In 2014, there were no commercial systems available that closed the loop between a continuous glucose monitor (CGM) and an insulin pump. For a variety of reasons — including government regulation hurdles — manufacturers were not ready to bring such systems to market. This meant that diabetes patients had to adjust the insulin pump settings based on the readings from the CGM, and often had to rely on traditional finger sticks and even manual injections as well. This can be complicated for adult patients, but can be especially challenging for children who have been diagnosed with Type 1 diabetes.
A woman with Type 1 diabetes and her husband decided to do something about this. They applied the “can do” attitude of the do-it-yourself (DIY) community to solve the problem. They studied the existing CGM and insulin pump devices that were available, and figured out how to interpret the data streams that they produced. They then used a small single-board computer (SBC) to bridge the communication gap between the two devices. In effect, they were able to hack their own artificial pancreas. The result was a system that helped keep the woman’s blood sugar levels steadier throughout the day. Even better, it was able to monitor her glucose levels while she slept, and adjusted the insulin doses accordingly so she did not have to wake up throughout the night to check her levels.
This would be a good story even if it ended there, but there’s more. The couple decided to make their designs and program code available as open source that could be distributed and modified freely. Thus the Open Artificial Pancreas project (OpenAPS) was born. It is illegal for someone to build and sell such a device without FDA clearance, but it is not against the law to build one for yourself (or your family member). An entire community has sprung up around the project, which has produced improvements in the programming and a more helpful user interface. According to the group’s website, you can build a system for less than $150 (provided that you already have a CGM and an insulin pump). The group estimates that there are more than 800 people worldwide with DIY closed loop systems. According to self-reporting, these systems have increased the median percent time within range (80-180 mg/dL) from 58% to 81%, and more than half reported a large improvement in sleep quality. The group has presented papers at the American Diabetes Association meetings.
We are now seeing FDA-cleared systems that link CGMs with insulin pumps, but it is likely that the DIY movement will continue to be a force within the digital health industry. DIY users are also experimenting with various types of implantable sensors and other devices, which could accelerate progress in the development of commercial devices of this sort. This home brew attitude will continue to address perceived problems and come up with novel solutions.