Glytec Receives FDA Breakthrough Device Designation for Glucommander Pediatrics, an Insulin Management Technology for Hospitalized Newborns and Infants

The designation covers hospitalized newborns and infants from birth to less than 2 years of age, a population for which no insulin dosing recommendation software has been FDA-cleared.

ATLANTA, Sept. 24, 2026 /PRNewswire/ -- Glytec, the healthcare technology company behind the FDA-cleared Glucommander, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for Glucommander Pediatrics, a proposed insulin dosing recommendation algorithm for hospitalized neonates and infants from birth to less than two years of age.

"Glucose values are among the most frequently collected measures in hospitalized 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 twenty years making insulin dosing safer for hospitalized patients, and the smallest patients have been last in line the entire time," said Patrick Cua, CEO of Glytec.

Why it matters for hospitals and care teams

Hyperglycemia is common in critically ill newborns and premature infants, and it is associated with poor outcomes in this population. Continuous intravenous insulin infusion is the standard of care. Insulin is a high-alert medication in every hospital setting, and the margin narrows as patient weight falls. In adult intensive care, technology-enabled insulin titration protocols have been shown to improve glucose control and reduce hypoglycemia compared with manual, paper protocols. The vision for Glucommander Pediatrics is that one day technology-enabled insulin titration protocols will be available for infants under the age of two.

Glucommander Pediatrics would expand Glucommander's technology into the NICU and PICU. Glucommander Pediatrics will be a separate, prescription-only product intended for hospitalized neonates and infants who require continuous IV insulin infusion for life-threatening or irreversibly debilitating conditions, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hyperglycemia of prematurity, and persistent hyperglycemia in critically ill patients receiving intensive care.

What the designation means

FDA's Breakthrough Devices Program is intended to give patients and clinicians more timely access to technologies that may offer more effective treatment for life-threatening or irreversibly debilitating conditions.

About Glytec

Glucommander has been FDA-cleared since 2006. Glytec serves more than 400 hospitals and health systems. Glucommander is available by prescription only.

Glucommander Pediatrics designation builds on twenty years of continuous innovation. Since Glucommander's first FDA clearance in 2006, Glytec has expanded its capabilities through multiple successive clearances, spanning both intravenous and subcutaneous insulin dosing and extending into pediatric patients ages 2 to 17 beginning in 2012.

Visit glytec.com or follow Glytec on LinkedIn.

Media Contact:

Glytec Public Relations
[email protected]

SOURCE Glytec, LLC