FDA Warns Against DIY Artificial Pancreas After Patient Injury


Advertisement

The U.S. Food and Drug Administration (FDA) is warning people with diabetes against the use of DIY artificial pancreas systems after one person suffered an accidental insulin overdose[1] with the use of such a device.

For a number of years, members of the diabetes community have been creating systems to monitor blood glucose levels and infuse insulin automatically using computer algorithms. These systems, informally known as artificial pancreases, are often comprised of components that, while individually approved by the FDA, have not been tested for use together, according to Bloomberg.[2]

The warning from the FDA was prompted by a report the agency received about a person using a DIY system who received too much insulin after getting “repeated incorrect high glucose values,” resulting in an insulin overdose the required medical attention. It is not clear, the FDA notes, whether the overdose resulted from inaccurate blood glucose values reported from an unauthorized sensor or from a software malfunction. The patient survived.

“Patient use of unauthorized diabetes-management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing,” the FDA states. “These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis[3] — the buildup of acids in blood — and death.”

An FDA-approved artificial pancreas device[4] — a hybrid closed loop system known as the MiniMed 670G — is manufactured by Medtronic.

For more information on DIY systems, read the statement by the FDA[5].

Want to learn more about diabetes technology? Read “10 Diabetes Technologies to Watch in 2019.”[6]

Endnotes:
  1. suffered an accidental insulin overdose: https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning
  2. according to Bloomberg.: https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning
  3. diabetic ketoacidosis: https://www.diabetesselfmanagement.com/managing-diabetes/blood-glucose-management/diabetic-ketoacidosis/
  4. FDA-approved artificial pancreas device: https://www.diabetesselfmanagement.com/blog/artificial-pancreas-type-1-diabetes-receives-fda-approval/
  5. the statement by the FDA: https://www.fda.gov/medical-devices/2019-safety-communications/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not
  6. “10 Diabetes Technologies to Watch in 2019.”: https://www.diabetesselfmanagement.com/blog/10-diabetes-technologies-watch-2019/

Source URL: https://www.diabetesselfmanagement.com/blog/fda-warns-against-diy-artificial-pancreas-after-patient-injury/


Diane Fennell: Diane Fennell has been an editor at Diabetes Self-Management magazine since 2003. She is currently the Editorial Director. (Diane Fennell is not a medical professional.)

Disclaimer of Medical Advice: You understand that the blog posts and comments to such blog posts (whether posted by us, our agents or bloggers, or by users) do not constitute medical advice or recommendation of any kind, and you should not rely on any information contained in such posts or comments to replace consultations with your qualified health care professionals to meet your individual needs. The opinions and other information contained in the blog posts and comments do not reflect the opinions or positions of the Site Proprietor.