This afternoon we announced that we will be working with Tidepool to create an interoperable automated insulin pump system. This means that both companies will be working closely with the Food and Drug Administration (FDA) through the regulatory process to garner approvals for the components needed for an interoperable system, including a future Bluetooth-enabled MiniMed ACE pump that would be compatible with the future Tidepool Loop app.
As you may be aware, Tidepool is a 501(c)(3) nonprofit organization dedicated to making diabetes data more accessible, actionable and meaningful. The organization is working on a future FDA-regulated, open source automated insulin delivery app – known as Tidepool Loop – for iPhone and Apple Watch. Tidepool Loop will work by connecting to an insulin pump and CGM, using Bluetooth LE, and running an algorithm every five minutes that adjusts a user’s basal rate and aims to help reduce or avoid high and low blood glucose.
Pairing our future Bluetooth-enabled MiniMed ACE pump with Tidepool Loop would enable an FDA-approved interoperable system – with pump and CGM components – that may be mixed and matched with the Tidepool Loop app as the person with diabetes chooses.
We want to thank you for your feedback as we have listened and engaged with individuals like you, across the diabetes community, to understand what is important to your diabetes management. We recognize that collaboration with Tidepool is a way to drive further industry innovation, and that by supporting interoperability we can offer new solutions that help individuals with diabetes achieve better health or improve quality of life.
We also want to reiterate that patient safety is our first priority. As we work to make this technology available, we will continue to ensure that our integrated sensor-augmented pump systems undergo rigorous clinical, quality, manufacturing, and regulatory controls to ensure they are safe and effective. The new Medtronic partnership with Tidepool will help bring community-driven innovation safely and with regulatory oversight to more people with diabetes.
The FDA will need to approve or clear both the Tidepool Loop app as well as a future Bluetooth-enabled MiniMed ACE pump that will work with Tidepool Loop before any commercial offering is available. If you would like to stay up to date on progress, please check for published updates at www.tidepool.org/loop.
Read the Tidepool blog post here.
Tags: automated insulin delivery
, blood sugar
, type 1 diabetes