FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States
The US Food and Drug Administration (FDA) has issued a warning against the use of unauthorized diabetes devices, including insulin pumps and continuous glucose monitors (CGMs), as well as other nonapproved devices and algorithms used to create systems for automated insulin delivery.
“These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death,” according to the FDA statement.
In response, the DIY Community and JDRF reacted.
This “Open Artificial Pancreas (OpenAPS)” movement was launched in 2015, when individuals in the type 1 diabetes community began hacking into older FDA-approved insulin pumps and developed open-source code to allow them to communicate with FDA-approved CGMs in order to “loop” for semiautomated insulin delivery. Estimates suggest that, worldwide, thousands of patients are now using such systems.
In a joint statement issued on Twitter, the core developers of Loop, OpenAPS, and AndroidAPS said “FDA is aware of the DIY community. This announcement brings up something very important we need to address; an opportunity for the DIY community to double down on its commitment to radical transparency and responsibility.”
According to the DIY groups’ statement, the case report in question was from outside of the United States, and the patient has since recovered.
The statement says in bold, “We want you to report adverse events on DIY systems, if and when they occur. We do not support any efforts to minimize or avoid discussing/reporting adverse events. Openly sharing — including any potential issues — is an equally important part of the ‘open’ aspects of the DIY diabetes community.”
In a statement sent to Medscape Medical News, JDRF president and chief executive officer Aaron Kowalski, PhD, said in part, “A growing number of people in the [type 1 diabetes (T1D)] community have benefitted from [DIY] automated insulin delivery approaches. Today’s warning from the FDA to not use unapproved and unauthorized devices for diabetes management is not unexpected — when the agency receives reports of adverse events, it is not uncommon for it to issue warnings.
In response to the widespread FDA warning, Katie Disimone, a DIY closed loop developer and member of the Tidepool team, wrote a wonderful discussion of the real issues surrounding the warning. I’ve attached the pdf of her piece below from her website: https://seemycgm.com.
Is this potential to over-deliver (or under-deliver) insulin unique to DIY closed-loop systems? Nope, absolutely not. And that is the message that all this news coverage is missing. The REAL story. Access to quality CGM devices is the underlying need to be addressed.
Any automated, closed-loop system (commercial or DIY) will only be as good as the CGM data that is feeding the system.
Ideally, the FDA’s warning message hammers home a point that really is sorely true. The access to quality health tools to safely manage T1D is lacking. T1D is so inherently risky. The slowness of the world’s government systems to help with access and affordability of quality CGMs is adding to our community’s collective risk.
Dear FDA…if access and affordability of quality CGM systems were addressed, DIY CGM apps would not be needed. Adverse events can happen on your FDA-approved devices as well. T1D is risky with syringes and finger sticks through the most advanced FDA-approved closed loops. The warning is that diabetes is risky, and we need quicker iteration and better development in the commercial markets.See My CGM Analysis of FDA warning against DIY systems