Tidepool Loop receives FDA clearance
Tidepool Loop is the first fully interoperable automated insulin dosing app, cleared by the FDA, that originated as a patient-led initiative.
Discretion on your wrist. It’s about time.
First automated insulin dosing app with Apple Watch compatibility
Born from the #WeAreNotWaiting community of innovators, Tidepool Loop is the first automated insulin dosing app cleared to enable control from a compatible Apple Watch.
Tidepool Loop is more than an app.
With Tidepool Loop, we are reimagining how people with diabetes can get started with automated insulin dosing, how to ask for help when needed, and how to fit control, discretion, and flexibility into your patient’s diabetes management.
Tidepool Loop is an app designed to automate your insulin dosing, intended for the management of type 1 diabetes in people with diabetes six years of age or older.
The first fully interoperable automated insulin dosing system
What if there was a world where anyone with diabetes and a smartphone might access the latest innovations coming from medtech, with the flexibility to choose the components to reduce their diabetes burden in the most meaningful way to them? That’s the promise of interoperability.
The US FDA has created new pathways for components (and the companies that make them) to work together so that users and prescribers might one day have more choices in the systems they use. They’ve determined three types of components and a regulatory pathway for each:
ACE Pump
"alternate controller-enabled pump"
What that means: the pump is designed to work safely with more than one type of controller or algorithm that adjusts insulin.
iAGC
“interoperable automated glycemic controller”
What that means: The algorithm (computing logic) has been designed to communicate with other compatible diabetes device components in a modular system.
This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.
iCGM
“integrated continuous glucose monitor”
What that means: the CGM system meets FDA’s criteria for accuracy and safety for dosing insulin.
Things you should know
Where is the press release?
You can read our official press release here!
What is Tidepool Loop?
Tidepool Loop is an app designed to automate your insulin dosing, intended for the management of type 1 diabetes in people with diabetes six years of age or older.
What are the blood glucose targets with Tidepool Loop?
Tidepool Loop will allow you to choose a glucose value or range that you want Tidepool Loop to work to bring your glucose to. Your Correction Range can be set as low as 87 mg/dL and it can be set as high as 180 mg/dL.
Is Tidepool Loop a good fit for kids?
Tidepool Loop is currently cleared for use for people with diabetes 6 years and older. Determining the right treatment method is a conversation best initiated with your child’s care team.
Where can I download and use Tidepool Loop on my phone?
Since receiving FDA clearance for Tidepool Loop, our team has been focused on finalizing the commercialization plans necessary with our device partners to support this interoperable system. Please fill out this form to be among to first to learn when Tidepool Loop will be available.
What insulin pump and CGM will Tidepool Loop work with?
We will have more to say about specific device compatibility as we work with our existing device partners on commercial launch timing. We look forward to sharing more updates soon!
Want to be in the loop?
Please fill out the Tidepool Loop interest form if you’d like to get updates on Tidepool Loop as there’s news to share.
©2024 Tidepool. Tidepool Loop is not currently available for use.
