When Canadian researchers discovered and isolated insulin in the 1920s, it was a pivotal moment for diabetics around the world. Insulin, a hormone made by the pancreas, allows the body to store glucose from the food we eat for future use, and it keeps blood-glucose levels in a safe range. Being able to inject insulin for the first time gave a new lifeline to diabetics, who don’t produce enough insulin on their own.
In people with type I diabetes, the pancreas only makes very little or no insulin at all, and dangerous drops and surges in blood-glucose are common if insulin doses aren’t well managed. These swings can lead to serious health complications like cardiovascular disease and blindness.
Despite a century of innovation, managing insulin is still highly manual, relying on people to make calculated decisions every day based on their physical activity levels and what they plan to eat. Most type I diabetics still perform finger prick tests multiple times a day to obtain their blood-glucose levels, and administer insulin injections manually. Others use insulin pumps and continuous glucose monitors, with a sensor placed under the skin, but these two devices still don’t talk to each other to make automated decisions for the user.
Taking the initiative themselves, some diabetics are hacking these systems in a DIY movement that is leading the development of the most sophisticated insulin delivery systems in the world.
University of Alberta PhD student Jonathan Garfinkel is one of them, and he is documenting his own experience hacking his sensor and pump to work together as an artificial pancreas. He and others are using free, open-source instructions from the internet to build the Loop, a closed-loop system that uses a smartphone and Bluetooth link to let the two devices talk to each other.
Using a bit of code, the Loop app takes the blood-glucose measurements and performs calculations to regulate the insulin pump; users still need to input carbs and exercise to help make adjustments, but it still removes a lot of the daily work needed to stay in a healthy blood-glucose range.
It’s a bit of a scary prospect for patients to hack a system together themselves because the stakes are so high. A miscalculation or wrong command could deliver a fatal overdose of insulin. Because there is no money changing hands, there is nothing illegal about it, even though it’s unregulated and still highly experimental.
Insulin pumps alone can be dangerous if used incorrectly, and they’ve been linked to more reports of injury and death than any other medical device, according to Health Canada’s database. But Loop is still leading the way for companies to innovate and bring regulated products similar to Loop to the market.
“What’s really interesting is that this bio-hacked loop system is actually outperforming many of the commercial products, and that’s driving the industry to make better products and to come out with them faster for regulatory approval,” said pharmacologist Peter Light, Director of the Alberta Diabetes Institute, in a press release.
“Within a few years, I think we will see mainstream, commercially available, Health Canada-approved systems that are better than the current versions.”
Part of the delay is in the higher restrictions that come with closing the loop between the sensor and the insulin pump. On its own, an insulin pump is a Class 3 medical device, but it goes up to Class 4 with automated adjustment in conjunction with the sensor.
According to Garfinkel, companies are starting to make progress. Omnipod is a new commercial pump that is compatible with Loop. Medtronic put the MiniMed 6670G on the market, a hybrid closed-loop device that self-adjusts every five minutes based on sensor data, but removes some of the potential for overdosing by asking users to push a button to deliver the high doses needed to cover meals.
Medtronic is also collaborating with 501(c)3 nonprofit Tidepool to create an FDA-approved Bluetooth app based on Loop.
Closed-loop systems could mean around-the-clock solutions for people with diabetes, improving health outcomes and taking the daily work out of managing their blood-glucose levels.
“This is a patient-led therapy,” adds Garfinkel. “It’s free and was developed with a pay-it-forward mentality. It’s changed my life.”