May 22, 2019
The FDA (US) issued a stern warning last week about do-it-yourself (DIY) artificial pancreas (AP) systems after a person with diabetes suffered an accidental insulin overdose while using a DIY AP. Although it isn’t clear how the malfunction occurred, the person who suffered the overdose, required immediate medical attention. The person has since recovered.
This is the first warning the FDA has issued about DIY systems.
The FDA statement reads, “These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use,” the agency wrote. “Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.”
What is a DIY AP or closed loop system?
DIY systems combine FDA-approved components, including insulin pumps and continuous glucose monitors (CGM), with open source software to deliver continuous doses of insulin. The Open Artificial Pancreas (OpenAPS) movement, led by Dana Lewis, was launched in 2015, and today thousands of people worldwide are using the systems.
The DIY movement, whose objective is to achieve optimal blood glucose results with the DIY technology, build their own glucose management devices, or combine assorted manufacturers’ devices into homemade artificial pancreas. One of the benefits of the DIY AP is a good night’s sleep, which for many with type 1 diabetes is out-of-reach. The movement’s efforts have been lauded by health researchers for their achievements, however, the FDA ‘s warning is speaking to both consumers and healthcare professionals about the serious risks that may develop from these untested technologies.