FDA Issues Warning on Do-It-Yourself Artificial Pancreas

The FDA on Friday issued its first-ever warning about do-it-yourself (DIY) artificial pancreas systems after a patient who used one suffered an accidental insulin overdose. The incident, and the FDA’s action, prompted a statement on Twitter from several well-known developers.

DIY systems combine FDA-approved components, including insulin pumps and continuous glucose monitors (CGM), with open source software to deliver continuous doses of insulin. It is estimated that the systems have attracted thousands of users who either have type 1 diabetes (T1D) or who are parents of children with T1D.

“The FDA is concerned about people with diabetes using unauthorized devices for diabetes management used alone or along with authorized devices,” the agency’s statement read. The FDA received a report of a “serious adverse event,” of a patient using a DIY system that included an “unauthorized algorithm.”

“This unauthorized system resulted in an insulin overdose requiring medical intervention. These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility,” the statement continued, adding that it was unclear exactly how the malfunction occurred.

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