Glytec Announces Fourth FDA 510(k) Clearance for Its Market-Leading Diabetes Therapy Management Software

Glytec Announces Fourth FDA 510(k) Clearance for Its Market-Leading Diabetes Therapy Management Software

The company’s eGlycemic Management System® featuring Glucommander™ has the broadest indications for use of any decision support solution for insulin titration.

WALTHAM, MA, August 16, 2017 – The pioneer of diabetes therapy management software, Glytec announces its fourth FDA clearance, adding a broad array of capabilities to Glucommander™, the core of its patented eGlycemic Management System®. As the first company to receive FDA clearance for an insulin titration decision support solution -- a milestone that occurred in 2006, the year it was founded -- Glytec continues to lead this critically important and evolving category of technology-enabled medication optimization.

This latest FDA clearance incorporates many highly anticipated product enhancements driven by feedback from the company’s significant user community. Among them:

  • a titration module designed expressly for inpatients receiving enteral nutrition
  • an insulin-to-carb ratio titration option for outpatients that complements the existing fixed meal bolus option
  • more streamlined transition of inpatients from intravenous to subcutaneous therapy
  • multiple user interface improvements
  • more robust workflow capabilities
  • greater flexibility in messaging of a dose adjustment for outpatients

Glytec’s comprehensive, cloud-hosted eGlycemic Management System® is the only solution that supports best practices in insulin management across all settings, inpatient and outpatient alike, which in today’s healthcare environment is critical to achieving the primary tenets of population health and succeeding with alternative reimbursement models.

With some 40% of all hospitalized patients requiring insulin therapy during their stay and several million Americans requiring it for chronic care, the consequences of mismanagement carry exceptionally high personal and societal costs. An abundance of evidence links insulin mismanagement 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. Not surprisingly, in the absence of Glytec’s solution, as many as 60% of patients prescribed insulin for chronic care experience hypoglycemia and among those with type 2 diabetes, greater than 50% discontinue therapy against a physician’s order.

eGMS® enables providers to standardize care and stage more efficient and effective interventions wherever patients may be, in or out of the hospital. The safety, efficacy and financial benefits of eGMS®, for both acute and chronic care, have been validated in more than 60 research studies over the course of the past 10 years.

The FDA-cleared Glucommander™ consists of complex proprietary algorithms that aid clinicians in the delivery of intravenous and subcutaneous insulin for adult and pediatric patients. It also provides guidance for transitions between therapies and between care settings. Glucommander™ is uniquely equipped to support all varieties of insulin, including long-acting basal preparations, NPH (intermediate-acting), rapid-acting analogues and regular insulin. All dosing recommendations provided by Glucommander™ are personalized to the individual patient and adjusted over time based on glucose measurements and other variables, a distinct advantage over one-dimensional insulin dosing calculators. Additionally, 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,” says Robby Booth, Senior Vice President Research & Development for Glytec. “We’ve continued to innovate and respond to the needs of our clients. Now, with diabetes reaching epidemic levels and costs spiraling out of control [one of every three Medicare dollars is spent on diabetes care], 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. We are well down the road in the development of our Therapy Advisor® and fulfillment of our vision to become the medication optimization company for all diabetes medications.”

Bob Leonard, President & CEO of Glytec, echoes Booth’s sentiments, and adds: “We have fundamentally built a technology category from the ground up, and this latest FDA clearance demonstrates our steadfast commitment to continuous innovation. Glytec’s platform provides substantive value to healthcare organizations and their patients, markedly improving safety while producing annualized savings as high as $20,000 per licensed bed1 in the acute care setting and $2,470 per patient2 from a chronic care perspective. 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.”

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1 ADA Scientific Sessions 2017; Safely Converting From Sliding Scale to Basal Bolus Insulin Across an Entire Medical Center via Implementation of the eGlycemic Management System.
2 JAMA 2001;285:182-9, Effect of Improved Glycemic Control on Health Care Costs and Utilization.

About Glytec

Founded in 2006, Glytec is the pioneer and leader in therapy management software for diabetes medication optimization, enabling healthcare organizations to achieve best practices for glucose control. The company’s comprehensive eGlycemic Management System® (eGMS®) has been proven to dramatically reduce the drivers of cost and clinical variation, including hypoglycemia and hyperglycemia; A1C levels; adverse drug events; mortality; length of stay; unnecessary admissions, readmissions and ED visits; and patient discontinuation of insulin therapy. eGMS® centers on an FDA-cleared insulin dosing solution that supports personalized intravenous and subcutaneous therapy for adult and pediatric populations. Its efficacy and safety have been validated by more than 60 research studies. eGMS® integrates seamlessly with EMR and connected device systems for streamlined use across the entire continuum of care, including at-home, provider-directed care managed through telehealth, population health and other value-based programs. The company’s cloud-hosted software-as-a-service (SaaS) delivery model allows for rapid implementation and anytime, anywhere access. Glytec has offices in Waltham, Massachusetts and Greenville, South Carolina. For more information, visit www.glytecsystems.com.

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