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This week’s FDA clearance of the new Tidepool Loop iPhone app means “looping” could be even simpler and likely far more accessible for people with type 1 diabetes (T1D). Here, we look at this groundbreaking technology and chat with Howard Look, CEO of Tidepool.
Tidepool is a nonprofit organization founded in 2013 by Look — whose daughter was diagnosed with T1D in 2011. First known for its now very successful (and free) blood glucose data management software, Look and his team largely credit the passionate do-it-yourself (DIY) diabetes looping community for the FDA clearance of Tidepool Loop.
Here, Look shares a look at the challenges they faced, and what makes this looping technology so unique.
What is the Tidepool Loop app?
The first of its kind, the Tidepool Loop app is an automated insulin delivery (AID) algorithm that was submitted for FDA review nearly two years ago. The app works by communicating with a compatible insulin pump and continuous glucose monitor (CGM) to adjust insulin doses automatically.
While the user will still manually input some information daily — including meals, physical activity, etc. — the app is constantly adjusting to help the user stay in their target blood glucose ranges as much as possible. The end goal, of course, is to prevent both high and low blood glucose levels as much as possible while decreasing the hour-by-hour burden of insulin and blood glucose management.
While other closed-loop insulin pump technology does already exist, Tidepool Loop is the first-ever app that can be integrated with compatible pumps and CGMs. Also, other closed-loop systems might communicate through an app on your phone, but they do not allow the user to make any dosing adjustments through the app.
Tidepool Loop allows the user to manage both blood glucose readings and insulin doses in one place: an app on your smartphone.
Quick facts about the Tidepool Loop app
- It’s cleared for use in people with type 1 diabetes ages 6 and older.
- There is no official date yet on when it will actually be available.
- It’s available by prescription only, so the process starts with your doctor. You can download the app at any time from the app store, but you’ll need a prescription code to access the functionality.
- The cost of Tidepool Loop has yet to be announced. Look says they will do everything they can to make it as accessible as possible.
- Tidepool continues to offer extensive patient support to help new users get started through a variety of resources.
How did Tidepool get started on the Loop app?
The original do-it-yourself (DIY) looping software was developed by a variety of passionate and brilliant people. It essentially allowed you to hack your non-AID insulin pump and connect it to an app in your smartphone through an intense number of steps. your phone. While the DIY looping community rallied to support newbies, it was cumbersome and complicated.
“In 2018, we took on the DIY looping project when it became really clear how popular this open-source DIY looping was,” explains Look who had one goal in mind: make this interoperable looping technology easily accessible to as many people as possible.
“We adopted the DIY loop source code and brought it into our existing regulatory quality management system,” says Look. With tremendous support from the #wearenotwaiting DIY community, JDRF, and the Jaeb Center for Health Research, Look and his team developed Tidepool Loop.
The first of its kind, what did it take to get FDA clearance?
“We learned a lot about the regulatory process and what the FDA calls a first-time sponsor,” explains Look, because Tidepool Loop is truly the first-ever interoperable AID smartphone app.
“The FDA was great and worked closely with us in the process. One thing we learned is that you never want to submit for FDA clearance in the middle of a pandemic. The agency was just really turned inside out. In 2020, one of our contacts there said they had literally 900 different COVID-19 tests in front of them, all seeking emergency-use authorization.”
“We learned a lot about what it takes to demonstrate safety and efficacy,” explains Look. “We worked so closely with the DIY community who participated in our observational study. The FDA is really embracing real-world evidence, and we have the #wearenotwaiting community to thank for helping us gather that evidence.”
The FDA has intense (and rightly so) standards when it comes to cyber security, assuring future users will be safe from potential hacks into the app.
“The biggest win in this process, though, is the interoperability of Tidepool Loop,” says Look. He and his team are passionately supportive of future looping technology from other companies.
“We think someone with diabetes should get to choose: which pump, which CGM, and which algorithm is right for you.”
The goal, says Look, is to develop relationships with every maker of any pump or CGM to ensure that people with diabetes can choose the Tidepool Loop app no matter what tech they use.
“We have an agreed-upon set of steps with the FDA that we can use for any new CGM or insulin pump, which means we don’t have to submit to the FDA again as long as we follow those steps.”
This also clears the way for future FDA applications for similar technology — something the Tidepool team is especially proud of. Look isn’t worried about future competition. He wants other developers of AID technology to join the effort in making diabetes management simpler and safer.
What can Tidepool Loop offer that other closed-loop algorithms can’t?
- It is the first and only app that allows you to truly manage diabetes from your Apple Watch or Apple iPhone versus simply seeing your blood glucose reading.
- Easy emojis that address meal digestion speed and glycemic index: You’ll see a lollipop (30-minute bolus), a taco (3-hour bolus), or pizza (5-hour bolus). While you still need to enter carb quantities for meal doses, this eliminates the need for complicated dosing using the “square” or “dual-wave” bolus options.
- It offers customizable target ranges with settings as low as 87 mg/dL and as high as 180 mg/dL.
- It offers “single screen glanceability” which means you can easily access everything you need to dose insulin without sorting through multiple screens.
- It offers “pre-meal mode” which allows telling the system you’re about to eat which enables a thoughtful pre-bolus process.
- It allows you to edit a meal entry after the fact — which is critical for parents of small children with T1D who might only eat half their sandwich after dosing for the whole meal.
- It allows you to set a “glucose safety limit” which means you can set the lowest blood glucose level you’d like the system to predict hypoglycemia and suspend insulin.
When is the Android version coming?
“We’re absolutely committed to delivering an Android version,” says Look. “The DIY loop was already written for the iPhone so we started there. As a non-profit, we are committed to the broadest possible access to this technology. Developing the Android version is a substantial development effort.”
Tidepool cannot offer a timeline for the Android version at this time.
What else is the Tidepool team working on?
“Last summer we added Tidepool Plus to our line of products,” says Look of their data management platform designed specifically for health care professionals to manage all their patients’ blood glucose data in one place.
“Our original data management product, Tidepool Web, became really popular during the pandemic, and we got great feedback from clinics asking if we could develop a version that could integrate with systems.”
Tidepool Plus allows clinicians to see all patients in one dashboard. They can then filter based on variables like:
- Pregnant women
- Frequent hypoglycemia
- Time-in-range over X%
“We have 350,000 clinics using Tidepool Plus,” says Look. “Telemedicine has exploded, and these clinics need more efficient ways to interact with their population. They can even use Tidepool Plus to show them all the patients who haven’t uploaded data that month. Then it will send reminders to those patients.”
“Our mission is to make diabetes data more meaningful, actionable, and accessible,” says Look. “With these products, we feel like we’re fulfilling that mission.”
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Tidepool Loop FDA Clearance: Chatting with CEO Howard Look
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