FDA authorizes first wearable to monitor ketones and blood sugar

People with diabetes now have access to a new early‑warning system that detects the onset of serious complications before they become life‑threatening. The system, developed by a collaboration between the University of Michigan’s Diabetes Research Center and wearable‑tech firm BioSense, uses continuous glucose monitoring data combined with machine‑learning algorithms to flag patterns associated with hypoglycemia, diabetic ketoacidosis, and cardiovascular strain.

When the device identifies a concerning trend, it sends an instant alert to the user’s smartphone and to their designated healthcare team. In pilot studies involving 1,200 participants, the system reduced emergency department visits for severe hypoglycemia by 28 % and lowered the incidence of ketoacidosis episodes by 18 %. The technology also logs the alerts for clinicians to review during routine check‑ups, providing a proactive tool for managing long‑term complications.

If adopted widely, this early‑warning platform could transform routine diabetes care by enabling timely interventions and reducing hospitalizations. Health officials are monitoring the results as the system moves toward broader regulatory approval and commercial availability later this year.