*Disclaimer: All content and information in this blog is for informational and educational purposes only. This article was medically reviewed and written by Amanda Ciprich, MS, RD. Last updated on 03/25/2024.
The diabetes community is one step closer to having access to Tidepool Loop. On March 18th, 2024, it was announced that Sequal's twiist Automated Insulin Delivery System powered by Tidepool Loop had received 510(k) clearance from the U.S Food and Drug Administration (FDA).
People with type 1 diabetes are one step closer having an automated insulin delivery device system with a high degree of customization. Continue reading to find out what Tidepool Loop is and what features you can expect to see.
What is Tidepool?
Tidepool is a non-profit organization with a mission to make diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. The organization currently offers an interoperable data visualization platform for people with diabetes and their care teams. Tidepool Loop was inspired by the #WeAreNotWaiting movement, which sought faster access to technology to help manage diabetes without relying on the often costly and inaccessible healthcare system. The group of individuals with diabetes have become leading innovators in the healthcare industry by offering innovative and effective solutions to address the limitations of modern automated insulin technology.
How is Tidepool Loop different from other insulin pumps?
Tidepool Loop is an innovative automated insulin delivery application that offers users some new novel features for insulin dosage management. This application works in conjunction with an insulin pump and continuous glucose monitor (CGM) to deliver insulin as needed with highly customizable features. Unlike other automated insulin pumps such as the Tandem t:slim X2, Omnipod 5, and Medtronic 780g, Tidepool Loop offers greater customization options, as the algorithm is housed as a standalone application rather than in the pump itself, in a separate application.
What are the glucose targets with Tidepool Loop?
Tidepool Loop has received FDA clearance for blood glucose targets ranging from 87 mg/dL to 180 mg/dL, making it a significant breakthrough in the management of diabetes. With a threshold starting at 87 mg/dL, Loop offers the lowest glucose target available in any commercially available insulin pump on the market.
This news is particularly exciting for pregnant individuals with diabetes, as current automated insulin pumps have targets that exceed the recommended guidelines for pregnancy. Loop offers a much-needed solution for pregnant individuals seeking tighter glucose control.
Tidepool Loop’s Pre-Meal Glucose Target
Tidepool Loop has a pre-meal target option that enables users to indicate that they plan to eat within the next 30 minutes. This feature prompts the algorithm to bring blood glucose levels within the user's programmed pre-meal target range.
This innovative feature is significant because it can lead to lower pre-meal glucose levels to reduce post-meal glycemic variability, providing a more consistent and controlled glucose experience for the individual with diabetes.
Can you Use an Extended Bolus with Tidepool Loop?
Traditional insulin pump therapy offers options such as extended bolus or dual wave bolus to help manage slow-digesting meals and coordinate the digestion of food with its impact on blood sugar levels, avoiding early low blood glucose followed by later high blood glucose.
Tidepool Loop takes this a step further with its innovative bolus calculator feature. It has the ability to mimic an extended bolus with a pizza icon, as well as other food emojis that indicate varying glycemic index or carbohydrate digestion rates. Users can select a lollipop emoji for fast-acting carbs and a 30-minute bolus of insulin, or a taco emoji for snacks and most meals, which triggers a 3-hour bolus. This allows for greater accuracy in matching insulin delivery with the rate of food digestion, keeping blood sugar levels in range.
How do you get access to Tidepool Loop?
It was recently announced a partnership with Sequal's twiist Automated Insulin Delivery System powered by Tidepool Loop. While there isn't an official release date yet, people with type 1 diabetes are one step closer having an automated insulin delivery device system with a high degree of customization. People with diabetes can visit Tidepool Loop's website to stay up to date with the latest announcements.
Summary
The FDA clearance of Tidepool Loop marks a major milestone in the management of diabetes. Although DIY Loop options are available to the public, it requires a certain level of technical understanding to set up the algorithms settings that may intimidate some users.
With FDA clearance, users can feel confident that Tidepool Loop is a safe option and expect greater guidance from their healthcare providers. This clearance is a significant step forward for the diabetes community to further the technology advancements of other automated insulin delivery technology.
Resources:
https://www.tidepool.org/tidepool-loop
https://twiist.com/
About Amanda Ciprich, MS, RD
Amanda Ciprich, a registered dietitian with a specialization in type 1 diabetes, was diagnosed with T1D herself at the age of 18. With her expertise and personal experience, she has authored two books, including "The Caregiver's Guide to Diabetes: Practical Advice for Caring for Your Loved One." As the founder of T1D Nutritionist, a virtual insurance-based private practice, Amanda provides counseling and guidance to individuals with T1D and their families, supporting them in effectively managing diabetes.
