JDRF Statement on FDA Safety Warning for DIY Systems
Despite significant advances in diabetes treatment options, the bulk of people with T1D do not achieve glycemic goals. Every day comes with high and low blood sugars, and every day people with diabetes assume considerable risk in managing their disease. Finding the best way to manage type 1 diabetes (T1D) can be challenging, and one size does not fit all. A growing number of people in the T1D community have benefitted from “do it yourself (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. We encourage the T1D community to report problems with DIY and other devices when they occur and for the agency to share information with the public as needed. JDRF believes every person who considers DIY approaches should weigh the risks and benefits from their own perspective. Our priority at JDRF is to enable more options that can improve the lives of people with diabetes, including versions of innovative DIY approaches that have been reviewed and approved by the FDA. That’s why, nearly two years ago, we launched a new initiative to support the development of open protocols for artificial pancreas (AP) technology. Our goals are to support innovation and safety, and we look forward to continue working with entire ecosystem – the DIYers, device companies, the FDA, and health plans – to ensure people with T1D have the options they need to best manage their disease.
Aaron J. Kowalski, Ph.D., JDRF President and CEO