Glytec receives FDA clearance for Glucommander 2.0 Enterprise software

Glytec, LLC, headquartered in Greenville, SC, announced today that its Glucommander™ 2.0 Enterprise software has been cleared by the FDA for pediatric use, ages 2 - 17. Glytec's Glucommander was the first insulin dosing software to be cleared for adult (ages 18+) intravenous use; it is the only company to achieve specific clearance for subcutaneous use, and now it is the only company cleared to offer this technology to hospitals caring for children.

Hypoglycemia, hyperglycemia, and, in particular, increased glucose variability are prevalent with pediatric intensive care patients and those children suffering with diabetes in general, all of which are issues associated with increased length of stay and mortality rates. Children pose unique treatment challenges related to medications, dietary control, meal planning and physical activity, all of which necessitate effective glycemic control.

Commenting on the announcement, Trefor Thomas, CEO & President of Glytec, said, "We're very pleased that the FDA has cleared our system for use with all children as young as two, and we expect to see substantial improvement in their outcomes, similar to what adult patients have been experiencing with our system for years."

Glytec's clinician-developed, algorithm-based insulin-dosing software is a network based application designed to consider each patient's insulin sensitivity to safely stabilize excursions while achieving and maintaining glucose levels within a clinician defined target range, allowing patients to achieve safe normoglycemia. This can translate to reductions in length of stay, infection rates, readmission rates, comorbidity, and even mortality.

Thomas added, "This latest advance again demonstrates Glytec to be the industry leader in glycemic management. Our organization has worked hard to earn the FDA clearance for an application designed around the unique needs of children, and we are excited to be the first to get clearance for pediatric dosing. We will continue to work on other ways to extend the safety and efficacy of insulin as a way to control elevated blood glucose levels without causing hypoglycemia."