Glytec gets FDA clearance for its insulin management technology

By Jeff Lagasse
03:54 pm

Diabetes therapy management software company Glytec has just secured its fourth FDA clearance, adding a slew of capabilities to its Glucommander product, the core of its eGlycemic Management System.
This latest FDA clearance incorporates some of the product enhancements that have been suggested by the company’s user community, including a titration module designed expressly for inpatients receiving enteral nutrition. Other enhancements include an insulin-to-carb ratio titration option for outpatients, which complements the existing fixed meal bolus option; a more streamlined transition of inpatients from intravenous to subcutaneous therapy; greater flexibility in messaging of a dose adjustment for outpatients; and some interface and workflow tweaks.
The eGlycemic Management System, hosted on the cloud, supports best practices in insulin management across all settings, inpatient and outpatient alike. In today’s healthcare environment, that’s critical to achieving the primary tenets of population health, as well as succeeding with alternative reimbursement models.
“This is a tremendous step forward,” Robby Booth, Glytec’s senior vice president of research and development, told MobiHealthNews. “We already were using the protocol in the outpatient space, but now we have some more options in terms of how messages are communicated to patients. … But you also have to improve the efficiency and the workflow for these healthcare professionals. Their outpatient caseload is just increasing, so we not only want to improve the efficiency, but streamline the workflow.”
By Glytec’s estimation, some 40 percent of all hospitalized patients requiring insulin therapy during their stay, and several million Americans require it for chronic care -- which means the consequences of mismanagement carry exceptionally high personal and societal costs. Insulin mismanagement can lead to increased rates of hypoglycemia, hyperglycemia, adverse drug events and mortality; prolonged lengths of stay; unnecessary admissions, readmissions and ED visits; and elevated A1C levels.
The Glucommander consists of complex proprietary algorithms that aid clinicians in the delivery of intravenous and subcutaneous insulins, for adults and children alike. It also can help steer the transition between different therapies and care settings. It’s equipped to support all varieties of insulin, including long-acting basal preparations, NPH (intermediate-acting), rapid-acting analogues, and regular insulin.
All of the dosing recommendations provided by Glucommander are personalized for each patient, and they’re adjusted over time based on glucose measurements and other variables. It’s also able to perform titration for outpatients, whether they’re prescribed a basal insulin regimen or a basal bolus insulin regimen.
Booth said Glytec has come a long way since it was founded in 2006.

“We’ve continued to innovate and respond to the needs of our clients,” he said. “Now, with diabetes reaching epidemic levels and costs spiraling out of control, not only is demand for Glucommander and the whole of our eGMS growing exponentially, providers are asking us to continue expanding our digital solutions portfolio and assist them in conquering the challenges of managing non-insulin therapies.”

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