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FDA Warns Against Using DIY Diabetes Devices

People with diabetes often rely on technology in order to manage their blood sugar and medications, especially those with type 1 diabetes who must take insulin. Due to sluggish progress in creating an FDA-approved artificial pancreas, some people have created their own DIY diabetes devices.

What is an artificial pancreas?

An artificial pancreas is essentially two devices that communicate with one another: a continuous glucose monitor (CGM) that continuously monitors blood sugar levels, and an insulin pump that releases insulin based on readings from the CGM. When these two devices can communicate with one another without much human intervention, this is called a hybrid closed-loop device, or artificial pancreas.



Tired of waiting for technology to catch up to their needs, an “Open Artificial Pancreas (OpenAPS)” movement began in 2015 when people with type 1 diabetes hacked their insulin pumps and CGMs, creating an artificial pancreas to delivery semi-automated insulin delivery. Although both devices were FDA-approved, “looping” them together had not yet been approved. Many of these people tweeted about their progress using the hashtag #WeAreNotWaiting.

It took more than two years before the industry caught up with the needs of these patients, and released the first FDA-approved hybrid closed-loop insulin delivery system, the Medtronic MiniMed 670G.

The dangers of DIY diabetes devices

The American Diabetes Association and FDA have both released official statements warning patients not to create their own DIY diabetes devices.

These devices can result in serious and potentially harmful health consequences because patients cannot guarantee the accuracy of the glucose readings and insulin dosing. For example, if the glucose reading is falsely high, the patient will receive too much insulin. Situations like this can create life-threatening emergencies, like severe hypoglycemia, coma, diabetic ketoacidosis, and even death.

However, some healthcare experts recognize these patients to be pioneers, moving the industry forward to better technology.

Endocrinologist Dr. Jeremy Hodson Pettus said, “I think this whole do-it-yourself pancreas movement is very important. There are people using it and it’s making a huge difference in their lives. I think it’s important for more people to know about it, and hopefully it will become more mainstream and more available.”

Find the FDA’s requirements for artificial pancreas devices here.