Some diabetes patients are building their own unapproved devices to manage blood sugar levels, which could pose numerous health risks for patients, the FDA said in a May 17 safety notice.
The FDA issued its warning after receiving an adverse event report in which a patient experienced an insulin overdose after using unapproved glucose monitoring and insulin dosing systems.
The systems use computer algorithms to connect glucose monitors to insulin pumps, reports Bloomberg. While most of their individual parts are FDA-approved, the actual systems have not been tested or cleared by the agency.
Use of such systems "could result in inaccurate glucose level readings or unsafe insulin dosing," the FDA said, which could lead to "low blood sugar, coma, diabetic ketoacidosis — the buildup of acids in blood — and death."
The safety warning highlights the tension between healthcare consumers who are increasingly seeking technology to gain more control over their health and regulators who are trying to protect the public's health, Bloomberg noted.