The Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing mobile application for use with compatible devices to help manage type 1 diabetes in patients 6 years of age and older.

The prescription-only device works with integrated continuous glucose monitors (iCGM) and alternate controller enabled pumps, and is the first to enable insulin delivery from a compatible Apple Watch. The app is designed to automate insulin dosing based on iCGM readings and predicted glucose values. It can also recommend and deliver correction insulin amounts, with a user’s confirmation, when glucose values are predicted to exceed predefined thresholds.

The FDA clearance was based on data from an observational study (ClinicaTrials.gov Identifier: NCT03838900) that evaluated the safety and effectiveness of the app in adults and children with type 1 diabetes. Over 6 months of follow-up, findings showed that use of the app was associated with improved time in range.

Tidepool, the nonprofit organization that developed Tidepool Loop, is currently working on finalizing agreements with device partners, including Dexcom.

References

1. Tidepool announces FDA clearance of Tidepool Loop. News release. Accessed January 24, 2023. https://www.businesswire.com/news/home/20230124006085/en/Tidepool-Announces-FDA-Clearance-of-Tidepool-Loop.
2. Lum JW, Bailey RJ, Barnes-Lomen V, et al. A real-world prospective study of the safety and effectiveness of the Loop open source automated insulin delivery system. Published online April 20, 2021. Diabetes Technology & Therapeutics doi:10.1089/dia.2020.0535