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Greenville-based Glytec LLC received approval from the Federal Drug Administration to offer its insulin-dosing software for use in pediatric patients ages 2 to 17. It already was the first insulin-dosing software cleared for intravenous use with adults.
Staff Report
Published May 23, 2012
Greenville-based Glytec LLC received approval from the Federal Drug Administration to offer its insulin-dosing software, Glucommander, for use in pediatric patients ages 2 to 17.
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Founded in 2006, Glytec offers real-time glycemic management systems for individualized dosage recommendations of insulin, glucose and saline, considering patient information such as demographics, lab results and risk factors. The systems can be installed locally or operated remotely across the Internet.
Hypoglycemia, hyperglycemia, and, in particular, increased glucose variability are prevalent with pediatric intensive care patients and those children suffering with diabetes, the company said. Children pose unique treatment challenges related to medications, dietary control, meal planning and physical activity, all of which necessitate effective glycemic control.
"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,” said Glytec President and CEO Trefor Thomas.
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