Tidepool Loop Gets FDA Clearance! Here Are Plenty of Reasons to Be Excited!

Tidepool FDA Approved

We live in a world where diabetes technology is expanding. Revolutionary advances in diabetes care are changing how we manage our health. We’ve gone from early clinical studies testing continuous glucose monitoring (CGM) devices to now having CGM data available on a smartwatch. So, it’s no surprise that when we hear about a new product, we have plenty of reasons to be excited! On January 24, 2023, the FDA gave the green light to a new automated insulin dosing application. Enter: Tidepool Loop.

A Quick Overview of Hybrid Closed-Loop Systems

For those who are not familiar with hybrid closed-loop systems, here’s a quick overview:

A Hybrid Closed-Loop (HCL) system involves communication between your insulin pump and your continuous glucose monitoring (CGM) device. The HCL system automatically increases basal insulin when your glucose levels are rising, and it reduces and/or stops insulin automatically when levels are decreasing or reaching a low blood sugar alert. The basal rate modulates 24/7 to improve your time in range (between 70-180 mg/dL for most people).

Although basal rates change throughout the day, you still have to enter carbs when you eat, hence the name “hybrid”. The term “closed-loop” usually refers to insulin delivered automatically throughout the day and overnight with the user not having to enter carbs.

The factors that go into automatic insulin delivery (AID) include your predicted glucose level, insulin on board, carbs consumed, duration of insulin action, and insulin sensitivity.

Several insulin pumps on the market such as Tandem, Omnipod, and Medtronic are hybrid closed-loop systems and utilize information provided by a Dexcom or Medtronic Guardian CGM. Each of these pump companies has developed their own proprietary AID (automatic insulin delivery) algorithm in a similar manner to Do It Yourself  or DIY Looping, not to be confused with Tidepool Loop. However, the main difference is the algorithm incorporated with each system. So what makes Tidepool Loop different from other closed-loop systems? That’s what we’re here to share with you.

The Exciting News!

The idea for the Tidepool Loop app was driven by collaborations with patients with type 1 diabetes, along with other organizations. Their project: an open-source, automated insulin delivery app compatible with your insulin pump and CGM.

Although there is another application called DIY Loop that is used for DIY Looping, Tidepool Loop is the first to receive FDA clearance. It’s also the first of its kind that allows for insulin delivery from a compatible Apple Watch.

The Tidepool Loop app will be available on Apple products and is intended for people with type 1 diabetes over the age of six. Good news for parents of young children with type 1 who would like to utilize this technology.

Tidepool Loop has the capability to connect to your insulin pumps and CGMs via Bluetooth. It will run an algorithm every five minutes and adjust your basal rate based on the predicted glucose level in the next 30-60 minutes to help reduce and/or avoid high and low blood glucose levels. Tidepool Loop can integrate all of your data and devices, and it monitors your devices in one place.

Build Your Own Hybrid Closed-Loop “Artificial Pancreas” System

From your iPhone or Apple Watch, Tidepool Loop’s algorithm will automatically increase, decrease, or suspend your basal insulin based on your CGM results from a compatible device. It can even recommend corrections based on your CGM predictions.

Essentially, a compatible CGM device will connect to Tidepool Loop. Through the app’s algorithm, it will send the information regarding your modulating basal rate to a compatible insulin pump. This app will replace the algorithm used in your current hybrid-closed loop system. Although there is no official announcement from Tidepool regarding which insulin pumps and CGM devices are available for integration with the app, the folks at Tidepool Loop have stated that it will allow for flexibility for users who have a preferred insulin pump and CGM.

As mentioned earlier, the app will be made available on Apple devices first, followed by Android.

We are very excited to share this news with you and hope you have the opportunity to try this technology out for yourself when it becomes available.








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