FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes
The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
The FDA recently cleared for marketing a prescription-only mobile application for automated insulin dosing in certain patients with type 1 diabetes.
The Tidepool Loop is intended for single-patient use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older, the FDA announced on Jan. 24. The app works with integrated continuous glucose monitors (CGMs) and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values.
The app can also recommend and, with the user's confirmation, control the delivery of correction insulin amounts when glucose values are predicted to exceed user-configurable thresholds. The algorithm technology is designed to be compatible with other individual interoperable devices that meet prespecified acceptance criteria.