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Exciting news reached the diabetes community in late January when Tidepool Loop received FDA clearance. This is the first time a community led initiative has received clearance from the FDA, and it is generating a lot of excitement in the diabetes community. Get ready 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 770g, Tidepool Loop offers greater customization options, as the algorithm is housed in a standalone application rather than in the pump itself, in a separate application.
What are the blood 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 low threshold of 87 mg/dL, Loop offers the tightest glucose control 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 pre-meal target range. This innovative feature is significant because it can lead to lower pre-meal blood sugars, which can help 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 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?
To get started with DIY Loop, individuals can visit the website to begin creating their own setup. However, to use the FDA-cleared Tidepool Loop app, a prescription is required. The availability of the FDA cleared Tidepool Loop has not been officially announced nor which devices will be compatible, and its public release date is currently unknown.
What is the Significance of Tidepool Loop FDA Clearance?
The FDA clearance of Tidepool Loop marks a major milestone in the management of diabetes. Although DIY Loop is 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.