The US Food and Drug Administration (FDA) has granted breakthrough device designation to Glytec’s proposed insulin dosing recommendation algorithm, Glucommander Pediatrics, for hospitalised newborns and infants under two years old.
The algorithm is intended for neonates and infants requiring continuous intravenous insulin infusion for irreversibly debilitating or life-threatening conditions.
These include diabetic ketoacidosis, hyperglycaemic hyperosmolar state, persistent hyperglycaemia, and hyperglycaemia of prematurity among critically ill patients receiving intensive care.