On June 17, 2024, the European Medicines Agency (EMA) granted approval for the continent’s first fully automated insulin dosing mobile application, marking a transformative step in diabetes management. The app, designed for individuals with type 1 and insulin-dependent type 2 diabetes, leverages real-time glucose monitoring data to calculate and recommend precise insulin dosages, reducing the risk of hypo- and hyperglycemic episodes.

This innovation integrates with continuous glucose monitors and smart insulin pens, creating a closed feedback loop that delivers dosing suggestions directly to patients and their healthcare teams. Clinicians can remotely access adherence and trend data, enabling proactive adjustments and more personalized care plans. Early clinical trials, as reported by the EMA, demonstrated notable improvements in glycemic control and patient satisfaction.

Healthcare professionals across Europe are optimistic that such digital therapeutics will ease the burden of diabetes self-management, foster adherence, and potentially reduce long-term complications. As this pioneering app becomes available, it sets a precedent for the integration of AI-driven tools in chronic disease care.