Tech-savvy families with members suffering from Type 1 diabetes aren’t waiting for commercial companies to develop—and the FDA to approve—artificial pancreases. Kate Linebaugh in The Wall Street Journal recounts the story of software engineer Jason Calabrese who hacked an old insulin pump so it could respond to the blood-sugar levels of his third-grade son, Andrew. The upgrade is possible because of improvements in sensors for real-time glucose monitoring.
The drawback for non-tech-savvy families is that the project is completely do-it-yourself. Someone selling an artificial pancreas would fall under the jurisdiction of the FDA. Linebaugh reports that Medtronic and Johnson & Johnson are working on commercial devices, and Medtronic plans to submit its version for regulatory approval next month. She reports that Francine Kaufman, chief medical officer for Medtronic’s diabetes division, expects the company’s FDA submission will exceed 100,000 pages. She hopes for approval next year.
Meanwhile, do-it-yourselfers can look to the Open Artificial Pancreas System (OpenAPS) project for help, including a reference design. As the website notes, OpenAPS is designed to use existing approved medical devices, commodity hardware, and open-source software.
Linebaugh reports that OpenAPS was started by Dana Lewis, a 27-year-old with Type 1 diabetes, who attracted attention to her effort through months of tweeting about it.
