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.
The prescription-only product would be separate from Glytec’s existing Glucommander technology. It would extend the company’s technology into neonatal intensive care units and paediatric intensive care units.
Hyperglycaemia is described as common among critically ill newborns and premature infants and is associated with poor results in this patient group. Continuous intravenous insulin infusion is the standard of care.
Glytec CEO Patrick Cua said: “Glucose values are among the most frequently collected measures in hospitalised patients, recorded across nearly every unit and service line.
“Care for newborns and infants sits at the far end of that problem, where the physiology is least stable, and the available tools are fewest.
“We have spent 20 years making insulin dosing safer for hospitalised patients, and the smallest patients have been last in line the entire time.”
Glytec said technology-enabled insulin titration protocols used in adult intensive care have improved glucose control and reduced hypoglycaemia compared with manual paper-based protocols.
The company envisages similar technology eventually becoming available for patients under two years old.
The FDA’s breakthrough devices programme is designed to support more timely access for patients and clinicians to technologies that may offer more effective treatment for life-threatening or irreversibly debilitating conditions.
Glucommander has held FDA clearance since 2006.
Since the original clearance, the company has received further clearances covering intravenous and subcutaneous insulin dosing. Glytec’s paediatric capabilities were extended in 2012 to patients aged two to 17.
Glytec serves over 400 hospitals and health systems.
