less complicated. “We’d rather be improving the algorithms and the features to have a better closed loop system than to be having to hack these devices that may or may not be on the market in a couple years.”
For those watching from the outside, who have heard about the benefits that open-protocol closed-loop systems provide but feel intimidated by the technological skill that’s now required, JDRF’s involvement gives hope that these advances will become more mainstream. As Finan says, “Through observing where the community has gone over the past few years, it’s become unignorable that there’s value out there to be harnessed and to be spread out so more patients can use it. So we’re just trying to figure out a way that we can do that safely and with the most efficacy.”