The FDA issued a warning against the use of DIY automated insulin dosing systems after the agency received notice that a person with diabetes had been hospitalized after an accidental overdose of insulin with a self-constructed “artificial pancreas” system.
According to the FDA, someone who utilized a self-constructed automated insulin pump system received too much insulin from their insulin pump. They were using a pump and continuous glucose monitor (CGM) which had not been tested by the agency for compatibility, according to the notice. Currently, regulators are not sure whether the error in dosing occurred because of inaccurate blood sugar readings from the CGM, inaccurate dosing from the pump, an error in the algorithm that automates basal insulin dosing, or some combination of errors from the various components of the system.
The devices used were not named in the notice. There also currently is no information released as to what DIY automated insulin dosing algorithm was used by the patient.
The warning notice to consumers also gives a length description of the FDA’s process to ensure true interoperability of diabetes devices, and a warning that those utilizing systems that have not gone through the FDA review process may be subjecting themselves to serious risk.
The DIY artificial pancreas movement began underground among hackers and developers who wished to improve insulin pump algorithms in order to create an automated insulin dosing systems. The early pioneers of the movement were frustrated with the perceived lack of progress in the development of FDA-approved automated insulin pump systems.
What was initially perceived as a fringe medical movement has moved closer to the mainstream in recent years, as several companies, including Tidepool and Bigfoot Biomedical, have been attempting to develop projects inspired by DIY automated insulin dosing systems or algorithms for FDA approval. Both researchers and FDA regulators have shown growing acceptance towards this patient-led movement, with formal research projects tracking health outcomes of DIY automated pump users, as well as forums held between health regulators and DIY automated pump stakeholders.
In the past year, the FDA also has unveiled rules for a new class of diabetes devices and algorithms that are designed to work interoperably with devices and algorithms designed by multiple companies. It is currently unclear how this warning might affect the FDA’s position on its collaborations with the DIY automated insulin dosing movement.
Update – 5/17/2019 – 3:30 pm EST – Stakeholders from the DIY automated insulin dosing community have reportedly released a joint statement in response to this warning. You can read it here.
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