Third-grader Andrew Calabrese carries his backpack everywhere he goes at his San Diego-area school. His backpack isn’t just filled with books, it is carrying his robotic pancreas.
The device, long considered the Holy Grail of Type 1 diabetes technology, wasn’t constructed by a medical-device company. It hasn’t been approved by regulators.
It was put together by his father.
Jason Calabrese, a software engineer, followed instructions that had been shared online to hack an old insulin pump so it could automatically dose the hormone in response to his son’s blood-sugar levels. Mr. Calabrese got the approval of Andrew’s doctor for his son to take the home-built device to school.
The Calabreses aren’t alone. More than 50 people have soldered, tinkered and written software to make such devices for themselves or their children. The systems—known in the industry as artificial pancreases or closed loop systems—have been studied for decades, but improvements to sensor technology for real-time glucose monitoring have made them possible.
The Food and Drug Administration has made approving such devices a priority and several companies are working on them. But the yearslong process of commercial development and regulatory approval is longer than many patients want, and some are technologically savvy enough to do it on their own.