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Tinkerers Build Their Own Pancreases, While Waiting for 100,000 Page Submission to FDA



(p. B1) 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.


. . .


(p. B2) "Biology isn't quite as easy as controlling the temperature in a room," said Francine Kaufman, chief medical officer for Medtronic's diabetes division. She sees do-it-yourself efforts as a sign of the interest in the technology, but distinct from the process of getting a commercial device to market. Dr. Kaufman estimates Medtronic's submission to the FDA will exceed 100,000 pages and hopes that the device will be approved in 2017.

The home-built project that the Calabreses followed, known as OpenAPS, was started by Dana Lewis, a 27-year-old with Type 1 diabetes in Seattle. Ms. Lewis began using the system in December 2014 as a sort of self-experiment. After months of tweeting about it, she attracted others who wanted what she had.


. . .


The FDA declined to comment on the project but said the agency is working with manufacturers to approve a device.

Sarah Howard became interested after she met Ms. Lewis last year. "My first question was: Was it legal?" said the 49-year-old, who has Type 1 diabetes, as does one of her two sons. "I didn't want to do anything illegal."

​After ​her husband ​built​ the system for her and her son, she said the main benefit is starting each day with her blood sugar in range and not having to wake in the night to check her son's glucose levels.



For the full story, see:

Kate Linebaugh. "Tech-Savvy Families Build Robotic Pancreas; Companies work on developing diabetes device, but approval process is too long for many patients." The Wall Street Journal (Mon., May 9, 2016): B1-B2.

(Note: ellipses added.)

(Note: the online version of the story has the Tech-Savvy Families Use Home-Built Diabetes Device; Companies work on artificial pancreas, but approval process is too long for many patients.")






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