This transcript has been edited for clarity.
Tidepool Loop was recently FDA approved, and I think this is a great milestone for people dealing with diabetes. I'm going to explain what this means. It allows patients to have more choice in managing their own disease.
A long while ago, parents were impatient to improve outcomes for their children with type 1 diabetes, and they began the do-it-yourself movement, where they took the tools we had available at the time — sensors, pumps, and eventually, control algorithms — and created systems that they used to manage their children. Now, these do-it-yourself systems are in use in many individuals who have type 1 diabetes.
These systems are not FDA approved and therefore have an element of complexity. People have to build the app on their phones, and they have to monitor updates and changes to their phones. Because they're not FDA approved, we don't have the same guidebook for it. Practitioners can't prescribe it, and the use of these systems really depends on Facebook groups and connections with other people who use do-it-yourself systems.
They created what is called Tidepool Loop. This takes the algorithm that was made by these do-it-yourselfers and turns it into an app that people can obtain from the Apple Store, for instance, and use with their hybrid closed-loop system.
The FDA has been working to make it easier for people with diabetes to interconnect their pieces. In my practice, I have people who like one sensor and not another, one pump and not another, or one system and not another. Yet, it's hard to pick and choose.
There are now three types of pieces with FDA approval integral to making hybrid closed-loop technology systems work. The first piece was iCGM, which means integrated continuous glucose monitor. This is a CGM that meets the FDA's criteria for accuracy and safety when it comes to dosing insulin. This type of CGM has already been approved and can be used in these new systems.
We also have the alternate controller-enabled pump. This is a pump designed to work safely with more than one type of algorithm that adjusts insulin. This pump can work with an algorithm that's approved and it can work with a CGM that's approved.
Now, we have iAGC, which is new to me, but it means interoperable automated glycemic controller. This is an algorithm designed to communicate with other compatible diabetes device components in these systems.
The approval of Tidepool Loop is so important because it basically completes what we need. We now have all three pieces that can talk to each other, and in theory, patients are going to be able to mix and match. They're going to be able to say, I want this algorithm with this pump and this sensor.
We're ways away from all of this happening in real time. The first thing we need to know is when and how we can get Tidepool Loop and which other components it will talk to. It's a huge first step in the process of allowing patients to choose which pieces they want and how they want to manage their diabetes. We'll all learn together what Tidepool Loop means to our patients, how it will change things for our patients, and who will want to use it.
I think it's important to recognize this as something that's going to be a real step for our patients and for providers, many of whom were reluctant to use non–FDA-approved algorithms. It will hopefully allow us to help our patients manage their diabetes more effectively.
Thank you so much to Tidepool and Howard Look for pushing hard to make this happen.
Thank you.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
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Cite this: Tidepool Loop Approval Gives More Choice in Managing T1D - Medscape - Feb 15, 2023.
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