Fourth FDA clearance announced for diabetes therapy management software
Glytec has received the fourth US Food and Drug Administration (FDA) 510(k) clearance for its eGlycemic Management System, featuring Glucommander, which is software for the management of diabetes therapy.
This fourth clearance incorporates several product enhancements that were driven by user feedback. These improvements include a titration module designed expressly for inpatients receiving enteral nutrition, more streamlined transition of inpatients from intravenous to subcutaneous therapy, more robust workflow capabilities as well as multiple user interface improvements.
The company’s management software is cloud-based and supports best practices in insulin management across all settings. The eGlycemic Management System enables providers to standardise care and stage interventions wherever patients may be — in or out of the hospital.
Glucommander consists of complex proprietary algorithms that assist in the delivery of intravenous and subcutaneous insulin for adult and paediatric patients. It also provides guidance for transitions between therapies and between care settings. All dosing recommendations are personalised to the patient and adjusted over time based on glucose measurements and other variables. Furthermore, Glucommander is able to perform titration for outpatients whether they’re prescribed a basal insulin regimen or a basal bolus insulin regimen.
“We’ve come a long way since we first went to market in 2006 with our Glucommander IV solution,” explained Robby Booth, senior vice president Research & Development for Glytec. “We’ve continued to innovate and respond to the needs of our clients.”
“We have fundamentally built a technology category from the ground up, and this latest FDA clearance demonstrates our steadfast commitment to continuous innovation,” added Bob Leonard, president & CEO of Glytec. “Glytec offers providers and payers the opportunity to uniquely address a significant unmet need as they look to create more proactive, population-based and personalized approaches to diabetes care.”