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Patient Hurt by Do-It-Yourself Pancreas Prompts FDA Warning
The U.S. Food and Drug Administration warned diabetics against building their own artificial pancreas system to help control blood sugar levels after a patient using one suffered an accidental insulin overdose.
A large community of diabetics has been using hacked-together, do-it-yourself systems to control their disease. The systems connect glucose monitors to insulin pumps using computer algorithms. They work around the clock, testing blood sugar and infusing insulin. Once the system is set up, they’re meant to require little effort by the patient.
While the individual components that make up a DIY system are generally approved by the FDA, they haven’t been tested or cleared for use together, the agency said in a statement. The accidental insulin overdose didn’t kill the patient, an FDA spokeswoman said.
“Patient use of unauthorized diabetes-management devices, alone or along with other devices, could result in inaccurate glucose level readings or
Continue reading at bloomberg.com
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Posted May 20, 2019telehealth