Tidepool Loop, the DIY Closed-Loop Insulin System, Just Won FDA Approval

Tidepool — a nonprofit long instrumental in the type 1 diabetes “looping” movement — has been granted FDA approval for its automated insulin dosing app Tidepool Loop. It could be a huge step towards mainstream acceptance for the diabetes looping movement, which began as a tiny group of patients eager to tinker with their diabetes devices.

Tidepool Loop is an app that coordinates between an insulin pump and a continuous glucose monitor (CGM). The system takes blood sugar measurements from the CGM and automatically instructs the insulin pump to deliver precise amounts of insulin to keep blood sugar within a desired range. Many people with diabetes find that automated insulin delivery significantly reduces diabetes stress, and many others have used it to achieve their best-ever glucose numbers.

Several years ago, a DIY system like Tidepool Loop was the only way for people with type 1 diabetes to enjoy automated insulin delivery. The diabetes tech firms caught up, and several closed-loop systems are now commercially available. Tidepool Loop is unique, though, because it wasn’t built by any one diabetes device manufacturer, and it therefore may eventually be compatible with multiple insulin pumps and CGMs. It should mean more closed-loop options, which should be great news for the diabetes patient community.

Tidepool’s insulin-dosing algorithm may also be more detailed and flexible than the systems currently available off-the-shelf from competitors like Omnipod and Medtronic. Although the nonprofit didn’t provide many details at first, we’re aware of a couple of headline features:

The Tidepool Loop app will be the first looping program to enable insulin delivery from an Apple Watch.
Users may be able to set blood sugar targets as low as 87 mg/dL — significantly closer to normal blood sugar levels than the targets allowed by other automated dosing algorithms on the market today.

The Tidepool Loop app was originally designed by a community of “loopers,” citizen-scientists and hackers with type 1 diabetes. The movement uses the hashtag #wearenotwaiting as a rallying cry; looping advocates have vowed to create homemade technological solutions for type 1 diabetes, rather than sit around and wait for tech companies and federal regulators to get there.

These patient-designed programs were the first closed-loop systems available for people with diabetes outside the confines of a controlled trial. And while the diabetes technology firms have been catching up in recent years, open-source advocates still prefer their homemade tech.

Today, only a few automated insulin delivery systems have been approved in the United States. Omnipod and Medtronic, for example, have proprietary apps that can only be used with their insulin pumps. But Tidepool Loop is not associated with any one insulin pump manufacturer. Today’s “loopers” prefer older, more hackable pumps, but the new FDA approval will allow Tidepool to make agreements with manufacturers of new insulin pumps eager to turn their devices into elements of a closed-loop system.

The approval came on the heels of another major vindication for the looping movement. Last autumn, the New England Journal of Medicine published a study showing that a competing open-source looping app increased time-in-range in both children and adults with type 1 diabetes.

Tidepool has not yet announced any partnerships with manufacturers of insulin pumps or CGMs, though it does have a development partnership with Dexcom. We’ll have to wait and see what comes next.

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