Welcome to the Loop Observational Study

What is the Loop Observational study?

The study is being done in collaboration with Loop developers to collect information from adults and children with type 1 diabetes using Loop. It is being paid for by the Helmsley Charitable Trust. The purpose of the study is to collect information from at least 300 – 1,250 adults and children with T1D using Loop in the United States. This information will be used to learn more about how well Loop works, what problems users have, how often severe hypoglycemia and diabetic ketoacidosis occur, and how well the system controls blood sugar levels.

Who can participate?

We are only accepting new Loop users who are 18 or younger at this time. You may participate if you currently have a RileyLink and are planning to use the do-it-yourself Loop automated insulin delivery system or have been using Loop for <7 days.

You will not be able to complete the enrollment process unless you are a new Loop user and are 18 years old or younger.


What will I have to do as a participant?

On the next page you will be able to review the consent form which has specific details about what you will be asked to do. Start by entering in your email address at the top of the page. We will NOT save this email address unless you submit the consent form agreeing to participate. Entering your email address helps us to search our system to confirm where you are in the startup process.


What happens after I submit the consent form?

There are a few additional steps you will have to do before you complete your first surveys. After completing the consent form, you will be directed to provide some basic contact information. Specifics about how this information is used is included in the consent form.

Once you’ve entered your contact information, we will ask you to confirm your Tidepool account email address. This Tidepool account will share your Loop and CGM data with us. We do provide links to instructions on how to share your Tidepool data with the Loop Study and ensure all of your applications are connected to Apple Health correctly.

Finally, you’ll be able to access your first set of surveys.



Next Step

Please read and review the consent form on the next page for additional information about the study and what you will do as a participant if you choose to participate.

If you have completed all the steps above, you may visit the Study Home page.