FDA Approves Another Advancement in Glycemic Management Software

Glucommander is now approved for various enhancements in its patient service capabilities.

A therapy management software product for diabetes patients has received its fourth US Food and Drug Administration (FDA) approval, furthering its capabilities in medical treatment optimization.

The product, Glucommander — Glytec System’s core of its eGlycemic Management System (eGMS) — has been approved for various enhancements in its patient service capabilities. The FDA green-lit a titration module designed for enteral nutrition, an insulin-to-carb ratio titration option for outpatients, and a streamlined transition capability for inpatients moving from intravenous to subcutaneous therapy.

Further enhancements include a multiple user interface improvement, an advancement of workflow performance, and more flexibility for healthcare professionals messaging outpatients regarding dose adjustments.

The cloud-hosted eGMS provides insulin management to both inpatients and outpatients, providing a supplemental form of care for the 40% of hospitalized patients requiring insulin therapy and the several million US patients requiring chronic insulin care, according to Glytec.

It additionally addresses the issue of insulin mismanagement frequently reported in patients, which could lead to adverse effects such as hypo- and hyperglycemia, hospitalization, and even death.

Glucommander is an amalgamation of proprietary algorithms that helps clinicians deliver intravenous and subcutaneous insulin for both adult and pediatric patients. Because of its capability to support all insulin varieties and personalize individual patient care, its new enhancements to titration options only makes it a more streamlined option for diabetes care.

According to Glytec, the absence of its solution in diabetes care leads to as many as 60% of chronic care patients presecribbed insulin experiencing hypoglycemia, and, greater than 50% of type 2 diabetes patients discontinuing therapy against a physician’s order.

Robby Booth, Senior Vice President Research & Development for Glytec, said the company's come a long way since first debuting Glucommander to the market in 2006.

"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," Booth said.

Moving towards the company's goal of optimizing all diabetes medication, Booth said Glytec is "well down the road" in developing a Therapy Advisor product.

Glytec president and chief executive officer Bob Leonard said their products have been shown to save chronic insulin patients up to $2,470 in care costs. The fourth and most recent FDA approval demonstrates the company's "steadfast commitment to continuous innovation," Leonard said.

"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," Leonard said.

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